Hip Osteoarthritis and Foot Orthoses Trial (HOOT)

Study Overview
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Brief Summary
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This trial is a randomized feasibility trial to determine the feasibility of comparing two different shoe inserts and on pain, quality of life and physical activity associated with hip osteoarthritis.

Detailed Description
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Participants will be randomized to one of two groups - contoured prefabricated foot orthoses or flat shoe inserts (the comparator). Participants will be asked to use the inserts daily for a six week period. Adherence to the intervention will be monitored using a daily diary, as well as adverse events and co-interventions. The primary outcome is feasibility domains (Demand, Implementation, Acceptability, Practicality) with secondary outcomes of change in hip-related pain and quality of life and physical activity levels. The primary time-point will be 6-weeks.

Official Title
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Hip Osteoarthritis and Foot Orthoses Trial (HOOT): A Randomized Feasibility Trial

Conditions
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Hip Osteoarthritis

Intervention / Treatment
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* Device: Foot orthoses
* Device: Flat shoe insert


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary symptomatic and radiographic hip OA, in accordance with the American College of Rheumatology (i) aged > 45 years; (ii) pain in the hip or groin for more than 3 months; (iii) average pain intensity over the past week of > 3 out of 10 (Numerical Rating Scale) during functional tasks like walking, climbing stairs or climbing in/out of a car; (iv) radiographic confirmation of hip osteoarthritis with a Kellgren-Lawrence score ≥ 2 within the last 12 months; (v) mild to moderate disability indicated by; able to reciprocally ascend and descend 10 stairs unaided, able to safely walk one city block, and able to jog five meters if required Exclusion Criteria: (i) other musculoskeletal lower limb or back conditions requiring assessment or treatment by a health professional (Doctor, Physiotherapist, Podiatrist etc) in the last 6 months; (ii) have received active treatment for their hip pain by a health professional (eg physiotherapist) in the last 3 months; (iii) history of hip trauma or surgery on the affected side; (iv) corticosteroid use (oral or intra-articular injection) in the past 3 months (v) neurological impairment or condition affecting lower limb function (vi) conditions or factors affecting ability to take part in the intervention, e.g., unavailable for a 6 week intervention period, routine use of gait aids, uncontrolled hypertension, or morbid obesity (body mass index > 40); (vii) Use of foot orthoses in the previous 12 months (viii) systemic inflammatory disease (e.g. rheumatoid arthritis); (ix) unable to write, read or comprehend English.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two-arm, participant blinded, parallel group feasibility RCT
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Foot orthoses<br> | Device: Foot orthoses<br>* Manufacturer: Foot Science International. Material: High grade thermoformable closed-cell polyolefin foam (medium density) Arch support: inbuilt. Covering: fabric Provided by: Study Practitioner: Registered physiotherapist > 2 years musculoskeletal experience will be trained to prescribe the insert according to the prescription algorithm. Where: Administered via telehealth When and how much: Week 0 to 1: one telehealth session with study practitioner to fit one pair of pre-fabricated orthoses Week 1 to 2: Follow-up session for questions if required Tailoring: Orthoses are fit to comfort. Lengths (S, S, M, L, XL, XXL) (dependent on participant's shoe size). Hardness = Medium density. Modifications: can be cut to size to assist in fit using the shoes original sock liner as a guide, by participants using standard scissors. Heat molding: optional. Adherence: Adherence recorded with diary/ log book (insert wear time)<br>* Other names: Foot Science International Ltd; Formthotic;|
| Sham Comparator: Flat shoe insert<br> | Device: Flat shoe insert<br>* Manufacturer: Foot Science International. Material: High grade thermoformable closed-cell polyolefin foam (medium density) Arch support: no. Covering: fabric Provided by: Study Practitioner: Registered physiotherapist > 2 years musculoskeletal experience will be trained to prescribe the insert according to the prescription algorithm. Where: Administered via telehealth When and how much: Week 0 to 1: one telehealth session with study practitioner to fit one pair of pre-fabricated orthoses Week 1 to 2: Follow-up session for questions if required Tailoring: Fit to comfort. Lengths (S, S, M, L, XL, XXL) (dependent on participant's shoe size). Hardness = Medium density. Modifications: can be cut to size to assist in fit using the shoes original sock liner as a guide, by participants using standard scissors. Heat molding: optional. Adherence: Adherence recorded with diary/ log book (insert wear time)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility: adherence | Recruitment rate (average 1 participant per week); 50% log-book completion rate (daily); drop-out <20%; 35 hours per week adherence to intervention (log book) | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hip-related pain | Hip osteoarthritis outcome score: pain sub-scale (HOOS-12). Scores range for 0 (better outcomes) - 100 (worse outcomes) | Baseline and 6 weeks | 
| Hip-related physical function | Hip osteoarthritis outcome score: function and daily living subscale. Scores range for 0 (better outcomes) - 100 (worse outcomes) | Baseline and 6 weeks | 
| Hip-related quality of life | hip osteoarthritis outcome score: quality of life subscale: Scores range for 0 (better outcomes) - 100 (worse outcomes) | Baseline and 6 weeks | 
| Fear of movement | Brief Fear of Movement Scale for osteoarthritis (BFOM); 0 to 24, with a higher score indicating lower fear of movement (better score) | Baseline and 6 weeks | 
| Depressive symptoms | Patient Health Questionnaire -9: Scored from 0 to 27, participants can be classified as having mild (≥ 5), moderate (≥ 10), moderately severe (≥ 15) and severe (≥ 20) depressive symptoms. | Baseline and 6 weeks | 
| Physical activity- Self-reported | The International Physical Activity Questionnaire: Participants will be asked to recall their physical activity over the last 7 days with regard to vigorous physical activity, moderate physical activity, walking and sitting. | Baseline and 6 weeks | 
| Physical activity- Walking based physical activity | Will be measured with a tri-axial accelerometer-based activity monitor that is attached on the thigh (activPAL model 4 micro; PAL Technologies Ltd, Glasgow, UK) and will be expressed as a) daily minutes of moderate and vigorous physical activity using the established 100 steps/minute threshold and b) total daily steps (which captures both inside and outside the home walking activity). | Baseline and 6 weeks | 
| Global rating of change- Physical activity | Seven point rating scale. Much better, better, a little better, no change, a little worse, worse, much worse | Week 6 | 
| Global rating of change- Symptoms | Seven point rating scale. Much better, better, a little better, no change, a little worse, worse, much worse | Week 6 |