Efficacy, safety, and cost-effectiveness analysis of adjuvant herbal medicine treatment, Palmijihwang-hwan, for chronic low back pain: a study protocol for randomized, controlled, assessor-blinded, multicenter clinical trial

This study is a randomized, assessor-blinded, multicenter, clinical trial with two parallel groups. Four Korean medicine hospitals will recruit 84 participants and randomly allocate them into the control or treatment group in a 1:1 ratio. The control group will receive acupuncture treatment at 11 local and 4 distal acupuncture points for 20  min twice a week for 6 weeks. The treatment group will receive the same acupuncture treatment as the control group and also take Palmijihwang-hwan for 6 weeks. The primary outcome will be the change in visual analog scale (VAS) score between baseline (visit 1) and completion of the intervention ( visit 12), and secondary outcomes will be pain-related clinical relevance (minimal clinical important difference or the proportion of the participants who decrease more than 30, or 50% on VAS), disability (Roland and Morris Disability Questionnaire), quality of life (EuroQol-5D), global assessment ( Patient Global Impression of Change), and economic analysis (cost-effectiveness and cost-utility analysis). Additionally, safety will be assessed.DiscussionThe results of our study will provide the clinical evidence about the efficacy, safety, and cost-effectiveness analysis of Palmijihwang-hwan for CLBP. There will be a chance to provide multiple subdivided influence of this treatment with various outcome measures, but lack of placebo is our limitation.Trial registrationClinical Research Information Service,KCT0002998. Registered on 12 July 20...
Source: Trials - Category: Research Source Type: clinical trials

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Conclusion: Insomnia was associated with disability in men, whereas aging and pain severity were associated with disability in women. Catastrophic thinking was not associated with disability in both sexes. PMID: 32454923 [PubMed - in process]
Source: Pain Research and Management - Category: Anesthesiology Authors: Tags: Pain Res Manag Source Type: research
CONCLUSIONS: The ODI appears to be a similarly unidimensional and internally consistent questionnaire in both genders without any substantial variability in the items' difficulty and discrimination. CLINICAL REHABILITATION IMPACT: The ODI produces psychometrically similar results in both genders. Small and clinically hardly significant gender-related differences in the properties of ODI can be neglected. PMID: 32452663 [PubMed - as supplied by publisher]
Source: European Journal of Physical and Rehabilitation Medicine - Category: Rehabilitation Authors: Tags: Eur J Phys Rehabil Med Source Type: research
Condition:   Low Back Pain Intervention:   Behavioral: Pain Neuroscience Education (PNE) Sponsor:   University of Utah Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
This study aimed to determine the predictors of fear-avoidance beliefs, pain, and disability indices in patients with chronic low back pain (LBP).Subjects and MethodsA cross-sectional study was carried out on patients with chronic LBP attending the rheumatology outpatient clinics at Suez Canal University Hospital. Convenience sampling was used, and the main outcome measures were fear-avoidance beliefs, pain, and disability indices, which were measured using structured questionnaires.ResultsMean age was 47  ± 13.4 years; mean body mass index (BMI) was 30.4 ± 5.47. Mean scores of the...
Source: Journal of Public Health - Category: Health Management Source Type: research
This clinical trial evaluated the independent and combined effects of a tricyclic antidepressant (desipramine) and cognitive behavioral therapy (CBT) for chronic back pain relative to an active placebo treatment. Participants (n = 142) were patients experiencing daily chronic back pain at an intensity of ≥4/10 who were randomized to a single-center, double-blind, 12-week, 4-arm, parallel groups controlled clinical trial of (1) low concentration desipramine titrated to reach a serum concentration level of 15 to 65 ng/mL; (2) CBT and active placebo medication (benztropine mesylate, 0.125 mg); (3) low concentration desipra...
Source: Pain - Category: Anesthesiology Tags: Research Paper Source Type: research
Weng and colleagues must be commended for their attempts to clarify the benefit/harm ratio of duloxetine in osteoarthritis and chronic low back pain1. Indeed, the high number of therapeutic options available shows the state of affairs is a lottery while these frequent conditions “associated with substantial work disability, morbidity, costs, and increased mortality rates” deserve robust evidence2. However, their conclusion “Duloxetine had modest to moderate effects… with mild adverse events” claiming “future randomized controlled trials should focus on comparing duloxetine…” deserves scrutiny.
Source: Osteoarthritis and Cartilage - Category: Rheumatology Authors: Tags: Letter to the Editor Source Type: research
Patients with chronic low back pain with higher levels of kinesiophobia have a 41% greater risk of developing a physical disability. The kinesiophobia model suggests that patients fear movements because of pain, associating movement with worsening of their state. Studies that apply the Pilates method for chronic low back pain achieve positive results in reducing pain and disability, and moderate results regarding kinesiophobia.
Source: Journal of Bodywork and Movement Therapies - Category: Physiotherapy Authors: Tags: Prevention and Rehabilitation Source Type: research
Low back pain is highly prevalent and a major source of disability worldwide. Spa therapy is frequently used to treat low back pain, but the associated level of evidence for efficacy is insufficient. To fill t...
Source: Trials - Category: General Medicine Authors: Tags: Study protocol Source Type: research
ConclusionTFF seems to be a powerful technique for lumbar spine stabilization in patients with chronic mechanical LBP related to lumbar MI. CT-guided technique is fast, precise, and safe and can be performed in simple analgo-sedation.
Source: Neuroradiology - Category: Radiology Source Type: research
CONCLUSION: Acupressure is a feasible, effective, safe, low cost nonpharmacologic method to treat CLBP. PMID: 32379678 [PubMed - as supplied by publisher]
Source: Complementary Therapies in Clinical Practice - Category: Complementary Medicine Authors: Tags: Complement Ther Clin Pract Source Type: research
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