Trial document

drksid header


Trial Description

start of 1:1-Block title


Multicentric prospective randomized trial on the effect of analgesic radiotherapy on painful arthroses dependent on the dose

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym


end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial


end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Painful arthroses are a frequent indication of an analgesic low-dose radiotherapy. There are ample retrospective data demonstrating very favourable results. In this trial, patients with painful arthroses of the knee joints or of the joints of the hand are examined. All of them receive a radiotherapy to the joints involved.
The effect of radiotherapy shall be demostrated at a high level of evidence for the first time comparing the effect of a standard dose (6 x 0.5Gy) to a very low dose (6x0.05Gy) applied within three weeks.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Painful arthroses are a frequent indication for analgesic low-dose radiotherapy. Sufficient retrospective data exist demonstrating very good and good results. In this trial, the analgesic effect of radioatherapy is to be demonstrated at a high level of evidence for the first time. The effect of a standard dose (6 x 0.5Gy within three weeks) is compared to that of a very low dose (6 x 0.05Gy within three weeks) which is regarded to yield nearly no analgesic effect. Patients with painful arthroses of the knees (as an example of bigger joints) or the hand/finger joints (as examples of smaller joints) can be included. The pain level will be graded according to the VAS-scale. Additionally, functional scores will be used (KOOS_PS, SACRAH-F) as well as a score for general quality of life (SF-12). Follow-up examinations will be performed after three and twelve moths after radiotherapy. In case of an insufficient result three months after radiotherapy the patient will be offered a second therapy series with the standard dose.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00011870
  •   2017/06/12
  •   [---]*
  •   yes
  •   Approved
  •   60/17, Ethik-Kommission bei der Ärztekammer des Saarlandes
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   M17.1 -  Other primary gonarthrosis
  •   M18.1 -  Other primary arthrosis of first carpometacarpal joint
  •   M19.04 -  [generalization M19.0: Primary arthrosis of other joints]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Radiotherapy of the joint, 6 single fractions of 0.5Gy each twice a week up to a total dose of 3.0Gy, total treatment time three weeks
  •   Radiotherapy of the joint, 6 single fractions of 0.05Gy each twice a week up to a total dose of 0.3Gy, total treatment time three weeks
end of 1:N-Block interventions
start of 1:1-Block design


  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Primary outcome: pain relief
tested three and twelve months after radiotherapy
using the VAS scale

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Improvement of function (three and twelve months after radiotherapy, KOOS-SF or SF_SACRAH-scores, respectively)
Improvement of general quality of life (three and twelve months after radiotherapy, SF-12 scores)
Use of analgesic medication (complete duration of the trial, medication protocol)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment


  •   Actual
  •   2017/07/03
  •   270
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   40   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- clinical diagnosis of a painful arthrosis of the knee joint or of joints of the hand with a minimum duration of symptoms of >= three months.
- radiological proof of the arthrosis
-typical clinical symptoms (pain after pressure, limitation of motion, swelling)
- typical functional deficitis (limitation of mobility or of painless walking distance, limitation of grabbing function
- sufficient general health status
- age >= 40 years
- written informed consent given

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- previous radiotherapy to the joint involved
- other cause of pain (trauma, rheumatoid arthritis - patients with arthrosis caused by a former rheumatoid arthritis can be included)
- intense venous insufficiency
- arterial occlusion disease
- lymphedema
- pregnancy, breastfeeding
- intense psychical disorder
- legal care for the patient by other persons

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses


end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitätsklinikum des Saarlandes
    • 66421  Homburg/Saar
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state


  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.