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Effect van lage dosis radiotherapie bij pijn bij milde heupartrose


- candidate number21607
- NTR NumberNTR4964
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-jan-2015
- Secondary IDs13-T-86, METC NL43876.096.13, CCMO
- Public TitleEffect van lage dosis radiotherapie bij pijn bij milde heupartrose
- Scientific TitleThe effect of low-dose radiotherapy on pain in mild osteoarthritis of the hip
- ACRONYMRadiotherapy, Osteoarthritis, Pain
- hypothesisOur hypothesis is that radiotherapy can achieve a pain-reducing effect of at least 20% after 6 months.
- Healt Condition(s) or Problem(s) studiedOsteoarthritis, Hip, Pain
- Inclusion criteria Painful, low-grade* osteoarthritis of the hip Above 50 years old Synovitis confirmed with ultrasound imaging Ability and willingness to follow instructions and to return for follow-up evaluations *: Kellgren-Lawrence grade I-II
- Exclusion criteria Patients diagnosed with reumathoid arthritis Patients with osseous metastasis Patients with rheumatoid factor > 20 kU/l or blood sedimentation rate > 20mm Patients with a moderate or severe osteoarthritis grade** Patients with a hip/spine dilemma Prostethic implant in the affected joint Not able or willing to undergo bone scintigraphy or blood sampling **: Kellgren-Lawrence grade III-IV
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2015
- planned closingdate31-dec-2016
- Target number of participants60
- InterventionsThe study design is a prospective, double-blind, randomized trial. We will include 60 patients with early osteoarthritis of the hip, not willing or not able to undergo surgery. The patients will be recruited in the orthopedic clinic of Orbis MC, after which they will be included and randomized. The patients will be randomized into three groups: 1: Irradiation (6x1 Gy) plus standard of care (n=24) 2: Sham (placebo) irradiation plus standard of care (n=24) 3: Standard of care alone (n=12)
- Primary outcomeTo determine the effect of LDRT on pain sensation after 1,2,3,6 months in early osteoarthritis of the hip, measured with a Visual Analogue Scale (VAS), compared to placebo 'sham' irradiation and standard-of-care conservative treatment.
- Secondary outcome To determine the effect of LDRT on patient reported outcome measures (PROM) including WOMAC and Oxford Hip Score. To determine the effect of LDRT on quality of life, assessed with the EuroQoL- 5D questionnaire. To investigate the relationship between effect of LDRT and level of synovitis, measured through ultrasound, bone scintigraphy and blood BSE level.
- TimepointsAt baseline and subsequent followup will be after 1, 2, 3 and 6 months.
- Trial web siteNA
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. M.G.M. Schotanus
- CONTACT for SCIENTIFIC QUERIESDrs. M.G.M. Schotanus
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsNA
- Brief summaryCurrently, radiotherapy for pain reduction in OA is an accepted and frequently used treatment in Germany and in Central and Eastern European countries. (Seegenschmiedt, 2000; Leer, 2007) In the 1960s and 70s, LDRT was also used for OA in The Netherlands, but it is not commonly practised anymore due to conflicting literature on this topic and fear of tumour induction. Even though some studies show excellent results regarding this treatment, the quality of the available literature is not convincing and level I evidence is still missing. (Seegenschmiedt, 2000 & 2008) Low-dose radiotherapy (LDRT) is an old but poorly investigated treatment modality for pain related to degenerative joint pathology such as osteoarthritis. It has been shown that low-dose radiotherapy can decrease inflammation activity and can thus possibly reduce local pain sensation. In early osteoarthritis of the hip, synovitis has a prominent role in pain sensation. Therefore, we will investigate the effect of low-dose radiotherapy on pain sensation in patients with mild osteoarthritis of the hip.
- Main changes (audit trail)
- RECORD22-jan-2015 - 12-mrt-2015


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