Osteoarthritis of the hip Musculoskeletal Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female aged =40 years 2. A clinical diagnosis of unilateral or bilateral hip OA, and confirmed on plain radiography within the last 24 months, as made by a trained clinician in the musculoskeletal service 3. Moderate to severe current hip pain 4. Symptom duration of episode of at least 6 weeks 5. Hip pain occurring on most days of the last month 6. Informed written consent provided by the patient
Exclusion criteria
Exclusion criteria: 1. Hip pain due to other disorders (e.g. trochanteric bursitis, avascular necrosis, pain referred from back) 2. Intra-articular corticosteroid injection into the affected hip or ipsilateral trochanteric bursa injection within the preceding 3 months 3. Any previous surgery on the affected hip 4. Clinical suspicion of local or systemic sepsis or infection 5. Current or previous infection of the affected hip 6. Significant trauma to the affected hip requiring immobilisation in the previous 3 months 7. Unwillingness to undergo study interventions 8. Unable to understand and complete self-report questionnaires written (or spoken) in English 9. Significant illness (known or suspected) including, but not limited to: 9.1. Inflammatory joint disease (e.g. rheumatoid arthritis, seronegative spondyloarthropathy (ankylosing spondylitis, psoriatic arthritis, reactive arthritis, inflammatory-bowel disease associated inflammatory arthritis)) 9.2. Polymyalgia rheumatica or other condition requiring regular oral steroid use 9.3. Malignancy (where malignancy is thought to be causing hip pain e.g. suspected bony metastases) 9.4. Any other severe medical illness which in the opinion of the local Principal Investigator (or other authorised clinical delegate) precludes trial participation 10. Pregnant or lactating females 11. Receiving anticoagulants (warfarin, dabigatran, rivaroxaban, apixaban or low molecular weight heparin) 12. Any history of hypersensitivity to triamcinolone acetonide or 1% lidocaine hydrochloride or any of their excipients (1N Hydrochloric Acid QS, 1N Sodium Hydroxide QS, Benzyl alcohol. Polysorbate 80, Sodium carboxymethylcellulose and Sodium chloride) 13. Contraindications to use of local anaesthetic: Complete heart block and hypovolaemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain, measured using the Numerical Rating Scale score for current pain (Dworkin 2005) at baseline, 2 weeks, 2 months, 4 months and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Joint function, measured using Western Ontario and McMaster University Arthritis Index (WOMAC v3.1) at baseline, 2 months, 4 months and 6 months 2. Participant’s self-reported global impression of change, measured at 2 weeks, 2 months, 4 months and 6 months 3. General health, measured using SF-12 at baseline, 2 months, 4 months and 6 months 4. Sleep disturbance, measured using a Likert-type scale at baseline, 2 months, 4 months and 6 months 5. Pain self-efficacy, measured at baseline, 2 months, 4 months and 6 months 6. Modified Brief Illness Perceptions Questionnaire, measured at baseline, 2 months, and 6 months 7. Satisfaction and experience, measured at baseline, 2 months and 6 months 8. Health status, measured using EQ5D-5L at baseline, 2 weeks, 2 months, 4 months and 6 months 9. Employment status, measured at baseline and 6 months 10. Performance at work, measured at baseline, 2 months, 4 months and 6 months 11. Absenteeism from work, measured at baseline, 2 months and 6 months 12. Health care utilisation, measured at 2 months and 6 months 13. Participant-incurred costs, measured at 2 months and 6 months 14. Other hip injections received, measured 2 months and 6 months 15. Self-reported adverse events, measured at 2 weeks, 2 months and 6 months 16. Adherence to best current treatment advice, measured at 2 months, 4 months and 6 months | — |
Countries
England, United Kingdom