None listed
Conditions
Interventions
Medical Device : The frozen shoulder subject group and the rotator cuff repair subject group are divided into the test group (digital therapy device use group) or the control group (conventional rehab
Sponsors
Orthocare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults aged 19 to 65 as of the date of written consent 2) Patients with frozen shoulder or rotator cuff repair who meet each criteria • Patients diagnosed with frozen shoulder whose passive range of motion of the shoulder joint is less than 50% of the lateral external rotation compared to the healthy side • Rotator cuff repair patients who underwent repair for partial tear of the supraspinatus tendon and full-thickness tear of less than 2.5 cm, and did not have frozen shoulder before surgery 3) Patients diagnosed with frozen shoulder or underwent rotator cuff repair in only one shoulder out of both shoulders 4) Those who agree to use an appropriate contraceptive method* from the date of signing the written consent form until 4 weeks after the end of the clinical trial (*Examples of contraception: copper intrauterine device (copper loop), hormone-containing intrauterine device, condom, vasectomy, tubal surgery, spermicide, vaginal contraceptive pill, subcutaneous implant, injectable contraceptive pill, female condom, oral contraceptive pill, etc.) 5) Those who have no influence on shoulder rehabilitation during the period of participation in this clinical trial Those who agree not to receive external treatment or therapy 6) Those who can use a smartphone and can perform self-exercise therapy using a test device 7) Those who can understand and follow instructions and participate throughout the entire clinical trial period 8) Those who voluntarily decide to participate in this clinical trial and give written consent to the subject consent form
Exclusion criteria
Exclusion criteria: If any of the following exclusion criteria are met, you cannot be enrolled in this clinical trial. Current disease and medical history 1) Patients diagnosed with secondary frozen shoulder due to trauma (shoulder fracture, dislocation) and/or systemic inflammatory disease, rheumatoid arthritis, or osteoarthritis of the humeral glenoid joint 2) For patients with frozen shoulder, patients with secondary frozen shoulder causes confirmed by X-ray, MRI, or ultrasound within 12 weeks from the screening date, such as osteoarthritis of the humeral glenoid joint, osteonecrosis, rotator cuff tear, biceps tendon tear, calcific tendonitis, or inflammatory joint disease 3) For patients with rotator cuff repair, patients with any of the following in the affected shoulder: • Patients with rotator cuff tears exceeding 2.5 cm in size • Patients with a history of previous shoulder surgery • Patients with traumatic rotator cuff tears • Patients with rotator cuff tears with fracture or osteoarthritis of the humeral glenoid joint • Patients with rotator cuff tears with frozen shoulder before surgery • Patients with labral repair and capsular release during surgery Patients who underwent screening 4) Those with the following comorbidities at the time of screening • Shoulder deformity • Rheumatoid arthritis • Osteoarthritis of the humerus glenoid joint • Metabolic bone disease • Infection of the shoulder area where clinical trial medical devices are applied • Fibromyalgia • Cervical radiculopathy • Reflex sympathetic dystrophy • Systemic inflammatory disease • Cognitive impairment • Epilepsy Contraindicated medications and concomitant treatments 5) Those taking narcotic analgesics 6) Those diagnosed with drug abuse and/or alcoholism Others 7) Those currently participating in another clinical trial or participating in another clinical trial within 30 days of the screening date 8) Pregnant or lactating women (pregnancy test is required for women of childbearing potential) 9) Those unable to comply with all aspects of the screening, evaluation, treatment, and follow-up schedule due to physical, neurological, or mental conditions 10) Others who are unable to communicate or have difficulty following instructions 11) Other subjects judged by the investigator to be unsuitable for this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in passive range of motion of the shoulder joint in frozen shoulder group;Changes in passive range of motion of the shoulder joint in the group after rotator cuff repair | — |
Secondary
| Measure | Time frame |
|---|---|
| Shoulder Pain Visual Analogue Scale Variation;Change in Shoulder Pain and Disability Index (SPADI);Change in Constant Shoulder Score (CSS);EQ-5D-5L change amount;Rotator cuff re-tear rate | — |
Countries
Korea, Republic of
Contacts
Public ContactJongho Kim
The Catholic University of Korea, Yeouido St. Mary's Hospital
Outcome results
None listed