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Comparison of complementary and alternative medicine with conventional mind-body therapies for chronic back pain: protocol for the Mind-body Approaches to Pain (MAP) randomized controlled trial.

ABSTRACT: The self-reported health and functional status of persons with back pain in the United States have declined in recent years, despite greatly increased medical expenditures due to this problem. Although patient psychosocial factors such as pain-related beliefs, thoughts and coping behaviors have been demonstrated to affect how well patients respond to treatments for back pain, few patients receive treatments that address these factors. Cognitive-behavioral therapy (CBT), which addresses psychosocial factors, has been found to be effective for back pain, but access to qualified therapists is limited. Another treatment option with potential for addressing psychosocial issues, mindfulness-based stress reduction (MBSR), is increasingly available. MBSR has been found to be helpful for various mental and physical conditions, but it has not been well-studied for application with chronic back pain patients. In this trial, we will seek to determine whether MBSR is an effective and cost-effective treatment option for persons with chronic back pain, compare its effectiveness and cost-effectiveness compared with CBT and explore the psychosocial variables that may mediate the effects of MBSR and CBT on patient outcomes.In this trial, we will randomize 397 adults with nonspecific chronic back pain to CBT, MBSR or usual care arms (99 per group). Both interventions will consist of eight weekly 2-hour group sessions supplemented by home practice. The MBSR protocol also includes an optional 6-hour retreat. Interviewers masked to treatment assignments will assess outcomes 5, 10, 26 and 52 weeks postrandomization. The primary outcomes will be pain-related functional limitations (based on the Roland Disability Questionnaire) and symptom bothersomeness (rated on a 0 to 10 numerical rating scale) at 26 weeks.If MBSR is found to be an effective and cost-effective treatment option for patients with chronic back pain, it will become a valuable addition to the limited treatment options available to patients with significant psychosocial contributors to their pain.Clinicaltrials.gov Identifier: NCT01467843.

SUBMITTER: Cherkin DC

PROVIDER: S-EPMC4052284 | biostudies-literature | 2014 Jun

REPOSITORIES: biostudies-literature

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Comparison of complementary and alternative medicine with conventional mind-body therapies for chronic back pain: protocol for the Mind-body Approaches to Pain (MAP) randomized controlled trial.

Cherkin Daniel C DC Sherman Karen J KJ Balderson Benjamin H BH Turner Judith A JA Cook Andrea J AJ Stoelb Brenda B Herman Patricia M PM Deyo Richard A RA Hawkes Rene J RJ

Trials 20140607

<h4>Background</h4>The self-reported health and functional status of persons with back pain in the United States have declined in recent years, despite greatly increased medical expenditures due to this problem. Although patient psychosocial factors such as pain-related beliefs, thoughts and coping behaviors have been demonstrated to affect how well patients respond to treatments for back pain, few patients receive treatments that address these factors. Cognitive-behavioral therapy (CBT), which ...[more]

PMID: 24906419

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Project description:Background: The mind-body therapies of traditional Chinese medicine include several intervention types and combine physical poses with conscious relaxation and breathing techniques. The purpose of this Evidence Map is to describe these different interventions and report related health outcomes. Methods: This evidence map is based on the 3iE Evidence Gap Map methodology. We searched seven electronic databases (BVS, PUBMED, EMBASE, PEDro, ScienceDirect, Web of Sciences, and PschyInfo) from inception to November 2019 and included systematic reviews only. Systematic reviews were analyzed based on AMSTAR 2. We used Tableau to graphically display quality assessment, the number of reviews, outcomes, and effects. Results: The map is based on 116 systematic reviews and 44 meta-analyses. Most of the reviews were published in the last 5 years. The most researched interventions were Tai Chi and Qi Gong. The reviews presented the following quality assessment: 80 high, 43 moderate, 23 low, and 14 critically low. Every 680 distinct outcome effect was classified: 421 as potential positive; 237 as positive; 21 as inconclusive/mixed; one potential negative and none no effect. Positive effects were related to chronic diseases; mental indicators and disorders; vitality, well-being, and quality of life. Potential positive effects were related to balance, mobility, Parkinson's disease, hypertension, joint pain, cognitive performance, and sleep quality. Inconclusive/mixed-effects justify further research, especially in the following areas: Acupressure as Shiatsu and Tuiná for nausea and vomiting; Tai Chi and Qi Gong for acute diseases, prevention of stroke, stroke risk factors, and schizophrenia. Conclusions: The mind-body therapies from traditional Chinese medicine have been applied in different areas and this Evidence Map provides a visualization of valuable information for patients, professionals, and policymakers, to promote evidence-based complementary therapies.

Project description:Importance:Mind-body therapies (MBTs) are emerging as potential tools for addressing the opioid crisis. Knowing whether mind-body therapies may benefit patients treated with opioids for acute, procedural, and chronic pain conditions may be useful for prescribers, payers, policy makers, and patients. Objective:To evaluate the association of MBTs with pain and opioid dose reduction in a diverse adult population with clinical pain. Data Sources:For this systematic review and meta-analysis, the MEDLINE, Embase, Emcare, CINAHL, PsycINFO, and Cochrane Library databases were searched for English-language randomized clinical trials and systematic reviews from date of inception to March 2018. Search logic included (pain OR analgesia OR opioids) AND mind-body therapies. The gray literature, ClinicalTrials.gov, and relevant bibliographies were also searched. Study Selection:Randomized clinical trials that evaluated the use of MBTs for symptom management in adults also prescribed opioids for clinical pain. Data Extraction and Synthesis:Independent reviewers screened citations, extracted data, and assessed risk of bias. Meta-analyses were conducted using standardized mean differences in pain and opioid dose to obtain aggregate estimates of effect size with 95% CIs. Main Outcomes and Measures:The primary outcome was pain intensity. The secondary outcomes were opioid dose, opioid misuse, opioid craving, disability, or function. Results:Of 4212 citations reviewed, 60 reports with 6404 participants were included in the meta-analysis. Overall, MBTs were associated with pain reduction (Cohen d?=?-0.51; 95% CI, -0.76 to -0.26) and reduced opioid dose (Cohen d?=?-0.26; 95% CI, -0.44 to -0.08). Studies tested meditation (n?=?5), hypnosis (n?=?25), relaxation (n?=?14), guided imagery (n?=?7), therapeutic suggestion (n?=?6), and cognitive behavioral therapy (n?=?7) interventions. Moderate to large effect size improvements in pain outcomes were found for meditation (Cohen d?=?-0.70), hypnosis (Cohen d?=?-0.54), suggestion (Cohen d?=?-0.68), and cognitive behavioral therapy (Cohen d?=?-0.43) but not for other MBTs. Although most meditation (n?=?4 [80%]), cognitive-behavioral therapy (n?=?4 [57%]), and hypnosis (n?=?12 [63%]) studies found improved opioid-related outcomes, fewer studies of suggestion, guided imagery, and relaxation reported such improvements. Most MBT studies used active or placebo controls and were judged to be at low risk of bias. Conclusions and Relevance:The findings suggest that MBTs are associated with moderate improvements in pain and small reductions in opioid dose and may be associated with therapeutic benefits for opioid-related problems, such as opioid craving and misuse. Future studies should carefully quantify opioid dosing variables to determine the association of mind-body therapies with opioid-related outcomes.

Project description:PurposeWalking and mind-body therapies (MBTs) are commonly recommended to relieve pain and improve function in patients with chronic low back pain (CLBP). The purpose of this study was to compare the effectiveness of walking and MBTs in CLBP.MethodsWe included randomized controlled trials (RCTs) comparing walking or MBTs to any other intervention or control in adults with CLBP. Studies were identified through PubMed, Cochrane Library, PsycINFO, Scopus, and ScienceDirect databases. The research was limited to studies published in English and French between January 2008 and December 2018. Two reviewers independently selected the studies, extracted data, and assessed studies quality using the Physiotherapy Evidence Database (PEDro) scale. Statistical analyses were performed under a random-effects model. We analyzed pain and activity limitation, with the calculation of standardized mean differences and 95% confidence intervals for the different treatment effects.ResultsThirty one randomized controlled trials involving 3193 participants were analyzed. Walking was as effective as control interventions in the short-term and slightly superior in the intermediate term with respect to pain (Standardized mean differences (SMD) = -0.34; 95% CI, -0.65 to -0.03; P = .03) and activity limitation (SMD = -0.30; 95% CI, -0.50 to -0.10; P = .003). In contrast, yoga was more effective than control interventions in the short term in terms of pain (SMD = -1.47; 95% CI, -2.26 to -0.68; P = .0003) and activity limitation (SMD = -1.17; 95% CI, -1.80 to -0.55; P = .0002). Yoga was no longer superior to the control interventions for pain at the 6-month follow-up.ConclusionMBTs, especially yoga, seem to be more effective in the short term, and walking seems to be more effective in the intermediate term, for the relief of pain and activity limitation in patients with CLBP. A combination of walking and MBTs fits the biopsychosocial model and might be valuable therapy for CLBP throughout follow-up due to combined effects.

Project description:ImportanceTreatment of chronic low back pain (LBP) in older adults is limited by the adverse effects of analgesics. Effective nonpharmacologic treatment options are needed.ObjectiveTo determine the effectiveness of a mind-body program at increasing function and reducing pain in older adults with chronic LBP.Design, setting, and participantsThis single-blind, randomized clinical trial compared a mind-body program (n = 140) with a health education program (n = 142). Community-dwelling older adults residing within the Pittsburgh metropolitan area were recruited from February 14, 2011, to June 30, 2014, with 6-month follow-up completed by April 9, 2015. Eligible participants were 65 years or older with functional limitations owing to their chronic LBP (≥11 points on the Roland and Morris Disability Questionnaire) and chronic pain (duration ≥3 months) of moderate intensity. Data were analyzed from March 1 to July 1, 2015.InterventionsThe intervention and control groups received an 8-week group program followed by 6 monthly sessions. The intervention was modeled on the Mindfulness-Based Stress Reduction program; the control program, on the "10 Keys" to Healthy Aging.Main outcomes and measuresFollow-up occurred at program completion and 6 months later. The score on the Roland and Morris Disability Questionnaire was the primary outcome and measured functional limitations owing to LBP. Pain (current, mean, and most severe in the past week) was measured with the Numeric Pain Rating Scale. Secondary outcomes included quality of life, pain self-efficacy, and mindfulness. Intent-to-treat analyses were conducted.ResultsOf 1160 persons who underwent screening, 282 participants enrolled in the trial (95 men [33.7%] and 187 women [66.3%]; mean [SD] age,74.5 [6.6] years). The baseline mean (SD) Roland and Morris Disability Questionnaire scores for the intervention and control groups were 15.6 (3.0) and 15.4 (3.0), respectively. Compared with the control group, intervention participants improved an additional -1.1 (mean, 12.1 vs 13.1) points at 8 weeks and -0.04 (mean, 12.2 vs 12.6) points at 6 months (effect sizes, -0.23 and -0.08, respectively) on the Roland and Morris Disability Questionnaire. By 6 months, the intervention participants improved on the Numeric Pain Rating Scale current and most severe pain measures an additional -1.8 points (95% CI, -3.1 to -0.05 points; effect size, -0.33) and -1.0 points (95% CI, -2.1 to 0.2 points; effect size, -0.19), respectively. The changes in Numeric Pain Rating Scale mean pain measure after the intervention were not significant (-0.1 [95% CI, -1.1 to 1.0] at 8 weeks and -1.1 [95% CI, -2.2 to -0.01] at 6 months; effect size, -0.01 and -0.22, respectively).Conclusions and relevanceA mind-body program for chronic LBP improved short-term function and long-term current and most severe pain. The functional improvement was not sustained, suggesting that future development of the intervention could focus on durability.Trial registrationclinicaltrials.gov Identifier: NCT01405716.

Project description:BackgroundIn 2016, Oregon introduced a policy to improve back pain treatment among Medicaid enrollees by expanding benefits for evidence-based complementary and alternative medical (CAM) services and establishing opioid prescribing restrictions.ObjectiveTo examine changes in CAM utilization following the policy and variations in utilization across patient populations.DesignA retrospective study of Oregon Medicaid claims data, examining CAM therapy utilization by back pain patients pre- vs post-policy. We used an interrupted time series analysis to evaluate changes in CAM use and examined the association between patient characteristics and CAM use post-policy using linear regression models.ParticipantsAdult Medicaid patients with back pain.InterventionThe Oregon Medicaid back pain policy, administered through Coordinated Care Organizations (CCOs).Main measuresUse of CAM services.Key resultsUse of any CAM service increased from 7.9% (95% CI 7.6-8.2%) prior to the policy to 30.9% (95% CI 30.4-31.3%) after the policy. Acupuncture increased from 0.3 to 5.6%, chiropractic from 0.3 to 11.1%, massage from 1.6 to 14.8%, PT/OT from 6.0 to 17.7%, and osteopathic from 1.4 to 1.9%. Interrupted time series showed an overall increase in proportion of back pain patients who used CAM service following the policy. Among those who accessed CAM, the policy did not appear to increase the number of services used. In the post period, CAM services were accessed more often by female and older enrollees and urban populations. Black, American Indian/Alaska Native, and Hispanic enrollees were less likely to access CAM services; for Black enrollees, this was true for all types of services.ConclusionsCAM service utilization increased among back pain patients following implementation of Oregon's policy. There was significant heterogeneity in uptake across service types, CCOs, and patient subgroups. Policymakers should consider implementation factors that might limit impact and perpetuate health disparities.

Project description:The purpose of this systematic review was to assess the effects of spinal manipulative therapy (SMT), acupuncture and herbal medicine for chronic non-specific LBP. A comprehensive search was conducted by an experienced librarian from the Cochrane Back Review Group (CBRG) in multiple databases up to December 22, 2008. Randomised controlled trials (RCTs) of adults with chronic non-specific LBP, which evaluated at least one clinically relevant, patient-centred outcome measure were included. Two authors working independently from one another assessed the risk of bias using the criteria recommended by the CBRG and extracted the data. The data were pooled when clinically homogeneous and statistically possible or were otherwise qualitatively described. GRADE was used to determine the quality of the evidence. In total, 35 RCTs (8 SMT, 20 acupuncture, 7 herbal medicine), which examined 8,298 patients, fulfilled the inclusion criteria. Approximately half of these (2 SMT, 8 acupuncture, 7 herbal medicine) were thought to have a low risk of bias. In general, the pooled effects for the studied interventions demonstrated short-term relief or improvement only. The lack of studies with a low-risk of bias, especially in regard to SMT precludes any strong conclusions; however, the principal findings, which are based upon low- to very-low-quality evidence, suggest that SMT does not provide a more clinically beneficial effect compared with sham, passive modalities or any other intervention for treatment of chronic low-back pain. There is evidence, however, that acupuncture provides a short-term clinically relevant effect when compared with a waiting list control or when acupuncture is added to another intervention. Although there are some good results for individual herbal medicines in short-term individual trials, the lack of homogeneity across studies did not allow for a pooled estimate of the effect. In general, these results are in agreement with other recent systematic reviews on SMT, but in contrast with others. These results are also in agreement with recent reviews on acupuncture and herbal medicine. Randomized trials with a low risk of bias and adequate sample sizes are directly needed.

Project description:Neuropsychiatric symptoms affect 37% of US adults and present in many important diagnoses including posttraumatic stress disorder, traumatic brain injury, and chronic pain. However, these symptoms are difficult to treat with standard treatments, and patients may seek alternative options. In this study, we examined the use of mind-body therapies by adults with neuropsychiatric symptoms.We compared mind-body therapy use (biofeedback, energy healing, meditation, guided imagery, yoga, deep-breathing exercises, hypnosis, progressive relaxation therapy, qigong, and tai chi) between adults with and without neuropsychiatric symptoms (anxiety, depression, insomnia, headaches, memory deficits, attention deficits, and excessive daytime sleepiness) in the 2007 National Health Interview Survey (N = 23,393). Use of ≥ 1 of these therapies in the prior 12 months was the primary outcome of interest. We also examined prevalence and reasons for mind-body therapy use in adults with neuropsychiatric symptoms. We performed logistic regression to examine the association between neuropsychiatric symptoms and mind-body therapy use to adjust for sociodemographic and clinical factors.Adults with ≥ 1 neuropsychiatric symptom used mind-body therapies more than adults without symptoms (25.3% vs 15.0%, P < .001). Prevalence increased with increasing number of symptoms (21.5% for 1 symptom, 32.4% for ≥ 3 symptoms, P < .001); differences persisted after adjustment for potential confounders (odds ratios, 1.39 [95% CI, 1.26-1.53] and 2.48 [95% CI, 2.18-2.82]). Reasons for mind-body therapy use among adults with ≥ 1 symptom included the ineffectiveness or expense of conventional medicine (30.2%). Most adults (nearly 70%) with ≥ 1 symptom did not discuss their mind-body therapy use with a conventional provider.Adults with ≥ 1 neuropsychiatric symptom use mind-body therapies frequently; more symptoms are associated with increased use. Future research is needed to understand the efficacy of these therapies.

Dataset Information

Comparison of complementary and alternative medicine with conventional mind-body therapies for chronic back pain: protocol for the Mind-body Approaches to Pain (MAP) randomized controlled trial.

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Comparison of complementary and alternative medicine with conventional mind-body therapies for chronic back pain: protocol for the Mind-body Approaches to Pain (MAP) randomized controlled trial.

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