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

Low Back Pain Clinical Trial

Official title:

Behavioral Interventions for Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00373867
• Other study ID #: R03AR051128
• Secondary ID: R03AR051128
• Status: Completed
• Phase: N/A
• First received: September 6, 2006
• Last updated: January 24, 2013
• Start date: January 2006
• Est. completion date: March 2008

Study information

• Verified date: January 2013
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Behavioral:
• Standard physical therapy
Treatment-based classification physical therapy
• Graded exercise
Graded exercise increases an individual's tolerance to activity over time

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

Locations

Country	Name	City	State
United States	Shands Rehabilitation at the University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 — View 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):145-57. doi: 1 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity		Measured at Week 4 and Month 6	No
Primary	Pain-related disability		Measured at Week 4 and Month 6	No
Secondary	Fear-avoidance beliefs		Measured at Week 4 and Month 6	No
Secondary	Pain catastrophizing		Measured at Week 4 and Month 6	No
Secondary	Physical impairment		Measured at Week 4 and Month 6	No