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

June 20, 2012 updated by: Joyce Anastasi, NYU Langone Health

Patient-Oriented TCM Intervention for DSP in HIV: A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Symptom diary Gracely Pain Scale
Time Frame: Baseline, Weekly and Follow-up visits
Baseline, Weekly and Follow-up visits

Secondary Outcome Measures

Outcome Measure
Time Frame
Subjective Peripheral Neuropathy Screen (SPNS) Clinical Global Impression Scale Neurological Assessment Form
Time Frame: Baseline, weekly and follow-up visits
Baseline, weekly and follow-up visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

Columbia University

Investigators

  • Principal Investigator: Joyce K Anastasi, PhD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

January 21, 2009

First Submitted That Met QC Criteria

January 21, 2009

First Posted (Estimate)

January 22, 2009

Study Record Updates

Last Update Posted (Estimate)

June 22, 2012

Last Update Submitted That Met QC Criteria

June 20, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAD3398

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Acupuncture / Moxibustion

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe