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  • Are psychosocial variables, sleep characteristics or central pain processing prognostic factors for outcome following rotator cuff repair? A protocol for a prospective longitudinal cohort study

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Patient-centred medicine
Protocol
Are psychosocial variables, sleep characteristics or central pain processing prognostic factors for outcome following rotator cuff repair? A protocol for a prospective longitudinal cohort study
  1. Ariane Schwank1,2,
  2. Thomas Struyf3,
  3. Filip Struyf1,
  4. Paul Blazey4,
  5. Michel Mertens1,
  6. David Gisi2,
  7. Markus Pisan5,
  8. Mira Meeus1,6
  1. 1Rehabilitation Sciences and Physiotherapy, University of Antwerp Faculty of Medicine and Health Sciences, Wilrijk, Belgium
  2. 2Institute for Therapy and Rehabilitation, Kantonsspital Winterthur, Winterthur, Zurich, Switzerland
  3. 3Department of Public Health and Primary Care, Katholieke Universiteit Leuven, Leuven, Belgium
  4. 4Centre for Hip Health and Mobility, The University of British Columbia, Vancouver, British Columbia, Canada
  5. 5Orthopaedics and Traumatology, Shoulder and Elbow Unit, Kantonsspital Winterthur, Winterthur, Zurich, Switzerland
  6. 6Department of Rehabilitation Sciences, University of Ghent, Ghent, Belgium
  1. Correspondence to Ariane Schwank; ariane.schwank{at}student.uantwerpen.be

Abstract

Introduction Prognosis following surgical rotator cuff repair (RCR) is often established through the assessment of non-modifiable biomedical factors such as tear size. This understates the complex nature of recovery following RCR. There is a need to identify modifiable psychosocial and sleep-related variables, and to find out whether changes in central pain processing influence prognosis after RCR. This will improve our knowledge on how to optimise recovery, using a holistic rehabilitation approach.

Methods and analysis This longitudinal study will analyse 141 participants undergoing usual care for first time RCR. Data will be collected 1–21 days preoperatively (T1), then 11–14 weeks (T2) and 12–14 months (T3) postoperatively. We will use mixed-effects linear regression to assess relationships between potential prognostic factors and our primary and secondary outcome measures—the Western Ontario Rotator Cuff Index; the Constant-Murley Score; the Subjective Shoulder Value; Maximal Pain (Numeric Rating Scale); and Quality of Life (European Quality of Life, 5 dimensions, 5 levels). Potential prognostic factors include: four psychosocial variables; pain catastrophising, perceived stress, injury perceptions and patients’ expectations for RCR; sleep; and four factors related to central pain processing (central sensitisation inventory, temporal summation, cold hyperalgesia and pressure pain threshold). Intercorrelations will be assessed to determine the strength of relationships between all potential prognostic indicators.

Our aim is to explore whether modifiable psychosocial factors, sleep-related variables and altered central pain processing are associated with outcomes pre-RCR and post-RCR and to identify them as potential prognostic factors.

Ethics and dissemination The results of the study will be disseminated at conferences such as the European Pain Congress. One or more manuscripts will be published in a peer-reviewed SCI-ranked journal. Findings will be reported in accordance with the STROBE statement and PROGRESS framework. Ethical approval is granted by the Ethical commission of Canton of Zurich, Switzerland, No: ID_2018-02089

Trial registration number NCT04946149.

  • shoulder
  • pain management
  • psychiatry
  • rehabilitation medicine
  • sleep medicine
  • neurophysiology
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2021-058803

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    Footnotes

    • Twitter @arianeschwank, @FilipStruyf, @michelmertens4

    • Contributors AS is the project leader, who receives support from FS and MMee with respect to topic-selection and study design. TS controls the statistical model and will support statistical data analysis. MMer and PB contributed to the protocol through critical review and intellectual content. DG and MP support the feasibility of the study and access to clinical data through the physiotherapy and orthopaedic clinic at Canton Hospital Winterthur. DG and MP also support data security by providing REDCap software. All authors gave final approval for publication of the present protocol version.

    • Funding This work is supported by the Swiss physiotherapy association physioswiss through a financial research prize to the first author. Canton Hospital Winterthur supported AS with study fee payment.

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting or dissemination plans of this research. Refer to the Methods section for further details.

    • Provenance and peer review Not commissioned; externally peer reviewed.