Dataset Information

Comparative Effectiveness of Chuna Manipulative Therapy for Non-Acute Lower Back Pain: A Multi-Center, Pragmatic, Randomized Controlled Trial.

ABSTRACT: Current evidence on the effectiveness and safety of Chuna manipulative therapy (CMT) for managing non-acute lower back pain (LBP) is insufficient. We investigated the comparative effectiveness and safety of CMT, a Korean style of manipulation, plus usual care (UC) compared to UC alone for non-acute LBP. We conducted a parallel, two-armed, multi-centered, assessor blinded, pragmatic, randomized controlled trial at four major Korean medical hospitals. Overall, 194 patients were randomly allocated to either CMT plus UC (n = 97) or UC alone (n = 97), for six weeks of treatment and six months follow-up. The primary outcome was measured using the numerical rating scale (NRS) of LBP intensity at 7 weeks. Secondary outcomes included NRS of leg pain, Oswestry Disability Index (ODI) for functional disability, patient global impression of change (PGIC) scale, and safety. A total of 194 patients were included in the intention-to-treat analysis, and 174 patients provided complete data for the primary outcome. At 7 weeks, clinically significant differences between groups were observed in the NRS of LBP (CMT + UC: -3.02 ± 1.72, UC: -1.36 ± 1.75, p < 0.001), ODI scores (CMT + UC: -5.65 ± 4.29, UC: -3.72 ± 4.63, p = 0.003), NRS of leg pain (CMT + UC: -2.00 ± 2.33, UC: -0.44 ± 1.86, p < 0.0001), and PGIC (CMT + UC: -0.28 ± 0.85, UC: 0.01 ± 0.66, p = 0.0119). Mild to moderate safety concerns were reported in 21 subjects. CMT plus UC showed higher effectiveness compared to UC alone in patients with non-acute LBP in reducing LBP and leg pain and in improving function with good safety results using a powered sample size and including mid-term follow-up.

SUBMITTER: Park SY

PROVIDER: S-EPMC7019562 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Comparative Effectiveness of Chuna Manipulative Therapy for Non-Acute Lower Back Pain: A Multi-Center, Pragmatic, Randomized Controlled Trial.

Park Sun-Young SY Hwang Eui-Hyoung EH Cho Jae-Heung JH Kim Koh-Woon KW Ha In-Hyuk IH Kim Me-Riong MR Nam Kibong K Lee Min Ho MH Lee Jun-Hwan JH Kim Namkwen N Shin Byung-Cheul BC

Journal of clinical medicine 20200105 1

Current evidence on the effectiveness and safety of Chuna manipulative therapy (CMT) for managing non-acute lower back pain (LBP) is insufficient. We investigated the comparative effectiveness and safety of CMT, a Korean style of manipulation, plus usual care (UC) compared to UC alone for non-acute LBP. We conducted a parallel, two-armed, multi-centered, assessor blinded, pragmatic, randomized controlled trial at four major Korean medical hospitals. Overall, 194 patients were randomly allocated ...[more]

PMID: 31948083

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Project description:BACKGROUND:Neck pain is a highly prevalent medical condition that incurs substantial social burden. Although manual therapy is widely used for treatment of neck pain, the body of evidence supporting its effectiveness and safety is not conclusive. The aim of this study is to examine the effect, safety, and cost-effectiveness of Chuna manual therapy, a traditional Korean manual therapy for treatment of various musculoskeletal complaints. METHODS/DESIGN:This study is the protocol for a two-armed parallel, assessor-blinded, multicenter, randomized controlled trial. A total 108 patients with chronic neck pain (time to onset ??3 months, numeric rating scale [NRS] of neck pain ??5) will be recruited at five Korean medicine hospital sites. Participants will be allotted to one of two groups (n =?54, respectively): the Chuna manual therapy group, and the usual care (conventional physical therapy and medication treatment) group. Ten sessions of Chuna manual therapy or usual care will be administered twice a week for five weeks. Since the study design does not permit patient or physician blinding, the outcome assessor and statistician will be blinded. The primary outcome will be the visual analogue scale (VAS) of neck pain at 5 weeks after randomization. Secondary outcomes include the VAS of radiating arm pain, NRS of neck pain and radiating arm pain, Vernon-Mior neck disability index (NDI), Northwick Park neck pain questionnaire (NPQ), EuroQol-5 Dimension (EQ-5D), EQ-VAS, patient global impression of change (PGIC), economic evaluation, adverse effects, and drug consumption. Follow-up outcome assessments will be conducted at 3, 6, 9, and 12 months after randomization. DISCUSSION:This study will evaluate the comparative effectiveness of Chuna manual therapy and usual care on chronic neck pain. Adverse events, and costs and effectiveness (utility) data will be evaluated to assess safety and exploratory cost-effectiveness (economic evaluation). This study aims to provide evidence on the effectiveness, safety, and cost-effectiveness of Chuna manual therapy. TRIAL REGISTRATION:Clinical Research Information Service (CRIS), KCT0002732 . Registered on 13 March 2018. ClinicalTrials.gov, NCT03294785 . Registered on 27 September 2017.

Project description:IntroductionMany patients experience acute lower back pain that becomes chronic pain. The proportion of patients using complementary and alternative medicine to treat lower back is increasing. Even though several moxibustion clinical trials for lower back pain have been conducted, the effectiveness and safety of moxibustion intervention is controversial. The purpose of this study protocol for a systematic review is to evaluate the effectiveness and safety of moxibustion treatment for non-specific lower back pain patients.Methods and analysisWe will conduct an electronic search of several databases from their inception to May 2017, including Embase, PubMed, Cochrane Central Register of Controlled Trial, Allied and Complementary Medicine Database, Wanfang Database, Chongqing VIP Chinese Science and Technology Periodical Database, China National Knowledge Infrastructure Database, Korean Medical Database, Korean Studies Information Service System, National Discovery for Science Leaders, Oriental Medicine Advanced Searching Integrated System, the Korea Institute of Science and Technology, and KoreaMed. Randomised controlled trials investigating any type of moxibustion treatment will be included. The primary outcome will be pain intensity and functional status/disability due to lower back pain. The secondary outcome will be a global measurement of recovery or improvement, work-related outcomes, radiographic improvement of structure, quality of life, and adverse events (presence or absence). Risk ratio or mean differences with a 95% confidence interval will be used to show the effect of moxibustion therapy when it is possible to conduct a meta-analysis.Ethics and disseminationThis review will be published in a peer-reviewed journal and will be presented at an international academic conference for dissemination. Our results will provide current evidence of the effectiveness and safety of moxibustion treatment in non-specific lower back pain patients, and thus will be beneficial to patients, practitioners, and policymakers.Trial registration numberCRD42016047468 in PROSPERO 2016.

Project description:Background contextLow back pain (LBP) is one of the leading causes of disability worldwide and among the most common reasons for seeking primary sector care. Chiropractors, physical therapists and general practitioners are among those providers that treat LBP patients, but there is only limited evidence regarding the effectiveness and economic evaluation of care offered by these provider groups.PurposeTo estimate the clinical effectiveness and to systematically review the literature of full economic evaluation of chiropractic care compared to other commonly used care approaches among adult patients with non-specific LBP.Study designSystematic reviews of interventions and economic evaluations.MethodsA comprehensive search strategy was conducted to identify 1) pragmatic randomized controlled trials (RCTs) and/or 2) full economic evaluations of chiropractic care for low back pain compared to standard care delivered by other healthcare providers. Studies published between 1990 and 4th June 2015 were considered. Primary outcomes included pain, functional status and global improvement. Study selection, critical quality appraisal and data extraction were conducted by two independent reviewers. Data from RCTs with low risk of bias were included in a meta-analysis to determine effect estimates. Cost estimates of full economic evaluations were converted to 2015 USD and results summarized using Slavin's qualitative best-evidence synthesis.ResultsSix RCTs and three full economic evaluations were scientifically admissible. Five RCTs with low risk of bias compared chiropractic care to exercise therapy (n = 1), physical therapy (n = 3) and medical care (n = 1). Overall, we found similar effects for chiropractic care and the other types of care and no reports of serious adverse events. Three low to high quality full economic evaluations studies (one cost-effectiveness, one cost-minimization and one cost-benefit) compared chiropractic to medical care. Given the divergent conclusions (favours chiropractic, favours medical care, equivalent options), mixed-evidence was found for economic evaluations of chiropractic care compared to medical care.ConclusionModerate evidence suggests that chiropractic care for LBP appears to be equally effective as physical therapy. Limited evidence suggests the same conclusion when chiropractic care is compared to exercise therapy and medical care although no firm conclusion can be reached at this time. No serious adverse events were reported for any type of care. Our review was also unable to clarify whether chiropractic or medical care is more cost-effective. Given the limited available evidence, the decision to seek or to refer patients for chiropractic care should be based on patient preference and values. Future studies are likely to have an important impact on our estimates as these were based on only a few admissible studies.

Project description:Chronic low back pain (LBP) and neck pain (NP) are highly prevalent conditions resulting in high economic costs. Treatment guidelines recommend relaxation techniques, such as progressive muscle relaxation, as adjuvant therapies. Self-care interventions could have the potential to reduce costs in the health care system, but their effectiveness, especially in a usual care setting, is unclear. The aim of these two pragmatic randomized studies is to evaluate whether an additional app-delivered relaxation is more effective in the reduction of chronic LBP or NP than usual care alone.Each pragmatic randomized two-armed study aims to include a total of 220 patients aged 18 to 65 years with chronic (>12 weeks) LBP or NP and an average pain intensity of???4 on a numeric rating scale (NRS) in the 7 days before recruitment. The participants will be randomized into an intervention and a usual care group. The intervention group will be instructed to practice one of these 3 relaxation techniques on at least 5 days/week for 15 minutes/day over a period of 6 months starting on the day of randomization: autogenic training, mindfulness meditation, or guided imagery. Instructions and exercises will be provided using a smartphone app, baseline information will be collected using paper and pencil. Follow-up information (daily, weekly, and after 3 and 6 months) will be collected using electronic diaries and questionnaires included in the app. The primary outcome measure will be the mean LBP or NP intensity during the first 3 months of intervention based on daily pain intensity measurements on a NRS (0?=?no pain, 10?=?worst possible pain). The secondary outcome parameters will include the mean pain intensity during the first 6 months after randomization based on daily measurements, the mean pain intensity measured weekly as the average pain intensity of the previous 7 days over 3 and 6 months, pain acceptance, 'LBP- and NP-related' stress, sick leave days, pain medication intake, adherence, suspected adverse reaction, and serious adverse events.The designed studies reflect a usual self-care setting and will provide evidence on a pragmatic self-care intervention that is easy to combine with care provided by medical professionals.ClinicalTrials.gov identifier Relaxback NCT02019498, Relaxneck NCT02019134 registered on 18 December 2013.

Dataset Information

Comparative Effectiveness of Chuna Manipulative Therapy for Non-Acute Lower Back Pain: A Multi-Center, Pragmatic, Randomized Controlled Trial.

Publications

Comparative Effectiveness of Chuna Manipulative Therapy for Non-Acute Lower Back Pain: A Multi-Center, Pragmatic, Randomized Controlled Trial.

Similar Datasets

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