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Trial registered on ANZCTR


Registration number
ACTRN12614000260628
Ethics application status
Approved
Date submitted
2/03/2014
Date registered
11/03/2014
Date last updated
29/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The Foot Orthosis versus Hip eXercises (FOHX) trial: Predicting success in patellofemoral pain patients.
Scientific title
A prospective randomised single-blinded clinical trial in a community setting will evaluate the outcome of foot orthoses compared to hip strengthening exercises in people with patellofemoral pain. The FOHX trial.
Secondary ID [1] 282699 0
nil
Universal Trial Number (UTN)
U1111-1162-3936
Trial acronym
The FOHX trial: The Foot Orthosis versus Hip eXercises trial.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patellofemoral Pain 289576 0
Condition category
Condition code
Musculoskeletal 289908 289908 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 291670 291670 0 0
Physiotherapy
Physical Medicine / Rehabilitation 291671 291671 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prefabricated foot orthoses. Orthoses will be adjusted to optimise participant comfort at the orthosis-foot interface, as well as to improve knee pain during physical tasks. Participants will use the orthoses during waking hours for 12 weeks. The orthoses will be fitted, reviewed and if required revised by a physiotherapist. In the first 6 weeks the participant will attend a physiotherapist clinic, 2 times a week for the first week and once a week for the remaining weeks with no sessions in the 5th week. These sessions will usually last approximately 30 minutes and no more than 45 minutes.

We aim to improve adherence to wearing these devices by (a) having the patient attend regular sessions with a physiotherapist over the first 6 weeks of the trial, (b) have the physiotherapist record in case file the level of adherence and any issues in this regard and strategies used in addressing these, and (c) patient recording in a diary over the last 6 weeks their level of wear of the devices as well as at exit by means of a questionnaire.
Intervention code [1] 287488 0
Treatment: Devices
Intervention code [2] 288908 0
Rehabilitation
Intervention code [3] 288909 0
Treatment: Other
Comparator / control treatment
Hip muscle strengthening exercises. The hip exercises will strengthen hip muscles that are reported weaker in people with patellofemoral pain than the pain free population. The hip exercises will be supervised by a physiotherapist in the clinic and done 3 times a week over a 4 week period. Each session will last approximately 45 minutes. There will be no home or self exercises done outside of the clinic. This will ensure adherence, but most importantly it will ensure optimal dosing (loading) of the muscles exercised. That is, the participants in the control group will not be required to continue doing the exercises outside of the 12 sessions in the clinic.
Control group
Active

Outcomes
Primary outcome [1] 289966 0
Global Rating of Change (GROC): Participants will be asked to rate their overall change on a 7-point scale to indicate if they are better, same or worse (-3: Much worse, -2: Worse, -1: A little worse, 0: same, +1: A little better, +2: Better, +3: Much better).
Timepoint [1] 289966 0
6 & 12 weeks
Secondary outcome [1] 303681 0
Kujala Patellofemoral Scale (KPS): This questionnaire is made up of 13 specific questions related to patellofemoral pain that cover a range of knee function under varying loads. Participants answer by selecting the best response to each question. Each question is scored and collectively added together to give a maximum of 100 points. A change of 10 or more points indicates a clinically meaningful change in function.
Timepoint [1] 303681 0
0, 6 & 12 weeks
Secondary outcome [2] 303682 0
Patient Specific Functional Scale (PSFS):Participants choose up to five tasks that are affected by their knee pain. Each task is scored on an 11 point numerical rating scale to indicate the impact of their symptoms (0: unable to do the task at all, 10: capacity to do the task is unaffected)
Timepoint [2] 303682 0
0, 6 & 12 weeks.
Secondary outcome [3] 303683 0
Pain Numerical Rating Scale (NRS): Participants will rate their average pain over the past 24hours, and worst pain over the past 7 days on an 11 point scale (0: no pain at all, 10: worst pain imaginable).
Timepoint [3] 303683 0
0, 6 & 12 weeks
Secondary outcome [4] 303684 0
International Physical Activity Questionnaire (IPAQ): Participants will be required to document the amount of time (minutes or hours per day or alternatively days per week) they spend sitting, walking, moderate or vigorous exercise.
Timepoint [4] 303684 0
0, 6 & 12 weeks
Secondary outcome [5] 303685 0
Tampa Scale of Kinesphobia (TSK): The questionnaire comprises of 17 statements about perception of movement, and the participant selects the most appropriate response to each statement ("Strongly Disagree", "Disagree,", "Agree", "Strongly Agree")
Timepoint [5] 303685 0
0, 6 & 12 weeks.
Secondary outcome [6] 303754 0
Hospital Anxiety and Depression Scale (HADS): Participants are required to select the most response to 14 statements about how they have felt over the past 7 days. Two subscales are intermingled within the 14 questions.
Timepoint [6] 303754 0
0, 6 & 12 weeks.
Secondary outcome [7] 303755 0
Patellofemoral Osteoarthritis and Outcome Scale (PFOOS): The questionnaire is made up of 5 separate subscales that cover pain, symptoms, sports and recreational activities, activities of daily living and quality of life. Participants select the most appropriate response to each question within the subscales.
Timepoint [7] 303755 0
0, 6 & 12 weeks.
Secondary outcome [8] 303756 0
Functional movements: Participants will be required to step up a 25cm step repetitively at a pace of a metronome set to 96 beats per minute. Following this, participants will do repetitive step downs from a 25cm step. A repetitive squatting task will require participants, in standing, to squat down to touch ipsilateral malleoli and return to upright standing. Each functional movements will be stopped if there is: (a) onset of knee pain, or (b) an increase in knee pain, or (c) no pain after 25 repetitions.
Timepoint [8] 303756 0
0, 6 & 12 weeks.
Secondary outcome [9] 303955 0
Foot Posture Index (FPI):This index assesses 6 components of foot posture in relaxed standing. Each component is scored on a 5 point scale (-2 to +2) and then collectively summed to give an overall figure that denotes if the participants foot is classified as "Supinated", "Neutral" or "Pronated".
Timepoint [9] 303955 0
0 & 12 weeks.
Secondary outcome [10] 303956 0
Foot mobility assessment: Participants will have static measures of foot width and dorsal arch height taken at 50% of foot length in a weight bearing and non-weight bearing posture. Navicular height will be measured with the subtalar joint in both a neutral and a relaxed posture.
Timepoint [10] 303956 0
0 & 12 weeks.
Secondary outcome [11] 303957 0
Hip Strength: Hip abduction, adduction and external rotation isometric muscle strength will be measured using a fixated hand held dynamometer.
Timepoint [11] 303957 0
0, 6 & 12 weeks.
Secondary outcome [12] 306292 0
EQ-5D: The EuroQoL (EQ-5D) is a generalised health-related quality of life measure. The questionnaire comprises of a visual scale participant mark to indicate their own health as well as 5 written sections that cover mobility, personal care, usual activity, pain/discomfort and anxiety/ depression. Participants select the statement that best describes their own health state.
Timepoint [12] 306292 0
0, 6 & 12 weeks.
Secondary outcome [13] 306293 0
Pain Catastrophizing Scale: This scale is a 13-item self-report scale to measure pain catastrophizing. The items are rated on a scale from 0-4 and has three different categories: Rumination, Magnification and Helplessness.
Timepoint [13] 306293 0
0, 6 & 12 weeks.
Secondary outcome [14] 306294 0
Satisfaction of treatment: This comprises of two questions
1. Overall satisfaction of treatment
2. Satisfaction to live with current symptoms.

Participants will be require to answer from 5 point scale (Very Satisfied to Very Dissatisfied).
Timepoint [14] 306294 0
6 & 12 weeks.
Secondary outcome [15] 306295 0
Success of Treatment: Participants will be ask two questions related to their perception of the success of the treatment
1. Participant's agreement that the treatment has been successful (Yes/ No)
2. Would the participant recommend the same treatment to a freind (Yes/ No)
Timepoint [15] 306295 0
6 & 12 weeks.
Secondary outcome [16] 306296 0
Self-reported Rate of Recovery: Participants will score how well they felt they have recovered from their knee pain on a scale ranging from 0% (meaning not at all) to 100% (meaning totally recovered).
Timepoint [16] 306296 0
6 & 12 weeks
Secondary outcome [17] 306299 0
Patient Acceptable Symptom State (PASS): Participants are asked in a statement if their current condition is satisfactory based on their general function and current pain. The answer will be yes or no.
Timepoint [17] 306299 0
6 & 12 weeks
Secondary outcome [18] 318720 0
Single Assessment Numerical Evaluation (SANE): Participants will be asked to rate how normal they would rate their knee today on a scale of 0 to 100%. 100% normal is defined as having no problems at all with the knee.
Timepoint [18] 318720 0
0, 6 & 12 weeks.

Eligibility
Key inclusion criteria
1. Patellofemoral pain of non-traumatic origin and greater than six weeks duration

2. Patellofemoral pain that is provoked by at least two of the following activities: squatting, jogging or running, hopping, jumping, stair ascending or descending.

3. Patellofemoral pain over the previous week equal to or greater than 3 out of 10 on a numerical pain rating scale.

4. Pain on palpation about the patella.
Minimum age
18 Years
Maximum age
40 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Concomitant injury or pathology of other knee structures (e.g. ligament, tendon or cartilage)

2. A history of knee surgery, patellofemoral dislocation or subluxation, Osgood-Schlatter’s disease, Sinding-Larsen-Johanssen Syndrome

3. A positive patella apprehension test or evidence of swelling at the knee

4. A foot condition that may preclude the use of foot orthoses

5. Pain at the hip, pelvis or low back

6. Physiotherapy treatment of patellofemoral pain that included foot orthoses or hip exercises in the last 12 months

6. Current use of anti-inflammatory or corticosteroid medication.

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)
Volunteers will respond to advertisements calling for subjects to participate in the trial.

Volunteers will pass through an interview and a physical examination/screen to assess eligibility for inclusion into the trial.

Those participants who are eligible will undertake baseline outcome measurements and then be randomly allocated to one of two interventions groups. Allocation will be concealed and generated by a computerised randomisation schedule developed by an off-site independent clinical trial unit (Clinical Trials & Biostatistics Unit, QIMR Berghofer Medical Research Institute, Brisbane Australia).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated radomisation schedule
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Single-blinded randomised controlled trial
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis
At an alpha or 0.05 and 80% power with an allowance of 10% loss to follow up, a sample size of 220 will be required to detect a difference in proportion of success of 25% in the orthoses group with mobile feet from the hip exercise group assuming the latter have a success rate ranging from 30 to 50%.

Analysis will be conducted blind to allocation by an independent clinical trial centre using appropriate regression and analytical procedures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment outside Australia
Country [1] 5750 0
Denmark
State/province [1] 5750 0
North Denmark: Aalborg

Funding & Sponsors
Funding source category [1] 287584 0
Government body
Name [1] 287584 0
National Health and Medical Research Council: Program grant Ref number 631717
Address [1] 287584 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 287584 0
Australia
Funding source category [2] 287608 0
Commercial sector/Industry
Name [2] 287608 0
Vionic Group LLC
Address [2] 287608 0
4040 Civic Center Drive ­ Suite 430
San Rafael CA 94903
Country [2] 287608 0
United States of America
Primary sponsor type
Individual
Name
Professor Bill Vicenzino
Address
School of Health and Rehabilitation Sciences
Therapies Building 84A
Therapies Road
University of Queensland
St Lucia 4072
Queensland
Country
Australia
Secondary sponsor category [1] 286332 0
None
Name [1] 286332 0
Address [1] 286332 0
Country [1] 286332 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289556 0
Medical Research Ethics Committee
Ethics committee address [1] 289556 0
The University of Queensland
Cumbrae-Stewart Building
Research Road
Brisbane Qld 4072 Australia
Ethics committee country [1] 289556 0
Australia
Date submitted for ethics approval [1] 289556 0
19/07/2013
Approval date [1] 289556 0
31/08/2013
Ethics approval number [1] 289556 0
2013000981

Summary
Brief summary
This trial will compare two commonly used treatments for patellofemoral pain, foot orthoses and hip strengthening exercises. There is evidence to support both approaches, and often debate revolves around counter-posing perspectives as to which may be more effective to use, yet the two treatment approaches have not directly compared before.

Previous foot orthoses trials have reported benefits on patient rated outcomes from use of foot orthoses over a flat shoe insert or adopting a wait-and-see approach in the treatment of patellofemoral pain.

Recent trials implementing hip strengthening exercises have demonstrated reduced pain and improved ability to climb stairs after strength exercises for the hip, in people with patellofemoral pain.

In the FOHX trial, participants will be randomly allocated into either wearing foot orthoses or performing hip muscle strengthening exercises.

The clinical trial will compare the outcome of the two treatments, and also identify the baseline profile (physical measures and patient perceptions) that are associated with the greatest response to foot orthoses or hip strengthening exercises.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40874 0
Prof Bill Vicenzino
Address 40874 0
School of Health and Rehabilitation Sciences,
Therapies Building 84A,
Therapies Road,
The University of Queensland,
St Lucia 4072
Brisbane QLD
Country 40874 0
Australia
Phone 40874 0
+617 3365 2781
Fax 40874 0
Email 40874 0
b.vicenzino@uq.edu.au
Contact person for public queries
Name 40875 0
Prof Bill Vicenzino
Address 40875 0
School of Health and Rehabilitation Sciences,
Therapies Building 84A,
Therapies Road,
The University of Queensland,
St Lucia 4072
Brisbane QLD
Country 40875 0
Australia
Phone 40875 0
+617 3365 2781
Fax 40875 0
Email 40875 0
b.vicenzino@uq.edu.au
Contact person for scientific queries
Name 40876 0
Prof Bill Vicenzino
Address 40876 0
School of Health and Rehabilitation Sciences,
Therapies Building 84A,
Therapies Road,
The University of Queensland,
St Lucia 4072
Brisbane QLD
Country 40876 0
Australia
Phone 40876 0
+617 3365 2781
Fax 40876 0
Email 40876 0
b.vicenzino@uq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary