ClinicalTrials.gg
Not yet recruitingNCT07603089MENO-FROSTUpdated May 22, 2026

Exploring the Link Between Menopause, Glucose Control, and Frozen Shoulder in Women

An observational study in Frozen Shoulder, sponsored by University of Nottingham. Not yet recruiting. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by University of Nottingham · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
340
Ages
18 Years and older
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Frozen Shoulder

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Keywords

  • frozen shoulder
  • menopause
  • glucose
03

In context

Bursitis

383 studies on the registry are indexed under Bursitis; 111 are open to participants now.

This study's planned enrollment of 340 is above the median of 50 across 29 observational studies indexed under Bursitis.

Browse Bursitis studies →

Lead sponsor

University of Nottingham is the lead sponsor of 465 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Eligibility criteria

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].
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
340 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. Menopause status at frozen shoulder onset

    Part 1: • Self-reported menopause status at the time of FS onset

    Time frame: Baseline

  2. Estimated HbA1c

    Part 2: Estimated HbA1c from continuous glucose monitoring (CGM)

    Time frame: 14 days

Secondary outcomes

  1. Type of menopause

    Part 1: Type of menopause

    Time frame: Baseline

  2. Frozen shoulder duration

    Part 1: Duration of FS symptoms

    Time frame: Baseline

  3. BMI and waist circumference

    Part 2: weight and height will be combined to report BMI in kg/m\^2

    Time frame: Baseline

  4. Serum fasting lipids

    Part 2: serum fasting lipid concentration

    Time frame: Baseline

  5. Step count

    Part 2: activity data from ActivPAL

    Time frame: 14 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07603089
Responsible party
Natalie Shur (Clinical Assistant Professor, University of Nottingham) — Principal investigator
First posted
May 22, 2026
Start date
Aug 2026 (estimated)
Primary completion
Sep 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
May 22, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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