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Onderzoek naar het effect van orthomanuele behandeling bij rugklachten.


- candidate number5757
- NTR NumberNTR1818
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-mei-2009
- Secondary IDs2008/24 METc VU
- Public TitleOnderzoek naar het effect van orthomanuele behandeling bij rugklachten.
- Scientific TitleEfficacy of orthomanual treatment in addition to usual care in patients with chronic low back pain in an academic pain clinic population.
- ACRONYMOOG
- hypothesisOrthomanual treatment is of additional value in the painclinic treatment of chronic low back pain.
- Healt Condition(s) or Problem(s) studiedNonspecific low back pain, Chronic
- Inclusion criteria1. Non-specific low back pain;
2. Duration at least 3 months;
3. Able to answer questionnaires in Dutch;
4. No previous orthomanual treatment.
- Exclusion criteria1. Specific low backpain, e.g.:
A. Spondylitis/ discitis;
B. Spondylolysis/ listhesis.
2. Contraindications for manipulation, e.g.:
A. Recent trauma;
B. Malignicy;
C. Osteoporosis;
D. Longstanding use of steroids;
E. Pregnancy.
3. Disorders hindering treatment, e.g.:
A. Anatomic anomalies ((hemi-)lumbalisation, (hemi-)sacralisation);
B. Low back surgery.
4. Disorders influencing the outcome, e.g.:
A. Lumbo-sacral radicular syndrome;
B. Systemic painsyndromes (fibromyalgia, RA);
C. Severe functional impairment of the lower extremity;
D. Severe scoliosis;
E. Muscular disease;
F. CVA.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2009
- planned closingdate1-aug-2012
- Target number of participants100
- Interventions1. Pain clinic treatment (usual care);
2. Pain clinic treatment + orthomanual treatment.
- Primary outcomeIntensity of low back pain on a 100 mm VAS Global perceived recovery, measured on a seven point scale ranging from "completely recovered"to "worse than ever.
- Secondary outcome1. Disability due to low back pain, measured by the Roland disability questionnaire;
2. Quality of life, measured by the Euroqol.
- Timepoints1. Baseline;
2. 3 months;
3. 6 months;
4. 12 months after start of treatment.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES W. Schuller
- CONTACT for SCIENTIFIC QUERIES W. Schuller
- Sponsor/Initiator EMGO Institute
- Funding
(Source(s) of Monetary or Material Support)
Netherlands Association for Orthomanual Medicine
- PublicationsN/A
- Brief summaryEfficacy study of the additional value of orthomanual treatment in the painclinic treatment of chronic low back pain.
- Main changes (audit trail)
- RECORD15-mei-2009 - 30-sep-2009


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