Dynamic Lycra Garments for Hip Dysplasia Feasibility Study

The Royal National Orthopaedic Hospital (RNOH) Adult Hip service treats many patients with hypermobility and hip dysplasia, the burden of both conditions including joint pain and instability affecting function and quality of life. Evidence suggests a highly significant association between these conditions.

Dynamic lycra garments are deployed in rehabilitation and exercise to support unstable areas of the body, enhance sensory feedback to improve movement patterns, reduce fatigue and pain and improve function.

A high prevalence of hypermobility has been found in populations living with hip dysplasia. 2 case studies have respectively highlighted the effective use of postural correction to reduce hip pain in an adult with acetabular dysplasia while lycra orthoses have reduced pain and improved stability in the hip. Larger scale studies assessing the effect of lycra garments across a clinical population of those presenting with combined hypermobility and hip dysplasia are needed to investigate the extent of generalisable effects.

The research question underpinning the project is as follows,"Can the use of dynamic compression shorts during daily activities improve short term physiotherapy treatment outcomes in hip dysplasia patients?".

This single cohort observational feasibility study will assess prevalence of hip dysplasia and hypermobility , refine the research protocol and measures , identify any complications of garment use, establish compliance and feedback on aspects of experience; gathering early evidence of effect and establish potential for future interventional study.

The intention of this study is primarily to establish the practicality of studying these effect of the garments over the treatment period and assess the justification for further quantitative study, rather than the adjunctive effect of the shorts themselves.

The findings will inform the development of an interventional study design which can more fully establish the generalisable degree to which this intervention can deliver effective relief from pain and disability for patients with hypermobility and hip dysplasia.

The investigators are aiming to recruit 8-10 participants with the aim of gathering chiefly qualitative outcomes. The research activities will be carried out within the Hip specialist clinic environment at the Trust Stanmore site. Prospective participants will be screened for inclusion by medical staff and then provided with a Patient Information Sheet (PIS), following which patients will be invited to a baseline measurement session with the research therapist. This feasibility study is not intended to be blinded and will be undertaken as an observational study of a single cohort.

The intervention, dynamic lycra shorts, are a Conformite Europeenne (CE) marked item which are marketed towards treating the symptoms of joint hypermobility amongst many other pathologies. No generalisable peer-reviewed evidence currently exists to support their treatment effectiveness in the current population of interest, as an adjunct to current approach which is based around exercise and education. Furthermore, qualitative aspects of use of these highly compressive lycra garments, such as impact on self-care or comfort, that could negatively impact on sustained use have not been explored in the peer-reviewed literature.

Before embarking upon a randomised trial it is important to confirm

• the incidence of presentation of the target population, Developmental Dysplasia of the Hip (DDH) patients who are suitable for study inclusion.
• the fraction of whom are likely to consent and then choose to remain within the study protocol until the planned conclusion.
• extent of compliance with the intervention.
• identify aspects of the protocol that, through researcher and participant experience, may require modification.
• gain informed participant feedback as to the potential benefits of further research on this and similar topics.
• the incidence of anxiety and/or depression in the target population.

The study will aim to include all adult (18+) patients with capacity and who are not classified as vulnerable individuals, who are identified as falling within the spectrum of hypermobility using validated scoring scales, with hip dysplasia signs deemed suitable for conservative care by the RNOH Hip Service medical team, and who are not under other current or planned treatments within the study duration that could affect the study outcomes. Individuals with a history of hip surgery or trauma to the hip will aso be excluded.

No upper age limit is applied. Those with identified co-morbidity including age-related degenerative changes to the hip which may obscure the effects of interest in the study may be excluded where clearly justified.

It will be made plain that each participant is free to withdraw from the study at any time without the need to provide a reason.

At the medical interview, these individuals will be provided with an information sheet and invited to contact the research team to signal their informed consent to take part in the study.

As physical attendance is required at the baseline and follow up sessions, and following confirmatory screening participants will be able to read and sign the study consent form in the presence of the research therapist. Screening will include hypermobility scoring and questionnaire based assessment of anxiety or depression related to experience of the hip pathology. As anxiety and depression are thought to be significant confounding factors when measuring the subjective impact of surgical treatment interventions, participants will complete the Hip Anxiety and Depression Score (HADS). The investigators will, however, welcome those testing positive for these psychological factors to continue onto the study on the basis that there is no reason to believe that the effect of the proposed intervention will be different for such individuals and assessment of this factor could provide valuable information about both cofactors and treatment benefits in future study and treatment protocols.

This study is observational and will not require allocation to intervention groups.

The data for each participant will be pseudonymised by assigning an identifier code at the point of study inclusion. All information, including screening data and outcome scoring together with limited demographic information will be stored under the identifier code.

At the study conclusion each participant will be asked to complete an experience questionnaire and have the opportunity to receive a debrief of their personal study data. They will also be followed up with a questionnaire asking them to reflect upon their qualitative experience and perceived personal and generalisable benefits of current and planned research into such conservative therapies.