Tui na for Peripheral Neuropathy Among People With HIV

Not Applicable

Not yet recruiting

• Conditions: Hiv
• Interventions: Behavioral: Therapeutic Chinese foot massage; Behavioral: Placebo massage

• Registration Number: NCT05596123
• Lead Sponsor: University of Houston Downtown

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).

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-17
• Study First Submitted QC: 2022-10-20
• Last Update Submitted: 2022-10-26
• Study First Posted: 2022-10-27
• Last Update Posted: 2022-10-28
• Study Start: 2023-02-01
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
therapeutic Chinese foot massage (TCFM)	Therapeutic Chinese foot massage	A one-to-one ratio will be used to randomly assign participants to the TCFM group or the placebo massage group.
The Placebo Massage Group	Placebo massage	Six weekly 25-minute TCFM sessions will be delivered to participants in the TCFM group.

Primary Outcome Measures

Name	Time	Method
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.