No registrations found.
ID
Source
Brief title
Health condition
Patients with Painful, low-grade* osteoarthritis of the hip who present themselves at the orthopedic outpatient clinic of Orbis Medisch Centrum·
Sponsors and support
Orthopedic surgeon
Atrium-Orbis MC
Sittard-Geleen
Intervention
Outcome measures
Primary outcome
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.
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.
Background summary
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.
Study objective
Our hypothesis is that radiotherapy can achieve a pain-reducing effect of at least
20% after 6 months.
Study design
At baseline and subsequent followup will be after 1, 2, 3 and 6 months.
Intervention
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)
dr H vd Hoffplein 1
M.G.M. Schotanus
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
m.schotanus@orbisconcern.nl
dr H vd Hoffplein 1
M.G.M. Schotanus
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
m.schotanus@orbisconcern.nl
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4840 |
| NTR-old | NTR4964 |
| Other | NL43876.096.13, CCMO : 13-T-86, METC |