Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
---|---|
Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
ClinicalTrials.gov Identifier: | NCT00000418 |
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.
Condition | Intervention | Phase |
---|---|---|
Acute Low Back Pain |
Procedure: Psychosocial intervention |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Psychosocial Intervention for Acute Low Back Pain (ALBP) |
Estimated Enrollment: | 211 |
Study Start Date: | September 1977 |
Estimated Study Completion Date: | March 2001 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Indiana | |
Indiana University School of Medicine | |
Indianapolis, Indiana, United States, 46202 |
Principal Investigator: | Morris Weinberger, Ph.D. | Indiana University School of Medicine |
Study ID Numbers: | P60 AR20582 Substudy EEHSR4, NIAMS-025 |
Study First Received: | November 3, 1999 |
Last Updated: | January 3, 2007 |
ClinicalTrials.gov Identifier: | NCT00000418 |
Health Authority: | United States: Federal Government |
OA Patient education Acute low back pain (ALBP) Social support systems |
Signs and Symptoms Neurologic Manifestations Low Back Pain Pain Back Pain |
Nervous System Diseases |