Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
114 participants
INTERVENTIONAL
2014-07-31
2016-10-31
Brief Summary
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Detailed Description
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Eligible participants will be scheduled for a face-to-face interview, at which time consent will be obtained and baseline measures will be collected. Baseline measures include collecting demographic data and information on depression, pain/pain free days and medication use.
To follow, a 4-week run-in period where usual care is delivered will be held to establish baseline pain levels. During this time, participants will be contacted at 2-week intervals to complete a brief pain assessment. If a waiting list becomes necessary, delay may become longer.
Participants will then be invited to participate in an 8-week, group-based acupuncture treatment intervention delivered by a licensed acupuncturist. The group will meet weekly for 8 consecutive weeks, each session lasting about 75 minutes held at the Center for Health and Healing located at 245 Fifth Ave in Manhattan. Sessions will be held during evening and weekend hours to facilitate scheduling.
We will collect information on pain, pain symptoms, mood, function and analgesic use at 1, 8, 12 and 24 week(s) following the beginning of the intervention. We will collect this information in-person or by telephone as preferred by the participant. Participants will not receive an incentive to attend group sessions but will receive incentives at enrollment and for completing research interviews at 12 and 24 weeks following treatment intervention ($20 at each of these three time points).
While subject records are confidential, there may be loss of confidentiality due to the group acupuncture setting. Intervention risks are low: Acupuncture needles are pre-sterilized and inserted once only and then properly discarded. Acupuncture therapy is safe with a 'relative' risk that is low. The risks associated with providing protected health information (PHI) will be minimized by assigning a unique participant identification code (ID number) that will be used to identify all data reported for each participant. The study staff will store all PHI in a secure and protected site at the Center for Health and Healing. The study results will be stored in a locked cabinet and any study information stored in a computer will be password protected. Only the study staff will have access to the study results.
Subjects will be reminded of the elements of participation.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Group Acupuncture
Participants will then be invited to participate in an 8-week, group-based acupuncture treatment intervention delivered by a licensed acupuncturist. The group will meet weekly for 8 consecutive weeks, each session lasting about 75 minutes.
Group Acupuncture
Interventions
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Group Acupuncture
Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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Beth Israel Medical Center
OTHER
Responsible Party
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Principal Investigators
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Benjamin Kligler, MD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Medical Center
Locations
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The Center for Health and Healing
New York, New York, United States
Countries
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Other Identifiers
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070-14
Identifier Type: -
Identifier Source: org_study_id