Acupuncture for Chronic Pain (ADDOPT)

January 27, 2012 updated by: Diane Mckee, Albert Einstein College of Medicine

Acupuncture to Decrease Disparities in Outcomes of Pain Treatment

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

235

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Albert Einstein College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture
Weekly acupuncture treatment for up to 14 weeks
Procedure: Acupuncture
Weekly acupuncture treatment for up to 14 weeks to augment usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Brief Pain Inventory
Time Frame: 1 mo pre-acupuncture and 6 mo
1 mo pre-acupuncture and 6 mo

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain Free Days
Time Frame: pre-acupuncture and 6 mo
pre-acupuncture and 6 mo
Pain Impact Questionnaire
Time Frame: 1 mo pre-acupuncture and 6 mo
1 mo pre-acupuncture and 6 mo
Quality of Life
Time Frame: 1 mo pre-acupuncture and 6 mo
1 mo pre-acupuncture and 6 mo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albert Einstein College of Medicine

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Melissa Diane McKee, MD, MS, Albert Einstein College of Medicine
  • Principal Investigator: Benjamin Kligler, MD, MPH, Albert Einstein College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

June 21, 2010

First Submitted That Met QC Criteria

June 22, 2010

First Posted (Estimate)

June 23, 2010

Study Record Updates

Last Update Posted (Estimate)

January 31, 2012

Last Update Submitted That Met QC Criteria

January 27, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-306
  • R21AT004543 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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