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

Halima I Hassan; Bashir Kaka; Fatima Bello; Francis Fatoye; Aminu A Ibrahim

doi:10.1186/s13018-024-04735-7

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

J Orthop Surg Res. 2024 Apr 30;19(1):272. doi: 10.1186/s13018-024-04735-7.

Authors

Halima I Hassan^{1

2}, Bashir Kaka^{1

3}, Fatima Bello⁴, Francis Fatoye⁵, Aminu A Ibrahim⁶

Affiliations

¹ Department of Physiotherapy, Faculty of Allied Health Sciences, College of Health Sciences, Bayero University, Kano, Kano State, Nigeria.
² Department of Physiotherapy, Ahmadu Bello University Teaching Hospital, Zaria, Kaduna State, Nigeria.
³ Division of Physiotherapy, School of Health Sciences, College of Health Sciences, University of KwaZulu-Nata, Westville, Durban, South Africa.
⁴ Endocrinology Unit, Department of Internal Medicine, Ahmadu Bello University Teaching Hospital, Zaria, Kaduna State, Nigeria.
⁵ Department of Health Professions, Faculty of Health, Psychology and Care, Manchester Metropolitan University, Manchester, UK.
⁶ Department of Physiotherapy, School of Basic Medical Sciences, Skyline University Nigeria, Kano, Kano State, Nigeria. aminu.ibrahim@sun.edu.ng.

Abstract

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.

Keywords: Conventional therapeutic exercises; Diabetes mellitus; Frozen shoulder; Low-level laser therapy; Muscle energy technique.

Publication types

Comparative Study
Clinical Trial Protocol
Randomized Controlled Trial

MeSH terms

Adult
Aged
Bursitis*
Diabetes Complications
Diabetes Mellitus
Female
Humans
Low-Level Light Therapy* / methods
Male
Middle Aged
Prospective Studies
Quality of Life
Randomized Controlled Trials as Topic
Range of Motion, Articular
Single-Blind Method
Treatment Outcome