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Psychosocial Treatment for Acute Low Back Pain

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.
 
ClinicalTrials.gov Identifier: NCT00000418
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : June 6, 2013
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Indiana University

Tracking Information
First Submitted Date  ICMJE November 3, 1999
First Posted Date  ICMJE November 4, 1999
Last Update Posted Date June 6, 2013
Study Start Date  ICMJE September 1977
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psychosocial Treatment for Acute Low Back Pain
Official Title  ICMJE Psychosocial Intervention for Acute Low Back Pain (ALBP)
Brief 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Acute Low Back Pain
Intervention  ICMJE Procedure: Psychosocial intervention
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
211
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE March 2001
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00000418
Other Study ID Numbers  ICMJE P60 AR20582 Substudy EEHSR4
P60AR020582 ( U.S. NIH Grant/Contract )
NIAMS-025
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Indiana University
Study Sponsor  ICMJE Indiana University
Collaborators  ICMJE National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators  ICMJE
Principal Investigator: Morris Weinberger, Ph.D. Indiana University School of Medicine
PRS Account Indiana University
Verification Date June 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP