Acupuncture Approaches for Chronic Pain (AADDOPT-2)
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|ClinicalTrials.gov Identifier: NCT02456727|
Recruitment Status : Completed
First Posted : May 28, 2015
Last Update Posted : April 17, 2018
Chronic pain is a major public health problem that places many burdens on individuals, including impairment of physical and psychological functioning, lost productivity, and side effects of medications used to treat pain. There is also substantial evidence that minority populations differ both in prevalence and outcomes of chronic pain; access to care is a key component in these differences. Strong evidence now supports the use of acupuncture in the treatment of chronic pain conditions, including when provided in the primary care setting to patients from ethnically diverse, medically underserved populations. Acupuncture is slowly being integrated into pain management in many conventional health care settings, but cost and reimbursement for this service remain obstacles to offering acupuncture, especially in primary care and safety net settings. Because group acupuncture can be offered at much lower cost, demonstrating that individual and group delivery are equally effective could reduce barriers to use of this effective pain management approach.
The primary aim of this study will be to evaluate whether acupuncture delivered in the group setting for patients with chronic pain is equal to acupuncture delivered in the individual setting. A secondary objective will be to use qualitative analysis to understand and describe the patient experience of both acupuncture approaches, and to utilize this data to inform intervention delivery and dissemination, to better incorporate the patient perspective.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain Osteoarthritis Neck Pain Back Pain||Procedure: Group/Community Acupuncture Procedure: Individual Acupuncture||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||720 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Acupuncture Approaches to Decrease Disparities in Outcomes of Pain Treatment - A Two Arm Comparative Effectiveness Trial|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||March 2018|
|Actual Study Completion Date :||March 2018|
Active Comparator: Individual Acupuncture
Participants will be treated weekly with individual acupuncture treatment sessions for 12 consecutive weeks. Quality of life assessments will be taken at baseline, and weeks 6, 12, and 24 post treatment initiation.
Procedure: Individual Acupuncture
Acupuncture treatment in an individual setting.
Active Comparator: Group Acupuncture
Participants will be treated weekly with group acupuncture treatments sessions for 12 consecutive weeks. Quality of life assessments will be taken at baseline, and weeks 6, 12, and 24 post treatment initiation.
Procedure: Group/Community Acupuncture
Acupuncture treatment in a group setting.
- Pain as measured by the Brief Pain Inventory (BPI) [ Time Frame: 24 Weeks ]Comparing the effectiveness of group and individual acupuncture to reduce pain and improve function among primary care patients with chronic pain from an ethnically diverse, medically underserved population. We will access pain, pain interference with function, health status and pain-related disability at baseline, 6, 12, and 24 weeks. The Brief Pain Inventory (BPI) short form will serve as the primary measure for pain. We hope to see a 30% or greater improvement of the BPI pain measure between baseline and week 12.
- Patient Quality of life measured through administering the Patient Reported Outcomes Measurement Information System (PROMIS) Quality of LIfe, and Patient Global Impression of Change (PGIC) [ Time Frame: 24 Weeks ]Quality of life will be measured through administering the Patient Reported Outcomes Measurement Information System (PROMIS) Quality of LIfe, and Patient Global Impression of Change (PGIC) standardized health-related quality of life questionnaires post intervention. We will also use qualitative methods to understand and incorporate the patient experience of acupuncture, to maximize patient centeredness of intervention and dissemination efforts, through conducting semi-structured interviews, with a subset of participants from each group (n=40), post intervention.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02456727
|United States, New York|
|Montefiore Medical Group|
|Bronx, New York, United States, 10461|
|Principal Investigator:||M. Diane McKee, MD, MS||Albert Einstein College of Medicine|
|Principal Investigator:||Benjamin Kligler, MD||Mount Sinai Beth Israel|