Hip Osteoarthritis
Conditions
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.
Interventions
DEVICEFoot 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)
DEVICEFlat 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)
Sponsors
La Trobe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Assessor blinding: Participants complete their own outcome measures (questionnaires) online and are thus not blind. Accelerometry data will be assessor blinded. All outcome measures will be analysed by an investigator blind to participant group allocation. Participants will be instructed not to divulge any aspect of their intervention to the research assistant conducting follow-up assessments. Participant blinding: Participants will be advised that they have an equal chance of being allocated to the either shoe insert, and thus are blind to allocation. Participants will also be blind to the study hypothesis, so they are unaware which of the interventions is 'active'. Physiotherapist blinding: It is not possible to blind the trial physiotherapist to group allocation. Trial Physiotherapists will however not be involved in assessment of outcome measures.
Intervention model description
Two-arm, participant blinded, parallel group feasibility RCT
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: adherence | 6 weeks | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hip-related physical function | Baseline and 6 weeks | Hip osteoarthritis outcome score: function and daily living subscale. Scores range for 0 (better outcomes) - 100 (worse outcomes) |
| Hip-related quality of life | Baseline and 6 weeks | hip osteoarthritis outcome score: quality of life subscale: Scores range for 0 (better outcomes) - 100 (worse outcomes) |
| Fear of movement | Baseline and 6 weeks | Brief Fear of Movement Scale for osteoarthritis (BFOM); 0 to 24, with a higher score indicating lower fear of movement (better score) |
| Depressive symptoms | Baseline and 6 weeks | 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. |
| Hip-related pain | Baseline and 6 weeks | Hip osteoarthritis outcome score: pain sub-scale (HOOS-12). Scores range for 0 (better outcomes) - 100 (worse outcomes) |
| Physical activity- Walking based physical activity | Baseline and 6 weeks | 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). |
| Global rating of change- Physical activity | Week 6 | Seven point rating scale. Much better, better, a little better, no change, a little worse, worse, much worse |
| Global rating of change- Symptoms | Week 6 | Seven point rating scale. Much better, better, a little better, no change, a little worse, worse, much worse |
| Physical activity- Self-reported | Baseline and 6 weeks | 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. |
Countries
Australia
Contacts
Primary ContactAdam Semciw, PhD
Backup ContactMatthew King, PhD
Outcome results
None listed