None listed
Conditions
Interventions
Drug : Patients in the duloxetine group will be prescribed the medication once daily for a total duration of three months. They will initially receive 30 mg daily for the first two weeks, and if no ad
Sponsors
Seoul National University Bundang Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients aged between 30 and 80 years. 2) Patients undergoing surgical repair for rotator cuff tear. 3) Patients who completed the HADS (Hospital Anxiety and Depression Scale) questionnaire during screening and are assigned to one of the following groups: - Psychiatric symptom group: HADS-A or HADS-D score = 8 ? Patients treated with duloxetine ? Patients not treated with duloxetine - Non-psychiatric symptom group: Both HADS-A and HADS-D scores < 8 4) Patients who voluntarily agree to participate in the clinical trial and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients with concomitant shoulder stiffness and rotator cuff tear 2) Patients with bilateral shoulder symptoms 3) Patients with a history of surgery, dislocation, or fracture on the affected shoulder 4) Patients with rheumatoid arthritis, degenerative arthritis, symptomatic acromioclavicular arthritis, calcific tendinitis, or a Bankart lesion 5) Patients undergoing revision surgery for rotator cuff tear, or with full-thickness subscapularis tear or previously repaired subscapularis 6) Patients requiring postoperative continuous passive motion (CPM) due to diabetes, shoulder stiffness, calcific tendinitis, or labral repair, or those who have failed rotator cuff repair 7) Patients with serious systemic conditions (cardiovascular, respiratory, gastrointestinal, neurological, endocrine, etc.) that may interfere with rehabilitation 8) Patients with concurrent cervical spine disorders (e.g., spondylosis, disc herniation, stenosis) or thyroid disease 9) Patients with infectious diseases, immune disorders, connective tissue diseases, or systemic bone diseases 10) Patients currently under treatment for diagnosed psychiatric disorders such as depression or anxiety disorders 11) Patients with contraindications to duloxetine (e.g., hepatic or renal impairment, or concurrent use of fluvoxamine or ciprofloxacin) 12) Patients deemed inappropriate for study participation by the investigator (e.g., individuals with severe psychiatric symptoms and impaired decision-making capacity) 13) Patients requiring active psychiatric intervention due to severe psychiatric symptoms 14) Women of childbearing potential, pregnant women, or breastfeeding women 15) Patients with a history of seizures 16) Patients with glaucoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Forward flexion after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Range of motion (except forward flexion at 3months after suergy), Pain Visual Analog Scale, Satisfaction Visual Analog Scale, Hospital Anxiety and Depression Scale;functional score (Simple Shoulder Test, American Shoulder and Elbow Surgeons score);cuff integrity evaluation using sono | — |
Countries
Korea, Republic of
Contacts
Public ContactYoung Ki Min
Seoul National University Bundang Hospital
Outcome results
None listed