Status:
NOT_YET_RECRUITING
Frozen Shoulder and Glucose Following Corticosteroid Injection
Lead Sponsor:
Central London Community Healthcare NHS Trust
Collaborating Sponsors:
University of Hertfordshire
Conditions:
Frozen Shoulder
Adhesive Capsulitis
Eligibility:
All Genders
45-65 years
Brief Summary
The goal of this clinical study is to look at what happens to blood sugar levels in people who have a frozen shoulder, who do not have diabetes after a corticosteroid injection in people with frozen s...
Detailed Description
Frozen shoulder is regarded one of the most painful conditions to affect the shoulder. It is associated with substantial and prolonged pain that affects sleep and permeates into every aspect of daily ...
Eligibility Criteria
Inclusion
- Aged between 45 and 65
- Without diabetes or pre-diabetes
- Glenohumeral external rotation range is equally limited actively and passively by at least 50% compared to the contralateral side.
- Other glenohumeral movements are equally limited actively and passively compared to the contralateral side in one or more additional planes of movement (such as hand behind the back/shoulder flexion/abduction/scaption).
- The symptoms have been present for at least one month.
- No significant abnormality on plain radiographs.
- Ability to provide informed consent
Exclusion
- Aged 44 and under and 66 and over
- People with frozen shoulder secondary to significant shoulder trauma (e.g., dislocation, fracture or full thickness tear requiring surgery) or other causes (e.g., recent breast cancer surgery or radiotherapy)
- People with prediabetes, type 1 and 2 diabetes
- A neurological disease affecting the shoulder
- Evidence of other shoulder disorders (e.g., inflammatory arthritis, rotator cuff disorders, glenohumeral joint instability) or with red flags consistent with the criteria set out by British Elbow and Shoulder Society (Rangan, 2015).
- Primary osteoarthritis of the glenohumeral joint on plain radiograph
- Calcific tendinitis
- Who have received corticosteroid injection for shoulder pain in the last 12 weeks
- On long term steroids or a recent short course of oral steroids
- Currently being treated with coumarin anticoagulants, such as warfarin
- Who have participated in another research study involving an investigational medicinal product in the past 12 weeks
- Significant renal or hepatic impairment
- Any other significant disease which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study.
- Systemically unwell or with infection
- Pregnant or breastfeeding
Key Trial Info
Start Date :
August 16 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06494657
Start Date
August 16 2024
End Date
April 30 2025
Last Update
August 13 2024
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