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Walter, Nike ; Loew, Thomas ; Alt, Volker ; Rupp, Markus

Effect of functional relaxation on the quality of life in patients with periprosthetic joint infection: Protocol for a randomised controlled trial

Walter, Nike , Loew, Thomas , Alt, Volker and Rupp, Markus (2022) Effect of functional relaxation on the quality of life in patients with periprosthetic joint infection: Protocol for a randomised controlled trial. BMJ Open 12 (10), e066066.

Date of publication of this fulltext: 31 Oct 2022 08:49
Article
DOI to cite this document: 10.5283/epub.53119


Abstract

Introduction Periprosthetic joint infection (PJI) is a devastating complication in orthopaedic and trauma surgery, which puts a high burden on the patients involving recurrent hospitalisation, prolonged courses of antibiotic medication, severe pain and long periods of immobility as well as high levels of psychological distress. Thus, this multicentre study aims at implementing body-oriented ...

Introduction Periprosthetic joint infection (PJI) is a devastating complication in orthopaedic and trauma surgery, which puts a high burden on the patients involving recurrent hospitalisation, prolonged courses of antibiotic medication, severe pain and long periods of immobility as well as high levels of psychological distress. Thus, this multicentre study aims at implementing body-oriented psychotherapy in clinical practice and evaluating its therapeutic effect on the quality of life. Methods and analysis A prospective, parallel two-armed randomised controlled trial with approximately n=270 patients with verified PJI treated surgically with a one-staged exchange, or a two-staged exchange will be conducted. Functional relaxation (FR) therapy will be implemented as a group therapy. FR originally belongs to the psychodynamically based body-oriented psychotherapy. Intervention techniques consist of minute movements of small joints, which are performed during relaxed expiration accompanied by an exploration of differences of body feelings. A group will include 3-8 patients, led by a specialist physiotherapist certified in FR once a week. The participants are consecutively admitted to the class and participate in 12 sessions. The control group will consist of patients receiving an unspecific 'placebo relaxation' intervention for the same duration. The primary efficacy endpoint is the mental component summary and physical component summary of quality of life assessed by the 36-Item Short Form Health Survey (SF-36) after 6 months. Secondary outcomes include SF-36 scores after 12 months, consumption of pain medication, mobility measured by the Parker mobility score and the physical activity measured by daily steps with an accelerometer (actibelt). Ethics and dissemination Approval from the Ethical Committee of the University Hospital Regensburg was received (file number: 21-2226-101). Written, informed consent to participate will be obtained from all participants. Results will be made available in the form of peer-reviewed publications and presentation in congresses.



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Details

Item typeArticle
Journal or Publication TitleBMJ Open
Publisher:BMJ PUBLISHING GROUP
Place of Publication:LONDON
Volume:12
Number of Issue or Book Chapter:10
Page Range:e066066
Date17 October 2022
InstitutionsMedicine > Lehrstuhl für Unfallchirurgie
Medicine > Abteilung für Psychosomatische Medizin
Identification Number
ValueType
10.1136/bmjopen-2022-066066DOI
KeywordsPRIMARY TOTAL HIP; COMPLEMENTARY THERAPY; KNEE ARTHROPLASTY; EFFICACY; DEPRESSION; INTERVENTION; ASTHMA; ORTHOPAEDIC & TRAUMA SURGERY; Knee; COMPLEMENTARY MEDICINE
Dewey Decimal Classification600 Technology > 610 Medical sciences Medicine
StatusPublished
RefereedYes, this version has been refereed
Created at the University of RegensburgYes
URN of the UB Regensburgurn:nbn:de:bvb:355-epub-531194
Item ID53119

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