Metformin Reduces the Incidence of Shoulder Stiffness After Arthroscopic Rotator Cuff Repair: A Randomized, Double-Blinded, Placebo-Controlled Trial
Abstract
Background: Shoulder stiffness after arthroscopic rotator cuff repair (RCR) is associated with a prolonged rehabilitation process and impaired functional outcomes. Previous studies have demonstrated that metformin can alleviate joint stiffness in animal models. However, its clinical effectiveness and safety require further confirmation in clinical practice.
Purpose/hypothesis: The purpose of this study was to investigate whether 3 months of postoperative treatment with metformin, compared with placebo, reduced the incidence of shoulder stiffness in patients after arthroscopic RCR. It was hypothesized that the postoperative administration of metformin would decrease the risk of postoperative shoulder stiffness.
Study design: Randomized controlled trial; Level of evidence, 1.
Methods: A total of 146 consecutive patients with rotator cuff tears were randomly assigned to receive a 500-mg dose of metformin or placebo twice daily for 3 months after arthroscopic RCR. The primary outcome was the incidence of shoulder stiffness at 3 months' follow-up. Secondary outcomes included the American Shoulder and Elbow Surgeons (ASES) score, pain, and patient satisfaction during the first postoperative year as well as concentrations of plasma fibrotic biomarkers at 3 months' follow-up. The primary and secondary outcomes were measured at baseline and 3 months, 6 months, and 1 year postoperatively. Safety was assessed by adverse events, and rotator cuff tendon healing was evaluated by…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 146 participants or records.
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