Effectiveness of Adding Behavioral Therapy to Physical Therapy to Treat Low Back Pain - Full Text View

Sponsors and Collaborators:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) University of Florida
Information provided by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:	NCT00373867

Purpose

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.

Condition	Intervention
Low Back Pain	Behavioral: Standard physical therapy Behavioral: Graded exercise Other: Graded exposure

MedlinePlus related topics: Back Pain Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Behavioral Interventions for Low Back Pain

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:

Pain intensity [ Time Frame: Measured at Week 4 and Month 6 ] [ Designated as safety issue: No ]
Pain-related disability [ Time Frame: Measured at Week 4 and Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Fear-avoidance beliefs [ Time Frame: Measured at Week 4 and Month 6 ] [ Designated as safety issue: No ]
Pain catastrophizing [ Time Frame: Measured at Week 4 and Month 6 ] [ Designated as safety issue: No ]
Physical impairment [ Time Frame: Measured at Week 4 and Month 6 ] [ Designated as safety issue: No ]

Enrollment:	108
Study Start Date:	January 2006
Estimated Study Completion Date:	March 2008
Estimated Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Standard: Active Comparator Standard treatment-based classification physical therapy	Behavioral: Standard physical therapy Treatment-based classification physical therapy
Graded exercise: Active Comparator Treatment-based classification physical therapy plus graded exercise	Behavioral: Graded exercise Graded exercise increases an individual's tolerance to activity over time
Graded exposure: Experimental 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.

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.

Eligibility

Ages Eligible for Study:	15 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373867

Locations

United States, Florida
Shands Rehabilitation at the University of Florida
Gainesville, Florida, United States, 32610

Sponsors and Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

University of Florida

Investigators

Principal Investigator:

Steven Z. George, PT, PhD

University of Florida

More Information

Publications indexed to this study:

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):145-57. Epub 2008 Sep 10.

Responsible Party:	University of Florida ( Steven George )
Study ID Numbers:	R03 AR051128
Study First Received:	September 6, 2006
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00373867
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Secondary prevention
Physical therapy
Fear-avoidance beliefs
Disability

Study placed in the following topic categories:

Signs and Symptoms
Neoplasm Metastasis
Neurologic Manifestations

Low Back Pain
Pain
Back Pain

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009