Hip Osteoarthritis and Foot Orthoses Trial (HOOT) (HOOT)

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

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 Overview

• Status: Recruiting
• Conditions: Hip Osteoarthritis
• Intervention / Treatment: Device: Foot orthoses; Device: Flat shoe insert

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 Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adam Semciw, PhD; Phone Number: +61394796452; Email: a.semciw@latrobe.edu.au
• Study Contact Backup: Name: Matthew King, PhD; Phone Number: +61394793531; Email: m.king@latrobe.edu.au

Study Locations

• Australia
  • Victoria
    • Bundoora, Victoria, Australia, 3086
      • Recruiting
      • La Trobe University
      • Contact: Adam I Semciw, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Foot orthoses	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); Other Names: Foot Science International Ltd; Formthotic
Sham Comparator: Flat shoe insert	Device: 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: La Trobe University
• Investigators: Principal Investigator: Adam Semciw, PhD, La Trobe University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): October 26, 2025

Study Registration Dates

• First Submitted: November 2, 2021
• First Submitted That Met QC Criteria: November 17, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: HOOT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No