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
Dorien A. Salentijn, Priscilla Jawahier, Marit van Barreveld, Tosca Vrolijk-van Hengel, Niels Schep, Marcel G. W. Dijkgraaf, Mark van Heijl, Ruben N. van VeenBackground:
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
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;
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