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

Primary Purpose

Peripheral Neuropathy

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Three Weekly Therapeutic Chinese Massage Sessions
Three Weekly Placebo Massage Sessions
Sponsored by
University of Houston Downtown
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Houston-Downtown

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

The Therapeutic Chinese Massage Group

The Placebo Massage Group

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Feasibility of this study design
recruitment and completion rates, patient safety, and treatment adherence and compliance

Secondary Outcome Measures

Change in Peripheral neuropathy related pain at the third visit
It will be measured by the Numeric Pain Scale
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)
Change in lower extremity functioning at the third visit
It will be measured by the Lower Extremity Functioning Scale

Full Information

First Posted
May 9, 2022
Last Updated
May 12, 2022
Sponsor
University of Houston Downtown
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1. Study Identification

Unique Protocol Identification Number
NCT05379140
Brief Title
Use Therapeutic Chinese Massage to Treat Peripheral Neuropathy in People With HIV
Official Title
Using Therapeutic Chinese Massage to Treat Peripheral Neuropathy in People With Human Immunodeficiency Virus: A Randomized Control Trial Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 10, 2021 (Actual)
Primary Completion Date
August 10, 2022 (Anticipated)
Study Completion Date
November 10, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Houston Downtown

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The Therapeutic Chinese Massage Group
Arm Type
Experimental
Arm Description
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.
Arm Title
The Placebo Massage Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Three Weekly Therapeutic Chinese Massage Sessions
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Three Weekly Placebo Massage Sessions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of this study design
Description
recruitment and completion rates, patient safety, and treatment adherence and compliance
Time Frame
through study completion, an average of one year
Secondary Outcome Measure Information:
Title
Change in Peripheral neuropathy related pain at the third visit
Description
It will be measured by the Numeric Pain Scale
Time Frame
Through study completion, an average of one year
Title
Change in health related quality of life at the third visit
Description
It will be measured by the Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36)
Time Frame
Through study completion, an average of one year
Title
Change in lower extremity functioning at the third visit
Description
It will be measured by the Lower Extremity Functioning Scale
Time Frame
Through study completion, an average of one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Houston-Downtown
City
Houston
State/Province
Texas
ZIP/Postal Code
77002
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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