Pilot Trial of Steroid Injection for Shoulder Pai
- Conditions
- Rotator cuff tendinopathyAdhesive capsulitis of the shoulder jointMedDRA version: 14.1Level: LLTClassification code 10040617Term: Shoulder painSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2012-000147-27-GB
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
•Male or female, aged 35 to 74 years
•Diagnosed with rotator cuff tendinopathy or adhesive capsulitis by a general practitioner trained in shoulder assessment, with duration of symptoms no greater than 6 months
•Willing to allow his or her usual General Practitioner to be notified of participation in the study and to be contacted for further information if an adverse event related to the trial occurs
•Able to complete follow-up data collection by questionnaire at 2, 4 and 12 weeks
•Willing and able to give informed consent for participation in the trial
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 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
•Female participants who are pregnant, lactating or planning pregnancy during the course of the study
•Participants who have participated in another research study involving an investigational product in the past 12 weeks
• Those having already received a shoulder injection in the past 12 months
•Those with other established chronic shoulder disorders (e.g. rheumatoid arthritis, other inflammatory poly-arthropathies and osteroarthritis)
•A history of previous shoulder surgery on the affected side
•Those with evidence of active infection anywhere, including temperature = to or > than 37.5oC
•Those currently prescribed anticoagulants
•Those either currently prescribed or likely to need during the following 12 months, systemic corticosteroids for any reason
•Immunocompromised
•Uncontrolled diabetes or uncontrolled hypertension
•A diagnosis of heart failure
•Those considered unable due to cognitive impairment to reliably report outcome measures
• Any other significant disease or disorder which, in the opinion of the general practitioner, may either put the participants at risk because of participation in the study, or may influence the participant's ability to participate in the study.
• Any patient who is allergic to corticosteroids and/or lidocaine.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To measure feasibility issues including rates of recruitment and loss to follow up, including withdrawal from a randomised trial of a corticosteroid shoulder injection in patients with rotator cuff tendinopathy or adhesive capsulitis.;Secondary Objective: To measure response to and satisfaction with the shoulder injection in such patients; to assess the suitability of the participant information materials; to identify any other issues relevant to the design of a larger, definitive efficacy trial.;Primary end point(s): As this is a feasibility study the primary outcome measures will be:<br><br>Proportion of screened patients eligible to enter the study<br>Proportion of eligible patients willing to provide consent<br>Rates of recruitment (per practice per week)<br>Loss to follow up including withdrawal<br>Adherence to the allocation treatment;Timepoint(s) of evaluation of this end point: At the end of study defined as the last follow-up assessment completed by the last patient.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The Oxford Shoulder Score at 4 and 12 weeks following the trial injection. <br>Satisfaction questionnaires at 2, 4 and 12 weeks following trial injection. <br><br>;Timepoint(s) of evaluation of this end point: 2, 4 and 12 weeks following the trial injection.