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Tui na for Peripheral Neuropathy Among People With HIV

Primary Purpose

Hiv

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Therapeutic Chinese foot massage
Placebo massage
Sponsored by
University of Houston Downtown
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hiv

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    therapeutic Chinese foot massage (TCFM)

    The Placebo Massage Group

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Lower extremity pain
    The numeric pain scale has a score range between 0 and 10. A higher score indicates more pain.
    Lower extremity functioning
    The lower extremity functioning scale has a score range between 0 and 80. A higher score indicates better functioning.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 17, 2022
    Last Updated
    October 26, 2022
    Sponsor
    University of Houston Downtown
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05596123
    Brief Title
    Tui na for Peripheral Neuropathy Among People With HIV
    Official Title
    Therapeutic Chinese Foot Massage for Peripheral Neuropathy Symptoms Among People With Human Immunodeficiency Virus: A a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2023 (Anticipated)
    Primary Completion Date
    February 1, 2025 (Anticipated)
    Study Completion Date
    February 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Houston Downtown

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hiv

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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.
    Masking
    ParticipantInvestigator
    Masking Description
    Participants, the outcome assessors, and the statistician will be unaware of the group assignment.
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    therapeutic Chinese foot massage (TCFM)
    Arm Type
    Experimental
    Arm Description
    A one-to-one ratio will be used to randomly assign participants to the TCFM group or the placebo massage group.
    Arm Title
    The Placebo Massage Group
    Arm Type
    Placebo Comparator
    Arm Description
    Six weekly 25-minute TCFM sessions will be delivered to participants in the TCFM group.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Therapeutic Chinese foot massage
    Intervention Description
    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
    Intervention Name(s)
    Placebo massage
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Lower extremity pain
    Description
    The numeric pain scale has a score range between 0 and 10. A higher score indicates more pain.
    Time Frame
    at 6 months
    Title
    Lower extremity functioning
    Description
    The lower extremity functioning scale has a score range between 0 and 80. A higher score indicates better functioning.
    Time Frame
    at 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 1) People who have received any non-pharmacological interventions, including massage to treat their PN symptoms in the past six months

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Tui na for Peripheral Neuropathy Among People With HIV

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