Back Pain: Malmivaara A

van Tulder M, Becker A, Bekkering T, Breen A, del Real MT, Hutchinson A, Koes B, Laerum E, Malmivaara A, Anonymous00002. · No affiliation provided · Eur Spine J. · Pubmed #16550447 No free full text.

This publication has no abstract.

Guzmán J, Esmail R, Karjalainen K, Malmivaara A, Irvin E, Bombardier C. · Institute for Work & Health, 481 University Avenue, Suite 800, Toronto, Ontario, Canada, M5G 2E9. · Cochrane Database Syst Rev. · Pubmed #17636646 No free full text.

Abstract: BACKGROUND: Chronic low back pain is, in many countries, the main cause of long term disability in middle age. Patients with chronic low back pain are often referred for multidisciplinary treatment. Previous published systematic reviews on this topic included no randomised controlled trials and pooled together controlled and non-controlled studies. OBJECTIVES: To assess the effect of multidisciplinary bio-psycho-social rehabilitation on pain, function, employment, quality of life and global assessment outcomes in subjects with chronic disabling low back pain. SEARCH STRATEGY: We searched MEDLINE, EMBASE, PsychLIT, CINAHL, Health STAR, and The Cochrane Library from the beginning of the database to June 1998 using the comprehensive search strategy recommended by the Back Review Group of the Cochrane Collaboration. Intervention specific key words for this review were: patient care team, patient care management, multidisciplinary, interdisciplinary, multiprofessional, multimodal, pain clinic and functional restoration. We also reviewed reference lists and consulted the editors of the Back Review Group of the Cochrane Collaboration. SELECTION CRITERIA: Design: randomised controlled trials comparing multidisciplinary bio-psycho-social rehabilitation with a non-multidisciplinary control intervention.Population: Adults with disabling low back pain of more than three months in duration.Intervention: Patients had to be assessed and treated by qualified professionals according to a plan that addresses physical and at least one of psychological, or social/occupational dimensions.Outcomes: Only trials which reported treatment effect in at least one of pain, function, employment status, quality of life or global improvement.Exclusion: Pure educational interventions (back schools) and pure physical interventions were excluded. DATA COLLECTION AND ANALYSIS: Selection, data extraction and quality grading of studies was done by two independent authors using pre-tested data forms. Study quality was assessed according to the scheme recommended by the Back Review Group of the Cochrane Collaboration. Trials with internal validity scores of five or more in a ten point scale were considered high quality. Discrepancies between authors were resolved by consensus or by a third author. Given the marked heterogeneity in study settings, interventions and control groups we decided not to pool trial results in a meta-analysis. Instead, we summarized findings by strength of evidence and nature of intervention and control treatments. The evidence was judged to be strong when multiple high quality trials produced generally consistent findings. It was judged to be moderate when multiple low quality or one high quality and one or more low quality trials produced generally consistent findings. Evidence was considered to be limited when only one randomised trial existed or if findings of existing trials were inconsistent. MAIN RESULTS: Ten trials (12 randomised comparisons) were included. They randomised a total of 1964 patients with chronic low back pain. There was strong evidence that intensive multidisciplinary bio-psycho-social rehabilitation with a functional restoration approach improved function when compared with inpatient or outpatient non-multidisciplinary treatments. There was moderate evidence that intensive multidisciplinary bio-psycho-social rehabilitation with a functional restoration approach improved pain when compared with outpatient non-multidisciplinary rehabilitation or usual care. There was contradictory evidence regarding vocational outcomes of intensive multidisciplinary bio-psycho-social intervention. Some trials reported improvements in work readiness, but others showed no significant reduction in sickness leaves. Less intensive outpatient psycho-physical treatments did not improve pain, function or vocational outcomes when compared with non-multidisciplinary outpatient therapy or usual care. Few trials reported effects on quality of life or global assessments. AUTHORS' CONCLUSIONS: The reviewed trials provide evidence that intensive multidisciplinary bio-psycho-social rehabilitation with a functional restoration approach improves pain and function. Less intensive interventions did not show improvements in clinically relevant outcomes.

van Tulder MW, Koes B, Malmivaara A. · Institute for Research in Extramural Medicine, EMGO, VU University Medical Center, van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands. · Eur Spine J. · Pubmed #16320031 No free full text.

Abstract: At present, there is an increasing international trend towards evidence-based health care. The field of low back pain (LBP) research in primary care is an excellent example of evidence-based health care because there is a huge body of evidence from randomized trials. These trials have been summarized in a large number of systematic reviews. This paper summarizes the best available evidence from systematic reviews conducted within the framework of the Cochrane Back Review Group on non-invasive treatments for non-specific LBP. Data were gathered from the latest Cochrane Database of Systematic Reviews 2005, Issue 2. The Cochrane reviews were updated with additional trials, if available. Traditional NSAIDs, muscle relaxants, and advice to stay active are effective for short-term pain relief in acute LBP. Advice to stay active is also effective for long-term improvement of function in acute LBP. In chronic LBP, various interventions are effective for short-term pain relief, i.e. antidepressants, COX2 inhibitors, back schools, progressive relaxation, cognitive-respondent treatment, exercise therapy, and intensive multidisciplinary treatment. Several treatments are also effective for short-term improvement of function in chronic LBP, namely COX2 inhibitors, back schools, progressive relaxation, exercise therapy, and multidisciplinary treatment. There is no evidence that any of these interventions provides long-term effects on pain and function. Also, many trials showed methodological weaknesses, effects are compared to placebo, no treatment or waiting list controls, and effect sizes are small. Future trials should meet current quality standards and have adequate sample size.

van Tulder MW, Koes B, Seitsalo S, Malmivaara A. · Institute for Research in Extramural Medicine, EMGO, VU University Medical Center, van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands. · Eur Spine J. · Pubmed #16320030 No free full text.

Abstract: Within the framework of evidence-based medicine high-quality randomised trials and systematic reviews are considered a necessary prerequisite for progress in orthopaedics. This paper summarises the currently available evidence on surgical and other invasive procedures for low back pain. Results of systematic reviews conducted within the framework of the Cochrane Back Review Group were used. Data were gathered from the latest Cochrane Database of Systematic Reviews 2005, Issue 2. The Cochrane reviews were updated using the evidence summary on surgery and other invasive procedures from the COST B13 European Guidelines for the Management of Acute and Chronic Non-Specific Low Back Pain. Facet joint, epidural, trigger point and sclerosant injections have not clearly been shown to be effective and can consequently not be recommended. There is no scientific evidence on the effectiveness of spinal stenosis surgery. Surgical discectomy may be considered for selected patients with sciatica due to lumbar disc prolapses that fail to resolve with the conservative management. Cognitive intervention Combined with exercises is recommended for chronic low back pain, and fusion surgery may be considered only in carefully selected patients after active rehabilitation programmes during 2 years time have failed. Demanding surgical fusion techniques are not better than the traditional posterolateral fusion without internal fixation.

Hayden JA, van Tulder MW, Malmivaara A, Koes BW. · Institute for Work & Health, 481 University Avenue, Suite 800, Toronto, Ontario, Canada, M5G 2E9. · Cochrane Database Syst Rev. · Pubmed #16034851 No free full text.

Abstract: BACKGROUND: Exercise therapy is widely used as an intervention in low-back pain. OBJECTIVES: To evaluate the effectiveness of exercise therapy in adult non-specific acute, subacute and chronic low-back pain versus no treatment and other conservative treatments. SEARCH STRATEGY: The Cochrane Central Register of Controlled Trials (Issue 3, 2004), MEDLINE, EMBASE, PsychInfo, CINAHL databases to October 2004; citation searches and bibliographic reviews of previous systematic reviews. SELECTION CRITERIA: Randomized controlled trials evaluating exercise therapy for adult non-specific low-back pain and measuring pain, function, return-to-work/absenteeism, and/or global improvement outcomes. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected studies and extracted data on study characteristics, quality, and outcomes at short, intermediate, and long-term follow-up. MAIN RESULTS: Sixty-one randomized controlled trials (6390 participants) met inclusion criteria: acute (11), subacute (6) and chronic (43) low-back pain (1 unclear). Evidence was found of effectiveness in chronic populations relative to comparisons at all follow-up periods; pooled mean improvement was 7.3 points (95% CI, 3.7 to 10.9) for pain (out of 100), 2.5 points (1.0 to 3.9) for function (out of 100) at earliest follow-up. In studies investigating patients (i.e. presenting to healthcare providers) mean improvement was 13.3 points (5.5 to 21.1) for pain, 6.9 (2.2 to 11.7) for function, representing significantly greater improvement over studies where participants included those recruited from a general population (e.g. with advertisements). There is some evidence of effectiveness of graded-activity exercise program in subacute low-back pain in occupational settings, though the evidence for other types of exercise therapy in other populations is inconsistent. There was evidence of equal effectiveness relative to comparisons in acute populations [pain: 0.03 points (95% CI, -1.3 to 1.4)].Limitations: This review largely reflects limitations of the literature, including low quality studies with heterogeneous outcome measures, inconsistent and poor reporting, and possibility of publication bias. AUTHORS' CONCLUSIONS: Exercise therapy appears to be slightly effective at decreasing pain and improving function in adults with chronic low-back pain, particularly in healthcare populations. In subacute low-back pain there is some evidence that a graded activity program improves absenteeism outcomes, though evidence for other types of exercise is unclear. In acute low-back pain, exercise therapy is as effective as either no treatment or other conservative treatments.

Koes BW, Malmivaara A, van Tulder MW. · ErasmusMC, University Medical Center Rotterdam, Department of General Practice, P.O. Box 1738, 3000 DR, Rotterdam, The Netherlands. · Best Pract Res Clin Rheumatol. · Pubmed #15949774 No free full text.

Abstract: During the past decades, the number of published randomised clinical trials evaluating the efficacy of conservative treatments for low back pain has substantially increased. At the same time several initiatives were undertaken in order to improve the methodological quality of published randomised clinical trials, also in the field of low back pain. We investigated how the methodological quality of randomised clinical trials in the field of low back pain developed over time since the first published trial in 1961. Methodological scores of 269 RCTs included in 15 Cochrane reviews of conservative treatment for low back pain were compared. Overall many trials showed methodological shortcomings. The median overall quality scores ranged from 36 to 82% depending on the type of intervention. There were no improvements in median overall methodological quality over time from 1960 to 2004. Improvements were apparent for a few validity criteria only.

Niemistö L, Kalso E, Malmivaara A, Seitsalo S, Hurri H, Anonymous00018. · Orton Orthopaedic Hospital, Invalid Foundation, Helsinki, Finland. · Spine (Phila Pa 1976). · Pubmed #12923479 No free full text.

Abstract: STUDY DESIGN: Systematic review. OBJECTIVE: To assess the effectiveness of radiofrequency denervation for the treatment of musculoskeletal pain disorders. SUMMARY OF BACKGROUND DATA: There is a lack of effective treatment for chronic zygapophysial joint pain and discogenic pain. Radiofrequency denervation appears to be an emerging technology, with substantial variation in its use. METHODS: Original articles for this review were identified by electronically searching MEDLINE, PsycLIT, EMBASE, and the Cochrane Library to February 2002, hand-screening references, and consulting experts in the field. Two reviewers selected the randomized controlled trials that met the inclusion criteria, extracted the data, and assessed the main results and methodologic quality of the selected trials. Finally, qualitative analysis was conducted to evaluate the level of scientific evidence. RESULTS: Of seven relevant randomized controlled trials, six were considered to be high quality. The selected trials included 275 randomized patients, 141 of whom received active treatment. One study examined cervical zygapophysial joint pain; two, cervicobrachial pain; three, lumbar zygapophysial joint pain; and one, discogenic low back pain. The sample sizes were small, follow-up times short, and there were deficiencies noted in patient selection, outcome assessments, and statistical analyses. CONCLUSIONS: There is limited evidence that radiofrequency denervation offers short-term relief for chronic neck pain of zygapophysial joint origin and for chronic cervicobrachial pain, and conflicting evidence for its effectiveness for lumbar zygapophysial joint pain. There is limited evidence suggesting that intradiscal radiofrequency may not be effective in relieving discogenic low back pain. Further high-quality randomized controlled trials are needed, with larger patient samples and data on long-term effects, for which current evidence is inconclusive.

Karjalainen K, Malmivaara A, van Tulder M, Roine R, Jauhiainen M, Hurri H, Koes B. · Occupational Medicine, Finnish Institute of Occupational Health, Topeliuksenkatu 41 aA, Helsinki, Finland. · Cochrane Database Syst Rev. · Pubmed #12804427 No free full text.

Abstract: BACKGROUND: Multidisciplinary biopsychosocial rehabilitation programs are widely applied for chronic low back pain patients. The biopsychosocial approach can also prevent chronicity, by providing rehabilitation for patients who still have pain past the initial acute phase. Nevertheless, multidisciplinary treatment programmes are often laborious and long processes and require good collaboration between the patient, the rehabilitation team and the work place. By using workplace visits and developing close relationships with occupational health care providers, one might expect patients' working ability to improve. OBJECTIVES: The objective of this systematic review was to determine the effectiveness of multidisciplinary rehabilitation for subacute low back pain among working age adults. SEARCH STRATEGY: The reviewed studies for this review were electronically identified from MEDLINE, EMBASE, PsycLIT, CENTRAL, Medic, the Science Citation Index, reference checking and consulting experts in the rehabilitation field. The original search was planned and performed for the broader area of musculoskeletal disorders. Trials on subacute low back pain were separated afterwards. The literature search was last updated in November 2002 in EMBASE and MEDLINE. SELECTION CRITERIA: From all references identified in our original search, we selected randomised controlled trials (RCTs) and non-randomised controlled clinical trials (CCTs). Trials had to assess the effectiveness of multidisciplinary rehabilitation for working age patients suffering from subacute low back pain (more than four weeks but less than three months). The rehabilitation program was required to be multidisciplinary, i.e., it had to consist of a physician's consultation plus either a psychological, social or vocational intervention, or a combination of these. DATA COLLECTION AND ANALYSIS: Four reviewers blinded to journal and author selected trials that met the specified inclusion criteria. Two experts in the field of rehabilitation evaluated the clinical relevance and applicability of the findings of the selected studies for actual clinical use. Two other reviewers blinded to journal and author extracted the data and assessed the main results and the methodological quality of the studies, using standardized forms. Finally, a qualitative analysis was performed to evaluate the level of scientific evidence for the effectiveness of multidisciplinary rehabilitation. MAIN RESULTS: After screening 1808 abstracts, and the references of 65 reviews, we found only two relevant studies that satisfied our criteria on subacute low back pain. No more studies were found during the updates. Both studies were considered to be methodologically low quality RCTs. The clinical relevance of included studies was sufficient. There was moderate scientific evidence showing that multidisciplinary rehabilitation, which includes a workplace visit or more comprehensive occupational health care intervention, helps patients to return to work faster, results in fewer sick leaves and alleviates subjective disability. REVIEWER'S CONCLUSIONS: We conclude that there is moderate evidence of positive effectiveness of multidisciplinary rehabilitation for subacute low back pain and that a workplace visit increases the effectiveness. But because this evidence is based on trials that had some methodological shortcomings, and several expensive multidisciplinary rehabilitation programmes are commonly used for uncomplicated/non-specific subacute low back problems, there is an obvious need for high quality trials in this field.

Niemisto L, Kalso E, Malmivaara A, Seitsalo S, Hurri H. · Rehabilitation Unit of Orton Orthopaedic Hospital, Orton Orthopaedic Hospital, Invalid Foundation, Tenholantie 10, Helsinki, Finland, 00280. · Cochrane Database Syst Rev. · Pubmed #12535508 No free full text.

Abstract: BACKGROUND: The diagnosis of cervical or lumbar zygapophyseal joint pain can only be made by using local anesthesia to block the nerves supplying the painful joint. There is a lack of effective treatment for chronic zygapophyseal joint pain or discogenic pain. Radiofrequency denervation appears to be an emerging technology, with substantial variation in its use between countries. OBJECTIVES: To assess the effectiveness of radiofrequency denervation for the treatment of musculoskeletal pain disorders. SEARCH STRATEGY: We searched MEDLINE, PsycLIT, and EMBASE from start to February 2002, plus the Cochrane Library 2002, Issue 2. The references of identified articles were checked and three experts in the field of radiofrequency treatment were consulted to identify studies we might have missed. SELECTION CRITERIA: Randomized controlled trials (RCTs) of radiofrequency denervation for musculoskeletal pain disorders, with no language or date restrictions. DATA COLLECTION AND ANALYSIS: Two reviewers selected RCTs that met predefined inclusion criteria, extracted the data, and assessed the main results and methodological quality of the selected trials, using standardized forms. Qualitative analysis was conducted to evaluate the level of scientific evidence. MAIN RESULTS: We found only nine articles, reporting on seven relevant RCTs. Six of the seven were considered to be high-quality. The selected trials included 275 randomized patients, 141 of whom received active treatment. One study examined cervical zygapophyseal joint pain, two cervicobrachial pain, three lumbar zygapophyseal joint pain, and one discogenic low-back pain. The study sample sizes were small, follow-up times short, and there were some deficiencies in patient selection, outcome assessments, and statistical analyses. The level of scientific evidence for the short-term effectiveness of radiofrequency denervation was limited for cervical zygapophyseal joint and cervicobrachial pain, and conflicting for lumbar zygapophyseal joint pain. There was limited evidence suggesting that intradiscal radiofrequency thermocoagulation was not effective for discogenic low-back pain. REVIEWER'S CONCLUSIONS: The selected trials provide limited evidence that radiofrequency denervation offers short-term relief for chronic neck pain of zygapophyseal joint origin and for chronic cervicobrachial pain; conflicting evidence on the short-term effect of radiofrequency lesioning on pain and disability in chronic low-back pain of zygapophyseal joint origin; and limited evidence that intradiscal radiofrequency thermocoagulation is not effective for chronic discogenic low-back pain. There is a need for further high-quality RCTs with larger patient samples and data on long-term effects, for which current evidence is inconclusive. Furthermore, RCTs are needed in non-spinal indications where radiofrequency denervation is currently used without any scientific evidence.

Malmivaara A, Airaksinen O. · Työterveyslaitos, työlääketieteen osasto 00250 Helsinki. · Duodecim. · Pubmed #11912766 No free full text.

This publication has no abstract.

Guzmán J, Esmail R, Karjalainen K, Malmivaara A, Irvin E, Bombardier C. · University of Manitoba Faculty of Medicine, S112-750 Bannatyne Avenue, Winnipeg, Manitoba, Canada, R3E 0W3. · Cochrane Database Syst Rev. · Pubmed #11869581 No free full text.

Abstract: BACKGROUND: Chronic low back pain is, in many countries, the main cause of long term disability in middle age. Patients with chronic low back pain are often referred for multidisciplinary treatment. Previous published systematic reviews on this topic included no randomised controlled trials and pooled together controlled and non-controlled studies. OBJECTIVES: To assess the effect of multidisciplinary bio-psycho-social rehabilitation on pain, function, employment, quality of life and global assessment outcomes in subjects with chronic disabling low back pain. SEARCH STRATEGY: We searched MEDLINE, EMBASE, PsychLIT, CINAHL, Health STAR, and The Cochrane Library from the beginning of the database to June 1998 using the comprehensive search strategy recommended by the Back Review Group of the Cochrane Collaboration. Intervention specific key words for this review were: patient care team, patient care management, multidisciplinary, interdisciplinary, multiprofessional, multimodal, pain clinic and functional restoration. We also reviewed reference lists and consulted the editors of the Back Review Group of the Cochrane Collaboration. SELECTION CRITERIA: Design: randomised controlled trials comparing multidisciplinary bio-psycho-social rehabilitation with a non-multidisciplinary control intervention. Population: Adults with disabling low back pain of more than three months in duration. Intervention: Patients had to be assessed and treated by qualified professionals according to a plan that addresses physical and at least one of psychological, or social/occupational dimensions. Outcomes: Only trials which reported treatment effect in at least one of pain, function, employment status, quality of life or global improvement. Exclusion: Pure educational interventions (back schools) and pure physical interventions were excluded. DATA COLLECTION AND ANALYSIS: Selection, data extraction and quality grading of studies was done by two independent reviewers using pre-tested data forms. Study quality was assessed according to the scheme recommended by the Back Review Group of the Cochrane Collaboration. Trials with internal validity scores of five or more in a ten point scale were considered high quality. Discrepancies between reviewers were resolved by consensus or by a third reviewer. Given the marked heterogeneity in study settings, interventions and control groups we decided not to pool trial results in a meta-analysis. Instead, we summarized findings by strength of evidence and nature of intervention and control treatments. The evidence was judged to be strong when multiple high quality trials produced generally consistent findings. It was judged to be moderate when multiple low quality or one high quality and one or more low quality trials produced generally consistent findings. Evidence was considered to be limited when only one randomised trial existed or if findings of existing trials were inconsistent. MAIN RESULTS: Ten trials (12 randomised comparisons) were included. They randomised a total of 1964 patients with chronic low back pain. There was strong evidence that intensive multidisciplinary bio-psycho-social rehabilitation with a functional restoration approach improved function when compared with inpatient or outpatient non-multidisciplinary treatments. There was moderate evidence that intensive multidisciplinary bio-psycho-social rehabilitation with a functional restoration approach improved pain when compared with outpatient non-multidisciplinary rehabilitation or usual care. There was contradictory evidence regarding vocational outcomes of intensive multidisciplinary bio-psycho-social intervention. Some trials reported improvements in work readiness, but others showed no significant reduction in sickness leaves. Less intensive outpatient psycho-physical treatments did not improve pain, function or vocational outcomes when compared with non-multidisciplinary outpatient therapy or usual care. Few trials reported effects on quality of life or global assessments. REVIEWER'S CONCLUSIONS: The reviewed trials provide evidence that intensive multidisciplinary bio-psycho-social rehabilitation with a functional restoration approach improves pain and function. Less intensive interventions did not show improvements in clinically relevant outcomes.

Guzmán J, Esmail R, Karjalainen K, Malmivaara A, Irvin E, Bombardier C. · Institute for Work and Health, Toronto, Canada M4W 1E6. · BMJ. · Pubmed #11420271 links to  free full text

Abstract: OBJECTIVE: To assess the effect of multidisciplinary biopsychosocial rehabilitation on clinically relevant outcomes in patients with chronic low back pain. DESIGN: Systematic literature review of randomised controlled trials. PARTICIPANTS: A total of 1964 patients with disabling low back pain for more than three months. MAIN OUTCOME MEASURES: Pain, function, employment, quality of life, and global assessments. RESULTS: Ten trials reported on a total of 12 randomised comparisons of multidisciplinary treatment and a control condition. There was strong evidence that intensive multidisciplinary biopsychosocial rehabilitation with functional restoration improves function when compared with inpatient or outpatient non-multidisciplinary treatments. There was moderate evidence that intensive multidisciplinary biopsychosocial rehabilitation with functional restoration reduces pain when compared with outpatient non-multidisciplinary rehabilitation or usual care. There was contradictory evidence regarding vocational outcomes of intensive multidisciplinary biopsychosocial intervention. Some trials reported improvements in work readiness, but others showed no significant reduction in sickness leaves. Less intensive outpatient psychophysical treatments did not improve pain, function, or vocational outcomes when compared with non-multidisciplinary outpatient therapy or usual care. Few trials reported effects on quality of life or global assessments. CONCLUSIONS: The reviewed trials provide evidence that intensive multidisciplinary biopsychosocial rehabilitation with functional restoration reduces pain and improves function in patients with chronic low back pain. Less intensive interventions did not show improvements in clinically relevant outcomes.

Karjalainen K, Malmivaara A, van Tulder M, Roine R, Jauhiainen M, Hurri H, Koes B. · Finnish Institute of Occupational Health, Helsinki, Finland. · Spine (Phila Pa 1976). · Pubmed #11224862 No free full text.

Abstract: STUDY DESIGN: A systematic review of randomized controlled trials was performed. OBJECTIVE: To evaluate the effectiveness of multidisciplinary biopsychosocial rehabilitation for subacute low back pain among working-age adults. SUMMARY OF BACKGROUND DATA: Multidisciplinary biopsychosocial rehabilitation programs are widely applied for patients with chronic low back pain. The multidisciplinary biopsychosocial approach for prolonged low back pain could be considered to prevent chronicity. Work site visits and a close relationship with occupational health care might produce results in terms of patients working ability. METHODS: Reviewed randomized controlled trials as well as controlled trials were identified from electronic bibliographic databases, reference checking, and consultation with experts in the rehabilitation field. Four blinded reviewers selected the trials. Two rehabilitation specialists evaluated the clinical relevance. Two other blinded reviewers extracted the data and assessed the main results along with the methodologic quality of the studies. A qualitative analysis was performed to evaluate the level evidence. RESULTS: Of 1808 references, only 2 relevant studies were included. Both were considered to be methodologically low-quality randomized controlled trials. The clinical relevance of the studies was sufficient. The level of scientific evidence was moderate, showing that multidisciplinary rehabilitation involving work site visit or more comprehensive occupational health care intervention helps patients return to work faster, makes sick leaves less, and alleviates subjective disability. CONCLUSIONS: There is moderate evidence showing that multidisciplinary rehabilitation for subacute low back pain is effective, and that work site visit increases the effectiveness, but because the analyzed studies had some methodologic shortcomings, an obvious need still exists for high-quality trials in this field.

van Tulder M, Malmivaara A, Esmail R, Koes B. · Institute for Research in Extramural Medicine, Free University, Amsterdam, The Netherlands. · Spine (Phila Pa 1976). · Pubmed #11064524 No free full text.

Abstract: STUDY DESIGN: A systematic review of randomized controlled trials was performed. SUMMARY OF BACKGROUND DATA: Exercise therapy is a widely used treatment for low back pain. OBJECTIVES: To evaluate the effectiveness of exercise therapy for low back pain with regard to pain intensity, functional status, overall improvement, and return to work. METHODS: The Cochrane Controlled Trials Register, Medline, Embase, PsycLIT, and reference lists of articles were searched. Randomized trials testing all types of exercise therapy for subjects with nonspecific low back pain with or without radiation into the legs were included. Two reviewers independently extracted data and assessed trial quality. Because trials were considered heterogeneous with regard to study populations, interventions, and outcomes, it was decided not to perform a meta-analysis, but to summarize the results using a rating system of four levels of evidence: strong, moderate, limited, or none. RESULTS: In this review, 39 trials were identified. There is strong evidence that exercise therapy is not more effective for acute low back pain than inactive or other active treatments with which it has been compared. There is conflicting evidence on the effectiveness of exercise therapy compared with inactive treatments for chronic low back pain. Exercise therapy was more effective than usual care by the general practitioner and just as effective as conventional physiotherapy for chronic low back pain. CONCLUSIONS: The evidence summarized in this systematic review does not indicate that specific exercises are effective for the treatment of acute low back pain. Exercises may be helpful for patients with chronic low back pain to increase return to normal daily activities and work.

Karjalainen K, Malmivaara A, van Tulder M, Roine R, Jauhiainen M, Hurri H, Koes B. · Finnish Institute of Occupational Health, Topeliuksenkatu 41 aA, Helsinki, Finland. · Cochrane Database Syst Rev. · Pubmed #10908528 No free full text.

Abstract: BACKGROUND: Multidisciplinary biopsychosocial rehabilitation programs are widely applied for chronic low back pain patients. The biopsychosocial approach for low back pain could also be considered to prevent chronicity by carrying out the rehabilitation if the acute pain is prolonged. Nevertheless multidisciplinary treatment programmes are often laborious and long processes and require good collaboration between the patient, the rehabilitation team and the work place. By workplace visits and close relationship with occupational health care one might expect results in terms of patients working ability. OBJECTIVES: The objective of this systematic review was to determine the effectiveness of multidisciplinary rehabilitation for subacute low back pain among working age adults. SEARCH STRATEGY: The reviewed studies for this structured Cochrane review were identified from electronic bibliographic databases, the Science Citation Index, reference checking and consulting experts in the rehabilitation field. The original search was planned and performed for more broad area of musculoskeletal disorders. Trials on subacute low back pain were separated afterwards. SELECTION CRITERIA: From all references found in our original search we selected randomized controlled trials (RCTs) and non-randomized controlled clinical trials (CCTs). Trials had to assess the effectiveness of multidisciplinary rehabilitation for working age patients suffering from subacute low back pain (more than 4 weeks but less than 3 months). The rehabilitation program was required to be multidisciplinary, i.e.; it had to consist of a physician's consultation plus either a psychological, social or vocational intervention, or a combination of these. DATA COLLECTION AND ANALYSIS: Four blinded reviewers selected the randomized controlled trials and controlled trials that met the specified inclusion criteria. Two experts in the field of rehabilitation evaluated the clinical relevance and applicability of the findings of the selected studies to actual clinical use. Two other blinded reviewers extracted the data and assessed the main results and the methodological quality of the studies using standardized forms. Finally, a qualitative analysis was performed to evaluate the level of scientific evidence for the effectiveness of multidisciplinary rehabilitation. MAIN RESULTS: After screening 1808 abstracts, and the references of 65 reviews, we found only 2 relevant studies that satisfied our criteria on subacute low back pain. They were both considered to be methodologically low quality randomized controlled trials. The clinical relevance of included studies was sufficient. The level of scientific evidence for the effectiveness of multidisciplinary rehabilitation was moderate on subacute low back pain showing that multidisciplinary rehabilitation which includes workplace visit or more comprehensive occupational health care intervention helps patients to return to work faster, makes sick leaves less and alleviates subjective disability. REVIEWER'S CONCLUSIONS: We conclude that there is moderate evidence of positive effectiveness of multidisciplinary rehabilitation for subacute low back pain and workplace visit increases the effectiveness. But because this evidence is based on the trials that had some methodological shortcomings and several expensive multidisciplinary rehabilitation programmes are commonly used for common subacute low back problems, there is an obvious need for high quality trials in this field.

van Tulder MW, Malmivaara A, Esmail R, Koes BW. · Institute for Research in Extramural Medicine, Vrije Universiteit, van der Boechorststraat 7, Amsterdam, NETHERLANDS, 1081 BT. · Cochrane Database Syst Rev. · Pubmed #10796344 No free full text.

Abstract: BACKGROUND: Exercise therapy is a widely used treatment for low back pain. OBJECTIVES: The objective of this review was to assess the effectiveness of exercise therapy for low back pain with regard to pain intensity, functional status, overall improvement and return to work. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register (1999, issue 1), MEDLINE (1966 - April 1999), EMBASE (1988 - September 1998), PsycLIT (from 1984 to April 1999) and reference lists of articles. SELECTION CRITERIA: Randomised trials of all types of exercise therapy for subjects with non-specific low back pain with or without radiation into the legs. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed trial quality. Because trials were considered heterogeneous with regard to study populations, interventions and outcomes, we decided not to perform a meta-analysis but to summarise the results using a rating system of four levels of evidence (strong, moderate, limited or no evidence). MAIN RESULTS: 39 RCTs were identified. There is strong evidence that exercise therapy is not more effective than inactive or other active treatments it has been compared with for acute low back pain. There is conflicting evidence on the effectiveness of exercise therapy compared with inactive treatments for chronic low back pain. Exercise therapy was more effective than usual care by the general practitioner and equally effective as conventional physiotherapy for chronic low back pain. REVIEWER'S CONCLUSIONS: The evidence summarised in this systematic review does not indicate that specific exercises are effective for the treatment of acute low back pain. Exercises may be helpful for chronic low back pain patients to increase return to normal daily activities and work.

Korhonen T, Karppinen J, Malmivaara A, Autio R, Niinimäki J, Paimela L, Kyllönen E, Lindgren KA, Tervonen O, Seitsalo S, Hurri H. · Department of Physical Medicine and Rehabilitation, Oulu University Hospital, Oulu, Finland. · Spine (Phila Pa 1976). · Pubmed #15454701 No free full text.

Abstract: STUDY DESIGN: An open-label trial. OBJECTIVES: To test the long-term efficacy of infliximab, a monoclonal antibody against tumor necrosis factor-alpha (TNF-alpha), in disc herniation-induced sciatica. SUMMARY OF BACKGROUND DATA: Our recent trial indicated that a single infusion of 3 mg/weight-kg of infliximab produced a rapid curative effect in disc herniation-induced sciatica. Here, we describe the 1-year effect of a 3 mg/kg of infliximab in these 10 patients and our experience with a lower dose of 1 mg/kg of infliximab for the same indication in 2 additional patients. METHODS: Patients with severe sciatica were treated with a single infusion of infliximab, 3 mg/weight-kg in 10 patients and 1 mg/kg in 2 patients, intravenously over 2 hours. The outcomes (leg and back pain on a 100-mm visual scale, Oswestry disability, clinical signs) were assessed at 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after the infusion. The outcomes with 3 mg/kg of infliximab were compared to 62 patients who received periradicular saline for sciatica in a previous trial. The resorption rate of disc herniations from baseline to 1 year was compared between infliximab and control groups. RESULTS: The response to 1 mg/kg of infliximab for leg pain was good only in 1 of the 2 patients treated, whereas the response to 3 mg/kg of infliximab for leg pain was sustained in most patients over the 1-year follow-up. The 1-year response significantly favored 3 mg/kg of infliximab over periradicular saline in leg pain (P = 0.005) and disability (P = 0.003). Neurologic abnormalities normalized more comprehensively in the infliximab group (P = 0.001). Reduction in disc herniation volume did not differ between the infliximab-treated patients and controls. CONCLUSIONS: The results showed that the beneficial effect of a single infusion of 3 mg/kg of infliximab for herniation-induced sciatica is sustained in most patients over a 1-year follow-up period. Furthermore, infliximab does not seem to interfere with the spontaneous resorption of disc herniations.

Karjalainen K, Malmivaara A, Mutanen P, Roine R, Hurri H, Pohjolainen T. · Department of Occupational Medicine, Finnish Institute of Occupational Health, Helsinki, Finland. · Spine (Phila Pa 1976). · Pubmed #15131431 No free full text.

Abstract: STUDY DESIGN: Randomized controlled trial. OBJECTIVES: To Investigate the long-term effectiveness, costs, and effect modifiers of a mini-intervention, provided in addition to the usual care, and the incremental effect of a worksite visit for patients with subacute disabling low back pain (LBP). SUMMARY OF BACKGROUND DATA: A mini-intervention was earlier proved to be an effective treatment for subacute LBP. Whether the beneficial effect is sustained is not known. Furthermore, modifiers of a treatment effect are largely unknown. METHODS: A total of 164 patients with subacute LBP randomized into a mini-intervention (A, n = 56), a mini-intervention plus a worksite visit (B, n = 51), or the usual care (C, n = 57). Mini-intervention consisted of a detailed assessment of the patients' history, beliefs, and physical findings by a physician and a physiotherapist, followed by recommendations and advice. The usual care patients received the conventional care. Pain, disability, health-related quality of life, satisfaction with care, days on sick leave, and health care consumption and costs were measured during a 24-month follow-up. Thirteen candidate modifiers were tested for each outcome. RESULTS: There were no differences between the three treatment arms regarding the intensity of pain, the perceived disability, or the health-related quality of life. However, mini-intervention decreased occurrence of daily (A vs., C, P = 0.01) and bothersome (A vs. C, P < 0.05) pain and increased treatment satisfaction. Costs resulting from LBP were lower in the intervention groups (A 4670 Euros, B 5990 Euros) than in C (C 9510 Euros) (A vs. C, P = 0.04; and B vs. C, not significant). The average number of days on sick leave was 30 in A, 45 in B, and 62 in C (A vs. C, P = 0.03; B vs. C, not significant). The perceived risk for not recovering was the strongest modifier of treatment effect. Mental and mental-physical workers in A and B were less often on sick leave than those in C. CONCLUSIONS: Mini-intervention is an effective treatment for subacute LBP. Despite lack of a significant effect on intensity of low back pain and perceived disability, mini-intervention, including proper recommendations and advice, according to the "active approach," is able to reduce LBP-related costs. The perceived risk of not recovering was the strongest modifier of treatment effect. In alleviating pain, the intervention was most effective among the patients with a high perceived risk of not recovering.

Karppinen J, Korhonen T, Malmivaara A, Paimela L, Kyllönen E, Lindgren KA, Rantanen P, Tervonen O, Niinimäki J, Seitsalo S, Hurri H. · Department of Physical Medicine and Rehabilitation, Oulu University Hospital, Finland. · Spine (Phila Pa 1976). · Pubmed #12698115 No free full text.

Abstract: STUDY DESIGN: An open-label study was conducted. OBJECTIVE: To evaluate the efficacy and safety of infliximab, a monoclonal chimeric antibody, against tumor necrosis factor-alpha (TNFalpha) for the treatment of severe sciatica. SUMMARY OF BACKGROUND DATA: Evidence from animal studies indicates that TNFalpha plays a role in the pathophysiology of sciatica. Anti-TNFalpha therapy has not been previously evaluated in sciatic patients. METHODS: In this study, 10 patients with disc herniation-induced severe sciatica received infliximab (Remicade 3 mg/kg) intravenously over 2 hours. The outcome was assessed at 1 hour, 1 week, 2 weeks, 1 month, and 3 months after the infusion and compared to historical control subjects consisting of 62 patients who received saline in a trial of periradicular infiltration for sciatica. Leg pain was the primary outcome, with more than a 75% decrease from the baseline score constituting a painless state. Fisher's exact test and repeated measures analysis of variance were used for statistical analysis. RESULTS: At 1 hour after the infusion, leg pain had decreased by 50%. At 2 weeks, 60% of the patients in the infliximab group were painless, as compared with 16% of the control patients (P = 0.006). The difference was sustained at 3 months (90% vs 46%; P = 0.014). Infliximab was superior over the whole follow-up period in terms of leg pain (P = 0.003) and back-related disability (P = 0.004). At 1 month, every patient in the infliximab group had returned to work, whereas 38% of the control subjects still were on sick leave (P = 0.02). None of the patients treated with infliximab underwent surgery during the follow-up period. No immediate or delayed adverse drug reactions and no adverse effects related to medication were observed. CONCLUSIONS: Anti-TNFalpha therapy is a promising treatment option for sciatica. There is an urgent need for a randomized controlled trial to evaluate whether thesepromising early results can be confirmed.

Karjalainen K, Malmivaara A, Pohjolainen T, Hurri H, Mutanen P, Rissanen P, Pahkajärvi H, Levon H, Karpoff H, Roine R. · Department of Occupational Medicine, Finnish Institute of Occupational Health, Helsinki, Finland. · Spine (Phila Pa 1976). · Pubmed #12642757 No free full text.

Abstract: STUDY DESIGN: Randomized controlled trial. OBJECTIVES: To investigate the effectiveness and costs of a mini-intervention, provided in addition to the usual care, and the incremental effect of a work site visit for patients with subacute disabling low back pain. SUMMARY OF BACKGROUND DATA: There is lack of data on cost-effectiveness of brief interventions for patients with prolonged low back pain. METHODS: A total of 164 patients with subacute low back pain were randomized to a mini-intervention group (A), a work site visit group (B), or a usual care group (C). Groups A (n = 56) and B (n = 51) underwent one assessment by a physician plus a physiotherapist. Group B received a work site visit in addition. Group C served as controls (n = 57) and was treated in municipal primary health care. All patients received a leaflet on back pain. Pain, disability, specific and generic health-related quality of life, satisfaction with care, days on sick leave, and use and costs of health care consumption were measured at 3-, 6-, and 12-month follow-ups. RESULTS: During follow-up, fewer subjects had daily pain in Groups A and B than in Group C (Group A Group C, = 0.002; Group B Group C, = 0.030). In Group A, pain was less bothersome (Group A Group C, = 0.032) and interfered less with daily life (Group A Group C, = 0.040) than among controls. Average days on sick leave were 19 in Group A, 28 in Group B, and 41 in Group C (Group A Group C, = 0.019). Treatment satisfaction was better in the intervention groups than among the controls, and costs were lowest in the mini-intervention group. CONCLUSIONS: Mini-intervention reduced daily back pain symptoms and sickness absence, improved adaptation to pain and patient satisfaction among patients with subacute low back pain, without increasing health care costs. A work site visit did not increase effectiveness.

Karppinen J, Ohinmaa A, Malmivaara A, Kurunlahti M, Kyllönen E, Pienimäki T, Nieminen P, Tervonen O, Vanharanta H. · Department of Physical Medicine and Rehabilitation, University Hospital of Oulu, Kajaanintie 50, FIN-09220 Oulu, Finland. · Spine (Phila Pa 1976). · Pubmed #11725240 No free full text.

Abstract: STUDY DESIGN: A subgroup analysis of a prospective, randomized controlled trial was performed. OBJECTIVE: To describe the cost effectiveness of periradicular infiltration with steroid in subgroups of patients with sciatica. SUMMARY OF BACKGROUND DATA: A recent trial on periradicular infiltration indicated that a methylprednisolone-bupivacaine combination had a short-term effect, as compared with that of saline. This report describes the efficacy and cost effectiveness of steroid in subgroups of patients with sciatic. METHODS: This study involved 160 patients with unilateral sciatica. Outcome assessments were leg pain (100-mm visual analog scale), disability on the Oswestry Low Back Disability Questionnaire, and the Nottingham Health Profile. Data on medical costs and sick leaves also were gathered. Patients were randomized for periradicular infiltration with either methylprednisolone-bupivacaine or saline. The adjusted between-group treatment differences at each follow-up assessment, the number of patients free of leg pain (responders, cutoff 75%), and efficacy by the area-under-the-curve method were calculated. For the cost-effectiveness estimate, the total costs were divided by the number of responders. The rate of operations in different subgroups was evaluated by Kaplan-Meier analysis. RESULTS: In the case of contained herniations, the steroid injection produced significant treatment effects and short-term efficacy in leg pain and in Nottingham Health Profile emotional reactions. For symptomatic lesions at L3-L4-L5, steroid was superior to saline for leg pain, disability, and straight leg raising in the short term. By 1 year, steroid seemed to have prevented operations for contained herniations, costing $12,666 less per responder in the steroid group (P < 0.01). For extrusions, steroid seemed to increase the operation rate, and the steroid infiltration was more expensive, costing $4445 per responder (P < 0.01). CONCLUSIONS: In addition to short-term effectiveness for contained herniations and lesions at L3-L4-L5, steroid treatment also prevented surgery for contained herniations. However, steroid was countereffective for extrusions. The results of the subgroup analyses call for a verification study.

Karppinen J, Malmivaara A, Kurunlahti M, Kyllönen E, Pienimäki T, Nieminen P, Ohinmaa A, Tervonen O, Vanharanta H. · Department of Physical Medicine and Rehabilitation, University Hospital of Oulu, Finland. · Spine (Phila Pa 1976). · Pubmed #11337625 No free full text.

Abstract: STUDY DESIGN: A randomized, double-blind trial was conducted. OBJECTIVES: To test the efficacy of periradicular corticosteroid injection for sciatica. SUMMARY OF BACKGROUND DATA: The efficacy of epidural corticosteroids for sciatica is controversial. Periradicular infiltration is a targeted technique, but there are no randomized controlled trials of its efficacy. METHODS: In this study 160 consecutive, eligible patients with sciatica who had unilateral symptoms of 1 to 6 months duration, and who never underwent surgery were randomized for double-blind injection with methylprednisolone bupivacaine combination or saline. Objective and self-reported outcome parameters and costs were recorded at baseline, at 2 and 4 weeks, at 3 and 6 months, and at 1 year. RESULTS: Recovery was better in the steroid group at 2 weeks for leg pain (P = 0.02), straight leg raising (P = 0.03), lumbar flexion (P = 0.05), and patient satisfaction (P = 0.03). Back pain was significantly lower in the saline group at 3 and 6 months (P = 0.03 and 0.002, respectively), and leg pain at 6 months (13.5, P = 0.02). Sick leaves and medical costs were similar for both treatments, except for cost of therapy visits and drugs at 4 weeks, which were in favor of the steroid injection (P = 0.05 and 0.005, respectively). By 1 year, 18 patients in the steroid group and 15 in the saline group underwent surgery. CONCLUSIONS: Improvement during the follow-up period was found in both the methylprednisolone and saline groups. The combination of methylprednisolone and bupivacaine seems to have a short-term effect, but at 3 and 6 months, the steroid group seems to experience a "rebound" phenomenon.

Mattila R, Malmivaara A, Kastarinen M, Kivelä SL, Nissinen A. · Lomaliittory, Helsinki, Finland. · Spine (Phila Pa 1976). · Pubmed #18091485 No free full text.

Abstract: STUDY DESIGN: Randomized controlled trial. OBJECTIVE: To assess the effects of a lifestyle intervention for hypertension on low back pain. SUMMARY OF BACKGROUND DATA: According to prospective etiologic studies, a causal association exists between certain lifestyle factors and low back pain. These factors are similar to those that elevate the risk for hypertension. Nevertheless, no randomized controlled trial has assessed effectiveness of lifestyle intervention for the treatment of hypertension on the prevalence of low back pain. METHODS: A total of 731 hypertensive employees from 45 worksites were assigned to multidisciplinary lifestyle interventions for hypertension in a rehabilitation center or to routine care in occupational or primary healthcare services during 12 months. Questionnaire data on low back pain were used to assess the effects of the intervention on the extent of low back pain and disability. RESULTS: The changes in prevalence and duration of low back pain, and related disability did not differ between the 2 groups, although there were favorable changes in some risk factors, such as body weight and physical inactivity. Subgroup analyses among patients with moderately heavy or heavy work showed that the prevalence of low back pain during the previous 12 months decreased more in the intervention than in the control group. CONCLUSION: Multidisciplinary lifestyle intervention aimed to reduce hypertension is not effective at reducing prevalence of low back pain or disability. However, in the subgroup of persons doing moderate or heavy work, the intervention seemed to reduce prevalence of low back pain during the 1-year follow-up.

van Tulder M, Malmivaara A, Hayden J, Koes B. · Institute for Research in Extramural Medicine, VU University Medical Center, Amsterdam, The Netherlands. · Spine (Phila Pa 1976). · Pubmed #17632400 No free full text.

Abstract: STUDY DESIGN: Critical appraisal of the literature. OBJECTIVES: The objective of this study was to assess if results of back pain trials are statistically significant and clinically important. SUMMARY OF BACKGROUND DATA: There seems to be a discrepancy between conclusions reported by authors and actual results of randomized controlled trials. Little attention has been paid to the problem of over-reporting of conclusions. METHODS: All 43 trials of the Cochrane review on exercise therapy for low back pain were included. Descriptive analyses were conducted. RESULTS: Eighteen trials reported positive conclusions in favor of exercise. Only six of the 43 studies showed both clinically important and statistically significant differences in favor of the exercise groups on function, and 4 on pain. CONCLUSION: It seems that many conclusions of studies of exercise therapy for chronic low back pain have been based on statistical significance of results rather than on clinical importance and, consequently, may have been too positive. Authors of trials should report not only statistical significance of results but also clinical importance.

Malmivaara A, Slätis P, Heliövaara M, Sainio P, Kinnunen H, Kankare J, Dalin-Hirvonen N, Seitsalo S, Herno A, Kortekangas P, Niinimäki T, Rönty H, Tallroth K, Turunen V, Knekt P, Härkänen T, Hurri H, Anonymous00042. · Finnish Office for Health Technology Assessment, National Research and Development Center, FinOHTA/Stakes, Helsinki, Finland. · Spine (Phila Pa 1976). · Pubmed #17202885 No free full text.

Abstract: STUDY DESIGN: A randomized controlled trial. OBJECTIVES: To assess the effectiveness of decompressive surgery as compared with nonoperative measures in the treatment of patients with lumbar spinal stenosis. SUMMARY OF BACKGROUND DATA: No previous randomized trial has assessed the effectiveness of surgery in comparison with conservative treatment for spinal stenosis. METHODS: Four university hospitals agreed on the classification of the disease, inclusion and exclusion criteria, radiographic routines, surgical principles, nonoperative treatment options, and follow-up protocols. A total of 94 patients were randomized into a surgical or nonoperative treatment group: 50 and 44 patients, respectively. Surgery comprised undercutting laminectomy of the stenotic segments in 10 patients augmented with transpedicular fusion. The primary outcome was based on assessment of functional disability using the Oswestry Disability Index (scale, 0-100). Data on the intensity of leg and back pain (scales, 0-10), as well as self-reported and measured walking ability were compiled at randomization and at follow-up examinations at 6, 12, and 24 months. RESULTS: Both treatment groups showed improvement during follow-up. At 1 year, the mean difference in favor of surgery was 11.3 in disability (95% confidence interval [CI], 4.3-18.4), 1.7 in leg pain (95% CI, 0.4-3.0), and 2.3(95% CI, 1.1-3.6) in back pain. At the 2-year follow-up, the mean differences were slightly less: 7.8 in disability (95% CI, 0.8-14.9) 1.5 in leg pain (95% CI, 0.3-2.8), and 2.1 in back pain (95% CI, 1.0-3.3). Walking ability, either reported or measured, did not differ between the two treatment groups. CONCLUSIONS: Although patients improved over the 2-year follow-up regardless of initial treatment, those undergoing decompressive surgery reported greater improvement regarding leg pain, back pain, and overall disability. The relative benefit of initial surgical treatment diminished over time, but outcomes of surgery remained favorable at 2 years. Longer follow-up is needed to determine if these differences persist.