ArthroRad trial: randomized multicenter single-blinded trial on the effect of low-dose radiotherapy for painful osteoarthritis-final results after 12-month follow-up.

OBJECTIVE: Updated report about the randomized comparison of the effect of radiotherapy on painful osteoarthritis (OA) applying a standard dose vs. a very low dose regime after a follow-up of 1 year. PATIENTS AND METHODS: Patients presenting with OA of the hand/finger and knee joints were included. After randomization (every joint region was randomized separately) the following protocols were applied: (a) standard arm: total dose 3.0 Gy, single fractions of 0.5 Gy twice a week; (b) experimental arm: total dose 0.3 Gy, single fractions of 0.05 Gy twice a week. The dosage was blinded for the patients. For evaluation the scores after 1­year visual analog scale (VAS), Knee Injury and Osteoarthritis Outcome Score-Short Form (KOOS-PS), Short Form Score for the Assessment and Quantification of Chronic Rheumatic Affections of the Hands (SF-SACRAH) and 12-item Short-Form Health Survey (SF-12) were used (for further details: see [1]). RESULTS: The standard dose was applied to 77 hands and 33 knees, the experimental dose was given to 81 hands and 30 knees. After 12 months, the data of 128 hands and 45 knees were available for evaluation. Even after this long time, we observed a favorable response of pain to radiotherapy in both trial arms; however, there were no reasonable statistically significant differences between both arms concerning pain, functional, and quality of life scores. Side effects did not occur. The only prognostic factor was the pain level before radiotherapy. CONCLUSIONS: We found a favorable pain relief and a limited response in the functional and quality of life scores in both treatment arms. The possible effect of low doses such as 0.3 Gy on pain is widely unknown.

The Short Form Score for the Assessment and Quantification of Chronic Rheumatic Affections of the Hands in Daily Clinical Routines-Its Sensitivity to Change and Preliminary Patient Relevant Variation Values: A Pilot Study.

OBJECTIVE: The SF-SACRAH was developed to assess the involvement of the hand in rheumatoid arthritis (RA) and hand osteoarthritis (HOA) patients in daily clinical routines. In this pilot study, its sensitivity to change will be assessed longitudinally, and preliminary thresholds for patient relevant changes are derived. METHODS: Ninety-nine outpatients suffering from HOA (n = 55) or RA (n = 44) completed the SF-SACRAH once initially. After approximately 3 months, patients repeated the SF-SACRAH. At both visits, patients rated their satisfaction (PATSAT) with the state of their disease (1 = very good to 5 = unsatisfactory). For assessing its sensitivity to change, SF-SACRAH changes in patients with stable, improving, or worsening conditions according to PATSAT were calculated in HOA and RA patients. The respective medians and highest values were used to estimate patient relevant variation values. SF-SACRAH changes and positive or negative PATSAT changes in HOA as well as RA patients were analyzed by applying the Kruskal-Wallis test. In RA patients, the DAS28 was also calculated. Spearman's rho was calculated to correlate SF-SACRAH changes with the EULAR response criteria. RESULTS: In HOA and RA patients, a statistically high correlation between PATSAT changes and SF-SACRAH values was revealed (p < 0.0001 in HOA and p < 0.01 in RA patients, respectively). The median changes in SF-SACRAH in patients with improving, stable, or worsening conditions according to PATSAT were HOA patients: PATSAT improving: ΔSF-SACRAH -1.6, PATSAT stable: ΔSF-SACRAH +0.8, PATSAT worsening: ΔSF-SACRAH +1.0; RA patients: PATSAT improving: ΔSF-SACRAH -0.9, PATSAT stable: ΔSF-SACRAH +0.2, PATSAT worsening: ΔSF-SACRAH +0.8. In RA patients, there is a moderate, but significant, correlation between DAS28 EULAR response criteria and SF-SACRAH changes (ΔDAS28 improving >0.6: ΔSF-SACRAH -0.4, ΔDAS28 <0.6: ΔSF-SACRAH +0.0, ΔDAS28 worsening >0.6: ΔSF-SACRAH +0.5; r = 0.433, p < 0.01). CONCLUSION: The SF-SACRAH constitutes a reliable tool for the assessment of hand impairment in patients with chronic rheumatic diseases. It proved to be sensitive to change in this short-term evaluation in both HOA and RA patients. Additionally, preliminary patient variation values for improvement (-1.60) and deterioration (+1.0) could be derived.