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

The Herbal Acupoint Patch for Improving Pain, Depression, and Quality of Life in Dialysis Patient With Fistula-related Pain: Holistic Study for A Double-blind Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Myofacial Pain; End Stage Chronic Renal Failure
• Intervention / Treatment: Other: Sham (No Treatment); Other: Artemisias-ginger patch (AGP)

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung City, Taiwan, 83301
    • Chang Gung Memorial Hospital in Kaohsiung branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham (No Treatment)	Other: Sham (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.
Experimental: Artemisias-ginger patch (AGP)	Other: Artemisias-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Pain Inventory (BPI)	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").	Weeks 0 (baseline), 2, 4, and 6 (2 weeks of follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Questionnaire Depression Rating Scale (PHQ-9)	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.	Week 0 (baseline) and 4
EuroQol-5-dimension questionnaire (EQ-5D)	The EQ-5D consists of five dimensions that are rated on a 3-point scale, where lower scores indicate better health status	Week 0(baseline) and 4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Routine blood analysis	The outine blood analysis includes CBC, Kt/V, K, Ca, P, K, albumin, hsCRP, AST, and ALT.	Week 0(baseline) and 4
Total number of analegics use in all HD sessions	Frequency of pain management including local analgesics, cryotherapy and oral painkillers during each dialysis was assessed within 12 sessions of study and was calculated by the number of participants in total.	Week 4
Total number of early termination of hemodialysis	Total number of stopping the dialysis machine before the scheduled time (e.g., less than 4 hours) during 4-week treatment	Week 4

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2024
• Primary Completion (Actual): August 31, 2025
• Study Completion (Actual): August 31, 2025

Study Registration Dates

• First Submitted: January 16, 2026
• First Submitted That Met QC Criteria: January 24, 2026
• First Posted (Actual): February 2, 2026

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 24, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pain; Neurologic Manifestations; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Renal Insufficiency, Chronic; Facial Pain; salicylhydroxamic acid
• Other Study ID Numbers: 202302043A3C501; CORPG8N0441 (Other Grant/Funding Number: Chang Gung Memorial Hospital in Kaohsiung branch)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data is being compiled and is expected to be submitted.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No