Tui na for Peripheral Neuropathy Among People With HIV

NCT05596123 | Unknown

• 1 other identifier: UHDowntown
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hiv

Outcome Measures

Primary Outcomes (2)

• Lower extremity pain

  The numeric pain scale has a score range between 0 and 10. A higher score indicates more pain.

  at 6 months

• Lower extremity functioning

  The lower extremity functioning scale has a score range between 0 and 80. A higher score indicates better functioning.

  at 6 months

Study Arms (2)

therapeutic Chinese foot massage (TCFM)

EXPERIMENTAL

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

The Placebo Massage Group

PLACEBO COMPARATOR

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

Behavioral: Placebo massage

Interventions

Therapeutic Chinese foot massage 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.

therapeutic Chinese foot massage (TCFM)

Placebo massage 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.

The Placebo Massage Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Houston Downtown: lead

Related Publications (1)

• 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.

  PMID: 36908633 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants, the outcome assessors, and the statistician will be unaware of the group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 27, 2022
• Study Start: February 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: October 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share