Partial Rotator Cuff Injury Combined With Stiff Shoulder

NCT ID: NCT07192302

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-12-31

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 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A (Early Surgery)

: Arthroscopic surgery within 6 weeks

Group Type: EXPERIMENTAL

Arthroscopy

Intervention Type: PROCEDURE

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

Group 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.

Group Type: SHAM_COMPARATOR

Drugs administration

Intervention Type: DRUG

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

Interventions

Arthroscopy

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

Intervention Type: PROCEDURE

Drugs administration

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jialiang Guo

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

GJL20250831

Identifier Type: -

Identifier Source: org_study_id