NCT04417101

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2020

Shorter than P25 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
27 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

June 4, 2020

Status Verified

May 1, 2020

Enrollment Period

12 months

First QC Date

May 27, 2020

Last Update Submit

June 2, 2020

Conditions

Myofascial Pain Syndrome

Outcome Measures

Primary Outcomes (1)

  • Quality of life during dialysis

    Kidney Disease Quality of Life 36-Item Short-Form Survey

    1 year

Secondary Outcomes (3)

  • Motor function of upper limb

    1 year

  • Muscle power

    1 year

  • Pain score during dialysis

    1 year

Study Arms (2)

JBT treatment

EXPERIMENTAL

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

No treatment

NO INTERVENTION

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

Interventions

Chinese HerbDRUG

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.

JBT treatment

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 36062127DERIVED

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Ephedrae herba

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Study Officials

  • Ming-Yen C Tsai

    長庚紀念醫院

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Yen C Tsai

CONTACT

+886975056534missuriae@yahoo.com.tw

Hwee-Yeong C Ng

CONTACT

+886975056085kujiben@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2020

First Posted

June 4, 2020

Study Start

July 1, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

June 4, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share