Comparative effectiveness of low-level laser therapy versus muscle energy technique among diabetic patients with frozen shoulder: a study protocol for a parallel group randomised controlled trial.

BACKGROUND: Diabetes mellitus is one of the fastest-growing health challenges of the twenty-first century with multifactorial impact including high rates of morbidity and mortality as well as increased healthcare costs. It is associated with musculoskeletal complications, with frozen shoulder being commonly reported. While low-level laser therapy (LLLT) and muscle energy technique (MET) are commonly used to manage  this condition, there remains a lack of agreement on the most effective approach, with limited research available on their comparative efficacy. OBJECTIVES: To evaluate the comparative effectiveness of LLLT versus MET among diabetic patients with frozen shoulder. METHODS: This is a single-centre, prospective, single-blind, randomised controlled trial with three parallel groups to be conducted at Ahmadu Bello University Teaching Hospital, Zaria, Kaduna State, Nigeria. Sixty diabetic patients with frozen shoulder will be randomly assigned into LLLT group, MET group, or control group in a 1:1:1 ratio. All the groups will receive treatment three times weekly for 8 weeks. The primary outcome will be shoulder function and the secondary outcomes will include pain intensity, shoulder ROM, interleukin-6 (IL-6), depression, anxiety, and quality of life (QoL). All outcomes will be assessed at baseline, at post 8-week intervention, and at 3 months follow-up. DISCUSSION: This will be the first randomised controlled trial to evaluate the comparative effectiveness of LLLT versus MET on both clinical and psychological parameters among diabetic patients with frozen shoulder. The findings of the study may provide evidence on the efficacy of these interventions and most likely, the optimal treatment approach for frozen shoulder related to diabetes, which may guide clinical practice. TRIAL REGISTRATION: Pan African Clinical Trials Registry (PACTR202208562111554). Registered on August 10, 2022.