Effectiveness of radiotherapy in osteoarthritis of the hand and knee

Effectiveness of radiotherapy in osteoarthritis of the hand and knee - RadiO

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41179

Enrollment

108

Registered

2014-10-02

Start date

2015-08-12

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Interventions

The experimental intervention arm consists of external beam radiotherapy with a total dose of 6 Gy. This total dose is applied in 6 fractions of 1 Gy, spread over 2 weeks, according to the 2002 cons

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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)

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)