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Effectiveness of Adding Behavioral Therapy to Physical Therapy to Treat Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard physical therapy
Graded exercise
Graded exposure
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Secondary prevention, Physical therapy, Fear-avoidance beliefs, Disability

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Quebec Task Force Spinal Disorders (QTFSD) classification of 1a: acute low back pain without pain radiation below the gluteal fold
  • QTFSD classification of 1b and 1c: subacute and chronic low back pain without pain radiation below the gluteal fold
  • QTFSD classification of 2a: acute low back pain with pain radiation to the knee
  • QTFSD classification of 2b and 2c: subacute and chronic low back pain with pain radiation to the knee
  • QTFSD classification of 3a, 3b, or 3c: acute, subacute, or chronic low back pain with pain radiation below the knee
  • Can read and speak English
  • Parent or guardian willing to provide informed consent if applicable

Exclusion Criteria:

  • QTFSD classification of 4a, 4b, or 4c: acute, subacute, or chronic low back pain with pain radiation below the knee and experiencing neurological symptoms
  • QTFSD classification of 5: likely lumbar nerve root compression
  • QTFSD classification of 6: confirmed lumbar nerve root compression
  • QTFSD classification of 7: confirmed lumbar spinal stenosis
  • QTFSD classification of 8: less than 6 months after surgery for back pain
  • QTFSD classification of 9.1: more than 6 months after surgery for back pain and not experiencing any symptoms
  • QTFSD classification of 11: other spinal disorders including cancer, disease inside bone, or fracture

Sites / Locations

  • Shands Rehabilitation at the University of Florida

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Standard

Graded exercise

Graded exposure

Arm Description

Standard treatment-based classification physical therapy

Treatment-based classification physical therapy plus graded exercise

Treatment-based classification physical therapy plus graded exposure

Outcomes

Primary Outcome Measures

Pain intensity
Pain-related disability

Secondary Outcome Measures

Fear-avoidance beliefs
Pain catastrophizing
Physical impairment

Full Information

First Posted
September 6, 2006
Last Updated
January 24, 2013
Sponsor
University of Florida
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00373867
Brief Title
Effectiveness of Adding Behavioral Therapy to Physical Therapy to Treat Low Back Pain
Official Title
Behavioral Interventions for Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Secondary prevention, Physical therapy, Fear-avoidance beliefs, Disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard
Arm Type
Active Comparator
Arm Description
Standard treatment-based classification physical therapy
Arm Title
Graded exercise
Arm Type
Active Comparator
Arm Description
Treatment-based classification physical therapy plus graded exercise
Arm Title
Graded exposure
Arm Type
Experimental
Arm Description
Treatment-based classification physical therapy plus graded exposure
Intervention Type
Behavioral
Intervention Name(s)
Standard physical therapy
Intervention Description
Treatment-based classification physical therapy
Intervention Type
Behavioral
Intervention Name(s)
Graded exercise
Intervention Description
Graded exercise increases an individual's tolerance to activity over time
Intervention Type
Other
Intervention Name(s)
Graded exposure
Intervention Description
Graded exposure places the individual in fearful situations and gradually increases their exposure to such situations.
Primary Outcome Measure Information:
Title
Pain intensity
Time Frame
Measured at Week 4 and Month 6
Title
Pain-related disability
Time Frame
Measured at Week 4 and Month 6
Secondary Outcome Measure Information:
Title
Fear-avoidance beliefs
Time Frame
Measured at Week 4 and Month 6
Title
Pain catastrophizing
Time Frame
Measured at Week 4 and Month 6
Title
Physical impairment
Time Frame
Measured at Week 4 and Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Quebec Task Force Spinal Disorders (QTFSD) classification of 1a: acute low back pain without pain radiation below the gluteal fold QTFSD classification of 1b and 1c: subacute and chronic low back pain without pain radiation below the gluteal fold QTFSD classification of 2a: acute low back pain with pain radiation to the knee QTFSD classification of 2b and 2c: subacute and chronic low back pain with pain radiation to the knee QTFSD classification of 3a, 3b, or 3c: acute, subacute, or chronic low back pain with pain radiation below the knee Can read and speak English Parent or guardian willing to provide informed consent if applicable Exclusion Criteria: QTFSD classification of 4a, 4b, or 4c: acute, subacute, or chronic low back pain with pain radiation below the knee and experiencing neurological symptoms QTFSD classification of 5: likely lumbar nerve root compression QTFSD classification of 6: confirmed lumbar nerve root compression QTFSD classification of 7: confirmed lumbar spinal stenosis QTFSD classification of 8: less than 6 months after surgery for back pain QTFSD classification of 9.1: more than 6 months after surgery for back pain and not experiencing any symptoms QTFSD classification of 11: other spinal disorders including cancer, disease inside bone, or fracture
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Z. George, PT, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shands Rehabilitation at the University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18786762
Citation
George SZ, Zeppieri G Jr, Cere AL, Cere MR, Borut MS, Hodges MJ, Reed DM, Valencia C, Robinson ME. A randomized trial of behavioral physical therapy interventions for acute and sub-acute low back pain (NCT00373867). Pain. 2008 Nov 15;140(1):145-157. doi: 10.1016/j.pain.2008.07.029. Epub 2008 Sep 10.
Results Reference
result
PubMed Identifier
18486557
Citation
Hirsh AT, George SZ, Bialosky JE, Robinson ME. Fear of pain, pain catastrophizing, and acute pain perception: relative prediction and timing of assessment. J Pain. 2008 Sep;9(9):806-12. doi: 10.1016/j.jpain.2008.03.012. Epub 2008 May 16.
Results Reference
result
PubMed Identifier
18349490
Citation
George SZ, Fritz JM, Childs JD. Investigation of elevated fear-avoidance beliefs for patients with low back pain: a secondary analysis involving patients enrolled in physical therapy clinical trials. J Orthop Sports Phys Ther. 2008 Feb;38(2):50-8. doi: 10.2519/jospt.2008.2647. Epub 2008 Jan 22.
Results Reference
result

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Effectiveness of Adding Behavioral Therapy to Physical Therapy to Treat Low Back Pain

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