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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

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:
        • Kontakt:
        • 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.

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

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

Andere Studien-ID-Nummern

  • 0006-15-MMC

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