Clinical trial NCT04417101: Chinese Herbal Medicine for Dialysis-related Myofascial Pain: Study Protocol for A Pilot Randomized Study
Official title: A Prospective Randomized Crossover Trial to Explore the Tolerability, Safety and Effectiveness of Chinese Herbal Medicine Among Patients With Dialysis-related Myofascial Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Myofascial Pain Syndrome
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Dialysis-related myofascial pain in hemodialysis (HD) patients is an important issue that is associated with many other psychosomatic problems. Effective interventions are required to alleviate pain problems in this group. Chinese herbal medicine (CHM) has been tried as a potential therapeutic method to improve pain. The aim of this study is to evaluate the effect of a CHM formula intervention on pain intensity, daily function, and quality of life, and safety among HD patients in dialysis center within a southern Taiwan context.


Eligibility criteria: Inclusion Criteria:

* Adults (aged ≥ 20 y) undergoing conventional HD three times a week via an AV fistula;
* To have myofascial trigger points (MTrPs) in one or more of the following muscles around the AV fistula: the flexor carpi radialis, palmaris longus, the pronator teres, the palmaris longus, and/or the finger flexor, diagnosed by dialysis-related myofascial pain, which must be experiencing pain during HD \[M1\];
* Onset of symptoms within 1 month before enrollment;
* Capable of giving adequate response to pain;
* Have an exquisite tenderness was found on palpation in the taut band with moderate intensity of pain at baseline (ie, a pain score \> 3 on a numeric rating scale);
* Can commit to not change their medication and dialytic method during the 10 weeks of this study.

Exclusion Criteria:

* Severe chronic or acute disease interfering with attendance for therapy;
* Have comorbid conditions such as rheumatoid arthritis, stroke, tumor, coagulopathy, chronic liver disease, radiculopathies of the upper limb, recent history of cervical/shoulder/arm surgery, or trauma;
* Have depression and/or presence of a psychiatric disorder;
* Have taken painkillers, muscle relaxant, and anti-inflammatory medications or used topical anesthetics in the past week;
* Have allergy to Chinese herbal product;
* Unable to understand or sign an informed consent form.

Primary outcomes:
measure: Quality of life during dialysis
timeFrame: 1 year
Secondary outcomes:
measure: Motor function of upper limb
timeFrame: 1 year
measure: Muscle power
timeFrame: 1 year
measure: Pain score during dialysis
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: 長庚紀念醫院
name: Ming-Yen C Tsai
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsu YT, Ng HY, Chen YH, Huang YC, Lee YY, Tsai MY. Assessing the efficacy and safety of Juan Bi Tang for dialysis-related myofascial pain in the fistula arm: Study protocol for a randomized cross-over trial. Front Public Health. 2022 Aug 19;10:925232. doi: 10.3389/fpubh.2022.925232. eCollection 2022.