Myofascial Pain SyndromePhase 2NCT04417101
Chinese Herbal Medicine for Dialysis-related Myofascial Pain: Study Protocol for A Pilot Randomized Study
A Phase 2 study testing Chinese Herb in people with Myofascial Pain Syndrome, run by Chang Gung Memorial Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Myofascial Pain Syndrome
- What is being tested?
- Chinese Herb
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 30 Jun 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this 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
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.
- Conditions
- Myofascial Pain Syndrome
- Being tested
- Chinese Herb
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Chinese Herb |
| No treatment | No intervention | Participants in the non-treatment period will receive conventional self-care management for myofascial pain syndrome. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life during dialysis
Kidney Disease Quality of Life 36-Item Short-Form Survey
Measured: 1 year
Secondary outcomes (3)
Motor function of upper limb
Fugl-Meyer Assessment for upper extremity
Measured: 1 year
Muscle power
Gripping algometer
Measured: 1 year
Pain score during dialysis
Visual Analogue Scale (0-100)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Jul 2020 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myofascial Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming-Yen C Tsai, Principal investigator, 長庚紀念醫院
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417101
- Sponsor's protocol ID
- 202000477A3
- Status last verified
- May 2020
- First submitted
- 27 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36062127
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04417101
- Acronym / sponsor ID
- 202000477A3
- Conditions
- Myofascial Pain Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JBT treatment | Experimental | Drug: Chinese HerbThe 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. |
| No treatment | No intervention | –Participants in the non-treatment period will receive conventional self-care management for myofascial pain syndrome. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chinese HerbThe 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. | Drug | JBT treatment |
Primary outcome
Quality of life during dialysis
Time frame: 1 year
Kidney Disease Quality of Life 36-Item Short-Form Survey
3 secondary outcomes
Motor function of upper limb
Time frame: 1 year
Muscle power
Time frame: 1 year
Pain score during dialysis
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Derived from this study: PubMed 36062127Hsu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming-Yen C Tsai principal investigator
長庚紀念醫院
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chinese Herb in people with Myofascial Pain Syndrome, run by Chang Gung Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming-Yen C Tsai (+886975056534, missuriae@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life during dialysis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04417101, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.