Acupuncture for Chronic Pain (ADDOPT)
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Pain focused on measuring acupuncture, health services research, chronic pain, health disparities
Eligibility Criteria
Inclusion Criteria:
- Chronic pain due to osteoarthritis, back pain or neck pain; English or Spanish speaking
Exclusion Criteria:
- Active substance abuse; cognitive impairment; coumadin therapy
Sites / Locations
- Albert Einstein College of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Acupuncture
Arm Description
Weekly acupuncture treatment for up to 14 weeks
Outcomes
Primary Outcome Measures
Brief Pain Inventory
Secondary Outcome Measures
Pain Free Days
Pain Impact Questionnaire
Quality of Life
Full Information
NCT ID
NCT01149317
First Posted
June 21, 2010
Last Updated
January 27, 2012
Sponsor
Albert Einstein College of Medicine
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT01149317
Brief Title
Acupuncture for Chronic Pain
Acronym
ADDOPT
Official Title
Acupuncture to Decrease Disparities in Outcomes of Pain Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Chronic pain is a significant public health problem, associated with impairments of physical and psychological functioning. While a third or more of the general population may suffer from chronic pain, it is often under recognized and under treated in health care settings. Low income and minority samples experience disparities in the prevalence of chronic pain, in perceived access to effective pain treatment, and in consultations for pain. A great deal of literature suggests that acupuncture offers potential benefit in the management of chronic pain, but it is rarely available to low income patients. The Acupuncture to Decrease Disparities in Outcomes of Pain Treatment (ADDOPT) project will introduce and evaluate the addition of acupuncture to the management of chronic pain for ethnically diverse, low-income primary care patients. The project represents a collaboration between the New York City Research and Improvement Networking Group (NYC RING), a practice-based research network dedicated to decreasing health disparities through primary care research, the Continuum Center for Health and Healing,The Swedish Institute School of Acupuncture, and Pacific College of Oriental Medicine. Our intervention will involve addition of weekly acupuncture sessions at 3 urban primary care practices. During training sessions at each practice, primary care providers will become familiar with acupuncture and indications for referral. Patients will be eligible if they experience chronic pain due to neck pain, back pain, or osteoarthritis. Our process evaluation, guided by Glasgow's REAIM framework, will assess barriers to implementation and adoption of the intervention in busy urban practices and acceptability to patients and providers. The investigators will employ a quasiexperimental design to assess primary outcomes (pain and quality of life) and obtain preliminary estimates of secondary outcomes (health care utilization and costs) of the intervention at each health center. This design will permit comparison across sites to discern practice level differences in uptake and outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
acupuncture, health services research, chronic pain, health disparities
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
235 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
Weekly acupuncture treatment for up to 14 weeks
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
Weekly acupuncture treatment for up to 14 weeks to augment usual care
Primary Outcome Measure Information:
Title
Brief Pain Inventory
Time Frame
1 mo pre-acupuncture and 6 mo
Secondary Outcome Measure Information:
Title
Pain Free Days
Time Frame
pre-acupuncture and 6 mo
Title
Pain Impact Questionnaire
Time Frame
1 mo pre-acupuncture and 6 mo
Title
Quality of Life
Time Frame
1 mo pre-acupuncture and 6 mo
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic pain due to osteoarthritis, back pain or neck pain; English or Spanish speaking
Exclusion Criteria:
Active substance abuse; cognitive impairment; coumadin therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Diane McKee, MD, MS
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Benjamin Kligler, MD, MPH
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Acupuncture for Chronic Pain
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