Psychosocial Treatment for Acute Low Back Pain
Primary Purpose
Acute Low Back Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Psychosocial intervention
Sponsored by
About this trial
This is an interventional treatment trial for Acute Low Back Pain focused on measuring OA, Patient education, Acute low back pain (ALBP), Social support systems
Eligibility 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
Sites / Locations
- Indiana University School of Medicine
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000418
First Posted
November 3, 1999
Last Updated
June 4, 2013
Sponsor
Indiana University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1. Study Identification
Unique Protocol Identification Number
NCT00000418
Brief Title
Psychosocial Treatment for Acute Low Back Pain
Official Title
Psychosocial Intervention for Acute Low Back Pain (ALBP)
Study Type
Interventional
2. Study Status
Record Verification Date
June 1999
Overall Recruitment Status
Completed
Study Start Date
September 1977 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2001 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Low Back Pain
Keywords
OA, Patient education, Acute low back pain (ALBP), Social support systems
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
211 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Psychosocial intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morris Weinberger, Ph.D.
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12209482
Citation
Damush TM, Weinberger M, Clark DO, Tierney WM, Rao JK, Perkins SM, Verel K. Acute low back pain self-management intervention for urban primary care patients: rationale, design, and predictors of participation. Arthritis Rheum. 2002 Aug;47(4):372-9. doi: 10.1002/art.10382.
Results Reference
background
PubMed Identifier
12687508
Citation
Damush TM, Weinberger M, Perkins SM, Rao JK, Tierney WM, Qi R, Clark DO. Randomized trial of a self-management program for primary care patients with acute low back pain: short-term effects. Arthritis Rheum. 2003 Apr 15;49(2):179-86. doi: 10.1002/art.10995.
Results Reference
background
Citation
Damush, Weinberger, Perkins, Rao, Tierney, Qi, & Clark. The cost-effectiveness of a self-management program for primary care patients with acute low back pain. 2002. In preparation.
Results Reference
background
Citation
Damush TM, Weinberger M, Tierney WM, Rao JK, Clark DO, & Perkins SM. A randomized trial of a self-management program for primary care patients with acute low back pain: 12-month outcomes. Poster presented at the annual meeting of the American College of Rheumatology, San Francisco, CA. Arthritis & Rheumatism. 2001;44:S206.
Results Reference
background
Citation
Damush TM, Weinberger M, Tierney WM, Rao JK, Clark DO, & Perkins SM. A randomized trial of a self-management program for primary care patients with acute low back pain: 4-month outcomes. Poster presented at the annual meeting of the American College of Rheumatology, Philadelphia, PA. Arthritis & Rheumatism. 2000;43:S9.
Results Reference
background
Citation
Damush TM, Weinberger M, Tierney WM, Rao J, Clark DO, Adams K, Perkins S, & Emsley C. A comparison between older and younger adults with acute low back pain on functional status and self-management. Poster presented at the annual meeting of the Gerontological Society of America, San Francisco, CA. The Gerontologist. 1999;39:S571.
Results Reference
background
PubMed Identifier
14638564
Citation
Damush TM, Weinberger M, Perkins SM, Rao JK, Tierney WM, Qi R, Clark DO. The long-term effects of a self-management program for inner-city primary care patients with acute low back pain. Arch Intern Med. 2003 Nov 24;163(21):2632-8. doi: 10.1001/archinte.163.21.2632.
Results Reference
background
PubMed Identifier
32216697
Citation
Gameza VA, Bell Lybecker M, Wara P. Laparoscopic Keyhole Versus Sugarbaker Repair in Parastomal Hernia: A Long-Term Case-Controlled Prospective Study of Consecutive Patients. J Laparoendosc Adv Surg Tech A. 2020 Jul;30(7):783-789. doi: 10.1089/lap.2020.0074. Epub 2020 Mar 27.
Results Reference
derived
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Psychosocial Treatment for Acute Low Back Pain
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