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Acupuncture/Moxibustion (Acu/Moxa) for Distal Symmetric Peripheral Neuropathy (DSP) in HIV (TCMAcuPilot)

This study has been completed.
Sponsor:
Collaborator:
Columbia University
Information provided by (Responsible Party):
Joyce Anastasi, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00826345
First received: January 21, 2009
Last updated: June 20, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Peripheral Neuropathy
HIV
AIDS
HIV Infections
 Other: Acupuncture / Moxibustion
Other: Acupuncture/Moxibustion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Patient-Oriented TCM Intervention for DSP in HIV: A Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Symptom diary Gracely Pain Scale [ Time Frame: Baseline, Weekly and Follow-up visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective Peripheral Neuropathy Screen (SPNS) Clinical Global Impression Scale Neurological Assessment Form [ Time Frame: Baseline, weekly and follow-up visits ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: January 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture/Moxibustion
Diagnostic Acupuncturists assessments will inform acupuncture/moxibustion treatment prescriptions for persons with HIV/AIDS experiencing distal peripheral neuropathy. This protocol is tailored specifically for the subject's unique diagnosis according to the symptoms being reported at each diagnostic acupuncture (DA) session.
 Other: Acupuncture / Moxibustion

Acupuncture/Moxibustion points will be administered per point prescription.

- Active
Placebo Comparator: Placebo Acupuncture / Moxibustion
Sham/placebo Arm: Points will be administered away from the classic/traditional true point location.
 Other: Acupuncture/Moxibustion
Sham/Placebo Acupuncture/Moxibustion - Not active

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00826345

Locations
United States, New York
Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
New York University School of Medicine
Columbia University
Investigators
Principal Investigator: Joyce K Anastasi, PhD Columbia University
  More Information

No publications provided

Responsible Party: Joyce Anastasi, Professor / Director Div. Special Studies in Symptom Management, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00826345     History of Changes
Other Study ID Numbers: AAAD3398
Study First Received: January 21, 2009
Last Updated: June 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
Peripheral Neuropathy
Neuropathy
HIV
 AIDS
DSP
alternative therapies

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Peripheral Nervous System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013