Self-management versus usual care for greater trochanteric pain syndrome (the HIPS trial): study protocol for a randomised controlled trial
Introduction Greater trochanteric pain syndrome (GTPS) is a common and disabling condition characterised by lateral hip pain. The condition often persists for several months, and there is low evidence for any superior treatment. The aim of this study protocol is to describe a randomised controlled t...
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BMJ Publishing Group
2025-04-01
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| author | Michael Skovdal Rathleff Are Hugo Pripp Jens Ivar Brox Britt Elin Øiestad Marianne Bakke Johnsen John Bjørneboe Niels Gunnar Juel Rikke Munk Killingmo Kaia B Engebretsen Thea Morin Melås Maren Lunder Wefring Sigrid Skatteboe Helene Lundgaard Søberg |
| author_facet | Michael Skovdal Rathleff Are Hugo Pripp Jens Ivar Brox Britt Elin Øiestad Marianne Bakke Johnsen John Bjørneboe Niels Gunnar Juel Rikke Munk Killingmo Kaia B Engebretsen Thea Morin Melås Maren Lunder Wefring Sigrid Skatteboe Helene Lundgaard Søberg |
| author_sort | Michael Skovdal Rathleff |
| collection | DOAJ |
| description | Introduction Greater trochanteric pain syndrome (GTPS) is a common and disabling condition characterised by lateral hip pain. The condition often persists for several months, and there is low evidence for any superior treatment. The aim of this study protocol is to describe a randomised controlled trial (RCT) investigating the effectiveness of a self-management programme versus usual care for patients with GTPS.Methods and analysis The study is designed as an observer-blinded, parallel group, superiority RCTcomparing a self-management programme (n=55) with usual care (n=55). Eligible patients with GTPS will be included based on reproduction of pain on palpation in the greater trochanteric region and at least one positive clinical provocation test. The self-management programme includes 3–5 individual sessions with a physiotherapist over 12 weeks, addressing physical, emotional and behavioural factors deemed relevant by the patient. Usual care will receive general information about GTPS, activity management and are free to seek further treatment in primary care as wanted. The primary outcome measure is the Norwegian version of the Victorian Institute of Sports Assessment for gluteal tendinopathy questionnaire (VISA-G-Norwegian). Outcomes will be assessed at baseline, 3, 6 and 12 months. A longitudinal mixed effects model will be used to assess the effectiveness of treatment on pain and disability across all time points, with the primary endpoint at 6 months. Cost-effectiveness will be expressed by mean incremental cost-effectiveness ratios (ICERs) from a societal and healthcare perspective. Bootstrapping will be used to estimate ICER uncertainty.Ethics and dissemination The Norwegian Regional Committees for Medical and Health Research Ethics have approved the project (2023/590816), and it will be in accordance with recommendations from the Data Inspectorate at Oslo University Hospital (22/26396). The results from the study will be disseminated through publications in peer-reviewed journals, in conference presentations and through the user representative.Trial registration number NCT06297148. |
| format | Article |
| id | doaj-art-e687c1b6932a4384b5601eb81a418dcd |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-04-01 |
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| spelling | doaj-art-e687c1b6932a4384b5601eb81a418dcd2025-08-20T01:53:11ZengBMJ Publishing GroupBMJ Open2044-60552025-04-0115410.1136/bmjopen-2024-090688Self-management versus usual care for greater trochanteric pain syndrome (the HIPS trial): study protocol for a randomised controlled trialMichael Skovdal Rathleff0Are Hugo Pripp1Jens Ivar Brox2Britt Elin Øiestad3Marianne Bakke Johnsen4John Bjørneboe5Niels Gunnar Juel6Rikke Munk Killingmo7Kaia B Engebretsen8Thea Morin Melås9Maren Lunder Wefring10Sigrid Skatteboe11Helene Lundgaard Søberg124 Department of Physical Therapy and Occupational Therapy, Aalborg University Hospital, Aalborg, Denmark1 Department of Rehabilitation Science and Health Technology, Oslo Metropolitan University, Oslo, Norway2 Department of Physical Medicine and Rehabilitation, Oslo University Hospital, Oslo, Norway1 Department of Rehabilitation Science and Health Technology, Oslo Metropolitan University, Oslo, Norway1 Department of Rehabilitation Science and Health Technology, Oslo Metropolitan University, Oslo, Norway2 Department of Physical Medicine and Rehabilitation, Oslo University Hospital, Oslo, Norway2 Department of Physical Medicine and Rehabilitation, Oslo University Hospital, Oslo, Norway1 Department of Rehabilitation Science and Health Technology, Oslo Metropolitan University, Oslo, Norway2 Department of Physical Medicine and Rehabilitation, Oslo University Hospital, Oslo, Norway1 Department of Rehabilitation Science and Health Technology, Oslo Metropolitan University, Oslo, Norway2 Department of Physical Medicine and Rehabilitation, Oslo University Hospital, Oslo, Norway2 Department of Physical Medicine and Rehabilitation, Oslo University Hospital, Oslo, Norway1 Department of Rehabilitation Science and Health Technology, Oslo Metropolitan University, Oslo, NorwayIntroduction Greater trochanteric pain syndrome (GTPS) is a common and disabling condition characterised by lateral hip pain. The condition often persists for several months, and there is low evidence for any superior treatment. The aim of this study protocol is to describe a randomised controlled trial (RCT) investigating the effectiveness of a self-management programme versus usual care for patients with GTPS.Methods and analysis The study is designed as an observer-blinded, parallel group, superiority RCTcomparing a self-management programme (n=55) with usual care (n=55). Eligible patients with GTPS will be included based on reproduction of pain on palpation in the greater trochanteric region and at least one positive clinical provocation test. The self-management programme includes 3–5 individual sessions with a physiotherapist over 12 weeks, addressing physical, emotional and behavioural factors deemed relevant by the patient. Usual care will receive general information about GTPS, activity management and are free to seek further treatment in primary care as wanted. The primary outcome measure is the Norwegian version of the Victorian Institute of Sports Assessment for gluteal tendinopathy questionnaire (VISA-G-Norwegian). Outcomes will be assessed at baseline, 3, 6 and 12 months. A longitudinal mixed effects model will be used to assess the effectiveness of treatment on pain and disability across all time points, with the primary endpoint at 6 months. Cost-effectiveness will be expressed by mean incremental cost-effectiveness ratios (ICERs) from a societal and healthcare perspective. Bootstrapping will be used to estimate ICER uncertainty.Ethics and dissemination The Norwegian Regional Committees for Medical and Health Research Ethics have approved the project (2023/590816), and it will be in accordance with recommendations from the Data Inspectorate at Oslo University Hospital (22/26396). The results from the study will be disseminated through publications in peer-reviewed journals, in conference presentations and through the user representative.Trial registration number NCT06297148.https://bmjopen.bmj.com/content/15/4/e090688.full |
| spellingShingle | Michael Skovdal Rathleff Are Hugo Pripp Jens Ivar Brox Britt Elin Øiestad Marianne Bakke Johnsen John Bjørneboe Niels Gunnar Juel Rikke Munk Killingmo Kaia B Engebretsen Thea Morin Melås Maren Lunder Wefring Sigrid Skatteboe Helene Lundgaard Søberg Self-management versus usual care for greater trochanteric pain syndrome (the HIPS trial): study protocol for a randomised controlled trial BMJ Open |
| title | Self-management versus usual care for greater trochanteric pain syndrome (the HIPS trial): study protocol for a randomised controlled trial |
| title_full | Self-management versus usual care for greater trochanteric pain syndrome (the HIPS trial): study protocol for a randomised controlled trial |
| title_fullStr | Self-management versus usual care for greater trochanteric pain syndrome (the HIPS trial): study protocol for a randomised controlled trial |
| title_full_unstemmed | Self-management versus usual care for greater trochanteric pain syndrome (the HIPS trial): study protocol for a randomised controlled trial |
| title_short | Self-management versus usual care for greater trochanteric pain syndrome (the HIPS trial): study protocol for a randomised controlled trial |
| title_sort | self management versus usual care for greater trochanteric pain syndrome the hips trial study protocol for a randomised controlled trial |
| url | https://bmjopen.bmj.com/content/15/4/e090688.full |
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