Partial Rotator Cuff Injury Combined With Stiff Shoulder

NCT07192302 | Active Not Recruiting Phase 1

• 1 other identifier: GJL20250831
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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)

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group A (Early Surgery)

EXPERIMENTAL

: Arthroscopic surgery within 6 weeks

Procedure: Arthroscopy

Group B (Rehabilitation-First)

SHAM COMPARATOR

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

Drug: Drugs administration

Interventions

Arthroscopy PROCEDURE

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

Group A (Early Surgery)

Drugs administration DRUG

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

Group B (Rehabilitation-First)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years.
• Symptomatic shoulder pain for \>2 weeks.
• MRI-confirmed partial-thickness rotator cuff tear (\>50% tendon thickness or \>5mm in length).
• 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.
• Failure of a brief (≥2 weeks) trial of conservative care (e.g., oral NSAIDs).

You may not qualify if:

• Age\< 18 or \>80 years.
• Full-thickness rotator cuff tear.
• Previous surgery on the affected shoulder.
• Glenohumeral osteoarthritis (Grade ≥2 Samilson-Prieto).
• Cervical radiculopathy as a primary cause of symptoms.
• Systemic inflammatory arthritis.
• Neurologic disorder affecting the shoulder.
• Contraindications to surgery or general anesthesia.
• Inability to comply with the rehabilitation protocol.

Sponsors & Collaborators

• Hebei Medical University Third Hospital: lead

Study Sites (1)

Jialiang Guo

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Conditions

Bursitis

Interventions

Arthroscopy; Administration, Inhalation

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Orthopedic Procedures; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2025
• First Posted: September 25, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)