Trial document




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  DRKS00011870

Trial Description

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Title

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

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Trial Acronym

ARTHRORAD-trial

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URL of the Trial

[---]*

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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.

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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.

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Organizational Data

  •   DRKS00011870
  •   2017/06/12
  •   [---]*
  •   yes
  •   Approved
  •   60/17, Ethik-Kommission bei der Ärztekammer des Saarlandes
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Secondary IDs

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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]
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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
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
  •   N/A
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Primary Outcome

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

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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)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/07/03
  •   270
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   40   Years
  •   no maximum age
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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

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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

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Addresses

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Sources of Monetary or Material Support

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    • Universitätsklinikum des Saarlandes
    • 66421  Homburg/Saar
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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