NCT01149317

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
235

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
Completed

Started May 2008

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 23, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 31, 2012

Status Verified

January 1, 2012

Enrollment Period

3.7 years

First QC Date

June 21, 2010

Last Update Submit

January 27, 2012

Conditions

Chronic Pain

Keywords

acupuncturehealth services researchchronic painhealth disparities

Outcome Measures

Primary Outcomes (1)

  • Brief Pain Inventory

    1 mo pre-acupuncture and 6 mo

Secondary Outcomes (3)

  • Pain Free Days

    pre-acupuncture and 6 mo

  • Pain Impact Questionnaire

    1 mo pre-acupuncture and 6 mo

  • Quality of Life

    1 mo pre-acupuncture and 6 mo

Study Arms (1)

Acupuncture

EXPERIMENTAL

Weekly acupuncture treatment for up to 14 weeks

Procedure: Acupuncture

Interventions

AcupuncturePROCEDURE

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

Acupuncture

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic pain due to osteoarthritis, back pain or neck pain; English or Spanish speaking

You may not qualify if:

  • Active substance abuse; cognitive impairment; coumadin therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Melissa Diane McKee, MD, MS

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

  • Benjamin Kligler, MD, MPH

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Dept of Family and Social Medicine

Study Record Dates

First Submitted

June 21, 2010

First Posted

June 23, 2010

Study Start

May 1, 2008

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

January 31, 2012

Record last verified: 2012-01

Locations

US(1)