Effectiveness of Adding Behavioral Therapy to Physical Therapy to Treat Low Back Pain
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|ClinicalTrials.gov Identifier: NCT00373867|
Recruitment Status : Completed
First Posted : September 8, 2006
Last Update Posted : January 28, 2013
|Condition or disease||Intervention/treatment|
|Low Back Pain||Behavioral: Standard physical therapy Behavioral: Graded exercise Other: Graded exposure|
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 individual's 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 individual's 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Behavioral Interventions for Low Back Pain|
|Study Start Date :||January 2006|
|Primary Completion Date :||March 2008|
|Study Completion Date :||March 2008|
Active Comparator: Standard
Standard treatment-based classification physical therapy
Behavioral: Standard physical therapy
Treatment-based classification physical therapy
Active Comparator: Graded exercise
Treatment-based classification physical therapy plus graded exercise
Behavioral: Graded exercise
Graded exercise increases an individual's tolerance to activity over time
Experimental: Graded exposure
Treatment-based classification physical therapy plus graded exposure
Other: Graded exposure
Graded exposure places the individual in fearful situations and gradually increases their exposure to such situations.
- Pain intensity [ Time Frame: Measured at Week 4 and Month 6 ]
- Pain-related disability [ Time Frame: Measured at Week 4 and Month 6 ]
- Fear-avoidance beliefs [ Time Frame: Measured at Week 4 and Month 6 ]
- Pain catastrophizing [ Time Frame: Measured at Week 4 and Month 6 ]
- Physical impairment [ Time Frame: Measured at Week 4 and Month 6 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00373867
|United States, Florida|
|Shands Rehabilitation at the University of Florida|
|Gainesville, Florida, United States, 32610|
|Principal Investigator:||Steven Z. George, PT, PhD||University of Florida|