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Clinical Trial NCT06494657 for Frozen Shoulder, Adhesive Capsulitis is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Frozen Shoulder and Glucose Following Corticosteroid Injection 10
Clinical Trial NCT06494657 is an observational study for Frozen Shoulder, Adhesive Capsulitis and is currently not yet recruiting. Enrollment is planned to begin on August 16, 2024 and continue until the study accrues 10 participants. Led by Central London Community Healthcare NHS Trust, this study is expected to complete by April 30, 2025. The latest data from ClinicalTrials.gov was last updated on August 13, 2024.
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 shoulder.
- The primary aim of this study will be to evaluate alterations in glucose levels for people without diabetes, following corticosteroid injection for frozen shoulder.
- The secondary aims are to observe a range...
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 function. Epidemiological research suggests the average onset is in the 6th decade, affecting up to 8% of men and 10% of women of working age may be affected. In people with diabetes this figure dramatically increases, w...Show More
Official Title
Frozen Shoulder: A Pragmatic Replicated N-of-1 Case Series Investigating Glucose Levels and Patient Reported Outcomes Following a Corticosteroid Injection.
Conditions
Frozen ShoulderAdhesive CapsulitisPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- RD24.001
NCT ID Number
Start Date (Actual)
2024-08-16
Last Update Posted
2024-08-13
Completion Date (Estimated)
2025-04-30
Enrollment (Estimated)
10
Study Type
Observational
Status
Not yet recruiting
Keywords
Corticosteroid
Injection
Hyperglycemia
Injection
Hyperglycemia
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
N/A | Corticosteroid injection Corticosteroid injection for frozen shoulder |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Mean glucose levels | The primary biochemical outcome is mean glucose (mmol/dL) levels pre and post injection. | 3 weeks |
Shoulder Pain and Disability Index | The primary clinical outcome is the functional questionnaire 'Shoulder Pain and Disability Index' before and after the injection. The SPADI is a 13-item patient completed instrument. Its categories include "pain" (5 items) and "disability" (8 items), with the total score often described as a percentage, resulting from the summation of each component. Overall total scores range from 0 to 130 with a percentage score of 0 indicating less shoulder disability and 100 indicating more shoulder dysfunction. | 3 weeks |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Quick Disabilities of the Arm, Shoulder, and Hand | The Quick Disabilities of the Arm, Shoulder, and Hand questionnaire is a subset of 11 items from the 30-item Disabilities of the Arm, Shoulder, and Hand and is a self-reported questionnaire in which the response options are presented as 5-point Likert scales. At least 10 of the 11 items must be completed for a score to be calculated and the scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb. | 3 weeks |
Pain Self Efficacy Questionnaire | The Pain Self Efficacy Questionnaire is a 10-item questionnaire, where patients rate their confidence from 0 points (not at all confident) to 6 points (completely confident). Total scores are calculated by summing the individual items with a range from 0 points (less self-efficacy) to 60 points (more self-efficacy) | 3 weeks |
Pittsburgh Sleep Quality Index | The 19 items are grouped into 7 components, including (1) sleep duration, (2) sleep disturbance, (3) sleep latency, (4) daytime dysfunction due to sleepiness, (5) sleep efficiency, (6) overall sleep quality, and (7) sleep medication use.
In scoring the Pittsburgh Sleep Quality Index, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. | 3 weeks |
Time in glucose range % | The time spent within various glucose ranges pre and post injection | 3 weeks |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
45 Years
Eligible Sexes
All
- 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
- 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
Central London Community Healthcare NHS TrustUniversity of HertfordshireStudy Central Contact
Contact: Christine Bilsborough Smith, MSc, 07967631668, [email protected]
Contact: Mindy Cairns, PhD, [email protected]
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