Effectiveness of radiotherapy in osteoarthritis of the hand and knee

Phase 2

Completed

• Conditions: Osteoarthritis; Arthritis; 10023213

• Registration Number: NL-OMON41179
• Lead Sponsor: Sint Maartenskliniek

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-07-10
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 111

Inclusion Criteria

Hand Osteoarthritis:
Hand osteoarthritis according to the 1990 ACR diagnostic criteria for hand osteoarthritis (Altman 1990)
Mean VAS pain during hand activities of both hands > 4;Knee Osteoarthritis:
Osteoarthritis in the index knee, according to the ACR classification criteria for symptomatic ostioarthritis of the knee (Altman 1986)
Mean VAS pain during activities of the index knee > 4;Both:
Treatment failure of non-surgical treatment options (pain medication and occupational or physical therapy)

Exclusion Criteria

Hand osteoarthritis:
Other active rheumatic diseases than osteoarthritis with possible hand localisation
Scheduled for surgical treatment of the hands in the next 6 months, or previous surgical treatment of the joints in the hands (eg release of median nerve entrapment or trigger finger correction are allowed);Knee osteoarthritis:
Other rheumatic diseases than osteoarthritis with possible knee localisation
Scheduled for surgical treatment of the knees in the next 6 months, or previous surgical treatment of the knee;Both:
Fibromyalgia according to the 2010 ACR diagnostic criteria for fibromyalgia (Wolfe 2011)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is the percentage of responders according to the<br /><br>2004 OMERACT-OARSI responder criteria (Pham 2004), 14 weeks after baseline:<br /><br>either improvement in pain or function >=50% and an absolute improvement of >=20<br /><br>points , or 2 in the following: pain, function or patient*s global assessment<br /><br>(all >=20% relative and >=10 points absolute).<br /><br>The following outcome measures will be used for the responders criteria:<br /><br>subscales pain and hand functioning of the AUSCAN questionnaire, for hand OA,<br /><br>and LEFS and KOOS questionnaires, for function and pain in knee OA,<br /><br>respectively, and patient global assessment on a VAS for both patient groups.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary study parameters are:<br /><br>- Synovitis, measured by MRI (Knee OA), ultrasound (Hand OA) and hsCRP serum<br /><br>level<br /><br>- Patient reported outcome measures for pain, function and stiffness<br /><br>(WOMAC-pain, WOMAC-function, WOMAC-stiffness) and quality of life (SF-36)<br /><br>- Health care use (questionnaire)<br /><br>- Physical examination of the joints (pain, swollen, bony enlargements, etc.)</p><br>