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Active, Not Recruiting

NCT Number: NCT07192302

Partial Rotator Cuff Injury Combined With Stiff Shoulder

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)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jialiang Guo

Shijiazhuang, Hebei, 050000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Arthroscopy

Procedure

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

Drugs administration

Drug

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

Primary outcomes

  1. Shoulder Pain and Disability Index (SPADI)

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

    Shoulder Pain and Disability Index (SPADI) from 0-100. The lower the number, the better the functional outcomes of the patients.

Sponsors and collaborators

Lead sponsor

Hebei Medical University Third Hospital

Other

Registry information

Official study title

the Treatment Strategy of Partial Rotator Cuff Injury in Stiff Shoulders

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2025
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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