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Acupuncture/Moxibustion for Peripheral Neuropathy in HIV

Primary Purpose

Peripheral Neuropathies, HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Acupuncture/Moxibustion
Sham acupuncture/Placebo moxibustion
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Neuropathies focused on measuring Acupuncture, HIV, AIDS, Symptom management, Non-invasive, Complementary Therapies, Treatment Experienced

Eligibility Criteria

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

Inclusion Criteria: Men and women who are HIV positive or Centers for Disease Control (CDC)-defined AIDS diagnosed subjects who are 18 years of age or older, and have a history of distal symmetrical peripheral neuropathy of the lower extremities (legs and feet) for two months or greater. Patients experiencing moderate pain severity. Verification from primary provider of subject's: HIV status, diagnosis of DSP, and agreement that patient is clinically suitable for the study. Individuals able to successfully complete a mini-mental status exam. Individuals who understand and agree to complete daily symptom diaries for the duration of the study. Individuals taking antiretroviral combinations must have completed an initial 8 weeks of a stable regime (same drug[s], dose, and frequency) prior to entry into the study. Individuals taking chronic pain medications must be on a stable regime (same drug, dose, and 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, and 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, B-12 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 isoniazid (INH), dapsone, or metronidazole within 8 weeks prior to enrollment. Severe heart disease, uncontrolled high blood pressure, lung disease, or renal failure. Pregnant women Individuals receiving acupuncture currently and less than 6 months prior to enrollment. Individuals with a history of receiving moxibustion. Individuals currently receiving other types of complementary therapies such as herbs, massage, reiki, etc. Individuals with plans for travel, lifestyle change, or other activity that would preclude attending all of the planned study sessions and/or recording daily diary information.

Sites / Locations

  • Columbia University School of Nursing, Acupuncture Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Acupuncture/Moxibustion

Sham acupuncture/Placebo moxibustion

Arm Description

Acupuncture/Moxibustion for Peripheral Neuropathy in HIV

Sham acupuncture/Placebo moxibustion for Peripheral Neuropathy in HIV

Outcomes

Primary Outcome Measures

Symptom diary
Gracely Pain Scale

Secondary Outcome Measures

Subjective Peripheral Neuropathy Scale
Clinical Global Impression Scale
Neurological Assessment Form

Full Information

First Posted
April 20, 2006
Last Updated
September 10, 2019
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00317291
Brief Title
Acupuncture/Moxibustion for Peripheral Neuropathy in HIV
Official Title
Acu/Moxa for Peripheral Neuropathy in Persons With HIV
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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: Condition 1: subjects receive acu/moxa treatment; and Condition 2 (Control Group): subjects receive sham acu/placebo moxa. 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).
Detailed Description
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: Condition 1: subjects receive Acu/Moxa Treatment; and Condition 2 (Control Group): subjects receive Sham acupuncture/Placebo moxibustion (Sham Acu/Placebo Moxa). 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: To establish the feasibility of the combined Acupuncture/Moxibustion treatment for 6 weeks of twice weekly sessions, in order to reduce the pain related to DSP among persons with HIV/AIDS, and to estimate the effect size of the Acu/Moxa treatment for a future clinical study. Inclusion of 2-, 4-, and 8-week no-treatment follow-up sessions will establish the maintainability of benefit. To determine the effect of combined Acupuncture/Moxibustion treatment for 6 weeks of twice weekly sessions on reducing symptoms of DSP (aching or burning pain, "pins and needles" sensation, and numbness) among persons with HIV/AIDS. To determine the effect of the combined Acupuncture/Moxibustion treatment for 6 weeks of twice weekly sessions on patient-perceived DSP symptom improvement and quality of life. To evaluate the logistics of a CAM clinical trial on persons with HIV/AIDS experiencing DSP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathies, HIV Infections
Keywords
Acupuncture, HIV, AIDS, Symptom management, Non-invasive, Complementary Therapies, Treatment Experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture/Moxibustion
Arm Type
Experimental
Arm Description
Acupuncture/Moxibustion for Peripheral Neuropathy in HIV
Arm Title
Sham acupuncture/Placebo moxibustion
Arm Type
Sham Comparator
Arm Description
Sham acupuncture/Placebo moxibustion for Peripheral Neuropathy in HIV
Intervention Type
Procedure
Intervention Name(s)
Acupuncture/Moxibustion
Intervention Description
Acupuncture/Moxibustion: 16 scheduled sessions
Intervention Type
Other
Intervention Name(s)
Sham acupuncture/Placebo moxibustion
Intervention Description
Sham acupuncture/Placebo moxibustion: 16 scheduled sessions
Primary Outcome Measure Information:
Title
Symptom diary
Title
Gracely Pain Scale
Secondary Outcome Measure Information:
Title
Subjective Peripheral Neuropathy Scale
Title
Clinical Global Impression Scale
Title
Neurological Assessment Form

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women who are HIV positive or Centers for Disease Control (CDC)-defined AIDS diagnosed subjects who are 18 years of age or older, and have a history of distal symmetrical peripheral neuropathy of the lower extremities (legs and feet) for two months or greater. Patients experiencing moderate pain severity. Verification from primary provider of subject's: HIV status, diagnosis of DSP, and agreement that patient is clinically suitable for the study. Individuals able to successfully complete a mini-mental status exam. Individuals who understand and agree to complete daily symptom diaries for the duration of the study. Individuals taking antiretroviral combinations must have completed an initial 8 weeks of a stable regime (same drug[s], dose, and frequency) prior to entry into the study. Individuals taking chronic pain medications must be on a stable regime (same drug, dose, and 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, and 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, B-12 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 isoniazid (INH), dapsone, or metronidazole within 8 weeks prior to enrollment. Severe heart disease, uncontrolled high blood pressure, lung disease, or renal failure. Pregnant women Individuals receiving acupuncture currently and less than 6 months prior to enrollment. Individuals with a history of receiving moxibustion. Individuals currently receiving other types of complementary therapies such as herbs, massage, reiki, etc. Individuals with plans for travel, lifestyle change, or other activity that would preclude attending all of the planned study sessions and/or recording daily diary information.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joyce K Anastasi, PhD, DrNP
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University School of Nursing, Acupuncture Laboratory
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

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Acupuncture/Moxibustion for Peripheral Neuropathy in HIV

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