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Trial registered on ANZCTR


Registration number
ACTRN12615001218583
Ethics application status
Approved
Date submitted
30/10/2015
Date registered
9/11/2015
Date last updated
26/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot double-blind randomised controlled trial comparing two physiotherapy interventions to treat femoroacetabular impingement.
Scientific title
A pilot double-blind placebo randomised controlled trial for people with femoroacetabular impingement, comparing a strengthening, education, manual therapy and fitness program with a stretching, education, manual therapy, fitness program
to determine the feasibility of RCT methodology for a larger trial and determining which physiotherapy program reduces participant's pain and improves function.
Secondary ID [1] 287345 0
Nil
Universal Trial Number (UTN)
Trial acronym
Femoroacetabular Impingement Rehabilitation STudy-FIRST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Femoroacetabular impingement 295996 0
Condition category
Condition code
Physical Medicine / Rehabilitation 296278 296278 0 0
Physiotherapy
Musculoskeletal 296279 296279 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Physiotherapy
The physiotherapy intervention will be delivered in 8x 30 minute sessions delivered over a twelve week period (1/week for 4 weeks, 1/fortnight for 8 weeks). They will also attend one 60 minute supervised gym session per week. Gym sessions will be semi-standardised and reflect same program tailored to suit the individual within the physiotherapy session. Physiotherapy treatment sessions will consists of:
i) manual hip mobilisation and stretching based on the persons clinical presentation addressing any assessed range of movement deficits in hip, knee and spinal joints;
ii) hip muscle retraining tailored according to any assessed strength deficits with progression based on achievement of repetition and resistance goals in a semi-standardised strength program
iii) trunk muscle retraining in same semi-standardised program
iv) functional, proprioceptive and sports- or activity-specific retraining tailored to assessed sport or occupational loads within same semi-standardised program
v) enhancing physical activity via a semi-standardised, 12 phase cardiovascular fitness program with progression based on achievement of training goal within set parameters for perceived effort and pain
vi) education will be individualised and could include topics including exercise, weight loss if appropriate and appropriate stretching.
This will be provided during the physiotherapy session.
The physiotherapist will supervise exercises during each visit for 15 minutes. A home exercise program will be performed independently at home 4 times per week for 60 minutes per session. An information and exercise manual will be provided to each participant as well as access to a mobile phone app which contains the home exercise program. Participants will be asked to record both the number of exercises completed and any associated symptoms for each exercise. They may record this in the app or in a paper, self-report diary if they prefer. Compliance with the home program will be reviewed at each visit, as well as use of medications and additional activity undertaken.
Intervention code [1] 292677 0
Rehabilitation
Comparator / control treatment
Control
In order to control for the psychosocial contact inherent with physiotherapy treatment, the control group intervention will also receive manual therapy tailored to any assessed range of motion deficits in hip or spinal joints.
They will also receive the same semi-standardised cardiovascular training program with progression based on achievement of training goals within parameters of perceived effort and pain.
The control participants will also receive the same individualised health education sessions covering topics such as exercise, diet, weight loss and appropriate stretching.
Control participants will not do any hip or trunk muscle retraining nor any functional proprioceptive or sports/activity specific retraining.
Control participants will instead do a semi-standardised stretching program which may be minimally modified by exercise selected if they cause discomfort.
The control sessions will be provided with the same frequency and duration as the physiotherapy sessions and control participants will also be provided with an exercise manual (of stretches only) and access to a mobile phone app with the stretch exercise program on it. They will also attend one gym session per week, consisting entirely of stretches and cardiovascular fitness. Control participants will also be required to complete a home program consisting of stretches and cardiovascular fitness only and record compliance in the app or in a paper self-report diary. Compliance with the home program will be reviewed at each visit, as well as use of medications and additional activity undertaken.
Control group
Active

Outcomes
Primary outcome [1] 295934 0
Feasibility of conducting a full scale RCT.
Feasibility will be assessed by evaluating ease and rate of recruitment and the number of eligible participants.
Qualitative data will include participant satisfaction with treatment, understanding of their hip problem and their experience of all the study procedures.
Timepoint [1] 295934 0
12 weeks post treatment commencement
Primary outcome [2] 296537 0
Participant compliance with treatment and control programs assessed by self-report exercise completion, attendance at physiotherapy and gym sessions, completion of home program and self-report diary.
Timepoint [2] 296537 0
12 weeks post treatment commencement
Primary outcome [3] 296538 0
Participant satisfaction with programs assessed via qualitative interview via a series of standardised questions related to participants' experience of the study processes, the programs and their understanding of their hip problem, following final physical assessment.
Timepoint [3] 296538 0
12 weeks post treatment commencement
Secondary outcome [1] 316949 0
Hip muscle strength measured using methods which have been previously published and are reliable. Hip muscle strength will be measured using a hand held dynamometer.
Timepoint [1] 316949 0
Baseline and 12 weeks post treatment commencement
Secondary outcome [2] 316950 0
Hip flexion and internal rotation range of movement.
These outcomes will be measured with an inclinometer at end of active movement range.
Timepoint [2] 316950 0
Baseline and 12 weeks post treatment commencement
Secondary outcome [3] 316951 0
International Hip Outcome Tool (iHOT).
This is a hip specific patient reported outcome measure which measures symptoms, job related activity, sporting activity and social activity.
Timepoint [3] 316951 0
Baseline and 12 weeks post treatment commencement
Secondary outcome [4] 316958 0
Perceived global change score.
This is a likert measure of patient reported perceived change between baseline and follow-up assessments.
Timepoint [4] 316958 0
Baseline and 12 weeks post commencement of intervention
Secondary outcome [5] 318706 0
Hip disability and Osteoarthritis Outcome Score (HOOS)-pain subscale. This is a hip-specific patient reported outcome measure with respect to pain.
Timepoint [5] 318706 0
12 weeks post treatment commencement
Secondary outcome [6] 318707 0
Hip disability and Osteoarthritis Outcome Score (HOOS)-activity subscale. This is a hip-specific patient reported outcome measure with respect to activities of daily living.
Timepoint [6] 318707 0
12 weeks post-treatment commencement
Secondary outcome [7] 318708 0
Hip disability and Osteoarthritis Outcome Score (HOOS)-sport and recreation subscale. This is a hip-specific patient reported outcome measure with respect to participation in sport and recreational activities.
Timepoint [7] 318708 0
12 weeks post treatment commencement

Eligibility
Key inclusion criteria
Hip/groin pain of more than 6 weeks duration,
Hip/groin pain on impingement test rated greater than 3/10 on Visual Analogue Scale (VAS),
Alpha angle greater than60degrees evident on hip x-ray.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Physiotherapy for their hip in the past 3 months,
Previous surgery on symptomatic hip,
Other systemic musculoskeletal conditions e.g. rheumatoid arthritis,
Unable to perform testing procedures,
Unable to commit to 12 weeks treatment program
Contraindication to x-ray (if required) e.g. pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation schedule will be generated and maintained centrally by Latrobe University and will be revealed via telephone by the project coordinator, to the treating physiotherapist following baseline assessment . Participants will be unaware of which intervention they will receive.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation in ratio of 2:1
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Individuals will respond to flyers/advertising/social media and contact the project coordinator. The project coordinator will screen interested people via telephone to partially determine their eligibility to participate using inclusion/exclusion criteria listed above. The coordinator will then organise an appointment to complete eligibility assessment at Federation University. Individuals will be tested for clinical impingement sign and x-ray alpha angle. If the individual has clinical impingement but has no hip x-ray, an x-ray investigation will be organised locally and assessed online to determine eligibility. Informed consent will be sought. If consent is given, the participant will then undergo baseline testing.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcomes measured at 12 weeks will include recruitment rate, compliance with all aspects of intervention and drop-out rate.
Secondary outcomes will be analysed using linear mixed regression models, including their respective baseline scores as a covariate, subjects as a random effect, treatment condition as a fixed factor and the covariate by treatment interaction. Participant characteristics (e.g. gender, age) will be included as covariates. We aim to detect the minimum clinically important improvement on this outcome as reported by Kemp et al.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/11/2015
Actual
1/12/2015
Date of last participant enrolment
Anticipated
14/11/2016
Actual
14/08/2016
Date of last data collection
Anticipated
Actual
14/01/2017
Sample size
Target
40
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 10206 0
3350 - Ballarat

Funding & Sponsors
Funding source category [1] 291906 0
University
Name [1] 291906 0
La Trobe Sport and Exercise Medicine Research Centre,La Trobe University
Country [1] 291906 0
Australia
Primary sponsor type
University
Name
La Trobe University, La Trobe Sport and Exercise Medicine Research Centre
Address
Cnr Kingsbury Dve and Plenty Rd
Bundoora,
Vic, 3086
Country
Australia
Secondary sponsor category [1] 290575 0
University
Name [1] 290575 0
Australian Centre for Research into Injury in Sport and its Prevention Federation University Australia, SMB Campus
Address [1] 290575 0
PO Box 663
Ballarat,
Victoria, 3353
Country [1] 290575 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293414 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 293414 0
Ethics committee country [1] 293414 0
Australia
Date submitted for ethics approval [1] 293414 0
13/08/2015
Approval date [1] 293414 0
02/11/2015
Ethics approval number [1] 293414 0
HEC15-076

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59826 0
Prof Kay Crossley
Address 59826 0
Office Of Allied Health
HS3 Level 05
La Trobe University,
Bundoora,
Vic 3086
Country 59826 0
Australia
Phone 59826 0
+61 3 9479 3902
Fax 59826 0
+61 3 9479 5768
Email 59826 0
k.crossley@latrobe.edu.au
Contact person for public queries
Name 59827 0
Sally Coburn
Address 59827 0
Office Of Allied Health
HS3 Level 05
La Trobe University,
Bundoora,
Vic 3086
Country 59827 0
Australia
Phone 59827 0
+61 457 311 203
Fax 59827 0
Email 59827 0
s.coburn@latrobe.edu.au
Contact person for scientific queries
Name 59828 0
Joanne Kemp
Address 59828 0
HS3, Level 5
School of Allied Health,
La Trobe University,
Bundoora, Vic. 3086
Country 59828 0
Australia
Phone 59828 0
+61 3 9479 1428
Fax 59828 0
Email 59828 0
j.kemp@latrobe.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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