A Symptom Management Efficacy Study to Reduce Distal Neuropathic Pain

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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. Our studies, using acupuncture and moxibustion (Acu/Moxa) to manage HIV DSP pain, show promise as an effective therapy. This study builds on preliminary data to test a novel approach, Acu/Moxa, to manage chronic lower-limb DSP pain in adults living with HIV. IMPACT: there are no FDA-approved agents for this indication in HIV. Effective management of DSP pain is an unmet therapeutic need for this population. Results from this study can provide patients and clinicians with an evidenced-based non-pharmacologic therapeutic option to manage this painful condition. The literature, our clinical experience, our preliminary studies and strength of our team provide a strong rationale to conduct a rigorous, randomized, blinded, placebo-controlled clinical trial of the efficacy of Acu/Moxa for HIV DSP pain that adheres to the CONSORT and STRICTA guidelines. 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. The primary intent-to-treat analysis of group differences in within-subject longitudinal change from baseline to Tx and F/U uses linear mixed models for repeated measures (LMMrm) with fixed effects for DA, treatment group, time, their interactions with covariate adjustment for the level of the outcome at baseline (SA#1 & SA#2). Preliminary studies estimate of “medium” effect sizes for the Gracely Pain Scale and 20% attrition indicates the need for 196 subjects to achieve 80% power and 5% alpha to detect the superiority of one active treatment to control, and one active treatment to the other. Cross-sectional and longitudinal associations between TCM diagnoses, NST assessments and pain medication use with change in patient-rated effectiveness will use multiple correlation/regression for aim #4.