Self-Management Exercise Regimen Versus Supervised Hand Therapy in Patients With Dorsal Dislocation or Hyperextension Injury With a Volar Plate Avulsion of the Proximal Interphalangeal Joint: The Randomized Controlled PINOT Study

Abstract

Background: Supervised hand therapy (SHT) with early mobilization is recommended for patients with a stable, congruent proximal interphalangeal (PIP) joint after dorsal dislocation or hyperextension injury with a volar plate avulsion. Early mobilization uses a dorsal block splint. A self-management exercise regimen (SMER) may offer a valuable alternative that reduces demand on therapists. We hypothesized that SMER is noninferior to SHT. Methods: Noninferiority was assessed in adult patients in a multicenter, open randomized trial. Noninferiority to SHT had to be shown in both the modified intention-to-treat (mITT) and per-protocol (PP) analysis sets. The predefined noninferiority margin was −8 points, about half the minimal clinically important difference, with a 1-sided critical P value of .025. Results: The mITT analysis set contained 100 patients in each treatment group. The mean difference at 3 months in Michigan Hand Outcomes Questionnaire (MHQ) change score from baseline was −0.6 (95% CI, −4.4 to 3.2; P noninferiority = .0001) against SMER. The PP analysis set consisted of 85 patients who followed SMER and 79 patients who received SHT. The mean difference at 3 months in MHQ change score from baseline was 0.4 (95% CI, −3.5 to 4.4; P noninferiority = .000026) in favor of SMER. No safety issues following SMER were observed. Conclusions: The randomized controlled trial showed that SMER for patients with a stable and congruent joint alignment after dorsal dislocation or hyperextension injury with a volar plate avulsion fracture of the PIP joint is clinically noninferior regarding hand function compared with SHT. Level of evidence: I