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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Myofascial Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Chinese Herb

Intervention Type DRUG

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 treatment

Participants in the non-treatment period will receive conventional self-care management for myofascial pain syndrome.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No