Clinical trial NCT03855111: Symptom Management Efficacy Study to Reduce Distal Neuropathic Pain
Official title: Symptom Management Efficacy Study to Reduce Distal Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neuropathic Pain
HIV Neuropathy
HIV/AIDS
Pain
Keywords: Neuropathic pain
HIV Neuropathy
HIV/AIDS
Symptom Management
Acupuncture
Pain
Pain Syndrome
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2019-02-26
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, blinded, placebo-controlled clinical trial
Primary purpose: TREATMENT

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 nonnarcotic and narcotic analgesics, antidepressants and anticonvulsants, are largely ineffective. In HIV there are no FDA-approved drugs for this indication. This study assesses in a randomized controlled clinical trial, the efficacy of novel non-pharmacologic pain management approaches to reduce HIV-related DSP pain and improve quality of life.

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 as nonnarcotic and narcotic analgesics, antidepressants and anticonvulsants, are largely ineffective. Effective management of DSP pain is an unmet therapeutic need for this population. This study is a randomized, blinded, placebo-controlled clinical trial of the efficacy of Acupuncture/Moxibustion (Acu/Moxa) for HIV DSP pain/discomfort.

Subjects with HIV-related lower limb DSP pain are randomized to one of four Conditions: 1) Standard (fixed) protocol Acu/Moxa, 2) Individualized (tailored) protocol Acu/Moxa, 3) Sham Acu/Placebo Moxa (control), or 4) WaitList (control). Subjects attend six weeks of twice weekly treatment sessions and 3 non-treatment follow-up sessions at weeks 9, 11, and 15. All subjects are assessed by a blinded diagnostic acupuncturist (DA) and those assigned to Conditions 1, 2 and 3 receive treatments by an unblinded treating acupuncturist (TA). Specific Aims are: #1 determine group differences in weekly average pain (Gracely Pain Scale) at the end of treatment (Tx) and end of follow-up (F/U); SA#2 determine group differences in improvement in specific sensory symptoms (Subjective Peripheral Neuropathy Screen and neurological sensory testing (NST)) and patient-rated effectiveness (Clinical Global Improvement, NIH PROMIS Pain Intensity and Health-Related Quality of Life (MOS-HIV)) at Tx and F/U; SA#3 determine group differences in safety profiles; and SA#4, explore how baseline measures, TCM diagnoses, NST and pain medication use predict response to treatment.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Gracely Pain Scale (GPS)
timeFrame: Change from baseline rating of pain/discomfort (Gracely Pain Scale) after 6 wks of twice-wkly treatment sessions (the end of the treatment phase) and at weeks 9, 11 and 15 (the follow-up phase - determine sustainability).
Secondary outcomes:
measure: Subjective Peripheral Neuropathy Screen (SPNS)
timeFrame: Change from baseline rating of neuropathy symptoms after 6 wks of twice-wkly treatment sessions (the end of the treatment phase) and at weeks 9, 11 and 15 (the follow-up phase - determine change and sustainability)
measure: NIH PROMIS Pain Scale
timeFrame: Change from baseline rating of pain intensity after 6 wks of twice-wkly treatment sessions (the end of the treatment phase) and at weeks 9, 11 and 15 (the follow-up phase - determine change and sustainability)
measure: Medical Outcome Survey - HIV (MOS-HIV)
timeFrame: Change from baseline rating of general health after 6 wks of twice-wkly treatment sessions (the end of the treatment phase) and at weeks 9, 11 and 15 (the follow-up phase - determine change and sustainability)
measure: Clinical Global Severity Improvement Scale (CGIs)
timeFrame: Change from baseline rating of pain intensity after 6 wks of twice-wkly treatment sessions (the end of the treatment phase) and at weeks 9, 11 and 15 (the follow-up phase - determine change and sustainability)
measure: Neurological Sensory Testing (NST)
timeFrame: Change from baseline neurological physical assessment after 6 wks of twice-wkly treatment sessions (the end of the treatment phase) and at weeks 9, 11 and 15 (the follow-up phase - determine change and sustainability)
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University, Division of Special Studies in Symptom Management
state: New York
Study officials:
References: