Hip Osteoarthritis and Foot Orthoses Trial (HOOT)

La Trobe University28 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hip Osteoarthritis

Interventions

Foot orthosesDEVICE

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 insertDEVICE

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)

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

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.

Locations (1)

La Trobe University

Bundoora, Victoria, Australia

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: 6 weeks

Secondary Outcomes

Hip-related pain

Hip osteoarthritis outcome score: pain sub-scale (HOOS-12). Scores range for 0 (better outcomes) - 100 (worse outcomes)