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Self-management versus usual care for greater trochanteric pain syndrome (the HIPS trial): study protocol for a randomised controlled trial

Por: Morin Melas · T. · Bjorneboe · J. · Juel · N. G. · Wefring · M. L. · Skatteboe · S. · Killingmo · R. M. · Engebretsen · K. B. · Rathleff · M. S. · Oiestad · B. E. · Soberg · H. L. · Pripp · A. H. · Brox · J. I. · Johnsen · M. B.
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.

‘There are things I have learned the hard way’ Patient experiences on lasting challenges 4 months after Transient Ischemic Attack: A qualitative study

Abstract

Background

Fatigue, depression, anxiety and cognitive difficulties are reported by 1/3 of patients following transient ischemic attack (TIA).

Aims

To explore the timeline and how the diagnosis impacts individuals experiencing lasting challenges after TIA. Furthermore, to identify what they believed facilitated return to everyday life.

Design

Qualitative exploratory study with a phenomenological-hermeneutic approach.

Methods

Individual semi-structured interviews and thematic analysis.

Results

Fifteen patients were included. Four themes were identified; (1) ‘They say it is transient – no, not for me’ where all participants described lasting challenges emphasizing invalidating fatigue and impaired social participation, (2) ‘I am a changed person; how does this impact my future?’ which reflects altered identity and elevated alertness to symptoms, (3) ‘Time has been my ally and new perspectives have evolved’ where most participants described improvement over time and a few considered the diagnosis a wake-up call to change lifestyle. Lastly (4) ‘What would have helped me recover?’ which unfolds that close, trustful relations influence positively. In addition, the system often failed to support. Participants described pressure to return to work and lack of trust and negative experiences when involving their general practitioner.

Conclusions

During the 4 months since diagnosis, participants experienced limitations impacting physical, psychological and social domains. They felt uninformed that lasting challenges could affect them. Different coping strategies were activated, and participants with close, supportive relations managed better. A pressure to return to work and a lack of trust in the general practitioner affected their recovery negatively. Overall, return to everyday life after TIA was considered stressful and appropriate support lacking.

Relevance to Clinical Practice

To be able to support patients with challenges following TIA, we as healthcare professionals need to understand the identified impact and life changing circumstances. Currently the system seemingly is not able to provide timely, sufficient and competent support.

Impact (Addressing)

What problem did the study address?

We know from the literature that up to 1/3 of patients following transient ischemic attack experience lasting challenges measured on a variety of questionnaires. This is paradoxical to a diagnosis defined by focal neurological symptoms that resolve within 24 h. It is unknown how patients with lasting challenges experience the timeline from diagnosis and until 4 months after, how the diagnosis impacts the lives of these individuals, and what they believe as beneficial in returning to their everyday life.

What were the main findings?

These participants with self-reported lasting challenges experienced substantial impacts on physical, psychological and social domains. Further, they felt alone with their struggles and when in need of support from the healthcare system, it failed to provide this. A pressure to return to work and a lack of trust in the general practitioner affected return to everyday life negatively, whereas close and supportive relations facilitated positively.

Where and on whom will the research have an impact?

This study will have an impact on the healthcare professionals that provide support and the (limited) follow-up services to patients after TIA. These healthcare professionals are often specialized nurses who need to know what these patients experience and need in order to act upon their struggles and provide timely support.

Reporting Method

The Standards of Reporting Qualitative Research (SRQR).

Patient or Public Contribution

Patients with TIA was involved in planning this study. They participated in a panel to plan a prospective observational cohort study and emphasized the importance of exploring the subjective perspectives of impact and prognosis for those patients struggling in a longer term (through qualitative interviews).

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