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

Peripheral Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05379140
• Other study ID #: CPHS #44-21
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 10, 2021
• Est. completion date: November 10, 2022

Study information

• Verified date: May 2022
• Source: University of Houston Downtown
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: November 10, 2022
• Est. primary completion date: August 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Houston-Downtown	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Houston Downtown

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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