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

NCT02444702 | Unknown DMC

• 1 other identifier: 0006-15-MMC
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

spinal stenosis, clinical predictors rules, MRI, fusion, low back pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• The Fear Avoidance Beliefs questionnaire (FABQ)

  6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op

• The International Physical Activity Questionnaire (IPAQ)

  6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op

• The Visual Analog Scale (VAS)

  6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op

• Lumbar myotomes function

  6 weeks pre-op, 6 months post op and 1 year post op

• The Long Distance Corridor Walk (LDCW)

  6 weeks pre-op, 6 months post op and 1 year

Other Outcomes (1)

• Morphological parameters

  6 weeks pre-op

Study Arms (1)

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.

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Participants' diagnosis may include unstable degenerative spondylolisthesis, radicular pain, or documented stenosis with referred pain

You may not qualify if:

• 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

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Assuta hospital

Tel Aviv, Israel

RECRUITING

Related Publications (11)

• Maniadakis N, Gray A. The economic burden of back pain in the UK. Pain. 2000 Jan;84(1):95-103. doi: 10.1016/S0304-3959(99)00187-6.

  PMID: 10601677 BACKGROUND

• Dankaerts W, O'Sullivan PB, Burnett AF, Straker LM. The use of a mechanism-based classification system to evaluate and direct management of a patient with non-specific chronic low back pain and motor control impairment--a case report. Man Ther. 2007 May;12(2):181-91. doi: 10.1016/j.math.2006.05.004. Epub 2006 Jul 31. No abstract available.

  PMID: 16877024 BACKGROUND

• Matsui H, Maeda A, Tsuji H, Naruse Y. Risk indicators of low back pain among workers in Japan. Association of familial and physical factors with low back pain. Spine (Phila Pa 1976). 1997 Jun 1;22(11):1242-7; discussion 1248. doi: 10.1097/00007632-199706010-00014.

  PMID: 9201863 BACKGROUND

• Lundon K, Bolton K. Structure and function of the lumbar intervertebral disk in health, aging, and pathologic conditions. J Orthop Sports Phys Ther. 2001 Jun;31(6):291-303; discussion 304-6. doi: 10.2519/jospt.2001.31.6.291.

  PMID: 11411624 BACKGROUND

• Masharawi YM, Peleg S, Albert HB, Dar G, Steingberg N, Medlej B, Abbas J, Salame K, Mirovski Y, Peled N, Hershkovitz I. Facet asymmetry in normal vertebral growth: characterization and etiologic theory of scoliosis. Spine (Phila Pa 1976). 2008 Apr 15;33(8):898-902. doi: 10.1097/BRS.0b013e31816b1f83.

  PMID: 18404110 BACKGROUND

• Luoma K, Riihimaki H, Luukkonen R, Raininko R, Viikari-Juntura E, Lamminen A. Low back pain in relation to lumbar disc degeneration. Spine (Phila Pa 1976). 2000 Feb 15;25(4):487-92. doi: 10.1097/00007632-200002150-00016.

  PMID: 10707396 BACKGROUND

• Ammendolia C, Chow N. Clinical outcomes for neurogenic claudication using a multimodal program for lumbar spinal stenosis: a retrospective study. J Manipulative Physiol Ther. 2015 Mar-Apr;38(3):188-94. doi: 10.1016/j.jmpt.2014.12.006. Epub 2015 Jan 22.

  PMID: 25620608 BACKGROUND

• Delitto A, Erhard RE, Bowling RW. A treatment-based classification approach to low back syndrome: identifying and staging patients for conservative treatment. Phys Ther. 1995 Jun;75(6):470-85; discussion 485-9. doi: 10.1093/ptj/75.6.470.

  PMID: 7770494 BACKGROUND

• Lubetzky-Vilnai A, Ciol M, McCoy SW. Statistical analysis of clinical prediction rules for rehabilitation interventions: current state of the literature. Arch Phys Med Rehabil. 2014 Jan;95(1):188-96. doi: 10.1016/j.apmr.2013.08.242. Epub 2013 Sep 10.

  PMID: 24036159 BACKGROUND

• Abbas J, Hamoud K, May H, Hay O, Medlej B, Masharawi Y, Peled N, Hershkovitz I. Degenerative lumbar spinal stenosis and lumbar spine configuration. Eur Spine J. 2010 Nov;19(11):1865-73. doi: 10.1007/s00586-010-1516-5. Epub 2010 Jul 21.

  PMID: 20652366 BACKGROUND

• Singh K, Samartzis D, Vaccaro AR, Nassr A, Andersson GB, Yoon ST, Phillips FM, Goldberg EJ, An HS. Congenital lumbar spinal stenosis: a prospective, control-matched, cohort radiographic analysis. Spine J. 2005 Nov-Dec;5(6):615-22. doi: 10.1016/j.spinee.2005.05.385.

  PMID: 16291100 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Spinal Stenosis

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Youssef Masharawi, DPT

  Tel Aviv University

  STUDY CHAIR

Central Study Contacts

Shay Shabat, Prof.

CONTACT

972-9-7471153; Shay.Shabat@clalit.org.il

Avihai Soroka, MscPT

CONTACT

972-522982802; yossefm@post.tau.ac.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2015
• First Posted: May 14, 2015
• Study Start: June 15, 2015
• Primary Completion: May 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 22, 2018

Record last verified: 2018-03

Locations

IL (1)