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

17 de mayo de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Tipo de estudio

De observación

Inscripción (Estimado)

340

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra de probabilidad

Población de estudio

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

Descripción

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].

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Menopause status at frozen shoulder onset
Periodo de tiempo: Baseline
Part 1: • Self-reported menopause status at the time of FS onset
Baseline
Estimated HbA1c
Periodo de tiempo: 14 days
Part 2: Estimated HbA1c from continuous glucose monitoring (CGM)
14 days

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Type of menopause
Periodo de tiempo: Baseline
Part 1: Type of menopause
Baseline
Frozen shoulder duration
Periodo de tiempo: Baseline
Part 1: Duration of FS symptoms
Baseline
BMI and waist circumference
Periodo de tiempo: Baseline
Part 2: weight and height will be combined to report BMI in kg/m^2
Baseline
Serum fasting lipids
Periodo de tiempo: Baseline
Part 2: serum fasting lipid concentration
Baseline
Step count
Periodo de tiempo: 14 days
Part 2: activity data from ActivPAL
14 days

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de agosto de 2026

Finalización primaria (Estimado)

1 de septiembre de 2027

Finalización del estudio (Estimado)

1 de septiembre de 2027

Fechas de registro del estudio

Enviado por primera vez

21 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

17 de mayo de 2026

Publicado por primera vez (Actual)

22 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

17 de mayo de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 26018

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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