Back to resultsChinese Herbal Medicine for Dialysis-related Myofascial Pain: Study Protocol for A Pilot Randomized Study
Primary Purpose
Myofascial Pain Syndrome
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Chinese Herb
Sponsored by
About this trial
This is an interventional treatment trial for Myofascial Pain Syndrome
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
JBT treatment
No treatment
Arm Description
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.
Participants in the non-treatment period will receive conventional self-care management for myofascial pain syndrome.
Outcomes
Primary Outcome Measures
Quality of life during dialysis
Kidney Disease Quality of Life 36-Item Short-Form Survey
Secondary Outcome Measures
Motor function of upper limb
Fugl-Meyer Assessment for upper extremity
Muscle power
Gripping algometer
Pain score during dialysis
Visual Analogue Scale (0-100)
Full Information
NCT ID
NCT04417101
First Posted
May 27, 2020
Last Updated
June 2, 2020
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04417101
Brief Title
Chinese Herbal Medicine for Dialysis-related Myofascial Pain: Study Protocol for A Pilot Randomized Study
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Anticipated)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
JBT treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
Participants in the non-treatment period will receive conventional self-care management for myofascial pain syndrome.
Intervention Type
Drug
Intervention Name(s)
Chinese Herb
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of life during dialysis
Description
Kidney Disease Quality of Life 36-Item Short-Form Survey
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Motor function of upper limb
Description
Fugl-Meyer Assessment for upper extremity
Time Frame
1 year
Title
Muscle power
Description
Gripping algometer
Time Frame
1 year
Title
Pain score during dialysis
Description
Visual Analogue Scale (0-100)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming-Yen C Tsai
Phone
+886975056534
Email
missuriae@yahoo.com.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Hwee-Yeong C Ng
Phone
+886975056085
Email
kujiben@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-Yen C Tsai
Organizational Affiliation
長庚紀念醫院
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36062127
Citation
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.
Results Reference
derived
Learn more about this trial
Chinese Herbal Medicine for Dialysis-related Myofascial Pain: Study Protocol for A Pilot Randomized Study
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