Peripheral NeuropathiesPhase 2NCT00317291
Acupuncture/Moxibustion for Peripheral Neuropathy in HIV
A Phase 2 study testing Acupuncture/Moxibustion in people with Peripheral Neuropathies and HIV Infections, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Peripheral Neuropathies, HIV Infections
- What is being tested?
- Acupuncture/Moxibustion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Jan 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University School of Nursing, Acupuncture Laboratory
New York, New York, 10032
About this study
Official title: Acu/Moxa for Peripheral Neuropathy in Persons With HIV
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).
Read the 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.
- Conditions
- Peripheral Neuropathies, HIV Infections
- Being tested
- Acupuncture/Moxibustion, Sham acupuncture/Placebo moxibustion
- Keywords
- Acupuncture, HIV, AIDS, Symptom management, Non-invasive, Complementary Therapies, Treatment Experienced
- Medical subject headings
- Peripheral Nervous System Diseases, HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture/MoxibustionProcedure or surgery
Acupuncture/Moxibustion: 16 scheduled sessions
Sham acupuncture/Placebo moxibustionOther
Sham acupuncture/Placebo moxibustion: 16 scheduled sessions
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture/Moxibustion | Experimental | Acupuncture/Moxibustion for Peripheral Neuropathy in HIV Receives: Procedure: Acupuncture/Moxibustion |
| Sham acupuncture/Placebo moxibustion | Sham comparator | Sham acupuncture/Placebo moxibustion for Peripheral Neuropathy in HIV Receives: Other: Sham acupuncture/Placebo moxibustion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom diary
Gracely Pain Scale
Secondary outcomes (3)
Subjective Peripheral Neuropathy Scale
Clinical Global Impression Scale
Neurological Assessment Form
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2006 (estimated)
- Study startNov 2005
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral NeuropathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Joyce K Anastasi, PhD, DrNP, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00317291
- Sponsor's protocol ID
- R21AT003092
- Other IDs
- AAAB4122
- Status last verified
- Sep 2009
- First submitted
- 20 Apr 2006
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acu/Moxa for Peripheral Neuropathy in Persons With HIV
- ClinicalTrials.gov ID
- NCT00317291
- Acronym / sponsor ID
- R21AT003092
- Conditions
- Peripheral Neuropathies, HIV Infections
- Keywords
- Acupuncture, HIV, AIDS, Symptom management, Non-invasive, Complementary Therapies, Treatment Experienced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Nov 2005
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 24 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture/Moxibustion | Experimental | Procedure: Acupuncture/MoxibustionAcupuncture/Moxibustion for Peripheral Neuropathy in HIV |
| Sham acupuncture/Placebo moxibustion | Sham comparator | Other: Sham acupuncture/Placebo moxibustionSham acupuncture/Placebo moxibustion for Peripheral Neuropathy in HIV |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture/MoxibustionAcupuncture/Moxibustion: 16 scheduled sessions | Procedure or surgery | Acupuncture/Moxibustion |
| Sham acupuncture/Placebo moxibustionSham acupuncture/Placebo moxibustion: 16 scheduled sessions | Other | Sham acupuncture/Placebo moxibustion |
Primary outcome
Symptom diary
Gracely Pain Scale
3 secondary outcomes
Subjective Peripheral Neuropathy Scale
Clinical Global Impression Scale
Neurological Assessment Form
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joyce K Anastasi, PhD, DrNP principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acupuncture/Moxibustion in people with Peripheral Neuropathies and HIV Infections, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom diary. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2019.