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

A Prospective Randomized Crossover Trial to Explore the Tolerability, Safety and Effectiveness of Chinese Herbal Medicine Among Patients With Dialysis-related Myofascial Pain

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.

Study Overview

• Status: Unknown
• Conditions: Myofascial Pain Syndrome
• Intervention / Treatment: Drug: Chinese Herb

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: JBT treatment; 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; 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.
NO_INTERVENTION: No treatment; 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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Ming-Yen C Tsai, 長庚紀念醫院

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2020
• Primary Completion (ANTICIPATED): June 30, 2021
• Study Completion (ANTICIPATED): June 30, 2021

Study Registration Dates

• First Submitted: May 27, 2020
• First Submitted That Met QC Criteria: June 2, 2020
• First Posted (ACTUAL): June 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 2, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 202000477A3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No