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

Chang Gung Memorial Hospital21 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

End Stage Chronic Renal Failure Myofacial Pain

Interventions

Artemisias-ginger patch (AGP)OTHER

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.

Sham (No Treatment)OTHER

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Chang Gung Memorial Hospital in Kaohsiung branch

Kaohsiung City, Taiwan

Outcomes

Primary Outcomes

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").

Time frame: Weeks 0 (baseline), 2, 4, and 6 (2 weeks of follow-up)

Secondary Outcomes

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.

Time frame: 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

Time frame: Week 0(baseline) and 4

Data from ClinicalTrials.gov

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