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...

Full description

Saved in:
Bibliographic Details
Main Authors: 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
Format: Article
Language:English
Published: BMJ Publishing Group 2025-04-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/15/4/e090688.full
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1850269268592033792
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
publisher BMJ Publishing Group
record_format Article
series BMJ Open
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
work_keys_str_mv AT michaelskovdalrathleff selfmanagementversususualcareforgreatertrochantericpainsyndromethehipstrialstudyprotocolforarandomisedcontrolledtrial
AT arehugopripp selfmanagementversususualcareforgreatertrochantericpainsyndromethehipstrialstudyprotocolforarandomisedcontrolledtrial
AT jensivarbrox selfmanagementversususualcareforgreatertrochantericpainsyndromethehipstrialstudyprotocolforarandomisedcontrolledtrial
AT brittelinøiestad selfmanagementversususualcareforgreatertrochantericpainsyndromethehipstrialstudyprotocolforarandomisedcontrolledtrial
AT mariannebakkejohnsen selfmanagementversususualcareforgreatertrochantericpainsyndromethehipstrialstudyprotocolforarandomisedcontrolledtrial
AT johnbjørneboe selfmanagementversususualcareforgreatertrochantericpainsyndromethehipstrialstudyprotocolforarandomisedcontrolledtrial
AT nielsgunnarjuel selfmanagementversususualcareforgreatertrochantericpainsyndromethehipstrialstudyprotocolforarandomisedcontrolledtrial
AT rikkemunkkillingmo selfmanagementversususualcareforgreatertrochantericpainsyndromethehipstrialstudyprotocolforarandomisedcontrolledtrial
AT kaiabengebretsen selfmanagementversususualcareforgreatertrochantericpainsyndromethehipstrialstudyprotocolforarandomisedcontrolledtrial
AT theamorinmelas selfmanagementversususualcareforgreatertrochantericpainsyndromethehipstrialstudyprotocolforarandomisedcontrolledtrial
AT marenlunderwefring selfmanagementversususualcareforgreatertrochantericpainsyndromethehipstrialstudyprotocolforarandomisedcontrolledtrial
AT sigridskatteboe selfmanagementversususualcareforgreatertrochantericpainsyndromethehipstrialstudyprotocolforarandomisedcontrolledtrial
AT helenelundgaardsøberg selfmanagementversususualcareforgreatertrochantericpainsyndromethehipstrialstudyprotocolforarandomisedcontrolledtrial