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Clinical Trial NCT07192302 for Rotator Cuff Tears of the Shoulder, Shoulder Adhesive Capsulitis, Shoulder Arthroscopy is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Partial Rotator Cuff Injury Combined With Stiff Shoulder Phase 1 80 Randomized

Active, not recruiting
Clinical Trial NCT07192302 is designed to study Treatment for Rotator Cuff Tears of the Shoulder, Shoulder Adhesive Capsulitis, Shoulder Arthroscopy. It is a Phase 1 interventional study that is active, not recruiting, having started on 1 June 2025, with plans to enroll 80 participants. Led by Hebei Medical University Third Hospital, it is expected to complete by 1 December 2026. The latest data from ClinicalTrials.gov was last updated on 16 January 2026.
Brief 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)
Detailed Description
Objective: To compare the clinical and functional outcomes of early surgical intervention (arthroscopic debridement/repair and capsular release) versus an initial structured, supervised rehabilitation program with delayed surgery only for non-responders, in patients with PTRCT and shoulder stiffness.

Methods: This will be a single-center, prospective, randomized, controlled, parallel-group trial. patients will be ra...

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Official Title

the Treatment Strategy of Partial Rotator Cuff Injury in Stiff Shoulders

Conditions
Rotator Cuff Tears of the ShoulderShoulder Adhesive CapsulitisShoulder Arthroscopy
Other Study IDs
  • GJL20250831
NCT ID Number
NCT07192302
Start Date (Actual)
2025-06-01
Last Update Posted
2026-01-16
Completion Date (Estimated)
2026-12
Enrollment (Estimated)
80
Study Type
Interventional
PHASE
Phase 1
Status
Active, not recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalGroup A (Early Surgery)
: Arthroscopic surgery within 6 weeks
Arthroscopy
Early Surgical Intervention in Patients with Partial Rotator Cuff Tears and Concomitant Shoulder Stiffness.
Sham ComparatorGroup B (Rehabilitation-First)
6-month structured physical therapy program. Patients who do not achieve a pre-defined successful outcome at 6 months will then undergo delayed surgery.
Drugs administration
Oral Medication for Conservative Management of Partial Rotator Cuff Tears with Concomitant Shoulder Stiffness.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Shoulder Pain and Disability Index （SPADI）
Shoulder Pain and Disability Index （SPADI） from 0-100. The lower the number, the better the functional outcomes of the patients.
6 month before surgery and 6 months after surgery
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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).

  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.
Hebei Medical University Third Hospital logoHebei Medical University Third Hospital
No contact data.
1 Study Locations in 1 Countries

Hebei

Jialiang Guo, Shijiazhuang, Hebei, 050000, China