Taking ACTION to reduce pain: ACTION study rationale, design and protocol of a randomized trial of a proactive telephone-based coaching intervention for chronic musculoskeletal pain among African Americans.
BACKGROUND
Rates of chronic pain are rising sharply in the United States and worldwide. Presently, there is evidence of racial disparities in pain treatment and treatment outcomes in the United States but few interventions designed to address these disparities. There is growing consensus that chronic musculoskeletal pain is best addressed by a biopsychosocial approach that acknowledges the role of psychological and environmental factors, some of which differ by race.


METHODS/DESIGN
The primary aim of this randomized controlled trial is to test the effectiveness of a non-pharmacological, self-regulatory intervention, administered proactively by telephone, at improving pain outcomes and increasing walking among African American patients with hip, back and knee pain. Participants assigned to the intervention will receive a telephone counselor delivered pedometer-mediated walking intervention that incorporates action planning and motivational interviewing. The intervention will consist of 6 telephone counseling sessions over an 8-10 week period. Participants randomly assigned to Usual Care will receive an informational brochure and a pedometer. The primary outcome is chronic pain-related physical functioning, assessed at 6 months, by the revised Roland and Morris Disability Questionnaire, a measure recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT). We will also examine whether the intervention improves other IMMPACT-recommended domains (pain intensity, emotional functioning, and ratings of overall improvement). Secondary objectives include examining whether the intervention reduces health care service utilization and use of opioid analgesics and whether key contributors to racial/ethnic disparities targeted by the intervention mediate improvement in chronic pain outcomes Measures will be assessed by mail and phone surveys at baseline, three months, and six months. Data analysis of primary aims will follow intent-to-treat methodology.


DISCUSSION
We will tailor our intervention to address key contributors to racial pain disparities and examine the effects of the intervention on important pain treatment outcomes for African Americans with chronic musculoskeletal pain.


TRIAL REGISTRATION
ClinicalTrials.gov: NCT01983228 . Registered 6 November 2013.
['Bhimani|Rozina H|RH|', 'Cross|Lee J S|LJ|', 'Taylor|Brent C|BC|', 'Meis|Laura A|LA|', 'Fu|Steven S|SS|', 'Allen|Kelli D|KD|', 'Krein|Sarah L|SL|', 'Do|Tam|T|', 'Kerns|Robert D|RD|', 'Burgess|Diana J|DJ|']
D001741:African Americans D059350:Chronic Pain D003376:Counseling D007722:Health Knowledge, Attitudes, Practice D054625:Healthcare Disparities D006801:Humans D000071252:Mentoring D059352:Musculoskeletal Pain D059408:Pain Management D010147:Pain Measurement D010174:Pamphlets D012107:Research Design D011795:Surveys and Questionnaires D013689:Telephone D016896:Treatment Outcome D014481:United States
Chronic musculoskeletal pain African American Randomized control trial Veterans administration