Trial document





This trial has been registered retrospectively.
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  DRKS00015180

Trial Description

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Title

Waterfiltered Infrared A wIRA treating gonarthrosis - a prospective randomised controlled study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The goal of the study is to show if the treatment with water filtered Infrared-A over the course of 4 weeks, in addition to the standard therapy, has a positive effect on arthrosis of the knee.

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Brief Summary in Scientific Language

The goal of the study is to show if the treatment with water filtered Infrared-A over the course of 4 weeks, in addition to the standard therapy, has a positive effect on gonarthrosis.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00015180
  •   2019/01/30
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  •   no
  •   Approved
  •   EA4/184/17, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   M17 -  Gonarthrosis [arthrosis of knee]
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Interventions/Observational Groups

  •   Intervention group with wIRA-treatment for at least 1h a day, over the course of 4 weeks. Other therapy options (Physical medicine, medication etc.) may be continued.
  •   Control group with standard therapy (Physical medicine, medication etc.)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

Pain: VAS (visual analogue scale)

Painkiller consumption per day: weekly questions

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Secondary Outcome

Global Assessment of the knee: VAS

Questions about the quality of life: VAS

Questions about problems with everyday life: VAS

Questions about the practicability of the wIRA-treatment, especially at home: VAS

Evaluation of the success of all therapeutic interventions: VAS

Overall assessment of the knee via Knee Injury and Osteoarthritis Outcome Score (KOOS score)

Mobility: Goniometry (range of movement in degrees)

Ability to put weight on the knee while standing: one-leg-stand time in seconds

Maximum walking time/distance as well as walking time/distance without pain: weekly estimation

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/05/30
  •   108
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   35   Years
  •   no maximum age
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Additional Inclusion Criteria

- Male and female patients, at least 35 years of age
- Pain for 3 months or longer
- pain clinically assessed as gonarthrosis
- No knee endoprosthesis
- No immediate surgeries planed

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Exclusion Criteria

- Immediate surgeries planed
- Knee endoprosthesis
- Insufficient compliance
- other conditions may prohibit taking part

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Addresses

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    • Arbeitsbereich Physikalische Medizin und Rehabilitation Charité Universitätsmedizin Berlin
    • Ms.  ÖA Dr. med.  Anett  Reißhauer 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Arbeitsbereich Physikalische Medizin und Rehabilitation Charité Universitätsmedizin Berlin
    • Mr.  Dr.  Max  Liebl 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Arbeitsbereich Physikalische Medizin und RehabilitationCharité Universitätsmedizin Berlin
    • Mr.  Dr.  Max  Liebl 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Dr. med. h.c. Erwin Braun Stiftung
    • Aeschenvorstadt 48
    • CH-4051  Basel
    • Switzerland
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Status

  •   Recruiting complete, follow-up complete
  •   2020/03/09
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.