背景:糖尿病是21世纪增长最快的健康挑战之一,具有多因素影响,包括高发病率和死亡率以及增加的医疗保健成本。它与肌肉骨骼并发症有关,肩周炎常被报道。虽然低水平激光治疗(LLLT)和肌肉能量技术(MET)通常用于治疗这种情况,对于最有效的方法仍然缺乏共识,关于它们的比较功效的研究有限。
目的:评估LLLT与MET在糖尿病肩周炎患者中的比较效果。
方法:这是一个单中心,prospective,单盲,在AhmaduBello大学教学医院进行三个平行组的随机对照试验,扎里亚,卡杜纳州,尼日利亚。将60名患有肩周炎的糖尿病患者随机分为LLLT组,MET组,或对照组,比例为1:1:1。所有组将接受每周三次的治疗,持续8周。主要结果将是肩关节功能,次要结果将包括疼痛强度,肩部ROM,白细胞介素-6(IL-6),抑郁症,焦虑,和生活质量(QoL)。所有结果将在基线时进行评估,在8周的干预后,并在3个月的随访。
结论:这将是第一个评估LLLT与MET在冻结肩糖尿病患者的临床和心理参数方面的比较有效性的随机对照试验。这项研究的结果可能为这些干预措施的有效性提供证据,与糖尿病相关的冻结肩的最佳治疗方法,可以指导临床实践。
背景:泛非临床试验注册(PACTR202208562111554)。2022年8月10日注册。
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.
OBJECTIVE: 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.
CONCLUSIONS: 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.
BACKGROUND: Pan African Clinical Trials Registry (PACTR202208562111554). Registered on August 10, 2022.