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

Myofascial Pain Syndrome Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04417101
• Other study ID #: 202000477A3
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: May 2020
• Source: Chang Gung Memorial Hospital
• Contact: Ming-Yen C Tsai
• Phone: +886975056534
• Email: missuriae[@]yahoo.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life during dialysis	Kidney Disease Quality of Life 36-Item Short-Form Survey	1 year
Secondary	Motor function of upper limb	Fugl-Meyer Assessment for upper extremity	1 year
Secondary	Muscle power	Gripping algometer	1 year
Secondary	Pain score during dialysis	Visual Analogue Scale (0-100)	1 year