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Psychosocial Treatment for Acute Low Back Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000418
First Posted: November 4, 1999
Last Update Posted: June 6, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Indiana University
  Purpose
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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Psychosocial Intervention for Acute Low Back Pain (ALBP)

Resource links provided by NLM:


Further study details as provided by Indiana University:

Estimated Enrollment: 211
Study Start Date: September 1977
Estimated Study Completion Date: March 2001
Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Morris Weinberger, Ph.D. Indiana University School of Medicine
  More Information

Publications:
Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00000418     History of Changes
Other Study ID Numbers: P60 AR20582 Substudy EEHSR4
P60AR020582 ( U.S. NIH Grant/Contract )
NIAMS-025
First Submitted: November 3, 1999
First Posted: November 4, 1999
Last Update Posted: June 6, 2013
Last Verified: June 1999

Keywords provided by Indiana University:
OA
Patient education
Acute low back pain (ALBP)
Social support systems

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms