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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
Sponsor:
Collaborators:
Montefiore Medical Center
Mount Sinai Beth Israel Department of Integrated Medicine
Pacific College of Oriental Medicine
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Diane Mckee, Albert Einstein College of Medicine

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Referred by a primary care provider from one of our participating primary care health centers
  • Provider-documented diagnosis of osteoarthritis (any joint), neck pain, OR back pain
  • Self-reported pain score of ≥4 for at least 3 months prior to program entry
  • Able to provide consent for treatment and data collection in either English or Spanish

Exclusion Criteria:

  • < 21 years of age
  • Chronic pain not documented OR self reported pain of ≥4 for less than 3 months.
  • Currently taking oral or injectable anticoagulants.
  • Lack of contact information OR unavailable for duration of entire treatment period (24 weeks)
  • Inability to consent to treatment and data collection.
  • Active psychosis
  • Active substance abuse

Information from the National Library of Medicine

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


Locations
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United States, New York
Montefiore Medical Group
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine
Montefiore Medical Center
Mount Sinai Beth Israel Department of Integrated Medicine
Pacific College of Oriental Medicine
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: M. Diane McKee, MD, MS Albert Einstein College of Medicine
Principal Investigator: Benjamin Kligler, MD Mount Sinai Beth Israel

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Responsible Party: Diane Mckee, Prof. Family and Social Medicine, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT02456727     History of Changes
Other Study ID Numbers: 2014-4192
First Posted: May 28, 2015    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Keywords provided by Diane Mckee, Albert Einstein College of Medicine:
Acupuncture
Group/Community Acupuncture
Individual Acupuncture
Chronic Pain
Underserved
Urban Primary Care
Osteoarthritis
Back Pain
Neck Pain
Additional relevant MeSH terms:
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Osteoarthritis
Back Pain
Chronic Pain
Neck Pain
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pain
Neurologic Manifestations
Signs and Symptoms