Clinical, Morphological and Functional Success Predictors Following Lumbar Spinal Surgery in Patients With Chronic Low Back Pain and Degenerative Disorders.

Study Overview
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Brief Summary
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The long term goal of this project is dual fold. First, the investigators wish to derive, validate and then test the impact of a clinical prediction rule to determine which patients who suffer from CLBP with degenerative changes of the lumbar spine and referred pain to the legs are likely to require surgery and have successful outcomes in the long term. Second, the investigators would like to establish robust methodology and statistical analysis guidelines for creating clinical prediction rules in physical therapy research. This observational cohort project is a first step towards those goals. Here the investigators specifically aim to identify personal, behavioral, psychological, morphological, and physical factors that can predict the need for surgery as well as level of participation restriction in patients who suffer from CLBP with degenerative conditions of the lumbar spine and referred pain to the legs. The investigators will also explore which parameters can predict success after 1 month, 6 and 12 months in patients who underwent decompression/fusion surgery.

Detailed Description
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A classification-based approach to identify specific characteristics of patients who seriously suffer from chronic low back pain (CLBP) with referred pain to the legs who are likely to respond to certain interventions has become a research priority in the medical milieu in general and in physical therapy in particularly.While several classifications have been developed to predict success following physical therapy interventions, some have methodological flaws and no clinical prediction rules have been created for patients with CLBP with degenerative changes of the lumbar spine and referred pain to the legs who are likely to require surgery and have successful outcome post-surgery. CLBP is multifactorial and morphological findings such as degenerative changes of the lumbar spine may not explain the phenomenon in full. The international classification of functioning, disability and health allows for a comprehensive description of the patient as a whole and can be used to classify patients according to their anatomy, pathology, impairments and capacity One-hundred and fifty patients who suffer from CLBP with degenerative conditions of the lumbar spine and referred pain to the legs and are candidates for lumbar decompression/fusion surgery will be recruited from a physician office at the Meir medical center, department of orthopaedic surgery, Kfar-Saba, Israel. The structure and pathology of their lumbar spine will be analyzed in detail from CT and MRI imaging (morphological measurements of their vertebra and the intervertebral discs). Another one-hundred and fifty CT and MRI imaging of non symptomatic low back group will be taken from the Meir medical center in order to characterize the symptomatic group and their degenerative changes.

Official Title
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Clinical, Morphological and Functional Success Predictors Following Lumbar Spinal Surgery in Patients With Chronic Low Back Pain and Degenerative Disorders.

Conditions
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Low Back Pain

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants' diagnosis may include unstable degenerative spondylolisthesis, radicular pain, or documented stenosis with referred pain Exclusion Criteria: Psychiatric illness Previous spine surgery Painful arthritic hip Hospitalization or surgery in the previous 6 months Alcohol consumption > 10 drinks/week Diabetes or other causes for poly neuropathy Metabolic bone disease, tumor, spinal deformity or contraindications to MRI

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CLBP and degenerative lumbar spine<br>Participants with CLBP (>12 weeks) and degenerative changes of the lumbar spine confirmed by CT imaging who were recommended surgery and chose to undergo surgery will be recruited from the department of Orthopedic Surgery at the Meir Medical Center, Kfar-Saba, Israel. Included participants will be men or women, aged 40-80 years, of any race or ethnic background. Participants' diagnosis may include unstable degenerative spondylolisthesis, radicular pain, or documented stenosis with referred pain. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in Oswestry Disability Index (ODI) score which is equal to or greater than 50% has been used consistently in Physical Therapy literature as the definition of success following an intervention |  | 6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op | 
| The Roland Morris Disability Questionnaire (RMQ) | Commonly used in CLBP research as measures of patients' participation restrictions | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Fear Avoidance Beliefs questionnaire (FABQ) | The FABQ was found to be an important prognostic factor for work-related outcomes in patients with sub-acute LBP and a component of clinical predictors rules predicting changes in ODI following physical therapy interventions for patients with LBP | 6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op | 
| The International Physical Activity Questionnaire (IPAQ) | The IPAQ was designed to provide a set of well-developed instruments that can be used internationally to obtain comparable estimates of physical activity | 6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op | 
| The Visual Analog Scale (VAS) | The VAS is one of the most commonly used pain measures in CLBP research and has been shown to be reliable in this population | 6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op | 
| Lumbar myotomes function | Will be taken by the Hand-held dynamometry (HHD) in order to assess the lower extremity muscle force output | 6 weeks pre-op, 6 months post op and 1 year post op | 
| The Long Distance Corridor Walk (LDCW) | comprised of a 2 minute warm up and a 400 meter walk as fast as possible | 6 weeks pre-op, 6 months post op and 1 year | 
| The 8 foot up and go | The 8-foot version of the Time-up-and-go test is part of the reliable and valid senior fitness test. Performance on the test indicates on sensory, motor, strength and balance function | 6 weeks pre-op, 6 months post op and 1 year | 
| The 30-seconds chair stand test | for lower body strength | 6 weeks pre-op, 6 months post op and 1 year | 
| Grip strength | Hand grip strength was found to be associated with changes in disability and pain following aquatic therapy in patients with CLBP | 6 weeks pre-op, 6 months post op and 1 year | 
| single leg stance test | measures static balance | 6 weeks pre-op, 6 months post op and 1 year | 
| The four square step test | measures dynamic balance | 6 weeks pre-op, 6 months post op and 1 year | 
| Passive straight leg raise (PSLR) | Passive straight leg raise (PSLR) up to first sensation of pain will be measured with an inclinometer | 6 weeks pre-op, 6 months post op and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal stenosis, clinical predictors rules, MRI, fusion, low back pain