20151027 - MILO Study Information Poster - RCT - [FINAL]-O page 1

20151027 - MILO Study Information Poster - RCT - [FINAL]-O

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  • IntroductionHip pain with mechanical symptoms, particularly acetabular labral tears and femoroacetabular impingement, are common complaints presenting to the military orthopaedic surgeon [1]. Residential multidisciplinary team (MDT) rehabilitation for patients with prearthritic hip pain has a long tradition in the UK military. Despite the popularity of this approach evidence supporting its effectiveness is lacking. It is therefore important to examine current UK military practice to ensure patients receive rehabilitation in the optimal clinical setting.

    Prearthritic, Intra-articular Hip Pain: The MILITARY HIP REHABILITATION OUTCOME (MILO) STUDY

    BACKGROUND INFORMATION TO THE RESEARCH PROGRAMME

    Purpose of the MILO study

    The aim of this randomised controlled trial is to compare the effects of a 7-day residential, MDT intervention, to usual outpatient care, on pain and physical function in military personnel undergoing treatment for prearthritic intra-articular hip pain. The study will be conducted on the Academic Department of Military Rehabilitation at DMRC Headley Court.

    Lead Investigator: Mr R Coppack (Clinical Research Manager) Academic Department of Military Rehabilitation (ADMR), DMRC Headley Court, Epsom, Surrey, KT18 6JW, UK. 01372947103 (w)E-Mail: DMRC-ClinicalResearchManager@mod.uk or russ.coppack100@mod.ukInvestigators: I McCurdie (lead Consultant), L Partridge (study physiotherapist)Research Supervisors: JL Bilzon, AN Bennett, AK Wills Oversight: Lt Col A Nicol, Military Clinical Director, DMRC Headley Court

    Academic Department of Military RehabilitationDMRC Headley Court, Epsom, Surrey, KT18 6JW

    References:1. Hunt D, Prather H, Harris-Hays M et al. Clinical outcomes analysis of conservative and surgical treatment of patients with clinical indicators of prearthritic intra- articular hip disorders. American Academy of Physical Medicine and Rehabilitation 2012;4:479-487.

    Inclusion Criteria Male

    Anterior or labral hip pain for at least 3 months

    Clinical signs and symptoms of prearthritic, intra-articular hip pathology/FAI diagnosed by a specialist Rehabilitation / rheumatology / SEM Consultant

    Physical examination findings or reproduction of pain in the groin or lateral hip with the log roll, anterior hip impingement test, or resisted straight leg raise test

    Sufficient time to keep therapeutic appointments

    Aged 18-years or over

    Exclusion Criteria

    Female

    Inflammatory arthropathy or hip infection or tumour or hip fracture

    Existing extra-articular hip disorder

    Major structural deformity of the hip

    Advanced degenerative disease of the hip (Tnnis classification 2-3)

    Any physical impairment or co- morbidities precluding the safe participation in the rehabilitation programme

    History of congenital / adolescent hip disease

    Cortico-steroid or analgesic injection intervention for hip within the previous 30-days

    Clinical signs of lumbar spine disease

    Aged 50-years or over

    Study Timeline Participant Flow Through the StudyPreliminary screening for hip pain

    at local unit. Patients consent to attend

    DMRC MIAC

    Assessed for eligibility by Consultant lead forhip rehabilitation at

    DMRC Headley Court MIAC

    Participants provide informed consent and randomised to treatment group

    Allocated to Individual Programme (IP) Outpatient Group

    Allocated to Residential (MDT) Group

    Baseline measures. Lead IP physiotherapist at DMRC

    deliver outpatient intervention

    Baseline measures. Multidisciplinary team at DMRC

    deliver residential intervention

    8 x individual treatment sessions over 6-weeks and home-based exercise

    Week 6 assessment measures immediately

    post-treatment

    Home exercise programme minimumx3 times per week

    Week 12 re-assessment atDMRC Consultant led MIAC

    7-day intensive, group-based,multidisciplinary intervention

    Week 1 (7-day) assessment measures immediately

    post-treatment

    Home exercise programme minimumx3 times per week

    Week 12 re-assessment atDMRC Consultant led MIAC

    Study Intervention GroupsGroup 1 Multidisciplinary Team Residential Group Comprehensive MDT inpatient rehabilitation at DMRC Participants complete seven therapy sessions per-day; session duration is 30-60 mins Treatment includes group / individual exercise, group education, one-to-one physiotherapy and occupational therapy Treatment is anchored by outcome measurements at baseline (T1) and upon completion of the intervention (T2).

    Group 2 Individual Programme Outpatient Group Physiotherapy led outpatient rehabilitation. Each treatment session is administered on a one-to-one basis. Eight appointment sessions (45-60 mins) over a period of 6-weeks Physiotherapist prescribed, self-managed home-based exercise (minimum 3-sessions per week) over the period of treatment Treatment is anchored by outcome measurements at baseline (T1) and upon completion of the intervention (T2).

    Main Outcomes Pain (visual analogue scale 1-100 mm)

    PROM (Copenhagen HAGOS and NAHS)

    Physical function - Six minute walk test

    Postural control - Y-balance test

    Hip Range of Motion (HROM)

    Functional Movement Screen (FMS)

    Occupational employability (FAA)

    General health status (EurQul 5D)

    Self / Treatment efficacy (SIRBS)

    Exercise adherence (training diary)

    Eligible patients should be referred to the DMRC Lower Limb MIAC (lead Consultant Dr Ian

    McCurdie). Referral should specify FAO MILO Study on the front page of the FMed 7. Study data

    collection commences Jan 2016

    Collaborators, Funding and EthicsThe MILO study is a collaboration between the MOD (DMRC Headley Court), the University of Bath and the Arthritis Research UK Centre for Sport, Exercise and Osteoarthritis (CSEOA). The Universities of Southampton and Bristol are secondary collaborators. The study is funded by the Arthritis Research UK Centre for Sport, Exercise and Osteoarthritis (Grant Reference 20194). The MILO study has been granted Ministry of Defence Research Ethics Committee (MODREC) approval (reference 576/MODREC/14).

    Prearthritic, Intra-articular Hip Pain: The MILITARY HIP REHABILITATION OUTCOME (MILO) STUDYBACKGROUND INFORMATION TO THE RESEARCH PROGRAMME

    IntroductionHip pain with mechanical symptoms, particularly acetabular labral tears and femoroacetabular impingement, are common complaints presenting to the military orthopaedic surgeon [1]. Residential multidisciplinary team (MDT) rehabilitation for patients with prearthritic hip pain has a long tradition in the UK military. Despite the popularity of this approach evidence supporting its effectiveness is lacking. It is therefore important to examine current UK military practice to ensure patients receive rehabilitation in the optimal clinical setting.

    Prearthritic, Intra-articular Hip Pain: The MILITARY HIP REHABILITATION OUTCOME (MILO) STUDY

    BACKGROUND INFORMATION TO THE RESEARCH PROGRAMME

    Purpose of the MILO study

    The aim of this randomised controlled trial is to compare the effects of a 7-day residential, MDT intervention, to usual outpatient care, on pain and physical function in military personnel undergoing treatment for prearthritic intra-articular hip pain. The study will be conducted on the Academic Department of Military Rehabilitation at DMRC Headley Court.

    Lead Investigator: Mr R Coppack (Clinical Research Manager) Academic Department of Military Rehabilitation (ADMR), DMRC Headley Court, Epsom, Surrey, KT18 6JW, UK. 01372947103 (w)E-Mail: DMRC-ClinicalResearchManager@mod.uk or russ.coppack100@mod.ukInvestigators: I McCurdie (lead Consultant), L Partridge (study physiotherapist)Research Supervisors: JL Bilzon, AN Bennett, AK Wills Oversight: Lt Col A Nicol, Military Clinical Director, DMRC Headley Court

    Academic Department of Military RehabilitationDMRC Headley Court, Epsom, Surrey, KT18 6JW

    References:1. Hunt D, Prather H, Harris-Hays M et al. Clinical outcomes analysis of conservative and surgical treatment of patients with clinical indicators of prearthritic intra- articular hip disorders. American Academy of Physical Medicine and Rehabilitation 2012;4:479-487.

    Inclusion Criteria Male

    Anterior or labral hip pain for at least 3 months

    Clinical signs and symptoms of prearthritic, intra-articular hip pathology/FAI diagnosed by a specialist Rehabilitation / rheumatology / SEM Consultant

    Physical examination findings or reproduction of pain in the groin or lateral hip with the log roll, anterior hip impingement test, or resisted straight leg raise test

    Sufficient time to keep therapeutic appointments

    Aged 18-years or over

    Exclusion Criteria

    Female

    Inflammatory arthropathy or hip infection or tumour or hip fracture

    Existing extra-articular hip disorder

    Major structural deformity of the hip

    Advanced degenerative disease of the hip (Tnnis classification 2-3)

    Any physical impairment or co- morbidities precluding the safe participation in the rehabilitation programme

    History of congenital / adolescent hip disease

    Cortico-steroid or analgesic injection intervention for hip within the previous 30-days

    Clinical signs of lumbar spine disease

    Aged 50-years or over

    Study Timeline Participant Flow Through the StudyPreliminary screening for hip pain

    at local unit. Patients consent to attend

    DMRC MIAC

    Assessed for eligibility by Consultant lead forhip rehabilitation at

    DMRC Headley Court MIAC

    Participants provide informed consent and randomised to treatment group

    Allocated to Individual Programme (IP) Outpatient Group

    Allocated to Resi