Frozen Shoulder
Conditions
Interventions
Experimental group:Under the guidance of ultrasound, 1 ml of 40mg/ml triamcinolone acetonide and 7ml of bupivacaine liposome containing 62mg were injected into the glenohumeral joint cavity
Control:Under the guidance of ultrasound, 1 ml of 40mg/ml triamcinolone acetonide and 7 ml of 1% lidocaine were injected into the articular cavity, and 8ml
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Adults older than 18 years; 2. Frozen shoulder patients who were clinically diagnosed as meeting the diagnostic criteria (6, 26); 3. Patients whose shoulder joint on the target side failed to receive physiotherapy for at least 3 months; 4. Be able to understand the research process, be willing to complete the follow-up and evaluation according to the plan, and sign the written informed consent;
Exclusion criteria
Exclusion criteria: 1. Patients who have been diagnosed with rheumatic immune disease and neurogenic disease resulting in shoulder joint movement disorder; 2. There was a history of the following shoulder diseases: full-thickness rotator cuff tear, labrum tear, shoulder osteoarthritis or chronic shoulder instability; 3. The shoulder joint on the target side has been operated on; 4. Those who have previously received radical mastectomy or modified radical mastectomy with axillary lymph node dissection, and radiotherapy field covering the shoulder joint or axillary region; 5. Skin or soft tissue infection at the injection site, or active systemic infection and fever; 6. Allergic or intolerant to amide local anesthetics (such as bupivacaine, lidocaine) or liposomal carrier components (such as phospholipids / cholesterol, etc.); 7. Patients with contraindications to intra-articular injection (27) 8. Received intra-articular injection of glucocorticoids, hyaluronic acid, PRP, etc. or suprascapular nerve block (ssnb) in the past 6 months; 9. Those who have received long-acting local anesthesia and analgesia treatment in recent 7 days may affect the efficacy evaluation; 10. Oral hormone history in recent 6 months; 11. Previous history of local anesthetic related convulsions, poor seizure control, malignant hyperthermia and other conditions that increase the risk of adverse reactions to local anesthetics.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of injection related adverse events 1 week after intra-articular injection treatment;OSS score at 9 months after intra-articular injection; | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of analgesic use within 1 and 2 weeks after treatment;Incidence of injection related adverse events within 2 weeks after treatment;Change of OSS score from baseline at 3 and 6 months after treatment;Changes of shoulder joint range of motion from baseline at 3, 6 and 9 months after treatment;Changes from baseline in shoulder pain and disability index (SPADI) scores at 3, 6, and 9 months after injection;The absolute value of the exercise adherence Rating Scale (ears) at 3, 6 and 9 months after injection;Shoulder joint X-ray and MRI indicators of patients at 3, 6, and 9 months after intra-articular injection; | — |
Countries
China
Contacts
Public ContactHongyi Zhu
Shanghai Sixth People‘s Hospital
Outcome results
None listed