Comparing shoe inserts for hip osteoarthritis pain relief

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

This study is testing whether two different types of shoe inserts can help people with hip osteoarthritis feel less pain and improve their daily activities.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 28 (estimated)
• Ages: 45 Years and up
• Sex: All
• Sponsor: La Trobe University (Academic / other)
• Locations: 1 site (Bundoora, Victoria)
• Trial ID: NCT05138380 on ClinicalTrials.gov

What this trial studies

This trial is a randomized feasibility trial that aims to compare the effectiveness of two types of shoe inserts—contoured prefabricated foot orthoses and flat shoe inserts—on pain, quality of life, and physical activity in individuals with hip osteoarthritis. Participants will be randomly assigned to one of the two groups and will use the assigned inserts daily for six weeks. The study will monitor adherence through daily diaries and assess feasibility through various domains, while also measuring changes in hip-related pain and quality of life as secondary outcomes. The primary focus is on determining the feasibility of the intervention within the specified timeframe.

Who should consider this trial

Good fit: Ideal candidates are individuals over 45 years old with symptomatic hip osteoarthritis confirmed by radiographic evidence and moderate pain levels.

Not a fit: Patients with other significant musculoskeletal conditions or those who have received recent treatment for hip pain may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a non-invasive method to alleviate pain and improve quality of life for patients with hip osteoarthritis.

How similar studies have performed: While the specific approach of comparing these two types of shoe inserts is novel, similar studies have shown that foot orthoses can provide benefits for various musculoskeletal conditions.

Eligibility criteria

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.

Where this trial is running

Bundoora, Victoria

• La Trobe University — Bundoora, Victoria, Australia (Recruiting)

Study contacts

• Principal investigator: Adam Semciw, PhD — La Trobe University
• Study coordinator: Adam Semciw, PhD

Conditions Hip Osteoarthritis