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| ID | Type | Description | Link |
|---|---|---|---|
| AAAB4122 |
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This is a sample-size-limited, randomized, blinded (subject and evaluator), sham acupuncture/placebo moxibustion (sham acu/placebo moxa) controlled clinical trial. The subjects in this study will be 50 men and women with HIV infection who have a diagnosis of distal symmetric peripheral neuropathy (DSP). Subjects will be randomized to one of two experimental intervention conditions:
All subjects in Conditions 1 and 2 will attend 16 scheduled sessions over 15 weeks, be administered the same instruments, and submit their daily symptom diaries for analysis. There will be six weeks of twice weekly treatment sessions, and three follow-up sessions at weeks 9, 11, and 15. All conditions will be identical in duration and be administered by licensed acupuncturists trained in traditional Chinese medicine (TCM).
Subjects in this early-phase clinical trial will be 50 men and women with HIV infection who have a diagnosis of Distal Symmetric Peripheral neuropathy (DSP). This study is a prospective, randomized, sham/placebo controlled, blinded (subject and evaluator), parallel groups clinical trial. Subjects will be randomized to one of two experimental intervention conditions:
Subjects in Conditions 1 and 2 will attend 16 scheduled sessions over 15 weeks. All subjects will: be blinded/masked to treatment assignments, attend the same number of protocol sessions, be administered the same instruments, and submit their symptom diaries for data entry and analysis. After a screening/intake session, randomization and treatment sessions will follow. There will be six weeks of twice weekly treatment sessions, and three follow-up sessions at weeks 9, 11 and 15. All conditions will be identical in duration and be administered by licensed acupuncturists trained in Traditional Chinese Medicine. The aims of this study include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture/Moxibustion | Experimental | Acupuncture/Moxibustion for Peripheral Neuropathy in HIV |
|
| Sham acupuncture/Placebo moxibustion | Sham Comparator | Sham acupuncture/Placebo moxibustion for Peripheral Neuropathy in HIV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture/Moxibustion | Procedure | Acupuncture/Moxibustion: 16 scheduled sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Symptom diary | ||
| Gracely Pain Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Peripheral Neuropathy Scale | ||
| Clinical Global Impression Scale | ||
| Neurological Assessment Form |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joyce K Anastasi, PhD, DrNP | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University School of Nursing, Acupuncture Laboratory | New York | New York | 10032 | United States |
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| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D009071 | Moxibustion |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Sham acupuncture/Placebo moxibustion | Other | Sham acupuncture/Placebo moxibustion: 16 scheduled sessions |
|
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |