A Comparative Study of the Effectiveness of Pharmacopuncture Therapy for Chronic Neck Pain: A Pragmatic, Randomized, Controlled Trial.
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ABSTRACT: Background
This two-arm, parallel, pragmatic, multicenter, clinical randomized, controlled trial with a 12-week follow-up period aimed to compare the effectiveness of pharmacopuncture therapy and physical therapy strategies for chronic neck pain.Methods
Eight sessions of pharmacopuncture therapy or physical therapy were administered within 2 weeks. The primary outcome was the visual analogue scale (VAS) score for neck pain. The secondary outcomes were the scores of the Northwick Park questionnaire (NPQ), VAS score for radiating arm pain, numeric rating scale (NRS) for neck and arm bothersomeness, neck disability index (NDI), patient global impression of change (PGIC), 12-item short form health survey (SF-12), and EuroQoL 5-dimension 5-level (EQ-5D-5L) instrument. The protocol was registered with Clinicaltrials.gov (NCT04035018) and CRIS (KCT0004243).Results
We randomly allocated 101 participants with chronic neck pain to the pharmacopuncture therapy (n = 50) or physical therapy group (n = 51). At the primary endpoint (week 5) the pharmacopuncture therapy group showed significantly superior effects regarding VAS score for neck pain and arm bothersomeness, NRS for neck pain, NDI, NPQ, and PGIC compared with the physical therapy group. These effects were sustained up to 12 weeks after follow-up.Conclusion
Compared with physical therapy, pharmacopuncture therapy had superior effects on the pain and functional recovery of patients with chronic neck pain.
SUBMITTER: Park KS
PROVIDER: S-EPMC8745044 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundNeck 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.MethodsThis 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.DiscussionThis 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.
| S-EPMC7402875 | biostudies-literature
Project description:PurposeChronic low back pain (LBP) is a common musculoskeletal disorder that affects everyday life; moreover, it occasionally causes disability and increases medical expenditure. This pragmatic randomized clinical trial aims to investigate the effects of pharmacopuncture on chronic LBP by comparing the effectiveness of pharmacopuncture and physiotherapy strategies.Patients and methodsIn this two-armed, parallel, multi-center randomized controlled study, the participants will randomly undergo 10 sessions of pharmacopuncture therapy or physiotherapy over five weeks based on the randomization outcomes. The primary outcome will be the numeric rating scale (NRS) score of LBP. The secondary outcomes will include the NRS score of radiating leg pain, visual analog scale (VAS) score of LBP and radiating leg pain, Oswestry disability index, the Korean version of the Roland-Morris disability questionnaire, patient global impression of change (PGIC), short Form-12 health survey version 2, and 5-level EuroQol-5 dimension (EQ-5D-5L).ConclusionThis protocol aims to examine the comparative effectiveness of pharmacopuncture, which is a widely used therapy in Korean medicine, with respect to the standard therapy through a pragmatic randomized controlled trial to present useful data to facilitate clinical or policy decision making.Trial registrationClinicaltrials.gov (NCT04833309); Clinical Research Information Service (KCT0006088).
| S-EPMC9443996 | biostudies-literature
Project description:BackgroundThis study aimed to evaluate the cost utility of pharmacopuncture in comparison with usual care for patients with chronic neck pain.MethodsA 12-week, multicenter, pragmatic randomized controlled trial was conducted, and 101 patients suffering from chronic neck pain for more than six months were randomly placed into the pharmacopuncture and usual care groups to receive four weeks of treatment and 12 weeks of follow-up observations. The quality-adjusted life year (QALY) was calculated using EQ-5D and SF-6D. Concerning costs in 2019, a primary analysis was performed on societal perspective cost, and an additional analysis was performed on healthcare perspective cost.ResultsCompared to usual care, pharmacopuncture was superior as it showed a slightly higher QALY and a lower incremental cost of $1,157 from a societal perspective. The probability that pharmacopuncture would be more cost-effective at a willingness-to-pay (WTP) of $26,374 was 100%. Pharmacopuncture was also superior from a healthcare perspective, with a lower incremental cost of $26. The probability that pharmacopuncture would be more cost-effective at a WTP of $26,374 was 83.7%.ConclusionsOverall, pharmacopuncture for chronic neck pain was found to be more cost-effective compared to usual care, implying that clinicians and policy makers should consider new treatment options for neck pain.Trial registrationNumber NCT04035018 (29/07/2019) Clinicaltrials.gov; Number KCT0004243 (26/08/2019) Clinical Research Information Service.
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Project description:BackgroundAlthough several studies have reported the effectiveness of acupuncture treatment for adhesive capsulitis (AC), research on pharmacopuncture therapy for AC remains limited. We compared the effectiveness and safety of pharmacopuncture and physiotherapy for AC.MethodsThis pragmatic, randomized, controlled, parallel-group pilot study enrolled patients with limitations of shoulder movement and a numeric rating scale (NRS) score for shoulder pain ≥5 randomized (1:1) to the pharmacopuncture therapy (PPT) and physiotherapy (PT) groups. Treatment sessions were administered twice weekly for 6 weeks, and the participants were followed up for 13 weeks after randomization. The primary outcome was the NRS score for shoulder pain, and the secondary outcomes were the visual analog scale (VAS), Shoulder Pain and Disability Index (SPADI), range of motion (ROM), patient global impression of change (PGIC), EuroQol 5-Dimension 5-Level (EQ-5D-5L), and Short Form 12 Health Survey (SF-12) scores. The intention-to-treat (ITT) analysis was set as the primary analysis.ResultsAmong 50 participants, for the primary endpoint (week 7) the PPT group showed a significantly superior improvement in NRS, VAS, SPADI, ROM for flexion, ROM for abduction, and EQ-5D-5L scores. The ROM for extension, ROM for adduction, physical component summary, and patient global impression of change were significantly better in the PPT than in the PT group, and these effects were sustained until week 13.ConclusionIn this pilot study, PPT showed better effects than PT, confirming the feasibility of a follow-up main study.Trial registrationClinicaltrials.gov (NCT05292482) and cris.nih.go.kr (KCT0007198).
| S-EPMC11367127 | biostudies-literature
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.
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Project description: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.
| S-EPMC7019562 | biostudies-literature
Project description:This study aimed to compare the cost-effectiveness of manual therapy and usual care for patients with chronic neck pain. A cost-utility analysis alongside a pragmatic randomized controlled trial was conducted in five South Korean hospitals. Data were procured from surveys and nationally representative data. Participants were 108 patients aged between 19 and 60 years, with chronic neck pain persisting for at least 3 months and a pain intensity score of ≥5 on the numerical rating scale in the last 3 days. The study was conducted for 1 year, including 5 weeks of intervention and additional observational periods. Participants were divided into a manual therapy (Chuna) group and a usual care group, and quality-adjusted life-years, costs, and the incremental cost-effectiveness ratio were calculated. The quality-adjusted life-years of the manual therapy group were 0.024 higher than that of the usual care group. From the societal perspective, manual therapy incurred a lower cost-at $2,131-and was, therefore, the more cost-effective intervention. From a healthcare system perspective, the cost of manual therapy was higher, with an incremental cost-effectiveness ratio amount of $11,217. Manual therapy is more cost-effective for non-specific chronic neck pain management from both a healthcare system and societal perspective.
| S-EPMC9131099 | biostudies-literature
Project description:Background: This study investigated the effectiveness and safety of pharmacopuncture for pain relief and functional improvement in patients with traffic accident (TA)-induced acute tension headaches. Methods: The study employed a parallel, single-centered, pragmatic, randomized controlled trial design. Eighty patients complaining of acute tension headaches were randomized into the integrative Korean medicine treatment (IKM treatment) group and the pharmacopuncture group on suboccipital muscles (suboccipital muscles pharmacopuncture + IKM treatment), with 40 participants assigned to each group. The patients in the pharmacopuncture group underwent pharmacopuncture as an add-on therapy, consisting of three sessions. Both groups were reassessed 2 months post-intervention. To assess the outcomes, the Numeric Rating Scale (NRS) for Headache, NRS for Neck Pain, Headache Disability Index, Headache Impact Test-6, EuroQol 5-Dimension, and Patient Global Impression of Change were used. Results: The improvement in the outcomes of the pharmacopuncture group was significantly greater than that of the comparison group on day 4 of hospitalization in terms of pain (difference in NRS of headache -2.59, 95% CI -3.06 to -2.12; NRS of Neck pain -1.05, 95% CI -1.50 to -0.59) and function (difference in HDI -24.78, 95% CI, -31.79 to -17.76; HIT-6 -6.13, 95% CI, -9.47 to -2.78). Additionally, in 2 months of follow-up, the recovery rate of headache was significantly higher in the pharmacopuncture group than in the comparison group. Conclusions: The pharmacopuncture group demonstrated superior outcomes in symptom improvement than the comparison group did, providing insights into novel and useful applications of pharmacopuncture in the clinical practice of Korean medicine.
| S-EPMC11312919 | biostudies-literature
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.
| S-EPMC4301893 | biostudies-literature
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.
| S-EPMC8783271 | biostudies-literature