Acupuncture for Chronic Pain

NCT ID: NCT01149317

Last Updated: 2012-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 235 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2012-01-31

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Acupuncture

Weekly acupuncture treatment for up to 14 weeks

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: PROCEDURE

Weekly acupuncture treatment for up to 14 weeks to augment usual care

Interventions

Acupuncture

Weekly acupuncture treatment for up to 14 weeks to augment usual care

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Diane Mckee

Associate Professor, Dept of Family and Social Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melissa Diane McKee, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Benjamin Kligler, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

Albert Einstein College of Medicine

The Bronx, New York, United States

Countries

United States

Other Identifiers

R21AT004543

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2007-306

Identifier Type: -

Identifier Source: org_study_id