Psychosocial Treatment for Acute Low Back Pain
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|ClinicalTrials.gov Identifier: NCT00000418|
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : June 6, 2013
|Condition or disease||Intervention/treatment||Phase|
|Acute Low Back Pain||Procedure: Psychosocial intervention||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||211 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Psychosocial Intervention for Acute Low Back Pain (ALBP)|
|Study Start Date :||September 1977|
|Estimated Study Completion Date :||March 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000418
|United States, Indiana|
|Indiana University School of Medicine|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Morris Weinberger, Ph.D.||Indiana University School of Medicine|