Clinical trial NCT05138380: Hip Osteoarthritis and Foot Orthoses Trial (HOOT)
Official title: Hip Osteoarthritis and Foot Orthoses Trial (HOOT): A Randomized Feasibility Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Osteoarthritis
Lead sponsor: La Trobe University
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 28
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm, participant blinded, parallel group feasibility RCT
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Feasibility: adherence
timeFrame: 6 weeks
Secondary outcomes:
measure: Hip-related pain
timeFrame: Baseline and 6 weeks
measure: Hip-related physical function
timeFrame: Baseline and 6 weeks
measure: Hip-related quality of life
timeFrame: Baseline and 6 weeks
measure: Fear of movement
timeFrame: Baseline and 6 weeks
measure: Depressive symptoms
timeFrame: Baseline and 6 weeks
measure: Physical activity- Self-reported
timeFrame: Baseline and 6 weeks
measure: Physical activity- Walking based physical activity
timeFrame: Baseline and 6 weeks
measure: Global rating of change- Physical activity
timeFrame: Week 6
measure: Global rating of change- Symptoms
timeFrame: Week 6
Other outcomes:
Locations:
city: Bundoora
country: Australia
facility: La Trobe University
state: Victoria
Study officials:
affiliation: La Trobe University
name: Adam Semciw, PhD
role: PRINCIPAL_INVESTIGATOR
References: