Clinical trial NCT02444702: Clinical, Morphological and Functional Success Predictors Following Lumbar Spinal Surgery in Patients With Chronic Low Back Pain and Degenerative Disorders.
Official title: Clinical, Morphological and Functional Success Predictors Following Lumbar Spinal Surgery in Patients With Chronic Low Back Pain and Degenerative Disorders.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Low Back Pain
Keywords: spinal stenosis, clinical predictors rules, MRI, fusion, low back pain
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2015-05-14
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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, and in Assuta hospital, Tel Aviv, 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

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op
measure: The Roland Morris Disability Questionnaire (RMQ)
timeFrame: up to 1 year
Secondary outcomes:
measure: The Fear Avoidance Beliefs questionnaire (FABQ)
timeFrame: 6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op
measure: The International Physical Activity Questionnaire (IPAQ)
timeFrame: 6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op
measure: The Visual Analog Scale (VAS)
timeFrame: 6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op
measure: Lumbar myotomes function
timeFrame: 6 weeks pre-op, 6 months post op and 1 year post op
measure: The Long Distance Corridor Walk (LDCW)
timeFrame: 6 weeks pre-op, 6 months post op and 1 year
measure: The 8 foot up and go
timeFrame: 6 weeks pre-op, 6 months post op and 1 year
measure: The 30-seconds chair stand test
timeFrame: 6 weeks pre-op, 6 months post op and 1 year
measure: Grip strength
timeFrame: 6 weeks pre-op, 6 months post op and 1 year
measure: single leg stance test
timeFrame: 6 weeks pre-op, 6 months post op and 1 year
measure: The four square step test
timeFrame: 6 weeks pre-op, 6 months post op and 1 year
measure: Passive straight leg raise (PSLR)
timeFrame: 6 weeks pre-op, 6 months post op and 1 year
Other outcomes:
measure: Morphological parameters
timeFrame: 6 weeks pre-op
Locations:
city: Tel Aviv
country: Israel
facility: Assuta hospital
Study officials:
affiliation: Tel Aviv University
name: Youssef Masharawi, DPT
role: STUDY_CHAIR
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