Hip Osteoarthritis and Foot Orthoses Trial (HOOT)

Hip Osteoarthritis Clinical Trial

— HOOT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05138380
• Other study ID #: HOOT
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: October 26, 2025

Study information

• Verified date: March 2023
• Source: La Trobe University
• Contact: Adam Semciw, PhD
• Phone: +61394796452
• Email: a.semciw[@]latrobe.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: October 26, 2025
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Device:
• Foot orthoses
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)
• Flat shoe insert
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)

Locations

Country	Name	City	State
Australia	La Trobe University	Bundoora	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
La Trobe University

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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