Symptom Management Efficacy Study to Reduce Distal Neuropathic Pain

New York University (NYU)

Status: Unknown

Conditions: HIV Neuropathy; Neuropathic Pain; Pain; HIV/AIDS

Treatments: Other: Standard Acupuncture / Moxibustion; Other: Individualized (Tailored) Active Acupuncture / Moxibustion

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03855111

NIH-1R01NR017917-01 (Other Grant/Funding Number)

S18-00257

Details and patient eligibility

About

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.

Full 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.

Enrollment: 196 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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196 participants in 4 patient groups

Standard (fixed) protocol Acu/Moxa - Active

Experimental group

Description:

Standard (Fixed) Acupuncture / Moxibustion Active Protocol Subjects receive active standard Acu/Moxa protocol aimed at reducing neuropathic pain/discomfort.

Treatment:

Other: Standard Acupuncture / Moxibustion

Individualized (tailored) protocol Acu/Moxa - Active

Experimental group

Description:

Individualized (Tailored) Active Acupuncture / Moxibustion Protocol Subjects receive active individualized Acu/Moxa protocol based on traditional Chinese medicine assessment aimed reducing neuropathic pain/discomfort.

Treatment:

Other: Individualized (Tailored) Active Acupuncture / Moxibustion

Sham Acu/Placebo Moxa (Control)

No Intervention group

Description:

Sham Acu/Placebo Moxa (Control) Note. All subjects randomized to the Control will be offered 12 active protocol acupuncture/ moxibustion treatments, at no cost, at the end of their study participation.

WaitList (Control)

No Intervention group

Description:

WaitList (Control) No treatment. Subjects receive all aspects of study participation with the exception of exposure to Acupuncture / Moxibustion. Note. All subjects randomized to the Control will then be offered 12 active protocol acupuncture/ moxibustion treatments, at no cost, at the end of their study participation.