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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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04417101
Enrollment
40
Registered
2020-06-04
Start date
2020-07-01
Completion date
2021-06-30
Last updated
2020-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myofascial Pain Syndrome

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.

Interventions

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.

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Quality of life during dialysis1 yearKidney Disease Quality of Life 36-Item Short-Form Survey

Secondary

MeasureTime frameDescription
Motor function of upper limb1 yearFugl-Meyer Assessment for upper extremity
Muscle power1 yearGripping algometer
Pain score during dialysis1 yearVisual Analogue Scale (0-100)

Contacts

Primary ContactMing-Yen C Tsai
missuriae@yahoo.com.tw+886975056534
Backup ContactHwee-Yeong C Ng
kujiben@gmail.com+886975056085

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026