Trial document





This trial has been registered retrospectively.
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  DRKS00003288

Trial Description

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Title

Pilot project in physiotherapy based on § 63, organized by IFK and BIG direkt gesund

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Trial Acronym

BIG PT

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URL of the Trial

http://www.big-direkt.de/leistungen/behandlung/physiotherapie_modellvorhaben.html

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Brief Summary in Lay Language

To this date, physicians prescribe the kind of physiotherapeutic treatment, its duration and frequency of application. This study aims to compare this conventional model of care with a model, where physiotherapists decide themselves on the kind of physiotherapeutic treatment, its duration and frequency of application. Participants with disorders of the spine or pelvis, and disorders of the extremities are recruited for this study. They all receive a physicians’ prescription before physiotherapeutic treatment. In the control-group situation, the physiotherapist treats in conformity with the prescription. In the model-group situation, he is free in his choice of treatment and in his choice of frequency and duration of treatment. Following hypotheses are investigated: If the physiotherapist decides on its own about the kind of treatment and on its frequency and duration:
a. … this leads to patients’ earlier return to work.
b. … this leads to enhanced efficiency of physiotherapeutic care.
c. …this leads to heightened patient satisfaction.
d. …this leads to reduced costs.

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Brief Summary in Scientific Language

In a randomized controlled trial (RCT) two groups with distinct treatment conditions are compared: in the intervention group, physiotherapists decide on the kind of treatment, and how often and how frequently the treatment is applied. In control groups, patients are treated in the former health system conditions along physicians’ prescriptions. Return to work serves as primary outcome. Secondary outcomes are treatment costs and efficiency, as well as patient satisfaction.

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Organizational Data

  •   DRKS00003288
  •   2012/08/10
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  •   no
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Secondary IDs

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Health Condition or Problem studied

  •   M00-M99 -  Diseases of the musculoskeletal system and connective tissue
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Interventions/Observational Groups

  •   Control group: physiotherapeutic treatment as prescribed by physician
  •   Intervention group: kind of treatment, number and frequency of sessions is defined by physiotherapist
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
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  •   Active control (effective treament of control group)
  •   Health care system
  •   Parallel
  •   N/A
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Primary Outcome

Days of sick leave, assessed at the end of treatment, 6 and 12 month after end of treatment

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Secondary Outcome

Measurements before begin and after end of treatment: functional findings (Visual Analogue Scale, Neutral-0-Method, Janda muscle function test), activity (timed-up-and-go-test), and participation (EQ-5D-D, lower extremity functional scale)
Measurement after end of treatment: treatment costs, patient satisfaction (ZUF-8)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2011/06/20
  •   620
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

1) Physicians’ Prescription for physiotherapy;
2) disorders of the spine or pelvis, or disorders of the extremities (ICD-10: M00-M99; diagnosis/es in indication groups WS1, WS2 OR diagnosis/es in indication groups EX1, EX2, EX3);
3) 18 years of age at min.

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Exclusion Criteria

Patients without prescription for physiotherapy, other diagnosis than the indication groups or no diagnosis, diagnosis in indications groups WS1 or WS2 AND EX1, EX2 or EX3.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • BIG direkt gesund
    • Ms.  Dr.  Andrea  Mischker 
    • Charlottencarree Markgrafenstrasse 62
    • 10969  Berlin
    • Germany
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    • Zürcher Hochschule für Angewandte Wissenschaften, Departement Gesundheit, Institut für Physiotherapie
    • Ms.  Prof. Dr.   Astrid  Schämann 
    • Technikumstrasse 71, Postfach
    • 8401  Winterthur
    • Switzerland
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    • Bundesverband selbstständiger Physiotherapeuten - IFK e.V.
    • Mr.  B.Sc. PT, M.Sc. PH  Michael  Heine 
    • Lise-Meitner-Allee 2
    • 44801   Bochum
    • Germany
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Sources of Monetary or Material Support

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    • BIG direkt gesund
    • Charlottencarree, Markgrafenstrasse 62
    • 10969  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/12/31
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Trial Publications, Results and other Documents

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