A Phase 1 interventional study of Arthroscopy and Drugs administration in Rotator Cuff Tears of the Shoulder, Shoulder Adhesive Capsulitis and Shoulder Arthroscopy, sponsored by Hebei Medical University Third Hospital. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-16.
Sponsored by Hebei Medical University Third Hospital · Phase 1, Interventional, and Treatment
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.
Exclusion Criteria:
: Arthroscopic surgery within 6 weeks
Procedure: Arthroscopy
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
Early Surgical Intervention in Patients with Partial Rotator Cuff Tears and Concomitant Shoulder Stiffness.
Oral Medication for Conservative Management of Partial Rotator Cuff Tears with Concomitant Shoulder Stiffness.
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
Plan to share: No
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This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Hebei Medical University Third Hospital