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

• Sponsor: University of Houston Downtown (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05379140
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 14
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Neuropathy	Behavioral: Three Weekly Therapeutic Chinese Massage Sessions; Behavioral: Three Weekly Placebo Massage Sessions	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Using Therapeutic Chinese Massage to Treat Peripheral Neuropathy in People With Human Immunodeficiency Virus: A Randomized Control Trial Pilot Study.
• Actual Study Start Date: Sep 10, 2021
• Anticipated Primary Completion Date: Aug 10, 2022
• Anticipated Study Completion Date: Nov 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: The Therapeutic Chinese Massage Group 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; 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.
Placebo Comparator: The Placebo Massage Group 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; 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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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)

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Houston-Downtown	Houston	Texas	United States	77002

Sponsors and Collaborators

• University of Houston Downtown

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Song Ge, Assistant Professor, University of Houston Downtown
• ClinicalTrials.gov Identifier: NCT05379140
• Other Study ID Numbers: CPHS #44-21
• First Posted: May 18, 2022
• Last Update Posted: May 18, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Peripheral Nervous System Diseases

Study Results

No Results Posted as of May 18, 2022