Tui na for Peripheral Neuropathy Among People With HIV

Sponsor

University of Houston Downtown (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05596123

Collaborator

(none)

120

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Peripheral neuropathy (PN) is a common neurological complication in people with human immunodeficiency virus (PHIV) with no Food and Drug Administration-approved treatment. Medications commonly used to treat HIV-related PN are not effective and have many side effects. HIV-related PN symptoms may be alleviated or treated with therapeutic Chinese foot massage (TCFM), a non-invasive, relatively safe, non-pharmacological intervention.

Condition or Disease	Intervention/Treatment	Phase
Hiv	Behavioral: Therapeutic Chinese foot massage Behavioral: Placebo massage	N/A

Detailed Description

This is a prospective, two-arm, double-blinded, randomized controlled trial. Aim: This trial aims to assess the effectiveness of TCFM on HIV-related PN in people with HIV (PHIV).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a prospective, two-arm, double-blinded, randomized controlled trial. A one-to-one ratio will be used to randomly assign participants to the TCFM group or the placebo massage group. Six weekly 25-minute TCFM sessions will be delivered to participants in the TCFM group. Six weekly 25-minute sessions of placebo massage will be delivered to participants in the placebo massage group.This is a prospective, two-arm, double-blinded, randomized controlled trial. A one-to-one ratio will be used to randomly assign participants to the TCFM group or the placebo massage group. Six weekly 25-minute TCFM sessions will be delivered to participants in the TCFM group. Six weekly 25-minute sessions of placebo massage will be delivered to participants in the placebo massage group.

Masking:

Double (Participant, Investigator)

Masking Description:

Participants, the outcome assessors, and the statistician will be unaware of the group assignment.

Primary Purpose:

Supportive Care

Official Title:

Therapeutic Chinese Foot Massage for Peripheral Neuropathy Symptoms Among People With Human Immunodeficiency Virus: A a Randomized Controlled Trial

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2025

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: therapeutic Chinese foot massage (TCFM) A one-to-one ratio will be used to randomly assign participants to the TCFM group or the placebo massage group.	Behavioral: Therapeutic Chinese foot massage Participants in the TCFM group will receive six weekly 25-minute TCFM sessions by a therapist. Each session will start with an assessment of the legs and toes of the affected extremity for broken skin and lesions, which the therapist will try to avoid. The participant will be positioned with support to their foot and legs, with the sole directed downward and the therapist directly in alignment with the soles of the foot. The therapist will sequentially perform the following four steps for each TCFM session.
Placebo Comparator: The Placebo Massage Group Six weekly 25-minute TCFM sessions will be delivered to participants in the TCFM group.	Behavioral: Placebo massage The same therapist will give six weekly 25-minute placebo massage sessions to participants in the placebo massage group. These sessions will include assessing the affected extremity's legs and toes for lesions and broken skin in order to avoid them during the massage, as well as gentle foot and toe rubbing without any point stimulation or other TCFM techniques.

Arm

Intervention/Treatment

Experimental: therapeutic Chinese foot massage (TCFM)

A one-to-one ratio will be used to randomly assign participants to the TCFM group or the placebo massage group.

Behavioral: Therapeutic Chinese foot massage

Participants in the TCFM group will receive six weekly 25-minute TCFM sessions by a therapist. Each session will start with an assessment of the legs and toes of the affected extremity for broken skin and lesions, which the therapist will try to avoid. The participant will be positioned with support to their foot and legs, with the sole directed downward and the therapist directly in alignment with the soles of the foot. The therapist will sequentially perform the following four steps for each TCFM session.

Placebo Comparator: The Placebo Massage Group

Six weekly 25-minute TCFM sessions will be delivered to participants in the TCFM group.

Behavioral: Placebo massage

The same therapist will give six weekly 25-minute placebo massage sessions to participants in the placebo massage group. These sessions will include assessing the affected extremity's legs and toes for lesions and broken skin in order to avoid them during the massage, as well as gentle foot and toe rubbing without any point stimulation or other TCFM techniques.

Outcome Measures

Primary Outcome Measures

Lower extremity pain [at 6 months]
The numeric pain scale has a score range between 0 and 10. A higher score indicates more pain.
Lower extremity functioning [at 6 months]
The lower extremity functioning scale has a score range between 0 and 80. A higher score indicates better functioning.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

have confirmed HIV diagnosis
self-report PN-related symptoms in their lower extremity, such as sharp, jabbing, throbbing, or burning pain, numbness, decreased sensation to pinprick, prickling or tingling feeling, lack of coordination and falling muscle weakness, and extreme sensitivity to touch
are not taking any medications, including pain medicine, to alleviate PN
age 18 years and older
can communicate with researchers in English or Mandarin Chinese
are not pregnant or lactating
are not concurrently enrolled in other clinical trials.

Exclusion Criteria:

People who have received any non-pharmacological interventions, including massage to treat their PN symptoms in the past six months

Contacts and Locations

Locations

No locations specified.

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:

NCT05596123

Other Study ID Numbers:

UHDowntown

First Posted:

Oct 27, 2022

Last Update Posted:

Oct 28, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Peripheral Nervous System Diseases

Study Results

No Results Posted as of Oct 28, 2022