Acupuncture for Chronic Pain

Chronic Pain Clinical Trial

— ADDOPT  

Official title:

Acupuncture to Decrease Disparities in Outcomes of Pain Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01149317
• Other study ID #: 2007-306
• Secondary ID: R21AT004543
• Status: Completed
• Phase: N/A
• First received: June 21, 2010
• Last updated: January 27, 2012
• Start date: May 2008
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: Albert Einstein College of Medicine of Yeshiva University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Procedure:
• Acupuncture
Weekly acupuncture treatment for up to 14 weeks to augment usual care

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine of Yeshiva University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Pain Inventory		1 mo pre-acupuncture and 6 mo	No
Secondary	Pain Free Days		pre-acupuncture and 6 mo	No
Secondary	Pain Impact Questionnaire		1 mo pre-acupuncture and 6 mo	No
Secondary	Quality of Life		1 mo pre-acupuncture and 6 mo	No