Low Back PainNCT00373867
Effectiveness of Adding Behavioral Therapy to Physical Therapy to Treat Low Back Pain
A study testing Standard physical therapy, Graded exercise and Graded exposure in people with Low Back Pain, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Standard physical therapy, Graded exercise and Graded exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Mar 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Shands Rehabilitation at the University of Florida
Gainesville, Florida, 32610
About this study
Official title: Behavioral Interventions for Low Back Pain
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Standard physical therapy, Graded exercise, Graded exposure
- Keywords
- Secondary prevention, Physical therapy, Fear-avoidance beliefs, Disability
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard physical therapyBehavioural
Treatment-based classification physical therapy
Graded exerciseBehavioural
Graded exercise increases an individual's tolerance to activity over time
Graded exposureOther
Graded exposure places the individual in fearful situations and gradually increases their exposure to such situations.
| Study group | Role | What they receive |
|---|---|---|
| Standard | Active comparator | Standard treatment-based classification physical therapy Receives: Behavioral: Standard physical therapy |
| Graded exercise | Active comparator | Treatment-based classification physical therapy plus graded exercise Receives: Behavioral: Graded exercise |
| Graded exposure | Experimental | Treatment-based classification physical therapy plus graded exposure Receives: Other: Graded exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Measured: Measured at Week 4 and Month 6
Pain-related disability
Measured: Measured at Week 4 and Month 6
Secondary outcomes (3)
Fear-avoidance beliefs
Measured: Measured at Week 4 and Month 6
Pain catastrophizing
Measured: Measured at Week 4 and Month 6
Physical impairment
Measured: Measured at Week 4 and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2006 (estimated)
- Study startJan 2006
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Steven Z. George, PT, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373867
- Sponsor's protocol ID
- R03AR051128
- Other IDs
- R03AR051128
- Status last verified
- Jan 2013
- First submitted
- 6 Sep 2006
- Last updated
- 28 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18786762Hirsh 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.
PubMed 18486557George 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.
PubMed 18349490
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Interventions for Low Back Pain
- ClinicalTrials.gov ID
- NCT00373867
- Acronym / sponsor ID
- R03AR051128
- Conditions
- Low Back Pain
- Keywords
- Secondary prevention, Physical therapy, Fear-avoidance beliefs, Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Jan 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 8 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Behavioral: Standard physical therapyStandard treatment-based classification physical therapy |
| Graded exercise | Active comparator | Behavioral: Graded exerciseTreatment-based classification physical therapy plus graded exercise |
| Graded exposure | Experimental | Other: Graded exposureTreatment-based classification physical therapy plus graded exposure |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard physical therapyTreatment-based classification physical therapy | Behavioural | Standard |
| Graded exerciseGraded exercise increases an individual's tolerance to activity over time | Behavioural | Graded exercise |
| Graded exposureGraded exposure places the individual in fearful situations and gradually increases their exposure to such situations. | Other | Graded exposure |
Primary outcome
Pain intensity
Time frame: Measured at Week 4 and Month 6
Pain-related disability
Time frame: Measured at Week 4 and Month 6
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2013.
- Results publication: PubMed 18786762George 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 publication: PubMed 18486557Hirsh 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 publication: PubMed 18349490George 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Z. George, PT, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard physical therapy, Graded exercise and Graded exposure in people with Low Back Pain, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Measured at Week 4 and Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00373867, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2013.