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

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ClinicalTrials.gov Identifier: NCT02444702
Recruitment Status : Recruiting
First Posted : May 14, 2015
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

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.

Condition or disease
Low Back Pain

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Clinical, Morphological and Functional Success Predictors Following Lumbar Spinal Surgery in Patients With Chronic Low Back Pain and Degenerative Disorders.
Actual Study Start Date : June 15, 2015
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Group/Cohort
CLBP and degenerative lumbar spine
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.



Primary Outcome Measures :
  1. 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 [ Time Frame: 6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op ]
  2. The Roland Morris Disability Questionnaire (RMQ) [ Time Frame: up to 1 year ]
    Commonly used in CLBP research as measures of patients' participation restrictions


Secondary Outcome Measures :
  1. The Fear Avoidance Beliefs questionnaire (FABQ) [ Time Frame: 6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op ]
    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

  2. The International Physical Activity Questionnaire (IPAQ) [ Time Frame: 6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op ]
    The IPAQ was designed to provide a set of well-developed instruments that can be used internationally to obtain comparable estimates of physical activity

  3. The Visual Analog Scale (VAS) [ Time Frame: 6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op ]
    The VAS is one of the most commonly used pain measures in CLBP research and has been shown to be reliable in this population

  4. Lumbar myotomes function [ Time Frame: 6 weeks pre-op, 6 months post op and 1 year post op ]
    Will be taken by the Hand-held dynamometry (HHD) in order to assess the lower extremity muscle force output

  5. The Long Distance Corridor Walk (LDCW) [ Time Frame: 6 weeks pre-op, 6 months post op and 1 year ]
    comprised of a 2 minute warm up and a 400 meter walk as fast as possible

  6. The 8 foot up and go [ Time Frame: 6 weeks pre-op, 6 months post op and 1 year ]
    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

  7. The 30-seconds chair stand test [ Time Frame: 6 weeks pre-op, 6 months post op and 1 year ]
    for lower body strength

  8. Grip strength [ Time Frame: 6 weeks pre-op, 6 months post op and 1 year ]
    Hand grip strength was found to be associated with changes in disability and pain following aquatic therapy in patients with CLBP

  9. single leg stance test [ Time Frame: 6 weeks pre-op, 6 months post op and 1 year ]
    measures static balance

  10. The four square step test [ Time Frame: 6 weeks pre-op, 6 months post op and 1 year ]
    measures dynamic balance

  11. Passive straight leg raise (PSLR) [ Time Frame: 6 weeks pre-op, 6 months post op and 1 year ]
    Passive straight leg raise (PSLR) up to first sensation of pain will be measured with an inclinometer


Other Outcome Measures:
  1. Morphological parameters [ Time Frame: 6 weeks pre-op ]
    morphological parameters in the lumbar spine will be analyzed from the CT imaging : a) Lumbar lordosis b) Sacral angle orientation, c) Pelvic tilt , d) Pelvis width e) Lumbar vertebral body and disc shape- the vertebral body and inter-vertebral disc lengths, widths, heights and wedging ,Lumbar vertebral arch shape



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02444702


Contacts
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Contact: Shay Shabat, Prof. 972-9-7471153 Shay.Shabat@clalit.org.il
Contact: Avihai Soroka, MscPT 972-522982802 yossefm@post.tau.ac.il

Locations
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Israel
Assuta hospital Recruiting
Tel Aviv, Israel
Contact: Eli Ashkenazy, Dr.    972-0546666008    ashkenazy@isc.co.il   
Contact: Avihai Soroka, MscPT    972-522982802    avihaisoroka@gmail.com   
Principal Investigator: Eli Ashkenazy, Dr.         
Sponsors and Collaborators
Meir Medical Center
Investigators
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Study Chair: Youssef Masharawi, DPT Tel Aviv University

Publications:

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Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT02444702     History of Changes
Other Study ID Numbers: 0006-15-MMC
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018

Keywords provided by Meir Medical Center:
spinal stenosis, clinical predictors rules, MRI, fusion, low back pain

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms