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. Author manuscript; available in PMC: 2018 May 11.
Published in final edited form as: EJOM. 2010;6(4):40–52.

TABLE 2.

Inclusion and Exclusion Study Criteria

Inclusion Criteria

  • Men and women 18 years or older

  • Diagnosed with HIV

  • Pain associated with HIV-related DSP of the lower extremities (legs and feet) for 2 months or greater

  • Experiencing ‘moderate’ pain based on the Gracely pain scale documented in a 1-week prospective self-report symptom diary

  • Verification from primary care provider of subject’s: HIV status, diagnosis of DSP, and provider’s agreement that subject is clinically suitable for the study(a)

  • Obtain a score of 24 or better on the mini-mental status examination

  • Stable regimen (same drug(s), dose & frequency) of antiretroviral medications for 8 weeks or more prior to study entry(b)

  • Stable regimen (same drug(s), dose & frequency) of analgesic medications and/or other medications which may have neuropathy listed as a side effect for a minimum of 21 days prior to study entry(c)

  • Ability to understand and agree to complete daily symptom diaries for the duration of the study.

Exclusion Criteria

  • Acute medical conditions or opportunistic infections (i.e. pneumocystis carinii pneumonia) which would require medical attention

  • Diagnosis of diabetes mellitus, vitamin B-12 deficiency, coagulopathies

  • History of severe cardiovascular disease, uncontrolled blood pressure, pulmonary disease, renal failure

  • Pregnant women(d)

  • Current alcohol or substance abuse

  • Using topically applied medications to the lower extremities

  • Current use of corticosteroids [rationale: steroids can decrease neuropathy signs and symptoms]

  • Treated with INH, dapsone or metronidazole within 8 weeks prior to study enrollment

  • Receiving acupuncture within 6 months of study enrollment

  • History of using moxibustion

  • Receiving other types of complementary therapies such as herbs, massage, reiki etc.

  • Plans for travel, lifestyle change, or other activity that would preclude attending all of the study sessions and/or recording daily symptom diary information

(a)

The statement of suitability is specific to the IRB requirements of our academic health science campus. All investigators are required to contact the patient’s physician and/or primary care provider to ensure that the provider is in agreement that their patient is clinically suitable for the clinical study in which the patient is planning to join.

(b)

Many antiretroviral agents are associated with increased side effects during the initial weeks of treatment and generally subside after 4–6 weeks of use. To minimise the chance that reduction in symptom severity may be attributable to cessation of antiretroviral therapy side effects, we will require that all subjects are on a stable regimen for a minimum of 8 weeks prior to study enrolment.

(c)

Since the study is 15 weeks in duration, it is anticipated that subjects will likely experience neuropathy symptoms. A criterion that totally denies the use of medications to reduce symptoms would be unethical and unrealistic, as well as potentially resulting in nonadherence to the study protocol. We will make note of any medications and handle this statistically.

(d)

Prior to study entry, all women are required to take a urine HCG test to rule out pregnancy and to record menses (date, duration and heaviness of flow) during the study. Safety data for acupuncture in pregnancy are not available.