The study of the superiority of oral low-dose prednisolone treatment combined with physiotherapy over oral celecoxib treatment with physiotherapy in frozen shoulder - A prospective, non-blinded, randomized multi-center study

JRCT ID: jRCTs031230729

Registered date:25/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: frozen shoulder
• Date of first enrollment: 25/03/2024
• Target sample size: 100
• Study type: Interventional

Intervention(s)

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 to ensure that symptoms do not flare up again at the next visit. 2.
2. exercise therapy (for both groups)
(1) Mobilization of the scapulothoracic joint.
(2) Perform passive elevation within the permissible range and internal/external rotation training using a bar.
(3) Excessive passive abduction training should be avoided.
(4) A checklist should be prepared for the above, and the content should be consistent.
In principle, outpatient rehabilitation is performed once a week until Day 84, but once every two weeks is acceptable for the patient's convenience.

Outcome(s)

• Primary Outcome: Difference in total Constant Score, a clinical score of the shoulder joint, at Day 56 and Day 0 after induction of oral medication
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: < 70age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Nagase Yuichi
• Source(s) of Monetary Support: Tokyo Metropolitan Hospital Organization