Acupuncture/Moxibustion (Acu/Moxa) for Distal Symmetric Peripheral Neuropathy (DSP) in HIV - NCT00826345-10032 (Clinical Trial 264969)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy264969.aspx
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| City: |
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New York |
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State:
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NY |
| Zip Code: |
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10032 |
| Conditions: |
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Peripheral Neuropathy - HIV - AIDS - HIV Infections |
| Purpose: |
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This preliminary study will investigate the use of Acupuncture and Moxibustion (Acu/Moxa)
for distal symmetric peripheral neuropathy (DSP) associated with HIV applying traditional
Chinese medicine (TCM) evaluations conducted by a diagnostic acupuncturist. The
investigators will evaluate the role of Acu/Moxa in reducing the symptoms of DSP related to
HIV/AIDS and treatment side effects. The effects of symptom reduction on quality of life
will also be examined. This application will establish a proof of principle for the role of
Acu/Moxa in the treatment of DSP and provide data that will serve as a foundation for
establishing a future larger clinical trial.
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| Study summary: |
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This study is a prospective, randomized, sham/placebo controlled, blinded (subject and
evaluator), parallel groups clinical trial. This preliminary study will investigate the use
of Acupuncture and Moxibustion (Acu/Moxa) for DSP associated with HIV applying TCM
evaluations conducted by a diagnostic acupuncturist. The investigators will evaluate the
role of Acu/Moxa in reducing the symptoms of DSP related to HIV/AIDS and treatment side
effects. The effects of symptom reduction on quality of life will also be examined. Data
from daily symptom diaries and questionnaires will be analyzed with mixed model analysis of
variance for between group difference in the temporal pattern of symptom reduction at
baseline, after 6 weeks of twice weekly treatment, and after a no-treatment follow-up
session. In addition, exploratory analyses will assess the logistics of a CAM clinical trial
for HIV/AIDS related DSP in preparation of a larger clinical trial. |
| Criteria: |
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Inclusion Criteria:
- Men and women HIV positive or CDC defined AIDS diagnosed subjects who are 18 years of
age or older, have a history of distal symmetrical peripheral neuropathy of the lower
extremities (legs and feet) for two months or greater.
- Experiencing patient rated pain severity at "moderate" on the Gracely pain scale
documented in 1 week prospective self report symptom diary.
- Verification from Primary provider of subject's: HIV status, diagnosis of DSP, and
their agreement that their patient is clinically suitable for the study.
- Individuals able to successfully complete a mini-mental status exam (obtaining a
score of 24 or above).
- Individuals who understand and agree to complete daily symptom diaries for the
duration of the study.
- Individuals taking antiretroviral combinations (a) must have completed an initial 8
weeks of a stable regime (same drug(s), dose & frequency) prior to entry into the
study.
- Individuals taking chronic pain medications (b) must be on a stable regime (same
drug, dose & frequency) for at least twenty one (21) days prior to entry into the
study.
- Individuals on all other medications which may have neuropathy listed as a side
effect must be on a stable regime (same drug(s), dose & frequency) for at least 21
days prior to entry in the study.
Exclusion Criteria:
- Individuals with an acute medical condition, i.e. pneumocystis carinii pneumonia,
tuberculosis and or other opportunistic infections or conditions that would require
medical attention.
- Individuals with diagnosis of diabetes mellitus, B12 deficiency
- Topically applied medications to the lower extremities.
- Individuals with alcohol and/or substance dependence.
- Individuals with bleeding tendency
- Currently receiving treatment with corticosteroids
- Use of INH, dapsone or metronidazole within 8 weeks prior to enrollment. |
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| Study is available at: |
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Columbia University
New York, NY 10032
United States
Primary Contact:
Ann Chung
Email: amc103@columbia.edu
Phone: 212-365-0346 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 16, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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