Tui na for Peripheral Neuropathy Among People With HIV

University of Houston Downtown

Status: Not yet enrolling

Conditions: Hiv

Treatments: Behavioral: Therapeutic Chinese foot massage; Behavioral: Placebo massage

Study type: Interventional

Funder types: Other

Identifiers

NCT05596123

UHDowntown

Details and patient eligibility

About

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.

Full 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).

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

therapeutic Chinese foot massage (TCFM)

Experimental group

Description:

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

Treatment:

Behavioral: Therapeutic Chinese foot massage

The Placebo Massage Group

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Placebo massage