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Trial NCT00000418

Resource URI: http://static.linkedct.org/resource/trials/NCT00000418
linkedct:brief_title Psychosocial Treatment for Acute Low Back Pain
linkedct:condition <http://static.linkedct.org/resource/condition/307>
linkedct:criteria Inclusion Criteria: - Acute low back pain Exclusion Criteria: - Chronic back pain (including surgery) - Disability claim for back pain - Nursing home resident - Severe impairment in hearing, vision, or speech - Unable to speak English - Severe comorbidity - Unable to contact by phone - Excluded by primary care physician
linkedct:description Acute low back pain (ALBP) is very prevalent in the United States, accounting for substantial morbidity, functional limitations, pain, and health care costs. Psychosocial interventions that target improved symptom control and patient functioning have the potential to improve the outcomes of patients with ALBP. This study evaluates a psychosocial intervention designed to enhance self-efficacy and social support for patients with ALBP. In this randomized, controlled trial, we will randomize eligible patients with ALBP to receive the intervention or usual care. The intervention program consists of: (1) patient education regarding ALBP; (2) explanations and rationales, in layperson's terms, of diagnostic and treatment options for ALBP; (3) discussions regarding the management of negative affect (i.e., depression, anger, fear, hostility, anxiety); (4) methods to involve social support systems; and (5) strategies to involve the primary care physician to reinforce patients' behaviors and progress. We will follow patients for 12 months and assess outcomes at 3 and 12 months. Primary outcomes are health-related quality of life (i.e., functional status, role function, back pain symptoms) and patient satisfaction with care. Secondary outcomes include health care use, direct health care costs, self-efficacy, and social support. We will also estimate the cost-effectiveness of the intervention. We will conduct this investigation among socioeconomically vulnerable patients with ALBP, a group that shoulders a disproportionate burden of disability and morbidity from musculoskeletal conditions and comorbid medical conditions.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date March 2001
linkedct:enrollment 211 (xsd:int)
linkedct:firstreceived_date November 3, 1999
linkedct:id NCT00000418
rdfs:label Trial NCT00000418
linkedct:lastchanged_date January 3, 2007
linkedct:lead_sponsor_agency National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
linkedct:location <http://static.linkedct.org/resource/location/184777>
linkedct:nct_id NCT00000418
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Psychosocial Intervention for Acute Low Back Pain (ALBP)
linkedct:org_study_id P60 AR20582 Substudy EEHSR4
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/42482>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000418>
linkedct:phase Phase 2
linkedct:reference <http://static.linkedct.org/resource/reference/14609>
linkedct:reference <http://static.linkedct.org/resource/reference/16971>
linkedct:reference <http://static.linkedct.org/resource/reference/20137>
linkedct:reference <http://static.linkedct.org/resource/reference/868>
linkedct:reference <http://static.linkedct.org/resource/reference/869>
linkedct:reference <http://static.linkedct.org/resource/reference/870>
linkedct:secondary_id NIAMS-025
linkedct:source National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
linkedct:start_date September 1977
linkedct:study_design Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct:summary Acute low back pain (severe pain that comes on suddenly and lasts a relatively short time) is very common in the United States, and accounts for substantial illness, functional limitations, pain, and health care costs. This study looks at whether a program designed to improve self-efficacy (a person's belief in his or her ability to reach a goal, such as managing one's own disease) and social support improves the health status of people with acute low back pain.
rdf:type linkedct:trials
linkedct:verification_date June 1999