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Trial registered on ANZCTR


Registration number
ACTRN12615000002583
Ethics application status
Approved
Date submitted
11/12/2014
Date registered
7/01/2015
Date last updated
1/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Patellofemoral joint osteoarthritis: the effect of foot orthoses on pain, function and bone marrow lesions. A pilot study
Scientific title
Patellofemoral joint osteoarthritis: the effect of custom foot orthoses compared to specialised footwear on pain, function and bone marrow lesions. A pilot study.
Secondary ID [1] 285745 0
Nil
Universal Trial Number (UTN)
U1111-1151-0192
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patellofemoral Joint Osteoarthritis 290659 0
Condition category
Condition code
Musculoskeletal 291038 291038 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 291039 291039 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: customised EVA (Shore 50) foot orthoses (Orthema Australasia) prescribed according to a predefined protocol, and/or motion control footwear (New Balance 857, Boston, Massachusetts).

Group 1 participants will be asked to wear the custom foot orthoses and prescribed footwear for a period of 4 months.

Group 2 participants will be asked to wear the prescribed footwear only, for a 4 month period.

The interventions are to be worn as often as is practical/possible during the 4 month period of the trial, aiming for at least 8 hours per day.

Adherence will be documented and encouraged by regular SMS reminders and emails to participants. Participants will be asked to keep a diary of the hours of use of foot orthoses and/or footwear per day, activity levels, and type of footwear worn when not wearing the prescribed footwear. Participants will have review appointments at 1, 2 and 4 months where diary completion will be reviewed, and any issues pertaining to the interventions can be discussed, and if necessary, rectified.
Intervention code [1] 288394 0
Treatment: Devices
Comparator / control treatment
Comparator treatment: prescribed motion control footwear.
Group 2 will wear the prescribed footwear for a 4-month period to determine the effects of footwear alone.

Adherence to the footwear condition will be documented at 2 and 4 months, and encouraged by regular SMS reminders to participants. Participants will be asked to keep a diary of the hours of use of the footwear use per day, activity levels, and type of footwear worn when not wearing the prescribed footwear.
Control group
Active

Outcomes
Primary outcome [1] 300921 0
The primary outcome for this study will be the feasibility of a Phase 3 trial. Feasibility will be assessed by evaluating recruitment rate, the number of eligible participants, the willingness of participants to commit to the study protocol, optimal time frames for manufacture and provision of the interventions, adherence to the interventions over the 4 months of the study, the number of adverse events, diary completion, and drop-out rate.
Timepoint [1] 300921 0
4 months
Secondary outcome [1] 305858 0
Anterior Knee Pain Scale: This questionnaire consists of 13 specific questions related to patellofemoral pain, symptoms and functional difficulties. Participants select the best response to each question. Each question is scored and collectively added together to give a score from 0 (maximal disability) to 100 (no disability). A change of 10 or more points indicates a clinically meaningful change in symptoms and function.
Timepoint [1] 305858 0
Baseline, 2 and 4 months
Secondary outcome [2] 305859 0
International Physical Activity Questionnaire (IPAQ): Participants will be required to document the amount of time (minutes to hours per day, or alternatively days per week) they spend sitting, walking, and doing moderate or vigorous exercise.
Timepoint [2] 305859 0
Baseline, 2 and 4 months
Secondary outcome [3] 305866 0
Patellofemoral Osteoarthritis Outcome Score (PFOOS): This questionnaire consists of 5 separate subscales that cover pain, symptoms, function in activities of daily living, function in sports and recreational activities, and knee-related quality of life. Participants select the most appropriate response to each question, and a normalised score for each subscale is calculated (0 = extreme knee problems, 100 = no knee problems).
Timepoint [3] 305866 0
Baseline, 2 and 4 months
Secondary outcome [4] 311627 0
Satisfaction of treatment will comprise 2 questions:
1. Overall satisfaction of treatment
2. Satisfaction to live with current symptoms

Participants will be asked to respond to each question using a 5-point scale (very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied).
Timepoint [4] 311627 0
2 and 4 months
Secondary outcome [5] 311628 0
Success of Treatment: Participants will be asked 2 questions related to their perception of treatment success.
1. Participant's agreement that the treatment has been successful (Yes/No)
2. Would the participant recommend the same treatment to a friend (Yes/No)
Timepoint [5] 311628 0
2 and 4 months
Secondary outcome [6] 311629 0
Self Reported Rate of Recovery: Participants will score how well they feel they have recovered from their knee pain, ranging from 0 (not at all) to 100 (totally recovered).
Timepoint [6] 311629 0
2 and 4 months
Secondary outcome [7] 311630 0
Patient Acceptable Symptoms State (PASS): Participants are asked in a statement if their current condition is satisfactory based on their general function and current pain (Yes/No).
Timepoint [7] 311630 0
2 and 4 months
Secondary outcome [8] 311956 0
Change in bone marrow lesion volume on magnetic resonance imaging (MRI) of the study knee. Bone marrow lesion volume will be measured according to an established protocol prior to the prescribed intervention, and at the end of the 4-month intervention period. Differences in bone marrow lesion volume pre- and post-intervention, within and between groups, will be evaluated.
Timepoint [8] 311956 0
Baseline and at 4 months
Secondary outcome [9] 331196 0
Participants will be asked to rate their average knee pain on a scale from 0 (no pain) to 10 (worst pain possible) over the past week.
Timepoint [9] 331196 0
Baseline, 2 and 4 months
Secondary outcome [10] 331197 0
PainDETECT: The painDETECT questionnaire will be used to identify the presence of neuropathic pain. This questionnaire consists of nine items; seven evaluating pain quality, one evaluating pain pattern, and one evaluating pain radiation; which contribute to an aggregate score ranging from 1 to 38. A higher score indicates more neuropathic–like symptoms.
Timepoint [10] 331197 0
Baseline, 2 and 4 months
Secondary outcome [11] 331198 0
Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36): This questionnaire is a generic measure of health-related quality of life. Thirty-six items are used to calculate eight scores across the following domains: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality (energy/fatigue), social functioning, role limitations due to emotional problems, and mental health. Transformed scores range from 0 (worst health state) to 100 (best health state).
Timepoint [11] 331198 0
Baseline, 2 and 4 months
Secondary outcome [12] 331199 0
EQ-5D: Quality of life will be measured using the EQ-5D (EuroQoL) questionnaire. The EQ-5D is a generic measure of health-related quality of life and has 5 dimensions: (i) mobility; (ii) self-care; (iii) usual activities; (iv) pain/discomfort; and (v) anxiety/depression. Each question has three possible responses: no problems, some problems, or extreme problems. The EQ-5D also has a health state scale which asks participants to rate their state of health on a 100-point scale, with 0 indicating worst imaginable health state and 100 indicating best imaginable health state.
Timepoint [12] 331199 0
Baseline, 2 and 4 months
Secondary outcome [13] 331200 0
Tampa Scale for Kinesiophobia: Kinesiophobia will be assessed with the Tampa Scale for Kinesiophobia. It consists of 17 statements on subjective experience of injury and physical activity, which are each scored on a 4-point Likert scale ranging from “strongly disagree” to “strongly agree”. A total score from 17 to 68 is then calculated by summing the individual item scores, where 17 represents no fear of movement or re-injury, and 68 indicates a greater fear.
Timepoint [13] 331200 0
Baseline, 2 and 4 months
Secondary outcome [14] 331201 0
Arthritis Self-Efficacy Scale : The Arthritis Self Efficacy scale is a 20-item scale with 3 subscales: self-efficacy for managing pain (5 items); self-efficacy for physical function (9 items); and self-efficacy for controlling other symptoms (6 items). Items are rated on a 10-point scale regarding their certainty of their ability to perform a task, manage their pain or control their symptoms, with 0 being very uncertain and 10 being very certain. Each subscale is scored individually as the mean of all items, with higher scores indicating higher self-efficacy.
Timepoint [14] 331201 0
Baseline, 2 and 4 months
Secondary outcome [15] 331202 0
Hospital Anxiety and Depression (HAD) Scale: The HAD scale is a 14-item scale that will be used to investigate whether there is an association between PFJ OA and emotional state. Seven questions relate to anxiety and seven to depression. Participants select the best of 4 responses to each item. Items are scored from 0 to 3 with scores for anxiety and depression summed separately to give total scores for each component. Scores of 0–7 represent no anxiety or depression, 8–10 is borderline, and 11–21 indicates the presence of an anxious or depressive state.
Timepoint [15] 331202 0
Baseline, 2 and 4 months
Secondary outcome [16] 331203 0
Rating on a 10cm visual analogue scale (VAS) the following: 1. Usual pain on movement in the previous week. Scale ranges from 0 (no pain) to 10 (worst pain imaginable).
Timepoint [16] 331203 0
Baseline, 2 and 4 months
Secondary outcome [17] 331204 0
Rating on a 10cm visual analogue scale (VAS), the following: 1. Usual pain during nominated aggravating activity in the previous week. Scale ranges from 0 (no pain) to 10 (worse pain imaginable).
Timepoint [17] 331204 0
Baseline, 2 and 4 months
Secondary outcome [18] 331205 0
Global rating of change (GROC): participants will be asked to rate their overall change on a 6-point Likert scale (completely recovered, much improved, improved, no change, worse, much worse)
Timepoint [18] 331205 0
2 and 4 months
Secondary outcome [19] 331206 0
Participants will be asked to rate their worst knee pain on a scale from 0 (no pain) to 10 (worst pain possible) over the past week.
Timepoint [19] 331206 0
Baseline, 2 and 4 months
Secondary outcome [20] 331207 0
Participants will be asked to rate their average amount of knee pain felt at rest over the past week on a scale from 0 (no pain) to 10 (worst pain possible).
Timepoint [20] 331207 0
Baseline, 2 and 4 months
Secondary outcome [21] 331208 0
Participants will be asked to rate their average amount of knee pain on movement over the last week on a scale from 0 (no pain) to 10 (worst pain possible).
Timepoint [21] 331208 0
Baseline, 2 and 4 months
Secondary outcome [22] 331209 0
Participants will be asked to rate the average amount of restriction caused by their knee to daily activities on a scale from 0 (no restriction) to 10 (maximum restriction possible) over the past week .
Timepoint [22] 331209 0
Baseline, 2 and 4 months
Secondary outcome [23] 331210 0
Participants will be asked to name the activity that caused the most knee pain in the last week and to rate the average amount of pain caused by this activity on a scale from 0 (no pain) to 10 (worst pain possible).
Timepoint [23] 331210 0
Baseline, 2 and 4 months
Secondary outcome [24] 331211 0
Participants will be asked to rate their maximum knee pain over the past week when walking on a scale from 0 (no pain) to 10 (worst pain possible) .
Timepoint [24] 331211 0
Baseline, 2 and 4 months
Secondary outcome [25] 331212 0
Participants will be asked to rate their maximum knee pain in the past week when sitting for one hour on a scale from 0 (no pain) to 10 (worst pain possible).
Timepoint [25] 331212 0
Baseline, 2 and 4 months
Secondary outcome [26] 331213 0
Participants will be asked to rate their maximum knee pain in the past week when rising from sitting on a scale from 0 (no pain) to 10 (worst pain possible).
Timepoint [26] 331213 0
Baseline, 2 and 4 months
Secondary outcome [27] 331214 0
Participants will be ask to rate their maximum pain in the past week when going up and down stairs on a scale from 0 (no pain) to 10 (worst pain possible).
Timepoint [27] 331214 0
Baseline, 2 and 4 months
Secondary outcome [28] 331215 0
Participants will be ask to rate their maximum pain in the past week when squatting on a scale from 0 (no pain) to 10 (worst pain possible).
Timepoint [28] 331215 0
Baseline, 2 and 4 months
Secondary outcome [29] 331216 0
Participants will be ask to rate their maximum pain in the past week when running on a scale from 0 (no pain) to 10 (worst pain possible).
Timepoint [29] 331216 0
Baseline, 2 and 4 months
Secondary outcome [30] 331217 0
Participants will be asked:
"Overall, how would you rate your knee pain now?"

Participants will be asked to circle the most appropriate response from the following:
no problem, mild, moderate, somewhat severe, severe
Timepoint [30] 331217 0
Baseline, 2 and 4 months

Eligibility
Key inclusion criteria
i) aged >= 40 years;
ii) anterior knee pain aggravated by at least two activities that load the patellofemoral joint (e.g. squatting, stair ambulation);
iii) pain during these activities present on most days in the past month;
iv) pain severity >30mm on a 100mm visual analogue scale during aggravating activities;
v) radiographic evidence of patellofemoral joint osteoarthritis (>= OARSI atlas grade 1), or MRI evidence (a definite osteophyte & partial or full thickness cartilage loss. Hunter et al, 2011).
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) concomitant pain from other knee structures (including TFJ), hip or lumbar spine;
(ii) recent treatment for patellofemoral pain (knee injections within the previous 3 months; foot orthoses or physiotherapy within the previous 12 months);
(iii) any foot condition precluding the use of foot orthoses;
(iv) knee or hip arthroplasty or osteotomy;
(v) planned lower limb surgery in the following 2 months;
(vi) moderate to severe concomitant tibiofemoral osteoarthritis (Kellgren and Lawrence grade >= 3 on radiograph);
(vii) neurological or systemic arthritis conditions;
(viii) physical inability to undertake testing procedures;
(ix) contraindications to x-ray (e.g. pregnant, breastfeeding);
(x) inability to understand written and spoken English.

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.
Telephone screenings will then be conducted to determine if a volunteer meets the inclusion criteria. All potentially eligible volunteers will then be required to undergo an x-ray to ensure radiographic evidence of patellofemoral osteoarthritis, and exclude moderate tibiofemoral joint osteoarthritis. Eligible and consenting participants will then be randomly allocated via concealed allocation to either the custom orthoses + footwear group, or the footwear only group after baseline testing. Allocation will be determined by a central administration site where the allocation schedule will be held.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation 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
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this is an exploratory pilot study, sample size has been chosen based on feasibility with respect to time and funding. As such, 22 participants per group (allowing for a drop out rate of 10%) will be selected, giving an overall total of 44 participants.

Analysis will be conducted blinded to group allocation.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
16/12/2014
Date of last participant enrolment
Anticipated
Actual
14/11/2016
Date of last data collection
Anticipated
20/03/2017
Actual
Sample size
Target
44
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
QLD,TAS
Recruitment postcode(s) [1] 7615 0
4072 - University Of Queensland
Recruitment postcode(s) [2] 15219 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 290327 0
Charities/Societies/Foundations
Name [1] 290327 0
The Australian Podiatry Education and Research Foundation
Country [1] 290327 0
Australia
Funding source category [2] 290328 0
Charities/Societies/Foundations
Name [2] 290328 0
The Australian Academy of Podiatric Sports Medicine
Country [2] 290328 0
Australia
Primary sponsor type
Individual
Name
Professor Kay Crossley
Address
School of Allied Health,
College of Science,
Health and Engineering ,
La Trobe University,
Bundoora ,
Victoria 3086
Country
Australia
Secondary sponsor category [1] 289047 0
Individual
Name [1] 289047 0
Professor Bill Vicenzino
Address [1] 289047 0
School of Health and Rehabilitation Sciences
Therapies Building 84A
Therapies Road,
University of Queensland
St Lucia 4072
Queensland
Country [1] 289047 0
Australia
Secondary sponsor category [2] 289067 0
Individual
Name [2] 289067 0
Dr Natalie Collins
Address [2] 289067 0
School of Health and Rehabilitation Sciences
Therapies Building 84A
Therapies Road,
University of Queensland
St Lucia 4072
Queensland
Country [2] 289067 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290274 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 290274 0
The University of Queensland
St Lucia, Queensland 4072
Ethics committee country [1] 290274 0
Australia
Date submitted for ethics approval [1] 290274 0
Approval date [1] 290274 0
10/03/2014
Ethics approval number [1] 290274 0
2014000068

Summary
Brief summary
Patellofemoral osteoarthritis is a common condition that results in pain and functional limitations. Custom foot orthoses are effective at improving pain and function in younger people with patellofemoral pain, and thus may also be of benefit in older people with patellofemoral osteoarthritis. This Phase 2 study aims to investigate the feasibility of a Phase 3 randomised controlled trial evaluating the effect of custom foot orthoses and footwear on pain, lower limb function and bone marrow lesions in patellofemoral osteoarthritis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44742 0
Prof Kay Crossley
Address 44742 0
School of Allied Health,
College of Science,
Health and Engineering ,
La Trobe University,
Bundoora ,
Victoria 3086
Country 44742 0
Australia
Phone 44742 0
+61 3 9479 3902
Fax 44742 0
Email 44742 0
[email protected]
Contact person for public queries
Name 44743 0
Kay Crossley
Address 44743 0
School of Allied Health,
College of Science,
Health and Engineering ,
La Trobe University,
Bundoora ,
Victoria 3086
Country 44743 0
Australia
Phone 44743 0
+61 3 9479 3902
Fax 44743 0
Email 44743 0
[email protected]
Contact person for scientific queries
Name 44744 0
Kay Crossley
Address 44744 0
School of Allied Health,
College of Science,
Health and Engineering ,
La Trobe University,
Bundoora ,
Victoria 3086
Country 44744 0
Australia
Phone 44744 0
+61 3 9479 3902
Fax 44744 0
Email 44744 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23304Study protocolWyndow et al. Journal of Foot and Ankle Research (2017) 10:19 DOI 10.1186/s13047-017-0200-yhttps://jfootankleres.biomedcentral.com/track/pdf/10.1186/s13047-017-0200-y?site=jfootankleres.biomedcentral.com 

Results publications and other study-related documents

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

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4447Study results articleYes 25 October 2019 Foot orthoses and footwear for th... [More Details]

Documents added automatically
No additional documents have been identified.