Use Therapeutic Chinese Massage to Treat Peripheral Neuropathy in People With HIV

Not Applicable

• Conditions: Peripheral Neuropathy
• Interventions: Behavioral: Three Weekly Placebo Massage Sessions; Behavioral: Three Weekly Therapeutic Chinese Massage Sessions

• Registration Number: NCT05379140
• Lead Sponsor: University of Houston Downtown

Brief Summary

Background: Peripheral neuropathy (PN) occurs in half of the people with human immunodeficiency virus (PHIV). Currently, there is no Food and Drug Administration-approved treatment for HIV-related PN. Only half of PHIV who take medications report a significant reduction in pain. Therapeutic Chinese Massage, structured palpations or movements of soft tissues of the body, is a promising non-harmful, and non-costly intervention that can potentially alleviate or even treat PN but relevant research is limited.

Method: Investigators conducted a single centered, two-arm, single-blinded randomized controlled trial pilot study to examine if a series of three weekly 25-minute therapeutic Chinese massage sessions by a therapist of therapeutic Chinese massage, compared with placebo massage, could reduce PN-related pain and improve lower extremity functioning in PHIV. Twenty PHIV were recruited from the AIDS Foundation Houston, Inc in Texas. Pain, lower extremity functioning, and health-related quality of life were assessed for both groups prior to and post-massage.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-10
• Status Verified: 2022-05
• Study First Submitted: 2022-05-09
• Study First Submitted QC: 2022-05-12
• Last Update Submitted: 2022-05-12
• Study First Posted: 2022-05-18
• Last Update Posted: 2022-05-18
• Primary Completion: 2022-08-10
• Study Completion: 2022-11-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Clinical diagnosis of HIV and peripheral neuropathy have self-reported PN-related pain in lower extremity are not taking any kind of medications to alleviate PN symptoms age at least 18 years old not pregnant or lactating

Exclusion Criteria

have received any kind of massage in the past three months Can not give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The Placebo Massage Group	Three Weekly Placebo Massage Sessions	The placebo massage group received three weekly 25-minute placebo massage that included gentle rubbing to the foot and toes without point stimulation or other techniques of Chinese Massage. The control group had the opportunity to receive the treatment after the study was completed.
The Therapeutic Chinese Massage Group	Three Weekly Therapeutic Chinese Massage Sessions	Participants in the therapeutic Chinese massage group received three weekly 25-minute therapeutic Chinese massage sessions. The intervention included acupressure to points along the distal lower extremity acupuncture points of the Gall Bladder Channel (GB 40 and then 34). Further Chinese Massage incorporates kneading, rolling, movement of the ankle, rotating, pulling, and scrubbing to the lower extremity.

Primary Outcome Measures

Name	Time	Method
Feasibility of this study design	through study completion, an average of one year	recruitment and completion rates, patient safety, and treatment adherence and compliance

Secondary Outcome Measures

Name	Time	Method
Change in Peripheral neuropathy related pain at the third visit	Through study completion, an average of one year	It will be measured by the Numeric Pain Scale
Change in health related quality of life at the third visit	Through study completion, an average of one year	It will be measured by the Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36)
Change in lower extremity functioning at the third visit	Through study completion, an average of one year	It will be measured by the Lower Extremity Functioning Scale

Trial Locations

Locations (1)

University of Houston-Downtown; 🇺🇸 Houston, Texas, United States