Hip Osteoarthritis and Foot Orthoses Trial (HOOT)

Not Applicable

Recruiting

• Conditions: Hip Osteoarthritis
• Interventions: Device: Flat shoe insert; Device: Foot orthoses

• Registration Number: NCT05138380
• Lead Sponsor: La Trobe University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-11-02
• Study First Submitted QC: 2021-11-17
• Study First Posted: 2021-12-01
• Study Start: 2022-02-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-10-09
• Last Update Posted: 2023-10-11
• Primary Completion: 2024-08-01
• Study Completion: 2025-10-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

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;

1. able to reciprocally ascend and descend 10 stairs unaided,
2. able to safely walk one city block, and
3. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flat shoe insert	Flat shoe insert	-
Foot orthoses	Foot orthoses	-

Primary Outcome Measures

Name	Time	Method
Feasibility: adherence	6 weeks	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)

Secondary Outcome Measures

Name	Time	Method
Fear of movement	Baseline and 6 weeks	Brief Fear of Movement Scale for osteoarthritis (BFOM); 0 to 24, with a higher score indicating lower fear of movement (better score)
Depressive symptoms	Baseline and 6 weeks	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.
Hip-related pain	Baseline and 6 weeks	Hip osteoarthritis outcome score: pain sub-scale (HOOS-12). Scores range for 0 (better outcomes) - 100 (worse outcomes)
Hip-related physical function	Baseline and 6 weeks	Hip osteoarthritis outcome score: function and daily living subscale. Scores range for 0 (better outcomes) - 100 (worse outcomes)
Physical activity- Walking based physical activity	Baseline and 6 weeks	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).
Global rating of change- Physical activity	Week 6	Seven point rating scale. Much better, better, a little better, no change, a little worse, worse, much worse
Hip-related quality of life	Baseline and 6 weeks	hip osteoarthritis outcome score: quality of life subscale: Scores range for 0 (better outcomes) - 100 (worse outcomes)
Physical activity- Self-reported	Baseline and 6 weeks	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.
Global rating of change- Symptoms	Week 6	Seven point rating scale. Much better, better, a little better, no change, a little worse, worse, much worse

Trial Locations

Locations (1)

La Trobe University; 🇦🇺 Bundoora, Victoria, Australia