- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02444702
Clinical, Morphological and Functional Success Predictors Following Lumbar Spinal Surgery in Patients With Chronic Low Back Pain and Degenerative Disorders.
21. März 2018 aktualisiert von: Meir Medical Center
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.
Studienübersicht
Status
Unbekannt
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Voraussichtlich)
200
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
-
Tel Aviv, Israel
- Rekrutierung
- Assuta hospital
-
Kontakt:
- Eli Ashkenazy, Dr.
- Telefonnummer: 972-0546666008
- E-Mail: ashkenazy@isc.co.il
-
Kontakt:
- Avihai Soroka, MscPT
- Telefonnummer: 972-522982802
- E-Mail: avihaisoroka@gmail.com
-
Hauptermittler:
- Eli Ashkenazy, Dr.
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
40 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
---|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
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
Zeitfenster: 6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op
|
6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op
|
|
The Roland Morris Disability Questionnaire (RMQ)
Zeitfenster: up to 1 year
|
Commonly used in CLBP research as measures of patients' participation restrictions
|
up to 1 year
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
The Fear Avoidance Beliefs questionnaire (FABQ)
Zeitfenster: 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
|
6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op
|
The International Physical Activity Questionnaire (IPAQ)
Zeitfenster: 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
|
6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op
|
The Visual Analog Scale (VAS)
Zeitfenster: 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
|
6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op
|
Lumbar myotomes function
Zeitfenster: 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
|
6 weeks pre-op, 6 months post op and 1 year post op
|
The Long Distance Corridor Walk (LDCW)
Zeitfenster: 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 weeks pre-op, 6 months post op and 1 year
|
The 8 foot up and go
Zeitfenster: 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
|
6 weeks pre-op, 6 months post op and 1 year
|
The 30-seconds chair stand test
Zeitfenster: 6 weeks pre-op, 6 months post op and 1 year
|
for lower body strength
|
6 weeks pre-op, 6 months post op and 1 year
|
Grip strength
Zeitfenster: 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
|
6 weeks pre-op, 6 months post op and 1 year
|
single leg stance test
Zeitfenster: 6 weeks pre-op, 6 months post op and 1 year
|
measures static balance
|
6 weeks pre-op, 6 months post op and 1 year
|
The four square step test
Zeitfenster: 6 weeks pre-op, 6 months post op and 1 year
|
measures dynamic balance
|
6 weeks pre-op, 6 months post op and 1 year
|
Passive straight leg raise (PSLR)
Zeitfenster: 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
|
6 weeks pre-op, 6 months post op and 1 year
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Morphological parameters
Zeitfenster: 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
|
6 weeks pre-op
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienstuhl: Youssef Masharawi, DPT, Tel Aviv University
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
15. Juni 2015
Primärer Abschluss (Voraussichtlich)
1. Mai 2018
Studienabschluss (Voraussichtlich)
1. Dezember 2018
Studienanmeldedaten
Zuerst eingereicht
12. Mai 2015
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
13. Mai 2015
Zuerst gepostet (Schätzen)
14. Mai 2015
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
22. März 2018
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
21. März 2018
Zuletzt verifiziert
1. März 2018
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 0006-15-MMC
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Schmerzen im unteren Rücken
-
Foundation IRCCS San Matteo HospitalAktiv, nicht rekrutierendGreater Trochanteric Pain Syndrome beider unteren ExtremitätenItalien
-
Bozok UniversityAbgeschlossen
-
Health Services Academy, Islamabad, PakistanUnbekanntmGesundheit | Wiederaufnahme | Teach-Back-KommunikationPakistan
-
Near East University, TurkeyAbgeschlossenLow-Level-LasertherapieZypern
-
Universidade Estadual Paulista Júlio de Mesquita...AbgeschlossenLasertherapie, Low-Level
-
Gazi UniversityAbgeschlossenGesäß-Tendinitis | Greater Trochanteric Pain Syndrome beider unteren ExtremitätenTruthahn
-
Tri-Service General HospitalUnbekanntLow-Level-Lasertherapie
-
Ankara City Hospital BilkentNoch keine RekrutierungRoboterchirurgie | Low-Flow-Anästhesie | NormalflussanästhesieTruthahn
-
University of Nove de JulhoAbgeschlossenKieferorthopädische Geräte | Low-Level-LichttherapieBrasilien
-
Ting LiUnbekanntNahinfrarotspektroskopie | Low-Level-Licht-/LasertherapieChina