Physiotherapy Program for Managing Adhesive Capsulitis in Patients with Diabetes: A Protocol for a Pilot Randomized Trial

Background: Adhesive capsulitis (AC) occurs five times more often in people with diabetes and leads to prolonged disability. Exercises and joint mobilization are usually used to manage AC. However, the recovery is slow and often incomplete. Aerobic exercises improve hyperglycemia and insulin sensitivity. Currently, no research has formally assessed the benefits of incorporating an aerobic training program into the treatment plan of AC in patients with diabetes. This single blind pilot randomized trial will compare the preliminary effect of a regular physiotherapy program (PT), to a regular PT program combined with a progressive walking program (PT+) in patients with and without diabetes who have AC. Methods: Patients (n= 40) will be recruited from St. Joseph's HealthCare Centre and associated primary care practices. Patients will be randomly assigned into either the regular PT program or regular PT combined with a progressive walking program. Patients will be referred to physical therapy facilities and the intervention will be chosen by the treating physical therapist. In the PT+ group, patients will be asked to perform free walking at their own pace for 30-45 minutes, five days per week, for six consecutive weeks. The primary outcome will be testing the functional performance of the shoulder using the Functional Impairment Test- Hand and Neck/ Shoulder/Arm (FIT-HaNSA) test. Secondary outcomes will include shoulder pain and function using the Shoulder Pain and Disability Index (SPADI) questionnaire; shoulder range of motion in flexion, abduction, and external rotation; muscles strength of shoulder flexors and abductors; and physical activity level using an accelerometer and the Rapid Assessment of Physical Activity (RAPA) questionnaire. The primary outcome will be evaluated at baseline and after six weeks. Secondary outcomes will be evaluated at baseline, and after three, six and 12 weeks from enrolment. Discussion: The novel approach taken in this pilot trial will establish the preliminary effect of a regular PT program combined with a progressive walking program and will evaluate a study design prior to the performance of a full-scale research project that may lead to better outcomes for managing adhesive capsulitis in people with diabetes.