HIV/AIDS, HIV Neuropathy, Neuropathic Pain, Pain
Conditions
Keywords
Neuropathic pain, HIV Neuropathy, HIV/AIDS, Symptom Management, Acupuncture, Pain, Pain Syndrome
Brief 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.
Interventions
OTHERStandard Acupuncture / Moxibustion
Standard (Fixed) Active Acupuncture / Moxibustion protocol aimed at reducing lower limb neuropathic pain/discomfort.
OTHERIndividualized (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.
Sponsors
New York University
National Institutes of Health (NIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Randomized, blinded, placebo-controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gracely Pain Scale (GPS) | After 6 weeks of twice-weekly treatment sessions (the end of the treatment phase) and at week 15 (the end of follow up phase). Change from baseline rating of pain/discomfort | The GPS is a scale of sensory pain. Participants rate their DSP pain by selecting one of 13 words to describe their average and worst DSP pain. Scores on a scale: "Nothing"=0 to "Extremely intense"=12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Peripheral Neuropathy Screen (SPNS) | After 6 weeks of twice-weekly treatment sessions and at week 15 (the end of follow up phase) Change from baseline rating of neuropathy symptoms | Describes neuropathy symptoms eg. "aching/burning", "pins and needles", "numbness" severity of symptoms. The scale is scored from 1 to 10. 1 is "minimal" and 10 is "extreme". |
| NIH PROMIS Pain Scale | Change from baseline rating of pain intensity after 6 weeks of twice-weekly treatment sessions (the end of the treatment phase) and at week 15 (the end follow-up phase) | NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity short form is used to assess "how much a person hurts". Pain intensity scale score from none (=1) to very severe (=5). Pain intensity rating change from baseline. Negative values (-) indicate pain improvement. Positive (+) values indicate worsening. |
| Medical Outcome Survey - HIV (MOS-HIV) | Change from baseline rating of general health after 6 weeks of twice-weekly treatment sessions (the end of the treatment phase) and at week15 (the follow-up phase) | The MOS-HIV is a general health-related quality of life questions in HIV dimensions of health. The MOS-HIV physical health and mental health subscales assess health status on a scale of: 0 to 100 with a mean of 50 and standard deviation of 15. Change in scale scores from baseline values are reported. Positive values indicate improvement. Negative values indicate worsening. |
| Clinical Global Severity Improvement Scale | Change from baseline rating of pain intensity after 6 weeks of twice-weekly treatment sessions (the end of the treatment phase) and at 15 (the end of follow-up phase) | The CGI severity of illness scale measures global severity of symptoms \[in the context of peripheral neuropathy\]. The CGI improvement is recorded at timepoints after baseline as a means to assess benefit. The participant rates severity of peripheral neuropathy on a scale of 0= No discomfort to 6= Very severe discomfort. For the CGI Pain Severity scale, we report the count and percentage of participants in each group who report moderately severe (4) or greater severity. The participant rates improvement on a scale of (6) = great improvement to (0) no improvement. CGI Severity and CGI Improvement are both expressed as the participant count and percent of each group. We analyzed the proportion of participants in each group in categories of improved, unchanged or worsened severity ratings or improvement ratings. For the CGI Pain Improvement scale, we report the count and percentage of participants in each group who report 3 or more levels of improvement. |
| Neurological Sensory Testing (NST) | Change from baseline neurological physical assessment at week 15 (the end of follow-up phase) | Neurological assessments with Neuro Sensory Testing (NST) include: sensory testing for lower limb pain and thermal sensation. |
Countries
United States
Participant flow
Recruitment details
Participants are recruited using flyers/brochures posted in HIV community-based organizations (CBO), advertisements in newspapers/ magazines with a healthcare section and by informing colleagues (MDs, physician assistants and nurse practitioners) working in the field of HIV in the NYC area.
Pre-assignment details
Of 194 screened participants, 161 met inclusion criteria and were randomized.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 59.8 Age in years STANDARD_DEVIATION 1.3 |
| Clinical Global Severity Improvement Scale (CGIs) | 51 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Gracely Pain Scale (GPS) | 7.94 DSP pain scores on a scale STANDARD_DEVIATION 1.61 |
| Medical Outcome Survey - HIV (MOS-HIV) "mental health" | 47.5 Scores on a scale STANDARD_DEVIATION 11.3 |
| Medical Outcome Survey - HIV (MOS-HIV) "physical health" | 30.9 Scores on a scale STANDARD_DEVIATION 7.14 |
| NIH PROMIS Pain Scale | 47 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 19 Participants |
| Subjective Peripheral Neuropathy Screen (SPNS) "aching/burning" | 6.74 DSP neuropathy symptom scores on a scale STANDARD_DEVIATION 1.7 |
| Subjective Peripheral Neuropathy Screen (SPNS) "numbness" | 6.85 DSP neuropathy symptom scores on a scale STANDARD_DEVIATION 1.91 |
| Subjective Peripheral Neuropathy Screen (SPNS) "pins and needles" | 6.65 DSP neuropathy symptom scores on a scale STANDARD_DEVIATION 2.09 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 54 | 0 / 27 | 0 / 26 |
| other Total, other adverse events | 13 / 54 | 8 / 54 | 3 / 27 | 0 / 26 |
| serious Total, serious adverse events | 0 / 54 | 0 / 54 | 0 / 27 | 0 / 26 |
Outcome results
None listed