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Active, not recruiting Phase 1

Partial Rotator Cuff Injury Combined With Stiff Shoulder

NCT07192302 · tracked via the Priya Life Science China tracker
Phase
Phase 1
Started
2025-06-01
Last updated
2026-01-16

Condition(s) studied

Rotator Cuff Tears of the ShoulderShoulder Adhesive CapsulitisShoulder Arthroscopy

Investigational drug(s) / intervention(s)

ArthroscopyDrugs administration

Arthroscopy: Early Surgical Intervention in Patients with Partial Rotator Cuff Tears and Concomitant Shoulder Stiffness.

Drugs administration: Oral Medication for Conservative Management of Partial Rotator Cuff Tears with Concomitant Shoulder Stiffness.

Study summary

A Randomized Controlled Trial Comparing Early Surgical Intervention Versus a Structured Rehabilitation Program with Delayed Surgery if Needed for Partial-Thickness Rotator Cuff Tears with Concomitant Shoulder Stiffness: The SPIRIT Trial (Surgery for Partial Tears with Immobility Randomized Intervention Trial)

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age 18-80 years. 2. Symptomatic shoulder pain for \>2 weeks. 3. MRI-confirmed partial-thickness rotator cuff tear (\>50% tendon thickness or \>5mm in length). 4. Concomitant shoulder stiffness, defined as passive range of motion loss of ≥25% in at least two planes (forward flexion, abduction, external rotation, or internal rotation) compared to the contralateral side. 5. Failure of a brief (≥2 weeks) trial of conservative care (e.g., oral NSAIDs). Exclusion Criteria: 1. Age\< 18 or \>80 years. 2. Full-thickness rotator cuff tear. 3. Previous surgery on the affected shoulder. 4. Glenohumeral osteoarthritis (Grade ≥2 Samilson-Prieto). 5. Cervical radiculopathy as a primary cause of symptoms. 6. Systemic inflammatory arthritis. 7. Neurologic disorder affecting the shoulder. 8. Contraindications to surgery or general anesthesia. 9. Inability to comply with the rehabilitation protocol.

Primary outcome measure(s)

  • Shoulder Pain and Disability Index (SPADI) — 6 month before surgery and 6 months after surgery
    Shoulder Pain and Disability Index (SPADI) from 0-100. The lower the number, the better the functional outcomes of the patients.

Trial sites (1)

FacilityCityRegionStatus
Jialiang Guo Shijiazhuang Hebei
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07192302 on ClinicalTrials.gov ↗ ← All trials in China