Symptom Management Efficacy Study to Reduce Distal Neuropathic Pain

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.

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.