- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02444702
Clinical, Morphological and Functional Success Predictors Following Lumbar Spinal Surgery in Patients With Chronic Low Back Pain and Degenerative Disorders.
21 marca 2018 zaktualizowane przez: 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.
Przegląd badań
Status
Nieznany
Warunki
Szczegółowy opis
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.
Typ studiów
Obserwacyjny
Zapisy (Oczekiwany)
200
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
-
Tel Aviv, Izrael
- Rekrutacyjny
- Assuta hospital
-
Kontakt:
- Eli Ashkenazy, Dr.
- Numer telefonu: 972-0546666008
- E-mail: ashkenazy@isc.co.il
-
Kontakt:
- Avihai Soroka, MscPT
- Numer telefonu: 972-522982802
- E-mail: avihaisoroka@gmail.com
-
Główny śledczy:
- Eli Ashkenazy, Dr.
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
40 lat do 80 lat (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
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
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
---|
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
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
Ramy czasowe: 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)
Ramy czasowe: up to 1 year
|
Commonly used in CLBP research as measures of patients' participation restrictions
|
up to 1 year
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
The Fear Avoidance Beliefs questionnaire (FABQ)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Morphological parameters
Ramy czasowe: 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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Krzesło do nauki: Youssef Masharawi, DPT, Tel Aviv University
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
15 czerwca 2015
Zakończenie podstawowe (Oczekiwany)
1 maja 2018
Ukończenie studiów (Oczekiwany)
1 grudnia 2018
Daty rejestracji na studia
Pierwszy przesłany
12 maja 2015
Pierwszy przesłany, który spełnia kryteria kontroli jakości
13 maja 2015
Pierwszy wysłany (Oszacować)
14 maja 2015
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
22 marca 2018
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
21 marca 2018
Ostatnia weryfikacja
1 marca 2018
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 0006-15-MMC
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Bóle krzyża
-
Hadassah Medical OrganizationNieznanyWpływ diety Low FODMAP w porównaniu z dietą bezglutenową na objawy IBS u dzieciIzrael
-
Université Victor Segalen Bordeaux 2Nanox International Laboratory (Belgique)ZakończonySkuteczność i tolerancja B-Back® na syndrom wypalenia zawodowegoFrancja
-
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo CompanyRekrutacyjnyRak piersi z przerzutami | Nieoperacyjny rak piersi | Rak piersi z ekspresją HER2-lowAustria, Belgia, Włochy, Hiszpania, Francja, Szwajcaria, Dania, Norwegia, Szwecja
-
Herlev HospitalZakończonyChoroba niedokrwienna serca | Biofeed Back Guided Zarządzanie stresemDania
-
AstraZenecaDaiichi SankyoRekrutacyjnyRak piersi z przerzutami | HER2-dodatni rak piersi | Nieoperacyjny rak piersi | Rak piersi z ekspresją HER2-lowKanada