frozen shoulder synovitis capsulitis contracture
Conditions
Interventions
1. oral medications
Low-dose prednisolone or nonsteroidal anti-inflammatory drugs (NSAIDs) should be taken until Day 112.
Patients will be observed for 56 days after discontinuation of the medications
steroid, NSAIDs, oral administration, physiotherapy
Sponsors
Nagase Yuichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with frozen shoulder who are attending or hospitalized at a facility participating in this study and who meet all selection criteria and none of the exclusion criteria will be included. 1. Age between 40 and less than 70 years old at the time of consent. 2. Frozen shoulder patients with passive flexion of less than 100 degrees, passive external rotation of less than 40 degrees, and passive internal rotation of less than the third lumbar vertebra 3. period of morbidity is 2 months or more and less than 8 months 4. Patients with abduction pain greater than or equal to 4 on the numeric rating scale (NRS) at the time of enrollment 5. Patients who have been fully informed about their participation in this study, and who have given written consent of their own free will after full understanding of the study.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of obvious trauma such as fracture or dislocation 2. Patients with osteoarthritis of the shoulder 3. Patients with a full-layer tear of the rotator cuff 4. Patients with obvious calcific rotator cuff tendinitis with a diameter of 3 mm or more on X-ray 5. Patients with a history of shoulder surgery on the affected side 6. Patients already taking diabetic medication, with HbA1c of 7.0 or higher 7. Patients with hypertension of 160/100 mmHg for men and 180/110 mmHg for women, with or without blood pressure treatment. 8. Patients with gastric ulcer or duodenal ulcer 9. Patients with a history of fragility fracture 10. Patients with infections, systemic mycosis, or tuberculosis for which no effective antimicrobial agents exist. 11. Patients who are outpatients due to psychosis. 12. Patients with keratitis herpetiformis, posterior capsular cataract, or glaucoma 13. Electrolyte abnormalities (abnormally low/high levels of sodium, potassium, phosphorus, calcium, or magnesium) defined as Grade 2 or higher in CTCAE v5.0 14. Patients in hospital for thrombosis or taking warfarin 15. Patients within 28 days after internal surgery 16. Patients with a history of acute myocardial infarction, undergoing treatment for heart failure, or in the perioperative period of coronary artery bypass reconstruction 17. Hepatic impairment (elevated AST, ALT) defined as Grade 2 or higher in CTCAE v5.0 18. Patients with chronic kidney disease stage 4 or higher 19. Pregnant women and lactating patients 20.Patients who have taken oral steroids within the past 3 months 21. Patients who have received intra-articular steroid injections into the affected shoulder within the past month. 22.Patients with hypersensitivity to prednisolone or NSAIDs (including aspirin asthma) 23. Other patients deemed inappropriate as subjects by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in total Constant Score, a clinical score of the shoulder joint, at Day 56 and Day 0 after induction of oral medication | — |
Secondary
| Measure | Time frame |
|---|---|
| Monthly numeric rating scale (NRS), shoulder joint range of motion, Constant Score at Day 0, Day 56, Day 112, Day 168, Shoulder 36 (Ver 1.3). Shoulder36 was developed by the Japanese Orthopaedic Association and the Japanese Society for Shoulder Arthroscopy, and consists of 36 questions in 6 areas: pain, range of motion, muscle strength, sense of health, daily life function, and sports ability.Blood samples are drawn to evaluate for worsening liver function, renal function, hypercholesterolemia, and diabetes at Day0, 56 and 112. | — |
Contacts
Public ContactYuichi Nagase
Tokyo Metropolitan Tama medical center
Outcome results
None listed