NCT03855111

Symptom Management Efficacy Study to Reduce Distal Neuropathic Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: New York University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuropathic Pain
• HIV Neuropathy
• HIV/AIDS
• Pain

Interventions

Type	Name	Description
OTHER	Standard Acupuncture / Moxibustion	Standard (Fixed) Active Acupuncture / Moxibustion protocol aimed at reducing lower limb neuropathic pain/discomfort.
OTHER	Individualized (Tailored) Active Acupuncture / Moxibustion	Individualized (tailored) protocol Acu/Moxa - Active. Acu/Moxa prescription based on TCM assessment. Protocol aimed at reducing lower limb neuropathic pain/discomfort.

Timeline

• Start date: 2019-01-14
• Primary completion: 2024-10-21
• Completion: 2024-10-21
• First posted: 2019-02-26
• Last updated: 2025-09-25

Locations

1 site across 1 country: United States