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Short term treatment versus long term management of neck and back disability in older adults utilizing spinal manipulative therapy and supervised exercise: a parallel-group randomized clinical trial evaluating relative effectiveness and harms.

ABSTRACT: Back and neck disability are frequent in older adults resulting in loss of function and independence. Exercise therapy and manual therapy, like spinal manipulative therapy (SMT), have evidence of short and intermediate term effectiveness for spinal disability in the general population and growing evidence in older adults. For older populations experiencing chronic spinal conditions, long term management may be more appropriate to maintain improvement and minimize the impact of future exacerbations. Research is limited comparing short courses of treatment to long term management of spinal disability. The primary aim is to compare the relative effectiveness of 12 weeks versus 36 weeks of SMT and supervised rehabilitative exercise (SRE) in older adults with back and neck disability.Randomized, mixed-methods, comparative effectiveness trial conducted at a university-affiliated research clinic in the Minneapolis/St. Paul, Minnesota metropolitan area.Independently ambulatory community dwelling adults???65 years of age with back and neck disability of minimum 12 weeks duration (n?=?200).12 weeks SMT?+?SRE or 36 weeks SMT?+?SRE.Blocked 1:1 allocation; computer generated scheme, concealed in sequentially numbered, opaque, sealed envelopes.Functional outcome examiners are blinded to treatment allocation; physical nature of the treatments prevents blinding of participants and providers to treatment assignment.36 weeks post-randomization.Self-report questionnaires administered at 2 baseline visits and 4, 12, 24, 36, 52, and 78 weeks post-randomization. Primary outcomes include back and neck disability, measured by the Oswestry Disability Index and Neck Disability Index. Secondary outcomes include pain, general health status, improvement, self-efficacy, kinesiophobia, satisfaction, and medication use. Functional outcome assessment occurs at baseline and week 37 for hand grip strength, short physical performance battery, and accelerometry. Individual qualitative interviews are conducted when treatment ends. Data on expectations, falls, side effects, and adverse events are systematically collected.Linear mixed-model method for repeated measures to test for between-group differences with baseline values as covariates.Treatments that address the management of spinal disability in older adults may have far reaching implications for patient outcomes, clinical guidelines, and healthcare policy.www.ClinicalTrials.gov; Identifier: NCT01057706.

SUBMITTER: Vihstadt C

PROVIDER: S-EPMC4255336 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Short term treatment versus long term management of neck and back disability in older adults utilizing spinal manipulative therapy and supervised exercise: a parallel-group randomized clinical trial evaluating relative effectiveness and harms.

Vihstadt Corrie C Maiers Michele M Westrom Kristine K Bronfort Gert G Evans Roni R Hartvigsen Jan J Schulz Craig C

Chiropractic & manual therapies 20140723

<h4>Background</h4>Back and neck disability are frequent in older adults resulting in loss of function and independence. Exercise therapy and manual therapy, like spinal manipulative therapy (SMT), have evidence of short and intermediate term effectiveness for spinal disability in the general population and growing evidence in older adults. For older populations experiencing chronic spinal conditions, long term management may be more appropriate to maintain improvement and minimize the impact of ...[more]

PMID: 25478141

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Project description:BACKGROUND CONTEXT:Chronic neck pain is a prevalent and disabling condition among older adults. Despite the large burden of neck pain, little is known regarding the cost-effectiveness of commonly used treatments. PURPOSE:This study aimed to estimate the cost-effectiveness of home exercise and advice (HEA), spinal manipulative therapy (SMT) plus HEA, and supervised rehabilitative exercise (SRE) plus HEA. STUDY DESIGN/SETTING:Cost-effectiveness analysis conducted alongside a randomized clinical trial (RCT) was performed. PATIENT SAMPLE:A total of 241 older adults (?65 years) with chronic mechanical neck pain comprised the patient sample. OUTCOME MEASURES:The outcome measures were direct and indirect costs, neck pain, neck disability, SF-6D-derived quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) over a 1-year time horizon. METHODS:This work was supported by grants from the National Center for Complementary and Integrative Health (#F32AT007507), National Institute of Arthritis and Musculoskeletal and Skin Diseases (#P60AR062799), and Health Resources and Services Administration (#R18HP01425). The RCT is registered at ClinicalTrials.gov (#NCT00269308). A societal perspective was adopted for the primary analysis. A healthcare perspective was adopted as a sensitivity analysis. Cost-effectivenesswas a secondary aim of the RCT which was not powered for differences in costs or QALYs. Differences in costs and clinical outcomes were estimated using generalized estimating equations and linear mixed models, respectively. Cost-effectiveness acceptability curves were calculated to assess the uncertainty surrounding cost-effectiveness estimates. RESULTS:Total costs for SMT+HEA were 5% lower than HEA (mean difference: -$111; 95% confidence interval [CI] -$1,354 to $899) and 47% lower than SRE+HEA (mean difference: -$1,932; 95% CI -$2,796 to -$1,097). SMT+HEA also resulted in a greater reduction of neck pain over the year relative to HEA (0.57; 95% CI 0.23 to 0.92) and SRE+HEA (0.41; 95% CI 0.05 to 0.76). Differences in disability and QALYs favored SMT+HEA. The probability that adding SMT to HEA is cost-effective at willingness to pay thresholds of $50,000 to $200,000 per QALY gained ranges from 0.75 to 0.81. If adopting a health-care perspective, costs for SMT+HEA were 66% higher than HEA (mean difference: $515; 95% CI $225 to $1,094), resulting in an ICER of $55,975 per QALY gained. CONCLUSION:On average, SMT+HEA resulted in better clinical outcomes and lower total societal costs relative to SRE+HEA and HEA alone, with a 0.75 to 0.81 probability of cost-effectiveness for willingness to pay thresholds of $50,000 to $200,000 per QALY.

Project description:ObjectiveTo assess the benefits and harms of spinal manipulative therapy (SMT) for the treatment of chronic low back pain.DesignSystematic review and meta-analysis of randomised controlled trials.Data sourcesMedline, PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, Physiotherapy Evidence Database (PEDro), Index to Chiropractic Literature, and trial registries up to 4 May 2018, including reference lists of eligible trials and related reviews.Eligibility criteria for selecting studiesRandomised controlled trials examining the effect of spinal manipulation or mobilisation in adults (≥18 years) with chronic low back pain with or without referred pain. Studies that exclusively examined sciatica were excluded, as was grey literature. No restrictions were applied to language or setting.Review methodsTwo reviewers independently selected studies, extracted data, and assessed risk of bias and quality of the evidence. The effect of SMT was compared with recommended therapies, non-recommended therapies, sham (placebo) SMT, and SMT as an adjuvant therapy. Main outcomes were pain and back specific functional status, examined as mean differences and standardised mean differences (SMD), respectively. Outcomes were examined at 1, 6, and 12 months. Quality of evidence was assessed using GRADE. A random effects model was used and statistical heterogeneity explored.Results47 randomised controlled trials including a total of 9211 participants were identified, who were on average middle aged (35-60 years). Most trials compared SMT with recommended therapies. Moderate quality evidence suggested that SMT has similar effects to other recommended therapies for short term pain relief (mean difference -3.17, 95% confidence interval -7.85 to 1.51) and a small, clinically better improvement in function (SMD -0.25, 95% confidence interval -0.41 to -0.09). High quality evidence suggested that compared with non-recommended therapies SMT results in small, not clinically better effects for short term pain relief (mean difference -7.48, -11.50 to -3.47) and small to moderate clinically better improvement in function (SMD -0.41, -0.67 to -0.15). In general, these results were similar for the intermediate and long term outcomes as were the effects of SMT as an adjuvant therapy. Evidence for sham SMT was low to very low quality; therefore these effects should be considered uncertain. Statistical heterogeneity could not be explained. About half of the studies examined adverse and serious adverse events, but in most of these it was unclear how and whether these events were registered systematically. Most of the observed adverse events were musculoskeletal related, transient in nature, and of mild to moderate severity. One study with a low risk of selection bias and powered to examine risk (n=183) found no increased risk of an adverse event (relative risk 1.24, 95% confidence interval 0.85 to 1.81) or duration of the event (1.13, 0.59 to 2.18) compared with sham SMT. In one study, the Data Safety Monitoring Board judged one serious adverse event to be possibly related to SMT.ConclusionSMT produces similar effects to recommended therapies for chronic low back pain, whereas SMT seems to be better than non-recommended interventions for improvement in function in the short term. Clinicians should inform their patients of the potential risks of adverse events associated with SMT.

Project description:BackgroundComplaints in the musculoskeletal system often start early in life and back and neck pain in children are well-established predictors for similar problems in adulthood. Despite lack of evidence of effectiveness, manipulative therapy is one of the most commonly used treatment modalities for back and neck pain in children. The primary objective of this study is to evaluate the effectiveness of manipulative therapy when added to an approach consisting of manual soft tissue treatment, exercises and advice as needed, in children aged 9-15 complaining of back and neck pain.MethodThe project is nested in the Childhood Health, Activity and Motor Performance School Study, which includes around 1200 children aged 9-15, who were all invited to participate in this randomized controlled trial in case they experienced back and/or neck pain during the two year inclusion period. Parents received text messages (SMS) on a weekly basis inquiring about the child's musculoskeletal pain. If pain was reported, the child was evaluated for inclusion into the trial and, if eligible, randomized into one of two intervention groups:Pragmatic advice, manual soft tissue treatment and exercisesThe above plus manipulative therapy By the end of data collection 237 children were included in the study. The primary outcome measure is number of recurrences of back and neck pain during the follow-up period (3-27 months). Secondary outcome measures are average duration of complaint time for each episode, total duration of complaint time, global perceived effect after two weeks, and change in pain intensity after 2 weeks. Baseline information includes quality of life, expectations to treatment, expectations to future course, age, gender, social class and physical education at school.DiscussionFor most common non-traumatic musculoskeletal complaints no standardized and evidence based treatment strategy exists. We want to evaluate the effectiveness of manipulative therapy in addition to an approach consisting of manual soft tissue treatment, exercises and advice as needed, in children aged 9-15 complaining of back and neck pain. To our knowledge this is the first large scale randomized controlled trial investigating the effectiveness of commonly used treatments for back and neck pain in children.Trial registrationClinicalTrials NCT01504698.

Project description:BackgroundRecurrent or persistent neck pain affects a vast number of people globally, leading to reduced quality of life and high societal costs. Clinically, it is a difficult condition to manage, and treatment effect sizes are often moderate at best. Activity and manual therapy are first-line treatment options in current guidelines. We aimed to investigate the combination of home stretching exercises and spinal manipulative therapy in a multicentre randomized controlled clinical trial, carried out in multidiscipline ary primary care clinics.MethodsThe treatment modalities utilized were spinal manipulative therapy and home stretching exercises compared to home stretching exercises alone. Both groups received 4 treatments for 2 weeks. The primary outcome was pain, where the subjective pain experience was investigated by assessing pain intensity (NRS - 11) and the quality of pain (McGill Pain Questionnaire). Neck disability and health status were secondary outcomes, measured using the Neck Disability Indexthe EQ-5D, respectively. One hundred thirty-one adult subjects were randomized to one of the two treatment groups. All subjects had experienced persistent or recurrent neck pain the previous 6 months and were blinded to the other group intervention. The clinicians provided treatment for subjects in both group and could not be blinded. The researchers collecting data were blinded to treatment allocation, as was the statistician performing data analyses. An intention-to-treat analysis was used.ResultsSixty-six subjects were randomized to the intervention group, and sixty-five to the control group. For NRS - 11, a B-coefficient of - 0,01 was seen, indication a 0,01 improvement for the intervention group in relation to the control group at each time point with a p-value of 0,305. There were no statistically significant differences between groups for any of the outcome measures.ConclusionBased on the current findings, there is no additional treatment effect from adding spinal manipulative therapy to neck stretching exercises over 2 weeks for patients with persistent or recurrent neck pain.Trial registrationThe trial was registered 03/07/2018 at ClinicalTrials.gov , registration number: NCT03576846.

Project description:Neck and back pain are among the most common causes of prolonged disability, and development of interventions with effect on pain, disability and return to work is important. Reduction of fear avoidance might be one mechanism behind improvement after interventions. The aim of the present study was to evaluate changes in pain and disability at the 12-month follow-up of patients with neck and back pain treated with a work-focused intervention compared to patients treated with standard interventions, and the influence of improvement fear avoidance beliefs during the interventions on pain, disability and return to work at 12-month follow-up.413 employed patients with back or neck pain referred to secondary care, and sick-listed between 4 weeks and 12 months, were randomized to a work-focused rehabilitation or control interventions. Follow-up was conducted 4 and 12 months after inclusion. The groups were compared (independent sample t-test) regarding differences in disability scores (Oswestry disability index/neck disability index) and pain (numeric rating scale) from baseline to 12-month follow-up. Changes in fear avoidance beliefs (FABQ) from baseline to 4 month follow-up were calculated, and the association between this change and return to work, pain and disability at 12 months were tested in stepwise multiple logistic regression models.Pain and, disability scores decreased to in both the work-focused and control intervention to 12-month follow-up, and there were no significant differences between the groups. FABQ decreased similarly in both groups to 4 month follow-up. The logistic regression model revealed an association between a reduced FABQ work score at 4 months and return to work within one year (adjusted OR 3.60, 95% CI 1.19 to 10.88). Reduced FABQ physical activity score at 4 months was associated with decreased disability after 12 months (adjusted OR (3.65. 95% CI 1.43 to 9.28).Short work-focused rehabilitation had the same effect on pain and disability as control interventions. Reduction in FABQ-W score after treatment seems to be an important predictor for return to work in both groups.Clinicaltrials.gov NCT00840697.

Dataset Information

Short term treatment versus long term management of neck and back disability in older adults utilizing spinal manipulative therapy and supervised exercise: a parallel-group randomized clinical trial evaluating relative effectiveness and harms.

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Short term treatment versus long term management of neck and back disability in older adults utilizing spinal manipulative therapy and supervised exercise: a parallel-group randomized clinical trial evaluating relative effectiveness and harms.

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