Tui na for Peripheral Neuropathy Among People With HIV

NCT ID: NCT05596123

Last Updated: 2022-10-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2025-02-01

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.

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).

Conditions

Hiv

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Therapeutic Chinese foot massage

Intervention Type: BEHAVIORAL

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.

The Placebo Massage Group

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

Group Type: PLACEBO_COMPARATOR

Placebo massage

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. have confirmed HIV diagnosis

2. 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

3. are not taking any medications, including pain medicine, to alleviate PN

4. age 18 years and older

5. can communicate with researchers in English or Mandarin Chinese

6. are not pregnant or lactating

7. are not concurrently enrolled in other clinical trials.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Houston Downtown

OTHER

Sponsor Role: lead

Responsible Party

Song Ge

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Zhu X, Ge S, Dune L, Yang C, Tian C, Wang Y. Tui Na for painful peripheral neuropathy in people with human immunodeficiency virus: A randomized, double-blind, placebo-controlled trial protocol. Front Neurol. 2023 Feb 23;14:1113834. doi: 10.3389/fneur.2023.1113834. eCollection 2023.

Reference Type: DERIVED

PMID: 36908633 (View on PubMed)

Other Identifiers

UHDowntown

Identifier Type: -

Identifier Source: org_study_id