Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001350314
Ethics application status
Approved
Date submitted
15/09/2017
Date registered
25/09/2017
Date last updated
29/11/2019
Date data sharing statement initially provided
29/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A double-blind randomised controlled trial comparing two physiotherapy interventions to treat hip impingement.
Scientific title
The physiotherapy for Femoroacetabular Impingement Rehabilitation STudy (PhysioFIRST): A participant and assessor blinded randomised controlled trial of physiotherapy to reduce pain and improve function for hip impingement.
Secondary ID [1] 292719 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PhysioFIRST
Linked study record
ACTRN12615001218583

Health condition
Health condition(s) or problem(s) studied:
Femoroacetabular impingement 304620 0
Physiotherapy 304621 0
Condition category
Condition code
Physical Medicine / Rehabilitation 303937 303937 0 0
Physiotherapy
Musculoskeletal 304049 304049 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The physiotherapy intervention will be delivered to participants in two consecutive 12 week phases. Phase I physiotherapy treatment (week 0-12), will consist of 6x 30 minute face to face physiotherapy sessions delivered fortnightly. Participants will also attend one 45 minute supervised gym session per week. Gym sessions will be semi-standardised and reflect the same program tailored to suit the individual within the face to face physiotherapy session and will be supervised by physiotherapists.
Physiotherapy face to face treatment and gym 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.
The physiotherapist will supervise exercises during each face to face session for 15 minutes. The same exercise program will be performed independently at home two times per week for 30 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.
Phase II physiotherapy treatment (week 13-24) consists of three 30min face to face treatment sessions (monthly) and continuation of the exercise program by attendance at a community gym three times per week., Face to face physiotherapy sessions will address any participant concerns regarding symptoms or their program and advise strength, functional and cardiovascular exercise progressions for the unsupervised gym sessions.
Intervention code [1] 299050 0
Rehabilitation
Intervention code [2] 299159 0
Treatment: Other
Comparator / control treatment
In order to control for the psychosocial contact inherent with physiotherapy treatment, the control group will receive the same number and duration of face to face treatments and gym sessions as the group receiving the intervention of interest. Treatment will be delivered in the same two consecutive 12 week phases.
In Phase I (week 0-12), the control participants' face to face treatment will also include manual therapy tailored to any assessed range of motion deficits in hip or spinal joints.
However they will receive a standardised cardiovascular training program with one progression based on achievement of training goals within parameters of perceived effort and pain.
The control participants will 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 or strengthening nor any functional proprioceptive or sports/activity specific retraining.
Control participants will instead do a standardised stretching program which may be minimally modified by exercise selected if they cause discomfort.
The 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. 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 participants will attend 3 monthly face to face sessions with the physiotherapist in Phase II (week 13-24) and attend a community gym 3 times per week to continue their cardiovascular and stretching program.
Control group
Active

Outcomes
Primary outcome [1] 303283 0
Perceived global rating of change, measured on a Likert scale.
Timepoint [1] 303283 0
Baseline, then 12 weeks and 24 weeks post intervention commencement
Primary outcome [2] 303284 0
International Hip Outcome Tool (IHOT-33) is a composite score measuring hip-related symptoms and quality of life and will be used in original published version.
Timepoint [2] 303284 0
Baseline, then 12 weeks and 24 weeks post intervention commencement
Secondary outcome [1] 338520 0
Hip flexion range of movement.
Range of movement will be measured with an inclinometer at end of active movement range.
Timepoint [1] 338520 0
Baseline, then 24 weeks post intervention commencement
Secondary outcome [2] 338521 0
Number of steps, measured by a Fitbit Flex 2 (TM).
Timepoint [2] 338521 0
Baseline, then 12 weeks and 24 weeks post intervention commencement
Secondary outcome [3] 338522 0
Single leg squat depth, measured via video. Knee adduction and pelvic obliquity will be measured using frontal plane projection, with markers placed on the anterior-superior iliac spine (ASIS), mid-patella and mid-anterior joint line, using our previously published methods (Charlton et al. Phys Med & Rehab, 2016)
Timepoint [3] 338522 0
Baseline, then 24 weeks post intervention commencement
Secondary outcome [4] 338775 0
Single leg balance (measured with the Star balance excursion test) which has been previously published and is reliable.
Timepoint [4] 338775 0
Baseline, then 24 weeks post-intervention commencement.
Secondary outcome [5] 338776 0
Trunk muscle endurance measuring time in sec to hold a side plank
Timepoint [5] 338776 0
Baseline, then 24 weeks post intervention commencement
Secondary outcome [6] 338796 0
Hip Osteoarthritis and disability Outcome Score (HOOS)
Timepoint [6] 338796 0
Baseline, then 12 weeks and 24 weeks post intervention commencement
Secondary outcome [7] 338797 0
Hip and Groin Outcome Score (HAGOS)
Timepoint [7] 338797 0
Baseline, then 12 weeks and 24 weeks post intervention commencement
Secondary outcome [8] 338798 0
Hip Sports Activity Scale (HSAS)
Timepoint [8] 338798 0
Baseline, then 12 weeks and 24 weeks post intervention commencement
Secondary outcome [9] 338799 0
Tampa Scale for Kinesiophobia
Timepoint [9] 338799 0
Baseline, then 12 weeks and 24 weeks post intervention commencement
Secondary outcome [10] 338800 0
Workplace Activity Limitations Scale (WALS)
Timepoint [10] 338800 0
Baseline, then 12 weeks and 24 weeks post intervention commencement
Secondary outcome [11] 338801 0
Expectations of outcome, measured on a Likert-type scale
Timepoint [11] 338801 0
Baseline, then 12 weeks post intervention commencement
Secondary outcome [12] 338802 0
Hunt questions relating to pre-injury physical activity
Timepoint [12] 338802 0
Baseline, then 12 weeks and 24 weeks post intervention commencement
Secondary outcome [13] 338918 0
Hunt questions investigating current activity level
Timepoint [13] 338918 0
Baseline, then 12 weeks and 24 weeks post intervention commencement
Secondary outcome [14] 338919 0
Very active minutes, measured by a Fitbit Flex 2 (TM).
Timepoint [14] 338919 0
Baseline, then 12 weeks and 24 weeks post intervention commencement
Secondary outcome [15] 338920 0
Hip internal rotation range of movement measured with an inclinometer
Timepoint [15] 338920 0
Baseline, then 24 weeks post intervention commencement.
Secondary outcome [16] 338975 0
Hip muscle flexion strength measured using methods which have been previously published and are reliable. Hip muscle strength will be measured using a hand held dynamometer.
Timepoint [16] 338975 0
Baseline and then 24 weeks post intervention commencement
Secondary outcome [17] 338976 0
Hip muscle extension strength measured using methods which have been previously published and are reliable. Hip muscle strength will be measured using a hand held dynamometer.
Timepoint [17] 338976 0
Baseline and then 24 weeks post intervention commencemnet
Secondary outcome [18] 338977 0
Hip muscle abduction strength measured using methods which have been previously published and are reliable. Hip muscle strength will be measured using a hand held dynamometer.
Timepoint [18] 338977 0
Baseline and then 24 weeks post intervention commencement
Secondary outcome [19] 338978 0
Hip muscle adduction strength measured using methods which have been previously published and are reliable. Hip muscle strength will be measured using a hand held dynamometer.
Timepoint [19] 338978 0
Baseline then 24 weeks post-intervention commencement
Secondary outcome [20] 338979 0
Hip muscle internal rotation strength measured using methods which have been previously published and are reliable. Hip muscle strength will be measured using a hand held dynamometer.
Timepoint [20] 338979 0
Baseline then 24 weeks post intervention commencement
Secondary outcome [21] 338980 0
Hip muscle external rotation strength measured using methods which have been previously published and are reliable. Hip muscle strength will be measured using a hand held dynamometer.
Timepoint [21] 338980 0
Baseline then 24 weeks post intervention commencement
Secondary outcome [22] 345647 0
EQ-5D.
Timepoint [22] 345647 0
Health-related quality of life as assessed using EQ-5D at baseline, 3, 6, 9, 12 and 18 months
Secondary outcome [23] 345648 0
Arthritis Self Efficacy Scale
Timepoint [23] 345648 0
Baseline, 3 and 6 months
Secondary outcome [24] 377444 0
Three-dimensional motion analysis and ground reaction force during walking, running, single-leg squat and Y-balance excursion task for subgroup; n=40.
Timepoint [24] 377444 0
A subgroup n=40 will be measured at baseline and 6 months.
Secondary outcome [25] 377445 0
3-T MRI images of participants' hip joint will be measured using the Scoring Hip Osteoarthritis with MRI (SHOMRI) classification that scores seven features; cartilage, bone marrow lesions, sub-chondral cysts, labral abnormalities, loose bodies, joint effusion and ligamentum teres abnormalities for subgroup; n=40
Timepoint [25] 377445 0
3-T MRI images will be obtained at baseline and 12 months

Eligibility
Key inclusion criteria
Eligible participants will be: i) aged 18-50 years; ii) have hip pain on impingement >3/10 on visual analogue scale; iii) have hip/groin pain for more than 6 weeks; iv) have radiographic FAI-alpha angle>60 degrees.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential participants will be excluded if they have: i) had physiotherapy within the three months; ii) previous hip or back surgery; iii) planned lower limb surgery in the next 24 weeks; iv) other musculoskeletal conditions, including rheumatoid arthritis; v) an inability to perform testing procedures; vi) an inability to commit to 24 week treatment program or baseline and follow-up assessments; vii) contra-indications to x-ray or MRI (including 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)
Randomisation schedule will be generated by NHMRC Clinical Trials Centre and recorded by unblinded chief investigator. Group allocation will be revealed via email to the treating physiotherapist following baseline assessment. Participants will be unaware of which intervention they receive.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation in a 1:1 ratio.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
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 determine their eligibility to participate using inclusion/exclusion criteria listed above. 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 24 weeks will include Perceived global rating of change score, plus change in IHot33 outcomes for quality of life and symptoms sub-scales.
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
Recruiting
Date of first participant enrolment
Anticipated
16/10/2017
Actual
1/03/2018
Date of last participant enrolment
Anticipated
30/04/2020
Actual
Date of last data collection
Anticipated
15/03/2021
Actual
Sample size
Target
164
Accrual to date
117
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 17504 0
3086 - La Trobe University
Recruitment postcode(s) [2] 17505 0
3068 - Clifton Hill
Recruitment postcode(s) [3] 17506 0
3122 - Hawthorn
Recruitment postcode(s) [4] 17507 0
3752 - South Morang
Recruitment postcode(s) [5] 17508 0
3350 - Ballarat

Funding & Sponsors
Funding source category [1] 297361 0
Government body
Name [1] 297361 0
National Health and Medical Research Council
Country [1] 297361 0
Australia
Funding source category [2] 297518 0
University
Name [2] 297518 0
La Trobe Sports and Exercise Medicine Research Centre
Country [2] 297518 0
Australia
Primary sponsor type
University
Name
La Trobe Sports and Exercise Medicine Research Centre
Address
La Trobe University
Cnr Kingsbury Dve and Plenty Rd
Bundoora
Vic
3086
Country
Australia
Secondary sponsor category [1] 296531 0
None
Name [1] 296531 0
Address [1] 296531 0
Country [1] 296531 0
Other collaborator category [1] 281078 0
Individual
Name [1] 281078 0
Dr Ben Mentiplay
Address [1] 281078 0
La Trobe Sport & Exercise Medicine research centre
Bldg HS3, Level 2
La Trobe University,
Kingsbury Drive,
Bundoora,
Vic. 3104
Country [1] 281078 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298461 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 298461 0
Ethics committee country [1] 298461 0
Australia
Date submitted for ethics approval [1] 298461 0
21/08/2017
Approval date [1] 298461 0
21/09/2017
Ethics approval number [1] 298461 0
HEC17-080

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

Contacts
Principal investigator
Name 77158 0
Dr Joanne Kemp
Address 77158 0
La Trobe Sport and Exercise Research Centre,
Level 5, HS3,
La Trobe University
Bundoora
Vic, 3086
Country 77158 0
Australia
Phone 77158 0
+61 484 776 536
Fax 77158 0
Email 77158 0
[email protected]
Contact person for public queries
Name 77159 0
Sally Coburn
Address 77159 0
La Trobe Sport and Exercise Research Centre,
Level 5, HS3,
La Trobe University
Bundoora
Vic, 3086
Country 77159 0
Australia
Phone 77159 0
+61 484 761 237
Fax 77159 0
Email 77159 0
[email protected]
Contact person for scientific queries
Name 77160 0
Joanne Kemp
Address 77160 0
La Trobe Sport and Exercise Research Centre,
Level 5, HS3,
La Trobe University
Bundoora
Vic, 3086
Country 77160 0
Australia
Phone 77160 0
+61 484 776 536
Fax 77160 0
Email 77160 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results only
When will data be available (start and end dates)?
data will be available once study results have been published approximately January 2021 but no end date is determined
Available to whom?
interested parties
Available for what types of analyses?
data will be available for IPD meta-analyses
How or where can data be obtained?
on data sharing registry


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePhysiotherapist-led treatment for femoroacetabular impingement syndrome (the PhysioFIRST study): A protocol for a participant and assessor-blinded randomised controlled trial.2021https://dx.doi.org/10.1136/bmjopen-2020-041742
EmbaseRelationship between hip muscle strength and hip biomechanics during running in people with femoroacetabular impingement syndrome.2022https://dx.doi.org/10.1016/j.clinbiomech.2022.105587
N.B. These documents automatically identified may not have been verified by the study sponsor.