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A study on the effectiveness of pharmacopuncture for chronic neck pain: A protocol for a pragmatic randomized controlled trial.

ABSTRACT: BACKGROUND:Neck pain is a common musculoskeletal disorder that impacts individuals' daily life, and might sometimes lead to disability and increased medical costs. Pharmacopuncture combines acupuncture with herbal medicine, in which herbal extracts are administered on the acupoints. We designed a pragmatic randomized controlled trial (RCT) to compare the effectiveness of pharmacopuncture and physical therapy as a treatment for chronic neck pain. METHODS:This study is a 2-armed, parallel, multi-center RCT. The participants will be randomly assigned to pharmacopuncture or physical therapy group to receive their respective 8-session treatments for 4 weeks. The primary outcome is the visual analogue scale of neck pain. Secondary outcomes is the Northwick Park questionnaire, visual analogue scale of radiating arm pain, numeric rating scale of the neck and arm bothersomeness, neck disability index, patient global impression of change, short form-12 health survey version 2, and 5-level EuroQol-5 dimension. DISCUSSION:This is a protocol for a pragmatic RCT that would attempt to present evidence conducive to clinical decision or policy-making by investigating the effectiveness of pharmacopuncture therapy, a widely used approach in Korean medicine clinical practice, in comparison to the standard therapy.

SUBMITTER: Park KS

PROVIDER: S-EPMC7402875 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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A study on the effectiveness of pharmacopuncture for chronic neck pain: A protocol for a pragmatic randomized controlled trial.

Park Kyoung Sun KS Lee Yoon Jae YJ Lee Jinho J Ha In-Hyuk IH

Medicine 20200701 31

<h4>Background</h4>Neck pain is a common musculoskeletal disorder that impacts individuals' daily life, and might sometimes lead to disability and increased medical costs. Pharmacopuncture combines acupuncture with herbal medicine, in which herbal extracts are administered on the acupoints. We designed a pragmatic randomized controlled trial (RCT) to compare the effectiveness of pharmacopuncture and physical therapy as a treatment for chronic neck pain.<h4>Methods</h4>This study is a 2-armed, pa ...[more]

PMID: 32756138

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Project description:BackgroundNeck 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/designThis 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.DiscussionThis 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 registrationClinical Research Information Service (CRIS), KCT0002732 . Registered on 13 March 2018. ClinicalTrials.gov, NCT03294785 . Registered on 27 September 2017.

Project description:BackgroundChronic 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.Methods/designEach 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.DiscussionThe 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.Trial registrationClinicalTrials.gov identifier Relaxback NCT02019498, Relaxneck NCT02019134 registered on 18 December 2013.

Project description:BackgroundChronic neck pain is a highly prevalent condition. Learning a relaxation technique is recommended by numerous guidelines for chronic neck pain. Smartphone apps can provide relaxation exercises; however, their effectiveness, especially in a self-care setting, is unclear.ObjectiveThe aim of this pragmatic randomized trial is to evaluate whether app-based relaxation exercises, including audio-based autogenic training, mindfulness meditation, or guided imagery, are more effective in reducing chronic neck pain than usual care alone.MethodsSmartphone owners aged 18 to 65 years with chronic (>12 weeks) neck pain and the previous week's average neck pain intensity ≥4 on the Numeric Rating Scale (0=no pain to 10=worst possible pain) were randomized into either an intervention group to practice app-based relaxation exercises or a control group (usual care and app for data entry only). For both groups, the follow-up data were collected using app-based diaries and questionnaires. The primary outcome was the mean neck pain intensity during the first 3 months based on daily measurements. Secondary outcomes included neck pain based on weekly measurements, pain acceptance, neck pain-related stress, sick-leave days, pain medication intake, and adherence, which were all measured until the 6-month follow-up. For the primary analysis, analysis of covariance adjusted for baseline neck pain intensity was used.ResultsWe screened 748 participants and enrolled 220 participants (mean age 38.9, SD 11.3 years; mean baseline neck pain 5.7, SD 1.3 points). The mean neck pain intensity in both groups decreased over 3 months; however, no statistically significant difference between the groups was found (intervention: 4.1 points, 95% CI 3.8-4.4; control: 3.8 points, 95% CI 3.5-4.1; group difference: 0.3 points, 95% CI -0.2 to 0.7; P=.23). In addition, no statistically significant between-group differences regarding neck pain intensity after 6 months, responder rate, pain acceptance, pain medication intake, or sick-leave days were observed. There were no serious adverse events that were considered related to the trial intervention. In week 12, only 40% (44/110) of the participants in the intervention group continued to practice the exercises with the app.ConclusionsThe study app did not effectively reduce chronic neck pain or keep the participants engaged in exercising in a self-care setting. Future studies on app-based relaxation interventions should take into account the most recent scientific findings for behavior change techniques.Trial registrationClinicalTrials.gov NCT02019134; https://clinicaltrials.gov/ct2/show/NCT02019134.International registered report identifier (irrid)RR2-10.1186/1745-6215-15-490.

Project description:BACKGROUND:Different types of pillows have been proposed for neck pain, but no previous randomized controlled trial has investigated the effectiveness of a "spring pillow" for adults with chronic nonspecific neck pain. OBJECTIVE:We evaluated the effectiveness of using a pillow made from viscoelastic polyurethane and 60 independent springs compared with an educational intervention in individuals with chronic nonspecific neck pain. DESIGN:This was a randomized controlled trial with crossover study design. SETTING:The setting was the Occupational Medicine Unit, University Hospital, Bologna (Italy). PARTICIPANTS:We recruited 70 adults with chronic nonspecific neck pain, of whom 64 completed the trial. INTERVENTION:Participants were randomly assigned to 2 groups. One group used the spring pillow for 4 weeks, and the other group followed educational advice for 4 weeks while continuing to use their own pillows. After 4 weeks of treatment and 4 weeks of washout, groups were crossed over. Pain perceived in the neck, thoracic, and shoulder areas and headache were the primary outcome measures. In addition, disability, sleep quality, subjective improvement, and pillow comfort were assessed. Measures were captured at pretreatment, after 4 weeks, after the 4-week washout period, and 4 weeks after crossover. The mean differences (MD) in outcomes between groups were assessed. RESULTS:Treatment with the spring pillow appeared to reduce neck pain (MD = -8.7; 95% confidence interval [CI] = -14.7 to -2.6), thoracic pain (MD = -8.4; 95% CI = -15.2 to -1.5), and headache (MD = -16.0; 95% CI = -23.2 to -8.7). Reductions in shoulder pain were not statistically significant between groups (MD = -6.9; 95% CI = -14.1-0.3). Neither the crossover sequence nor the period (first vs second intervention administration) significantly affected the results. LIMITATIONS:Education may not have been the best comparator for the spring pillow; drug consumption, actual pillow use, and the implementation of the educational suggestions as prescribed were not controlled. CONCLUSIONS:Use of the spring pillow in this study was more effective than an educational intervention for improving cervical, thoracic, and head pain. Whether a spring pillow is more effective than other ergonomic pillows remains to be tested.

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A study on the effectiveness of pharmacopuncture for chronic neck pain: A protocol for a pragmatic randomized controlled trial.

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A study on the effectiveness of pharmacopuncture for chronic neck pain: A protocol for a pragmatic randomized controlled trial.

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