The Herbal Acupoint Patch for Dialysis Patient With Fistula-related Pain (Fistula Pain)

Chang Gung Medical Foundation

Status and phase: Completed; Phase 2; Phase 1

Conditions: Myofacial Pain; End Stage Chronic Renal Failure

Treatments: Other: Artemisias-ginger patch (AGP); Other: Sham (No Treatment)

Study type: Interventional

Funder types: Other

Identifiers

NCT07380581

CORPG8N0441 (Other Grant/Funding Number)

202302043A3C501

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

21 participants in 2 patient groups

Sham (No Treatment)

Sham Comparator group

Treatment:

Other: Sham (No Treatment)

Artemisias-ginger patch (AGP)

Experimental group

Treatment:

Other: Artemisias-ginger patch (AGP)