Status:

UNKNOWN

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

Lead Sponsor:

Chang Gung Memorial Hospital

Conditions:

Myofascial Pain Syndrome

Eligibility:

All Genders

20+ years

Phase:

PHASE2

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 p...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

July 1 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 30 2021

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT04417101

Start Date

July 1 2020

End Date

June 30 2021

Last Update

June 4 2020

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