Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000418
Status:
COMPLETED
Last Update Posted:
2013-06-06
First Post:
1999-11-03
Brief Title:
Psychosocial Treatment for Acute Low Back Pain
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Psychosocial Intervention for Acute Low Back Pain ALBP
Status:
COMPLETED
Status Verified Date:
1999-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 persons belief in his or her ability to reach a goal such as managing ones 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 laypersons terms of diagnostic and treatment options for ALBP 3 discussions regarding the management of negative affect ie 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 ie 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
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 laypersons terms of diagnostic and treatment options for ALBP 3 discussions regarding the management of negative affect ie 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P60AR020582 | NIH | None | None |
| NIAMS-025 | US NIH GrantContract | None | httpsreporternihgovquickSearchP60AR020582 |