Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT06494657
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
65 Years
Study:
NCT06494657
Study Brief:
Protocol Section:
NCT06494657