Frozen Shoulder and Glucose Following Corticosteroid Injection
NCT Number: NCT06494657
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Frozen Shoulder|Adhesive Capsulitis
Interventions: OTHER: Corticosteroid injection
Sponsor: Central London Community Healthcare NHS Trust
Collaborators: University of Hertfordshire
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-16
Completion Date: 2025-04-30

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 of clinical, physiological, and psychosocial outcomes following corticosteroid injection for people with frozen shoulder.

Participants will wear a glucose measuring device, attached to the upper arm collecting readings of glucose levels for 14 days.

Participants will undergo a corticosteroid injection as part of usual care.

Primary Outcome Measures: 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
Secondary Outcome Measures: 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