Partial Rotator Cuff Injury Combined With Stiff Shoulder

Hebei Medical University Third Hospital

Status and phase: Active, not recruiting; Phase 1

Conditions: Rotator Cuff Tears of the Shoulder; Shoulder Arthroscopy; Shoulder Adhesive Capsulitis

Treatments: Drug: Drugs administration; Procedure: Arthroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT07192302

GJL20250831

Details and patient eligibility

About

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)

Full 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 randomized (1:1) to either:

Group A (Early Surgery): Arthroscopic surgery within 6 weeks of randomization.

Group B (Rehabilitation-First): A 6-month structured physical therapy program. Patients who do not achieve a pre-defined successful outcome at 6 months will then undergo delayed surgery.

Primary outcome will be the change in the American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Score from baseline to 12 months. Secondary outcomes include pain (VAS), range of motion (ROM), Constant-Murley Score, Single Assessment Numeric Evaluation (SANE), and rates of conversion to surgery. Outcomes will be assessed at baseline 6 months and 6 months after surgery.

Expected Outcomes: The investigators hypothesize that the early surgery group will demonstrate faster initial improvement in pain and function. However, the investigators anticipate that by 6 months, a significant proportion of the rehabilitation-first group will avoid surgery altogether and achieve non-inferior, if not equivalent, outcomes compared to the early surgery group.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Group A (Early Surgery)

Experimental group

Description:

: Arthroscopic surgery within 6 weeks

Treatment:

Procedure: Arthroscopy

Group B (Rehabilitation-First)

Sham Comparator group

Description:

6-month structured physical therapy program. Patients who do not achieve a pre-defined successful outcome at 6 months will then undergo delayed surgery.

Treatment:

Drug: Drugs administration