M J M Minten1, M M Leseman-Hoogenboom2, M Kloppenburg3, M C Kortekaas4, J W Leer5, P M P Poortmans6, F H J van den Hoogen7, A A den Broeder8, C H M van den Ende9. 1. Department of Rheumatology, Sint Maartenskliniek, Nijmegen, The Netherlands. Electronic address: m.minten@maartenskliniek.nl. 2. Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, The Netherlands. Electronic address: Tilly.Leseman-Hoogenboom@radboudumc.nl. 3. Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands; Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands. Electronic address: G.Kloppenburg@lumc.nl. 4. Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands; Department of Rheumatology, Flevoziekenhuis, Almere, The Netherlands. Electronic address: M.C.Kortekaas@lumc.nl. 5. Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, The Netherlands. Electronic address: janwillemleer@gmail.com. 6. Department of Radiation Oncology, Institut Curie, Paris, France. Electronic address: philip.poortmans@curie.fr. 7. Department of Rheumatology, Sint Maartenskliniek, Nijmegen, The Netherlands; Department of Rheumatology, Radboud University Medical Center, Nijmegen, The Netherlands. Electronic address: F.vandenHoogen@maartenskliniek.nl. 8. Department of Rheumatology, Sint Maartenskliniek, Nijmegen, The Netherlands; Department of Rheumatology, Radboud University Medical Center, Nijmegen, The Netherlands. Electronic address: A.denbroeder@maartenskliniek.nl. 9. Department of Rheumatology, Sint Maartenskliniek, Nijmegen, The Netherlands; Department of Rheumatology, Radboud University Medical Center, Nijmegen, The Netherlands. Electronic address: E.vandenende@maartenskliniek.nl.
Abstract
OBJECTIVES:Low-dose radiation therapy (LDRT) is widely used as treatment for osteoarthritis (OA) in some countries, while relatively unknown in others. Systematic literature review displayed a lack of high-level evidence for beneficial effects in clinical practice. The aim was to assess the efficacy of LDRT on symptoms and inflammation in hand OA patients in a randomised, blinded, sham-controlled trial, using validated outcome measures. DESIGN:Hand OA patients, ≥50 years, with pain≥5 (scale 0-10) and non-responding to conservative therapy were included and randomised 1:1 to receive LDRT (6 × 1 Gy in 2 weeks) or sham (6 × 0 Gy in 2 weeks). Primary outcome was the proportion of OMERACT-OARSI responders, 3 months post-intervention. Secondary outcomes were pain and functioning (Australian/Canadian Hand Osteoarthritis Index; AUSCAN), quality of life (Short Form Health Survey; SF36) and inflammatory outcomes: erythrocyte sedimentation rate and C-reactive protein serum levels, effusion, synovial thickening and power Doppler signal on ultrasound (range 0-3). RESULTS:Fifty-six patients were included. After 3 months, no significant difference in responders was observed between groups (LDRT: 8 (29%); sham: 10 (36%); difference -7% (95%CI -31-17%)). Also, differences in clinical and inflammatory outcomes between groups were small and not significant. CONCLUSIONS: We were unable to demonstrate a substantial beneficial effect of LDRT on symptoms and inflammation in patients with hand OA, compared to sham treatment. Although a small effect can not be excluded, a treatment effect exceeding 20% is very unlikely, given the confidence interval. Therefore, in the absence of other high-level evidence, we advise against the use LDRT as treatment for patients with hand OA. CLINICAL TRIAL REGISTRATION NUMBER: NTR4574 (Dutch Trial Register).
RCT Entities:
OBJECTIVES: Low-dose radiation therapy (LDRT) is widely used as treatment for osteoarthritis (OA) in some countries, while relatively unknown in others. Systematic literature review displayed a lack of high-level evidence for beneficial effects in clinical practice. The aim was to assess the efficacy of LDRT on symptoms and inflammation in hand OA patients in a randomised, blinded, sham-controlled trial, using validated outcome measures. DESIGN: Hand OA patients, ≥50 years, with pain ≥5 (scale 0-10) and non-responding to conservative therapy were included and randomised 1:1 to receive LDRT (6 × 1 Gy in 2 weeks) or sham (6 × 0 Gy in 2 weeks). Primary outcome was the proportion of OMERACT-OARSI responders, 3 months post-intervention. Secondary outcomes were pain and functioning (Australian/Canadian Hand Osteoarthritis Index; AUSCAN), quality of life (Short Form Health Survey; SF36) and inflammatory outcomes: erythrocyte sedimentation rate and C-reactive protein serum levels, effusion, synovial thickening and power Doppler signal on ultrasound (range 0-3). RESULTS: Fifty-six patients were included. After 3 months, no significant difference in responders was observed between groups (LDRT: 8 (29%); sham: 10 (36%); difference -7% (95%CI -31-17%)). Also, differences in clinical and inflammatory outcomes between groups were small and not significant. CONCLUSIONS: We were unable to demonstrate a substantial beneficial effect of LDRT on symptoms and inflammation in patients with hand OA, compared to sham treatment. Although a small effect can not be excluded, a treatment effect exceeding 20% is very unlikely, given the confidence interval. Therefore, in the absence of other high-level evidence, we advise against the use LDRT as treatment for patients with hand OA. CLINICAL TRIAL REGISTRATION NUMBER: NTR4574 (Dutch Trial Register).
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