Effectiveness of supervised early exercise program in patients with arthroscopic rotator cuff repair: Study protocol clinical trial

Héctor Gutiérrez-Espinoza, Felipe Araya-Quintanilla, Sebastian Pinto-Concha, Jonathan Zavala-González, Gonzalo Gana-Hervias, Iván Cavero-Redondo, Celia Álvarez-Bueno, Héctor Gutiérrez-Espinoza, Felipe Araya-Quintanilla, Sebastian Pinto-Concha, Jonathan Zavala-González, Gonzalo Gana-Hervias, Iván Cavero-Redondo, Celia Álvarez-Bueno

Abstract

Background: Based on the available evidence, it is difficult to make a clinical decision about the best exercise program and to establish the most favorable time to start postoperative treatment after rotator cuff (RC) repair. The aim of this trial is to evaluate the effects of adding a supervised early exercise program to standard treatment for functional improvement and pain relief compared with standard treatment alone in patients with arthroscopic RC repair.

Method/design: A total of 118 patients between the ages of 18 and 50 years with arthroscopic RC repair will be randomized to 2 treatment arms. The control group will receive a standard exercise program based on a consensus statement on shoulder rehabilitation developed by the American Society of Shoulder and Elbow Therapists. The intervention group will receive a supervised early exercise program in combination with standard treatment. This supervised exercise program will be based on electromyographic evidence. Three evaluations will be performed: before surgery, at 6 weeks, and at 12 weeks. The primary outcome measure will be the shoulder function by the Constant-Murley questionnaire, and the secondary outcome measures will be the upper limb function by the disabilities of the arm, shoulder, and hand questionnaire; pain by the visual analog scale; and the shoulder range of motion by a goniometer.

Discussion: We hypothesize that patients who receive a supervised early exercise program in combination with standard treatment will benefit more in respect to shoulder function, pain reduction, and range of motion than those who receive a standard exercise program. If this is confirmed, our study can be used clinically to enhance the recovery of patients with arthroscopic RC repair.

Trial registration: Brazilian registry of clinical trials UTN number U1111-1224-4143. Registered December 18, 2018.

Conflict of interest statement

The authors have no conflicts of interest to disclose.

Figures

Figure 1
Figure 1
Standard protocol items: recommendations for interventional trials (SPIRIT) figure. BMI = body mass index, DASH = disabilities of the arm, shoulder, and hand, t = assessment time in months, VAS = visual analog scale.
Figure 2
Figure 2
Detailed description of the supervised early exercise program.
Figure 3
Figure 3
Flow diagram of patients through phases of clinical study.

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