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

NCT00373867 | Completed DMC

• 1 other identifier: R03AR051128
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Secondary prevention; Physical therapy; Fear-avoidance beliefs; Disability

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  Measured at Week 4 and Month 6

• Pain-related disability

  Measured at Week 4 and Month 6

Secondary Outcomes (3)

• Fear-avoidance beliefs

  Measured at Week 4 and Month 6

• Pain catastrophizing

  Measured at Week 4 and Month 6

• Physical impairment

  Measured at Week 4 and Month 6

Study Arms (3)

Standard

ACTIVE COMPARATOR

Standard treatment-based classification physical therapy

Behavioral: Standard physical therapy

Graded exercise

ACTIVE COMPARATOR

Treatment-based classification physical therapy plus graded exercise

Behavioral: Graded exercise

Graded exposure

EXPERIMENTAL

Treatment-based classification physical therapy plus graded exposure

Other: Graded exposure

Interventions

Standard physical therapy BEHAVIORAL

Treatment-based classification physical therapy

Standard

Graded exercise BEHAVIORAL

Graded exercise increases an individual's tolerance to activity over time

Graded exercise

Graded exposure OTHER

Graded exposure places the individual in fearful situations and gradually increases their exposure to such situations.

Graded exposure

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Shands Rehabilitation at the University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (3)

• 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.

  PMID: 18786762 RESULT

• 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.

  PMID: 18486557 RESULT

• 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.

  PMID: 18349490 RESULT

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Steven Z. George, PT, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2006
• First Posted: September 8, 2006
• Study Start: January 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: January 28, 2013

Record last verified: 2013-01

Locations

US (1)