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

NCT05379140 | Unknown

• 1 other identifier: CPHS #44-21
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• Feasibility of this study design

  recruitment and completion rates, patient safety, and treatment adherence and compliance

  through study completion, an average of one year

Secondary Outcomes (3)

• Change in Peripheral neuropathy related pain at the third visit

  Through study completion, an average of one year

• Change in health related quality of life at the third visit

  Through study completion, an average of one year

• Change in lower extremity functioning at the third visit

  Through study completion, an average of one year

Study Arms (2)

The Therapeutic Chinese Massage Group

EXPERIMENTAL

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.

Behavioral: Three Weekly Therapeutic Chinese Massage Sessions

The Placebo Massage Group

PLACEBO COMPARATOR

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.

Behavioral: Three Weekly Placebo Massage Sessions

Interventions

Three Weekly Therapeutic Chinese Massage Sessions BEHAVIORAL

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.

The Therapeutic Chinese Massage Group

Three Weekly Placebo Massage Sessions BEHAVIORAL

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 Placebo Massage Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Houston Downtown: lead

Study Sites (1)

University of Houston-Downtown

Houston, Texas, 77002, United States

Location

Related Publications (1)

• Ge S, Dune L, Liu M, Fu G, Ma H, Hu J, Lin X, Li J. Feasibility of therapeutic Chinese massage (tui na) for peripheral neuropathy among people with human immunodeficiency virus: findings of a pilot randomized controlled trial. Front Neurol. 2023 Dec 1;14:1148150. doi: 10.3389/fneur.2023.1148150. eCollection 2023.

  PMID: 38107641 DERIVED

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 18, 2022
• Study Start: September 10, 2021
• Primary Completion: August 10, 2022
• Study Completion: November 10, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)