EUCTR2014-003412-37-GB
Active, not recruiting
Phase 1
Improving outcomes for patients with hip osteoarthritis: a randomised controlled trial - Hip Injection Trial (HIT)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Keele University
- Enrollment
- 348
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 2 years, as made by a trained clinician in the musculoskeletal service
- •3\. Moderate to severe current hip pain (a score of 4 or more on a 0\-10 numeric rating scale)
- •4\. Symptom duration of episode of at least 6 weeks
- •5\. Hip pain occuring on most days of the last month
- •6\. Informed written consent provided by the patient
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 116
Exclusion Criteria
- •Participants with the following characteristics are ineligible for the trial:
- •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 proceding 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:
Outcomes
Primary Outcomes
Not specified
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