Peripheral Neuropathy
Conditions
Brief summary
Background: Peripheral neuropathy (PN) occurs in half of the people with human immunodeficiency virus (PHIV). Currently, there is no Food and Drug Administration-approved treatment for HIV-related PN. Only half of PHIV who take medications report a significant reduction in pain. Therapeutic Chinese Massage, structured palpations or movements of soft tissues of the body, is a promising non-harmful, and non-costly intervention that can potentially alleviate or even treat PN but relevant research is limited. Method: Investigators conducted a single centered, two-arm, single-blinded randomized controlled trial pilot study to examine if a series of three weekly 25-minute therapeutic Chinese massage sessions by a therapist of therapeutic Chinese massage, compared with placebo massage, could reduce PN-related pain and improve lower extremity functioning in PHIV. Twenty PHIV were recruited from the AIDS Foundation Houston, Inc in Texas. Pain, lower extremity functioning, and health-related quality of life were assessed for both groups prior to and post-massage.
Interventions
BEHAVIORALThree Weekly Therapeutic Chinese Massage Sessions
Participants in the therapeutic Chinese massage group received three weekly 25-minute therapeutic Chinese massage sessions. The intervention included acupressure to points along the distal lower extremity acupuncture points of the Gall Bladder Channel (GB 40 and then 34). Further Chinese Massage incorporates kneading, rolling, movement of the ankle, rotating, pulling, and scrubbing to the lower extremity.
BEHAVIORALThree Weekly Placebo Massage Sessions
The placebo massage group received three weekly 25-minute placebo massage that included gentle rubbing to the foot and toes without point stimulation or other techniques of Chinese Massage. The control group had the opportunity to receive the treatment after the study was completed.
Sponsors
University of Houston Downtown
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Clinical diagnosis of HIV and peripheral neuropathy have self-reported PN-related pain in lower extremity are not taking any kind of medications to alleviate PN symptoms age at least 18 years old not pregnant or lactating
Exclusion criteria
have received any kind of massage in the past three months Can not give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of this study design | through study completion, an average of one year | recruitment and completion rates, patient safety, and treatment adherence and compliance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Peripheral neuropathy related pain at the third visit | Through study completion, an average of one year | It will be measured by the Numeric Pain Scale |
| Change in health related quality of life at the third visit | Through study completion, an average of one year | It will be measured by the Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) |
| Change in lower extremity functioning at the third visit | Through study completion, an average of one year | It will be measured by the Lower Extremity Functioning Scale |
Countries
United States
Outcome results
None listed