None listed
Conditions
Interventions
Procedure/Surgery : In this study, patients diagnosed with adhesive capsulitis of the shoulder who have experienced symptoms for more than 1 month and have not shown improvement with conventional cons
Sponsors
Hallym University Medical Center-Kangnam
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients who have voluntarily decided to participate in this clinical trial and provided written informed consent. - Patients with unilateral shoulder pain. - Patients aged 40 years or older with type 2 diabetes mellitus who have been diagnosed with **adhesive capsulitis of the shoulder** (defined as functionally limited active and passive shoulder range of motion with no specific findings on shoulder radiographs, excluding cases of osteopenia or calcific tendinitis: forward flexion <100°, external rotation <45°, or internal rotation below the L1 vertebral level). - Patients with symptoms persisting for more than 1 month and no improvement with conventional conservative treatments (e.g., medication, physical therapy). - Patients without skin conditions or allergies that would interfere with the application of a continuous glucose monitoring (CGM) device.
Exclusion criteria
Exclusion criteria: - Patients with type 1 diabetes mellitus. - Patients with bilateral shoulder pain. - Patients with symptomatic cervical spine disorders. - Patients who have received injection therapy in the affected shoulder within the past 3 months. - Patients with a history of shoulder surgery. - Patients with shoulder trauma, such as fractures or dislocations, or those with a history of breast cancer, cervical spine disorders, or upper back diseases or surgeries. - Patients with the following concomitant shoulder conditions: full-thickness rotator cuff tear, acromioclavicular arthritis, shoulder instability, or septic arthritis. - Patients with the following radiological abnormalities: tumors, osseous structures causing subacromial space narrowing, or glenohumeral osteoarthritis. - Patients with the following musculoskeletal conditions: polyarthritis, rheumatoid arthritis, or fibromyalgia. - Patients with systemic diseases that may affect the outcomes of this study, such as cardiovascular disease, endocrine disorders, kidney disease, liver disease, or smoking. - Patients with neurological disorders. - Patients who are pregnant or breastfeeding. - Patients who plan to become pregnant during the study period or are unwilling to use contraception. - Patients unable to understand patient-reported outcome questionnaires used for efficacy evaluation or those with communication difficulties. - Patients unwilling to participate in the study or those who may have difficulty attending follow-up visits as scheduled. - Patients who have participated in another clinical trial within 3 months prior to this study. - Patients deemed unsuitable for study participation by the investigator due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ASES and VAS scores at 12 weeks after injection | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in average blood glucose levels measured by CGM before and after injection;Changes in HbA1c levels before injection and at 12 weeks post-injection | — |
Countries
Korea, Republic of
Contacts
Public ContactSANGHYEON LEE
Hallym University Medical Center-Kangnam
Outcome results
None listed