End Stage Chronic Renal Failure, Myofacial Pain
Conditions
Brief summary
To evaluate the effect of a traditional Chinese medicine (TCM) intervention on pain relief, mood and quality of life (QOL) in hemodialytic patients at a dialysis center in Southern Taiwan.
Interventions
OTHERArtemisias-ginger patch (AGP)
The TCM powder using extract powder that consists of Draconis Sanguis, Rz. Zingiberis Recens, and Artemisia princeps had been formulated into uniform 3X3 cm patch under the supervision of senior pharmacists. The 3 acupoints applied by study drug were LI 10, LU 5 and TE 5 with HD three times a week for 4 weeks.
OTHERSham (No Treatment)
The sham HAT was applied on 3 acupoints including LI 10, LU 5 and TE 5 with HD three times a week for 4 weeks.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* maintenance HD \> 6 months , * reporting fistula pain during HD sessions that was associated with a hypersensitive palpable nodule in a taut band, at least 6 times in the past month, * a NRS pain score \>4, * no changes in pain relievers such as NSAIDs, opioids, topical ointments, or muscle relaxants over the past week, * voluntarily agreed to participate in the trial and presented written informed consent.
Exclusion criteria
* severe comorbid organ dysfunction, * existence of cervical radiculopathy or thoracic outlet syndrome * inflammation of the skin or soft tissue at the fistula site, * dementia, * psychiatric diseases, * allergy to herbal patch * currently participating in other clinical studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory (BPI) | Weeks 0 (baseline), 2, 4, and 6 (2 weeks of follow-up) | Pain severity and interference are rated on a numerical rating scale (NRS) from 0 ("no pain"/"does not interfere") to 10 ("worst imaginable pain"/"completely interferes"). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Questionnaire Depression Rating Scale (PHQ-9) | Week 0 (baseline) and 4 | PHQ-9 is a 9-item, self-administered diagnostic tool used to screen for, diagnose, monitor, and measure the severity of depression in primary care and mental health settings. It scores symptoms based on the DSM-5 criteria over the past two weeks, with a total score ranging from 0 to 27. |
| EuroQol-5-dimension questionnaire (EQ-5D) | Week 0(baseline) and 4 | The EQ-5D consists of five dimensions that are rated on a 3-point scale, where lower scores indicate better health status |
Countries
Taiwan
Outcome results
None listed