Status:
COMPLETED
Symptom Management Efficacy Study to Reduce Distal Neuropathic Pain
Lead Sponsor:
New York University
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Neuropathic Pain
HIV Neuropathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Distal sensory peripheral neuropathy (DSP) is a chronic, debilitating painful condition affecting quality of life in persons living with HIV. Treatments prescribed to manage DSP pain, such as nonnarco...
Detailed Description
Distal sensory peripheral neuropathy (DSP) is a chronic, debilitating painful condition affecting quality of life in 20%-50% of persons living with HIV. Treatments prescribed to manage DSP pain, such ...
Eligibility Criteria
Inclusion
- Men and women, 18 years of age or older, HIV+ or AIDS diagnosed, with a history of DSP of the lower extremities for the past three months or greater.
- Primary care provider (PCP) verification of HIV status, diagnosis of DSP, \& subject clinical suitability for the study.
- Evidence of lower limb neuropathy (bilateral ankle reflexes absent or depressed relative to the knee, decreased sensation to vibration, pin prick and temperature with distal sensory loss grading to normal in the proximal limb)
- GPS rated pain severity of "moderate" or above, documented in 1-week prospective self-report symptom diary (SD).
- Any antiretroviral Rx must have 3 months of stable regimen (same drugs, dose \& frequency) prior to enrollment.
- Any pain medications must have 3 months of stable regimen prior to enrollment.
- Those on a stable pharmacologic regimen are expected to remain on the regimen for the duration of the study.
- Must understand and agree to complete daily symptom diaries for the duration of the study.
- Successfully complete a mini-mental status exam (obtaining a score of 24 or above).
Exclusion
- Any acute condition requiring medical care (eg. opportunistic infection).
- Conditions that may mimic HIV DSP symptoms: i.e. diabetes(3), coagulopathies, B12 deficiency, etc.
- Use any topically applied medications to the lower extremities.
- Alcohol and/or substance dependence.
- Use of injectable corticosteroids or any medications known to be neurotoxic within 3 months prior to enrollment.
- Pregnant women or unwilling to use an acceptable form of birth control.
- Receiving acupuncture within 6 months prior to enrollment.
- Any history of receiving moxibustion.
- Currently receiving any other complementary therapies such as herbs, massage, reiki etc.
- Relocation or plans that interfere with attending all of the planned study sessions and/or recording SD information.
Key Trial Info
Start Date :
January 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2024
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT03855111
Start Date
January 14 2019
End Date
October 21 2024
Last Update
September 25 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
New York University, Division of Special Studies in Symptom Management
New York, New York, United States, 10010