Hip Osteoarthritis and Foot Orthoses Trial (HOOT)
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- Primary symptomatic and radiographic hip OA, in accordance with the American College of Rheumatology
- aged > 45 years
- pain in the hip or groin for more than 3 months
- 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
- radiographic confirmation of hip osteoarthritis with a Kellgren-Lawrence score ≥ 2 within the last 12 months
- mild to moderate disability indicated by able to reciprocally ascend and descend 10 stairs unaided
- mild to moderate disability indicated by able to safely walk one city block
- mild to moderate disability indicated by able to jog five meters if required
Exclusion criteria
- other musculoskeletal lower limb or back conditions requiring assessment or treatment by a health professional (Doctor, Physiotherapist, Podiatrist etc) in the last 6 months
- have received active treatment for their hip pain by a health professional (eg physiotherapist) in the last 3 months
- history of hip trauma or surgery on the affected side
- corticosteroid use (oral or intra-articular injection) in the past 3 months
- neurological impairment or condition affecting lower limb function
- 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)
- Use of foot orthoses in the previous 12 months
- systemic inflammatory disease (e.g. rheumatoid arthritis)
- unable to write, read or comprehend English
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- NA
Study ID
NCT05138380
Intervention or treatment
DEVICE: Foot orthoses
DEVICE: Flat shoe insert
Conditions
- Hip Osteoarthritis
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Research sites nearby
Closest Location:
La Trobe University
Select from list below to view details:
La Trobe University
Bundoora, Victoria, Australia
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Who is running the clinical trial?
La Trobe University
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Foot orthoses
| Device: Foot orthoses |
SHAM_COMPARATOR: Flat shoe insert
| Device: Flat shoe insert |
What is the study measuring?
Primary Outcome
| 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
| 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 |
References
Clinical Trials Gov: Hip Osteoarthritis and Foot Orthoses Trial (HOOT)Other trials to consider
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