Study design: Prospective randomized pilot trial.
Background: Adhesive capsulitis (AC) occurs five times more often in people with diabetes. Exercises are usually recommended to manage AC. However, the recovery is slow and often incomplete, especially for patients with diabetes. 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.
Purpose: This pilot trial compared the effect of a regular physiotherapy (PT) program (PT) to a regular PT program combined with a progressive walking program (PT+) in patients with and without diabetes who have AC.
Methods: Eight patients with (n=3) and without (n=5) diabetes (five men and three women, with a mean age of 57 years) were included. Patients were randomly allocated either to PT or PT+ groups. The functional performance of shoulder was the primary outcome as measured using the Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA) test. Secondary outcomes included shoulder pain and function; shoulder range of motion in flexion, abduction, and external rotation; muscle strength of shoulder flexors and abductors; and physical activity level. The primary outcome was evaluated at baseline and after six weeks. Secondary outcomes were evaluated at baseline, and after three, six and 12 weeks from enrollment.
Setting: Single centre study at a tertiary-care hospital.
Results: A total of 13 patients were contacted with study details, only eight patients accepted to participate, with a 62% recruitment rate. Adherence to research centre visits was (97%). Patients in both groups showed improvement in all outcome measures, with a mean change of PT= 38 ± 17, and PT+= 6 ± 33 seconds for FIT-HaNSA from baseline to six weeks follow-up. Future studies, with 80% power (a=0.05, ß=0.20) to detect a 20% between-group difference, would require a sample size of 89 participants per group.
Conclusion: This randomized pilot trial established that conducting a large-scale study to assess the effect of the physiotherapy program for managing AC is feasible. The current findings suggest that physiotherapy exercises may be effective in reducing pain and improving shoulder function and ROM in patients with and without diabetes who have AC. Researchers should be aware of the recruitment challenges and should work on minimizing performance and detection bias by blinding study personnel and outcome assessors.
Adhesive capsulitis, Diabetes, Physiotherapy, Pilot trial