Chinese Herbal Medicine for Dialysis-related Myofascial Pain: Study Protocol for A Pilot Randomized Study

Study Overview
=================
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.

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

Conditions
-----------------
Myofascial Pain Syndrome

Intervention / Treatment
-----------------
* Drug: Chinese Herb


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JBT treatment<br>The participants will be instructed to take their Chinese herbal medicine formula (CHM), which named Juan Bi Tang, and take it as a dose of 3 g (per bag) each time, trice daily for 4 weeks. | Drug: Chinese Herb<br>* The participants will be instructed to take their JBT and take it as a dose of 3 g (per bag) each time, trice daily for 4 weeks.<br>|
| No Intervention: No treatment<br>Participants in the non-treatment period will receive conventional self-care management for myofascial pain syndrome. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life during dialysis | Kidney Disease Quality of Life 36-Item Short-Form Survey | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor function of upper limb | Fugl-Meyer Assessment for upper extremity | 1 year | 
| Muscle power | Gripping algometer | 1 year | 
| Pain score during dialysis | Visual Analogue Scale (0-100) | 1 year |