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

Study Overview
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Brief Summary
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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.

Official Title
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Using Therapeutic Chinese Massage to Treat Peripheral Neuropathy in People With Human Immunodeficiency Virus: A Randomized Control Trial Pilot Study.

Conditions
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Peripheral Neuropathy

Intervention / Treatment
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* Behavioral: Three Weekly Therapeutic Chinese Massage Sessions
* Behavioral: Three Weekly Placebo Massage Sessions


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The Therapeutic Chinese Massage Group<br>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<br>* 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.<br>|
| Placebo Comparator: The Placebo Massage Group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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