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) STUDYBACKGROUND 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 CourtAcademic Department of Military RehabilitationDMRC Headley Court, Epsom, Surrey, KT18 6JWReferences: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 overExclusion 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 overStudy Timeline Participant Flow Through the StudyPreliminary screening for hip pain at local unit. Patients consent to attend DMRC MIACAssessed for eligibility by Consultant lead forhip rehabilitation at DMRC Headley Court MIACParticipants provide informed consent and randomised to treatment group Allocated to Individual Programme (IP) Outpatient GroupAllocated to Residential (MDT) GroupBaseline measures. Lead IP physiotherapist at DMRC deliver outpatient interventionBaseline measures. Multidisciplinary team at DMRC deliver residential intervention8 x individual treatment sessions over 6-weeks and home-based exerciseWeek 6 assessment measures immediatelypost-treatmentHome exercise programme minimumx3 times per weekWeek 12 re-assessment atDMRC Consultant led MIAC7-day intensive, group-based,multidisciplinary interventionWeek 1 (7-day) assessment measures immediatelypost-treatmentHome exercise programme minimumx3 times per weekWeek 12 re-assessment atDMRC Consultant led MIACStudy 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 2016Collaborators, 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) STUDYBACKGROUND 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 CourtAcademic Department of Military RehabilitationDMRC Headley Court, Epsom, Surrey, KT18 6JWReferences: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 overExclusion 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 overStudy Timeline Participant Flow Through the StudyPreliminary screening for hip pain at local unit. Patients consent to attend DMRC MIACAssessed for eligibility by Consultant lead forhip rehabilitation at DMRC Headley Court MIACParticipants provide informed consent and randomised to treatment group Allocated to Individual Programme (IP) Outpatient GroupAllocated to Residential (MDT) GroupBaseline measures. Lead IP physiotherapist at DMRC deliver outpatient interventionBaseline measures. Multidisciplinary team at DMRC deliver residential intervention8 x individual treatment sessions over 6-weeks and home-based exerciseWeek 6 assessment measures immediatelypost-treatmentHome exercise programme minimumx3 times per weekWeek 12 re-assessment atDMRC Consultant led MIAC7-day intensive, group-based,multidisciplinary interventionWeek 1 (7-day) assessment measures immediatelypost-treatmentHome exercise programme minimumx3 times per weekWeek 12 re-assessment atDMRC Consultant led MIACStudy 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 2016Collaborators, 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).