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Exploring the Link Between Menopause, Glucose Control, and Frozen Shoulder in Women (MENO-FROST)

2026年5月17日 更新者:Natalie Shur、University of Nottingham

Exploring the Association Between Menopausal Status, Metabolic Health, and Frozen Shoulder in Women: a Cross-sectional Observational Study

Background

Frozen shoulder (FS) is a common condition and affects how the shoulder moves, making it very stiff and sore. The shoulder joint becomes inflamed and tightened due to scarring in the joint called fibrosis. It can take years to get better, and for around 50% of individuals the symptoms last even longer. FS causes a profound negative impact on physical and mental health, including disturbed sleep, low mood, difficulty performing everyday activities and, in many cases, are unable to continue working. FS affects around 1 in 10 people, and almost twice as many women as men between the ages of 40-60 years, but it is unknown why. It is thought to either be related to changes in sex hormones during the menopause, or due to the way the body handles sugar and fat, which changes with the menopause. However, associations between the menopause transition and FS are not well established and previous evidence has been poor quality. Current treatments include physiotherapy, a steroid injection or surgery but none of these treat the underlying cause of FS. Women with FS said they would like to know why they developed FS and more early treatment options to avoid a long recovery or an operation.

Aim This study aims to understand if there is a link between the menopause, changes in blood sugar levels and FS in women.

Plan In Part 1, women who have had FS will fill in an electronic questionnaire to give us information about their menopause status at the onset of FS, how long their symptoms lasted, what treatments they tried, and if they had any other health conditions. This will enable us to determine the relationship between the menopause and the onset of FS.

In Part 2, the investigators will invite 18 perimenopausal women with recently diagnosed FS and 18 matched women without FS to attend a one-day visit at the University of Nottingham. The investigators will measure their blood sugar levels over two weeks using a small monitor on their arm. The investigators will assess their menopause symptoms and shoulder related outcomes using validated questionnaires. The investigators will assess their shoulder movement and measure body fat and muscle levels, physical activity levels, diet, and take a blood sample to test sex hormones, inflammation and lipids, as well as markers related to frozen shoulder. This will help us to assess the relationship between blood glucose control and the onset of FS in perimenopausal women.

Impact This research will help us understand if there's a link between menopause, blood sugar control, and FS. It could lead to new clinical trials testing treatments early in FS, such as a glucose lowering medication or hormone therapy, to help women recover faster and avoid surgery. This may improve clinical outcomes in women with FS and reduce costs associated with treating FS. This important question came directly from patients and has not been studied in depth before. The investigators plan to share the results widely through health newsletters, podcasts, research conferences, and medical journals.

研究概览

地位

尚未招聘

条件

研究类型

观察性的

注册 (估计的)

340

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

取样方法

概率样本

研究人群

Part 1: Any woman over 18 years of age with a current or previous history of frozen shoulder

Part 2: Perimenopausal women with recent diagnosis of primary frozen shoulder and matched controls

描述

Part 1

Inclusion criteria:

• Any women > 18 years with a history of frozen shoulder diagnosed by a clinician

Exclusion criteria:

• Any women without a clear previous diagnosis of frozen shoulder

Part 2:

Inclusion criteria:

  • Perimenopausal women (self-assessment)
  • Aged 40-60 years
  • Diagnosed with FS within the last 12 months OR
  • Matched controls (women aged 40-60 years without FS).

Exclusion criteria:

  • Diabetes mellitus,
  • Thyroid dysfunction,
  • Secondary FS (e.g. posttraumatic),
  • Use of medications influencing hormonal or metabolic parameters (e.g. hormone replacement therapy [HRT].

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Menopause status at frozen shoulder onset
大体时间:Baseline
Part 1: • Self-reported menopause status at the time of FS onset
Baseline
Estimated HbA1c
大体时间:14 days
Part 2: Estimated HbA1c from continuous glucose monitoring (CGM)
14 days

次要结果测量

结果测量
措施说明
大体时间
Type of menopause
大体时间:Baseline
Part 1: Type of menopause
Baseline
Frozen shoulder duration
大体时间:Baseline
Part 1: Duration of FS symptoms
Baseline
BMI and waist circumference
大体时间:Baseline
Part 2: weight and height will be combined to report BMI in kg/m^2
Baseline
Serum fasting lipids
大体时间:Baseline
Part 2: serum fasting lipid concentration
Baseline
Step count
大体时间:14 days
Part 2: activity data from ActivPAL
14 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2027年9月1日

研究完成 (估计的)

2027年9月1日

研究注册日期

首次提交

2026年4月21日

首先提交符合 QC 标准的

2026年5月17日

首次发布 (实际的)

2026年5月22日

研究记录更新

最后更新发布 (实际的)

2026年5月22日

上次提交的符合 QC 标准的更新

2026年5月17日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 26018

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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