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Comparative effectiveness and economic evaluation of Chuna manual therapy for chronic neck pain: protocol for a multicenter randomized controlled trial.

ABSTRACT: 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.

SUBMITTER: Do HJ

PROVIDER: S-EPMC6267027 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Comparative effectiveness and economic evaluation of Chuna manual therapy for chronic neck pain: protocol for a multicenter randomized controlled trial.

Do Ho Jeong HJ Shin Joon-Shik JS Lee Jinho J Lee Yoon Jae YJ Kim Me-Riong MR Cho Jae-Heung JH Kim Koh-Woon KW Ha In-Hyuk IH

Trials 20181129 1

<h4>Background</h4>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.<h4>Methods/design</h4>This study is the protocol for ...[more]

PMID: 30497483

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Project description:ImportanceThe incidence rate of neck pain is increasing worldwide, and the disease is associated with a high social burden. Manual therapy has been widely applied in the treatment of neck pain, but a high-quality, pragmatic randomized clinical trial for this treatment has not been conducted to date.ObjectiveThis study aimed to compare the effectiveness of Chuna manual therapy with that of usual care for patients with chronic neck pain.Design, setting, and participantsA multicenter, assessor-blinded, pragmatic, randomized clinical trial was conducted between October 18, 2017, and June 28, 2019. This intention-to-treat analysis included 108 patients with chronic neck pain persisting for at least 3 months; patients were recruited from 5 hospitals in Korea.InterventionsTen sessions (2 sessions per week for 5 weeks) of Chuna manual therapy or usual care (electrotherapy and oral medication) were conducted.Main outcomes and measuresThe main outcome was the difference in visual analog scale (VAS) score for chronic neck pain between baseline and 5 weeks after randomization.ResultsThis randomized clinical trial recruited 108 patients (mean [SD] age, 38.4 [9.3] years; 73 women [67.6%]). Fifty-four patients were allocated to the Chuna therapy group, and 54 received usual care. At 5 weeks after randomization, manual therapy showed statistically superior results compared with usual care in terms of pain (difference in chronic neck pain VAS, 16.8 mm; 95% CI, 10.1-23.5 mm), function (difference in Neck Disability Index, 8.6%; 95% CI, 4.2%-13.1%), and quality of life (difference in the European Quality of Life-5 Dimension 5 Levels (EQ-5D-5L) scores, -0.07 points; 95% CI, -0.11 to -0.02 points). Regarding the 1-year cumulative values measured using area under the curve analyses, superior outcomes were attained in the manual therapy group in terms of the numerical rating scale for chronic neck pain (1.3 points; 95% CI, 0.5-2.0 points), Neck Disability Index (6.7%; 95% CI, 2.5%-10.9%), Neck Pain Questionnaire (7.4%; 95% CI, 2.3%-12.6%), and EQ-5D-5L scores (-0.03 points; -0.07 to 0.00 points).Conclusions and relevanceIn this randomized clinical trial, for patients with chronic neck pain, Chuna manual therapy was more effective than usual care in terms of pain and functional recovery at 5 weeks and 1 year after randomization. These results support the need to consider recommending manual therapies as primary care treatments for chronic neck pain.Trial registrationClinicalTrials.gov identifier: NCT03294785.

Project description:BACKGROUND:Chronic obstructive pulmonary disease (COPD) is a challenging disease whose prevalence has increased over the last decades. Non-pharmacological therapies such as pulmonary rehabilitation occupy a core position in patient management. Among these therapies, manual therapy reduces symptoms and increases exercise capacity targeting musculoskeletal problems. Chuna, a traditional Korean manual therapy, has improved pulmonary disorders in clinical practice but unfortunately has not had its effects reported. This systematic review aims to evaluate the effectiveness and safety of manual therapy, focused on the use of Chuna in the management of COPD patients. METHODS:The following databases will be used in this study: MEDLINE via PubMed, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), China National Knowledge Database (CNKI), KoreaMed, Korean Medical Database (KMbase), and Oriental Medicine Advanced Searching Integrated System (OASIS). The primary outcome comprises lung function and exercise capacity. Secondary outcomes included symptoms, quality of life, and adverse events. We will include randomized controlled trials (RCTs) and crossover studies. Two independent reviewers will screen the searched studies, determine if they are suitable for inclusion, and perform data extraction. The risk of bias will be assessed using the Cochrane risk of bias tool. When appropriate, data will be pooled across studies for meta-analysis using a fixed or random effects model. When quantitative synthesis is not appropriate, the evidence will be summarized qualitatively. RESULTS:This study will provide a comprehensive review of the available evidence to assess the efficacy of Chuna for COPD patients. Results will be published in a peer-reviewed journal and disseminated electronically and in print. CONCLUSIONS:This study will provide high-quality current evidence for evaluation the efficacy of Chuna for patients with COPD. Clinicians, patients and policy makers may find this review useful in making decisions regarding the use of Chuna for patients with COPD. PROSPERO REGISTRATION NUMBER:CRD42019141150.

Project description:IntroductionNeck pain is a global burdensome problem, with a large proportion of neck pain cases becoming chronic. Although physical exercise is a commonly prescribed treatment, the evidence on the effectiveness of isolated exercise interventions remains limited. Traditional pairwise randomised controlled trials (RCTs) and meta-analyses are limited in only comparing two interventions. This protocol describes the design of a network meta-analysis, which enables a comparative investigation of all physical exercise interventions for which RCTs are available. We aim to systematically compare the effectiveness of different types of physical exercise in people with chronic non-specific neck pain.Methods and analysisNine electronic databases (AMED, CINAHL, Cochrane Central Register of Controlled Trials, Embase, MEDLINE, Physiotherapy Evidence Database, PsycINFO, Scopus and SPORTDiscus) were searched for RCTs from inception to 12 March 2019. Titles and abstract firstly, and full-text papers secondly, will be screened by two reviewers. Data will be extracted by two reviewers. The primary outcome measure is effectiveness of the intervention. Methodological quality of included studies will be assessed by two reviewers using the PEDro scale. The overall quality of evidence will be assessed with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework, which has been adapted for network meta-analyses. The available evidence will be summarised using a network diagram. A contribution matrix will be presented to allow assessment of direct and indirect evidence. Forest plots will be constructed to visualise effects of all included exercise interventions. Pairwise effect sizes will be calculated by including all evidence available in the network. Effect measures for treatments that have not been compared in a pairwise RCT can be compared indirectly by contrasting effect sizes of comparisons with a common comparator.Ethics and disseminationThis work synthesises evidence from previously published studies and does not require ethics review or approval. A manuscript describing the findings will be submitted for publication in a peer-reviewed scientific journal.Prospero registration numberCRD42019126523.

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.

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Comparative effectiveness and economic evaluation of Chuna manual therapy for chronic neck pain: protocol for a multicenter randomized controlled trial.

Publications

Comparative effectiveness and economic evaluation of Chuna manual therapy for chronic neck pain: protocol for a multicenter randomized controlled trial.

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