Our hypothesis is that radiotherapy can achieve a pain-reducing effect of at least 20% after 6 months.
ID
Bron
Verkorte titel
Aandoening
Patients with Painful, low-grade* osteoarthritis of the hip who present themselves at the orthopedic outpatient clinic of Orbis Medisch Centrum·
Ondersteuning
Orthopedic surgeon
Atrium-Orbis MC
Sittard-Geleen
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To 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.
Achtergrond van het onderzoek
Currently, 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.
Doel van het onderzoek
Our hypothesis is that radiotherapy can achieve a pain-reducing effect of at least
20% after 6 months.
Onderzoeksopzet
At baseline and subsequent followup will be after 1, 2, 3 and 6 months.
Onderzoeksproduct en/of interventie
The 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)
Algemeen / deelnemers
dr H vd Hoffplein 1
M.G.M. Schotanus
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
m.schotanus@orbisconcern.nl
Wetenschappers
dr H vd Hoffplein 1
M.G.M. Schotanus
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
m.schotanus@orbisconcern.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
· 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
· 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
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL4840 |
NTR-old | NTR4964 |
Ander register | NL43876.096.13, CCMO : 13-T-86, METC |