Hiv
Conditions
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).
Interventions
BEHAVIORALTherapeutic 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.
BEHAVIORALPlacebo 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.
Sponsors
University of Houston Downtown
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants, the outcome assessors, and the statistician will be unaware of the group assignment.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed