Clinical trial NCT01149317: Acupuncture for Chronic Pain
Official title: Acupuncture to Decrease Disparities in Outcomes of Pain Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: acupuncture
health services research
chronic pain
health disparities
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2010-06-23
Enrollment: 235
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Brief Pain Inventory
timeFrame: 1 mo pre-acupuncture and 6 mo
Secondary outcomes:
measure: Pain Free Days
timeFrame: pre-acupuncture and 6 mo
measure: Pain Impact Questionnaire
timeFrame: 1 mo pre-acupuncture and 6 mo
measure: Quality of Life
timeFrame: 1 mo pre-acupuncture and 6 mo
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Melissa Diane McKee, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Albert Einstein College of Medicine
name: Benjamin Kligler, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: