Tui na for Peripheral Neuropathy Among People With HIV

Hiv Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05596123
• Other study ID #: UHDowntown
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: February 1, 2025

Study information

• Verified date: October 2022
• Source: University of Houston Downtown
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hiv
• Peripheral Nervous System Diseases

Intervention

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 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Houston Downtown

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower extremity pain	The numeric pain scale has a score range between 0 and 10. A higher score indicates more pain.	at 6 months
Primary	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