Partial Rotator Cuff Injury Combined With Stiff Shoulder

Phase 1Active Not RecruitingNCT07192302

Hebei Medical University Third Hospital80 enrolled

Overview

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)

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Rotator Cuff Tears of the Shoulder Shoulder Adhesive Capsulitis Shoulder Arthroscopy

Interventions

ArthroscopyPROCEDURE

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

Drugs administrationDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Jialiang Guo

Shijiazhuang, Hebei, China

Outcomes

Primary Outcomes

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.

Time frame: 6 month before surgery and 6 months after surgery

Data from ClinicalTrials.gov

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