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

Primary Purpose

Peripheral Neuropathy, HIV, AIDS

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Acupuncture / Moxibustion

Acupuncture/Moxibustion

About this trial

This is an interventional treatment trial for Peripheral Neuropathy focused on measuring Peripheral Neuropathy, Neuropathy, HIV, AIDS, DSP, alternative therapies

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Columbia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Acupuncture/Moxibustion

Placebo Acupuncture / Moxibustion

Arm Description

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.

Sham/placebo Arm: Points will be administered away from the classic/traditional true point location.

Outcomes

Primary Outcome Measures

Symptom diary Gracely Pain Scale

Secondary Outcome Measures

Subjective Peripheral Neuropathy Screen (SPNS) Clinical Global Impression Scale Neurological Assessment Form

Full Information

NCT ID

NCT00826345

First Posted

January 21, 2009

Last Updated

June 20, 2012

Sponsor

NYU Langone Health

Collaborators

Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT00826345

Brief Title

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

Acronym

TCMAcuPilot

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

NYU Langone Health

Collaborators

Columbia University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Neuropathy, HIV, AIDS, HIV Infections

Keywords

Peripheral Neuropathy, Neuropathy, HIV, AIDS, DSP, alternative therapies

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acupuncture/Moxibustion

Arm Type

Experimental

Arm Description

Arm Title

Placebo Acupuncture / Moxibustion

Arm Type

Placebo Comparator

Arm Description

Sham/placebo Arm: Points will be administered away from the classic/traditional true point location.

Intervention Type

Other

Intervention Name(s)

Acupuncture / Moxibustion

Intervention Description

Acupuncture/Moxibustion points will be administered per point prescription. - Active

Intervention Type

Other

Intervention Name(s)

Acupuncture/Moxibustion

Intervention Description

Sham/Placebo Acupuncture/Moxibustion - Not active

Primary Outcome Measure Information:

Title

Symptom diary Gracely Pain Scale

Time Frame

Baseline, Weekly and Follow-up visits

Secondary Outcome Measure Information:

Title

Subjective Peripheral Neuropathy Screen (SPNS) Clinical Global Impression Scale Neurological Assessment Form

Time Frame

Baseline, weekly and follow-up visits

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joyce K Anastasi, PhD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

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

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