Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00373867
Status:
COMPLETED
Last Update Posted:
2013-01-28
First Post:
2006-09-06
Brief Title:
Effectiveness of Adding Behavioral Therapy to Physical Therapy to Treat Low Back Pain
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Behavioral Interventions for Low Back Pain
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Low back pain is a very common problem and the most common cause of job-related disability While some occurrences of low back pain disappear within a couple of days other occurrences take much longer to resolve or lead to more serious conditions The purpose of this study is to determine the effectiveness of two behavioral types of therapy in reducing future disability in people who are receiving physical therapy for low back pain and tend to fear and avoid pain
Detailed Description:
Psychosocial factors such as fear and avoidance appear to play a role in the development of long-term disability from low back pain The Fear-Avoidance Model of Exaggerated Pain Perception FAMEPP is a biopsychosocial model that attempts to explain how and why some individuals develop a more substantial psychological component to their low back pain problem than do others FAMEPP suggests that an individuals pain-related fear and avoidance are the most important factors in determining whether long-term disability will result from an episode of low back pain For example FAMEPP suggests that individuals with high pain-related fear and avoidance are likely to use an avoidance response to low back pain leading to both physical and psychological consequences In contrast individuals with low pain-related fear and avoidance are likely to use a confrontation type of response to low back pain and gradually return to their normal social and physical functioning
Treatment based on FAMEPP involves two specific behavioral interventions that encourage people to confront their low back pain The first intervention graded exposure places the individual in fearful situations and gradually increases their exposure to such situations The second intervention graded exercise increases an individuals tolerance to activity over time The purpose of this pilot study is to determine the effectiveness of graded exposure and graded exercise when combined with traditional physical therapy in reducing future disability in adults with low back pain who tend to fear and avoid pain
Participants in this study will be randomly assigned to one of three groups
Group 1 will undergo graded exposure in addition to normal physical therapy during treatment sessions
Group 2 will undergo graded exercise in addition to normal physical therapy during treatment sessions
Group 3 will participate in only normal physical therapy during treatment sessions
The number of treatment sessions will vary depending on how a participant is improving At Week 4 and Month 6 all participants will be evaluated with a pain symptom assessment and questionnaires on pain intensity pain-related disability fear-avoidance beliefs overreaction to pain and physical impairment There will be no other follow-up visits for this study
Treatment based on FAMEPP involves two specific behavioral interventions that encourage people to confront their low back pain The first intervention graded exposure places the individual in fearful situations and gradually increases their exposure to such situations The second intervention graded exercise increases an individuals tolerance to activity over time The purpose of this pilot study is to determine the effectiveness of graded exposure and graded exercise when combined with traditional physical therapy in reducing future disability in adults with low back pain who tend to fear and avoid pain
Participants in this study will be randomly assigned to one of three groups
Group 1 will undergo graded exposure in addition to normal physical therapy during treatment sessions
Group 2 will undergo graded exercise in addition to normal physical therapy during treatment sessions
Group 3 will participate in only normal physical therapy during treatment sessions
The number of treatment sessions will vary depending on how a participant is improving At Week 4 and Month 6 all participants will be evaluated with a pain symptom assessment and questionnaires on pain intensity pain-related disability fear-avoidance beliefs overreaction to pain and physical impairment There will be no other follow-up visits for this study
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 |
|---|---|---|---|
| R03AR051128 | NIH | None | httpsreporternihgovquickSearchR03AR051128 |