Low Back PainNCT02444702
Clinical, Morphological and Functional Success Predictors Following Lumbar Spinal Surgery in Patients With Chronic Low Back Pain and Degenerative Disorders.
An observational study of Low Back Pain, run by Meir Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Low Back Pain
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Jun 2015to Dec 2018
- Phase
- Observational
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Participants' diagnosis may include unstable degenerative spondylolisthesis, radicular pain, or documented stenosis with referred pain
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Assuta hospital
Tel Aviv
Eli Ashkenazy, Dr., 972-0546666008, ashkenazy@isc.co.il
Avihai Soroka, MscPT, 972-522982802, avihaisoroka@gmail.com
About this study
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.
Read the 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.
- Conditions
- Low Back Pain
- Keywords
- spinal stenosis, clinical predictors rules, MRI, fusion, low back pain
- Medical subject headings
- Low Back Pain, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: up to 1 year
Secondary outcomes (11)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 weeks pre-op, 6 months post op and 1 year
The 30-seconds chair stand test
for lower body strength
Measured: 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
Measured: 6 weeks pre-op, 6 months post op and 1 year
single leg stance test
measures static balance
Measured: 6 weeks pre-op, 6 months post op and 1 year
The four square step test
measures dynamic balance
Measured: 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
Measured: 6 weeks pre-op, 6 months post op and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study start15 Jun 2015
- Primary completionMay 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Youssef Masharawi, DPT, Study chair, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444702
- Sponsor's protocol ID
- 0006-15-MMC
- Status last verified
- Mar 2018
- First submitted
- 12 May 2015
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 10601677Dankaerts 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.
PubMed 16877024Matsui 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.
PubMed 9201863Lundon 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.
PubMed 11411624Masharawi 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.
PubMed 18404110Luoma 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.
PubMed 10707396Ammendolia 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.
PubMed 25620608Delitto 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.
PubMed 7770494Lubetzky-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.
PubMed 24036159Abbas 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.
PubMed 20652366Singh 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.
PubMed 16291100
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Morphological and Functional Success Predictors Following Lumbar Spinal Surgery in Patients With Chronic Low Back Pain and Degenerative Disorders.
- ClinicalTrials.gov ID
- NCT02444702
- Acronym / sponsor ID
- 0006-15-MMC
- Conditions
- Low Back Pain
- Keywords
- spinal stenosis, clinical predictors rules, MRI, fusion, low back pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 15 Jun 2015 (actual)
- Primary completion
- May 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 14 May 2015 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Participants' diagnosis may include unstable degenerative spondylolisthesis, radicular pain, or documented stenosis with referred pain
Key exclusion criteria (7 listed)
- Psychiatric illness
- Previous spine surgery
- Painful arthritic hip
- Hospitalization or surgery in the previous 6 months
- Alcohol consumption > 10 drinks/week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
The Roland Morris Disability Questionnaire (RMQ)
Time frame: up to 1 year
Commonly used in CLBP research as measures of patients' participation restrictions
11 secondary outcomes
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 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 Visual Analog Scale (VAS)
Time frame: 6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op
Lumbar myotomes function
Time frame: 6 weeks pre-op, 6 months post op and 1 year post op
The Long Distance Corridor Walk (LDCW)
Time frame: 6 weeks pre-op, 6 months post op and 1 year
The 8 foot up and go
Time frame: 6 weeks pre-op, 6 months post op and 1 year
The 30-seconds chair stand test
Time frame: 6 weeks pre-op, 6 months post op and 1 year
Grip strength
Time frame: 6 weeks pre-op, 6 months post op and 1 year
single leg stance test
Time frame: 6 weeks pre-op, 6 months post op and 1 year
The four square step test
Time frame: 6 weeks pre-op, 6 months post op and 1 year
Passive straight leg raise (PSLR)
Time frame: 6 weeks pre-op, 6 months post op and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Background: PubMed 10601677Maniadakis 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.
- Background: PubMed 16877024Dankaerts 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.
- Background: PubMed 9201863Matsui 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.
- Background: PubMed 11411624Lundon 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.
- Background: PubMed 18404110Masharawi 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.
- Background: PubMed 10707396Luoma 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.
- Background: PubMed 25620608Ammendolia 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.
- Background: PubMed 7770494Delitto 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.
- Background: PubMed 24036159Lubetzky-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.
- Background: PubMed 20652366Abbas 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.
- Background: PubMed 16291100Singh 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.
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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.
Youssef Masharawi, DPT study chair
Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Meir Medical Center at 1 site in Israel.
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 1 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: status not confirmed, as of the sponsor's last update on 22 Mar 2018. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shay Shabat, Prof. (972-9-7471153, Shay.Shabat@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op). 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 NCT02444702, which also lists 11 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 22 Mar 2018.