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CompletedNCT04640220Updated Jan 10, 2022

Improvement of Range of Motion in Frozen Shoulder in Breast Cancer Survivors

An interventional study of Intra-articular steroid injection in Breast Neoplasm, Shoulder Capsulitis and Range of Motion, sponsored by Yeungnam University Hospital. Completed at 1 site in Korea, Republic of. Open to female participants. Per ClinicalTrials.gov, last updated 2022-01-10.

Sponsored by Yeungnam University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Sex
Female
01

Study summary

The prevalence of shoulder joint disease is high in breast cancer patients. The cause of adhesive capsulitis is not clearly identified. However, the following are known as relevant factors that are the restriction of the use of the arm after surgery, inflammation due to autoimmune action, radiation therapy, and adhesion of the surgical site. The purpose of this study is to compare and analyze the effect of intrathecal steroid injection in breast cancer survivors with adhesive capsulitis.

02

Conditions studied

  • Breast Neoplasm
  • Shoulder Capsulitis
  • Range of Motion

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03

In context

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

This study's enrollment of 28 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Yeungnam University Hospital is the lead sponsor of 8 studies on the registry; 2 are open to participants now.

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

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients who underwent breast cancer surgery within 6 months.
  • Patients with shoulder pain and limited range of motion

Exclusion criteria

Exclusion Criteria:

  • Patients with infection
  • Bilateral shoulder pain patient
  • Patients with uncontrolled diabetes
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Adhesive capsulitis in breast cancer survivors

    Intra-articular steroid injection

    Procedure: Intra-articular steroid injection

Interventions

  • ProcedureIntra-articular steroid injection

    Ultrasound-guided Gleno-humeral joint steroid (Triamcinolone 40mg with 0.5% lidocaine ) injection

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What researchers measure

Primary outcomes

  1. Range of motion of shoulder joint

    A goniometer is an instrument which measures the available range of motion at a joint.Flexion, Extension,Adduction,Abduction, Internal Rotation,External rotation

    Time frame: Change from baseline at 3 months

Secondary outcomes

  1. Change in score on Shoulder Pain and Disability Index (SPADI)

    SPADI is a scale consisting of 0-10; 0 being the best and 10 being the worse pain ever; higher scores mean a worse outcome.

    Time frame: Change from baseline at 3 months

  2. Axillary recess capsule thickness

    Ultrasound measurements of axillary recess capsule thickness in unilateral frozen shoulder

    Time frame: Change from baseline at 3 months

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Study locations

1 site
  • Yeungnam University Hospital
    Daegu, 42127, Korea, Republic of
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2020 to primary completion in Dec 2021, 14 months.

Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's 14 months is below that.

Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 12, 2020
First posted
Nov 23, 2020
StartActual
Oct 26, 2020
Primary completionActual
Dec 31, 2021
CompletionActual
Dec 31, 2021
Last update
Jan 10, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04640220
Lead sponsor
Yeungnam University Hospital
Responsible party
Dong Gyu Lee (Assistant professor, Yeungnam University Hospital) — Principal investigator
First posted
Nov 23, 2020
Start date
Oct 26, 2020
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021
Last update
Jan 10, 2022

Study contacts

Dong Gyu Dong Gyu, M.D., Ph.D.
principal investigator · College of medicine, Yeungnam University

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 completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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