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van CCT (UK)

van CCT (UK)

Revalideren na een lumbale hernia operatie.

- candidate number10555
- NTR NumberNTR3156
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-nov-2011
- Secondary IDs80-82310-97-11043 / NL35897.029.11; ZonMW / METC
- Public TitleRevalideren na een lumbale hernia operatie.
- Scientific TitleRehabilitation After Lumbar Disc Surgery.
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedLumbar disk, Surgery
- Inclusion criteriaPatients who underwent a first time, single level lumbar discectomy, aged between 18-69 years.
- Exclusion criteriaCo-morbidities of the lumbar spine (e.g., fractures, carcinomas osteoporosis), cauda equina syndrome. Furthermore patients who are pregnant and patients with general contraindications for exercise therapy will be excluded.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2012
- planned closingdate1-jun-2014
- Target number of participants200
- InterventionsIntervention group: Physiotherapy directly after discharge. Patients receive instructions and information regarding appropriate ‘use of body mechanics’ for the whole body and will be taught back protection methods. Depending on a clinical assessment the rehabilitation program will focus on relaxation positions and techniques, stretching exercises in order to increase soft tissue flexibility and joint mobility, and/or stabilizing and strengthening exercises (as tolerated by the patient). Patients will receive a home exercise program as well. The aim is that there will be 6 treatment sessions within the first 6 weeks after discharge from the hospital 6 weeks, but the exact number of sessions is at the discretion of the therapist. After these 6 weeks the patient visits the neurosurgeon, which is customary in the participating hospitals (and in the majority of the hospitals in the Netherlands as well). At the six weeks consultation the neurosurgeons decides whether continuation of therapy is necessary.

Control group: No treatment during 6 weeks after discharge. Also in this group the patient visits the neurosurgeon after 6 weeks. At the six weeks consultation the neurosurgeons decides whether the patient still should be referred to therapy or not.
- Primary outcome1. Global perceived recovery (7-point scale);
2. Functional status (Oswestry Disability Index (ODI));
3. Pain intensity (leg and back) (11-point NRS);
4. General health (SF-12);
5. Quality of life (EuroQol);
6. Costs of production losses (Prodisq).
- Secondary outcome-
- TimepointsMeasurements will take place at baseline and after 3, 6, 9, 12 and 26 weeks.
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator Vrije Universiteit Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryIn the Netherlands there are two strategies for rehabilitation of patients following lumbar disc surgery. In some hospitals rehabilitation is restricted to the hospital phase and after discharge there is no more supervised rehabilitation. However, there are also hospitals that continue rehabilitation directly after discharge, during the first 6 weeks after surgery. This rehabilitation is mainly delivered by PTs in a primary care setting. Since January 1st, 2006, patients can also directly access PT without a referral (DTF). Then the PT has to decide after initial assessment if rehabilitation is indicated and some PTs opt for continuation of the rehabilitation while others don’t. So, regardless of the specific procedure (referral by neurosurgeon or DTF) there is wide variation in care. This project will provide an answer to the question whether rehabilitation should be started directly after discharge from the hospital or not, and will guide evidence-based decision making for patients who undergo lumbar disc surgery.
- Main changes (audit trail)17-mei-2017 -MT
1. Duration and severity of symptoms preoperative, psychosocial factors ((Örebro Musculoskeletal Pain Screening Questionnaire);
2. Fear avoidance beliefs (Fear-Avoidance Beliefs Questionnaire);
3. Patient expectancies (Credibility and Expectancy Questionnaire).
- RECORD18-nov-2011 - 19-mei-2017

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