Breast NeoplasmNCT04640220
Improvement of Range of Motion in Frozen Shoulder in Breast Cancer Survivors
A study testing Intra-articular steroid injection in people with Breast Neoplasm and Shoulder Capsulitis, run by Yeungnam University Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Neoplasm, Shoulder Capsulitis, Range of Motion
- What is being tested?
- Intra-articular steroid injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Oct 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who underwent breast cancer surgery within 6 months.
- Patients with shoulder pain and limited range of motion
Who cannot join
- Patients with infection
- Bilateral shoulder pain patient
- Patients with uncontrolled diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Intra-articular Steroid Injection in Breast Cancer Survivors With Adhesive Capsulitis According to the Thickness of Axillary Capsulitis Thickness
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.
- Conditions
- Breast Neoplasm, Shoulder Capsulitis, Range of Motion
- Being tested
- Intra-articular steroid injection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular steroid injectionProcedure or surgery
Ultrasound-guided Gleno-humeral joint steroid (Triamcinolone 40mg with 0.5% lidocaine ) injection
| Study group | Role | What they receive |
|---|---|---|
| Adhesive capsulitis in breast cancer survivors | Experimental | Intra-articular steroid injection Receives: Procedure: Intra-articular steroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline at 3 months
Secondary outcomes (2)
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.
Measured: Change from baseline at 3 months
Axillary recess capsule thickness
Ultrasound measurements of axillary recess capsule thickness in unilateral frozen shoulder
Measured: Change from baseline at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start26 Oct 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Adhesive capsulitis patients who underwent breast cancer operation
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeungnam University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Gyu Lee, Yeungnam University Hospital
- Investigators
- Dong Gyu Dong Gyu, M.D., Ph.D., Principal investigator, College of medicine, Yeungnam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640220
- Sponsor's protocol ID
- 2020-07-064-002
- Status last verified
- Jan 2022
- First submitted
- 12 Nov 2020
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Intra-articular Steroid Injection in Breast Cancer Survivors With Adhesive Capsulitis According to the Thickness of Axillary Capsulitis Thickness
- ClinicalTrials.gov ID
- NCT04640220
- Acronym / sponsor ID
- 2020-07-064-002
- Conditions
- Breast Neoplasm, Shoulder Capsulitis, Range of Motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Yeungnam University HospitalUniversity, hospital or other
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 23 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Adhesive capsulitis patients who underwent breast cancer operation
| Arm | Type | Receives |
|---|---|---|
| Adhesive capsulitis in breast cancer survivors | Experimental | Procedure: Intra-articular steroid injectionIntra-articular steroid injection |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who underwent breast cancer surgery within 6 months.
- Patients with shoulder pain and limited range of motion
Key exclusion criteria (3 listed)
- Patients with infection
- Bilateral shoulder pain patient
- Patients with uncontrolled diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-articular steroid injectionUltrasound-guided Gleno-humeral joint steroid (Triamcinolone 40mg with 0.5% lidocaine ) injection | Procedure or surgery | Adhesive capsulitis in breast cancer survivors |
Primary outcome
Range of motion of shoulder joint
Time frame: Change from baseline at 3 months
A goniometer is an instrument which measures the available range of motion at a joint.Flexion, Extension,Adduction,Abduction, Internal Rotation,External rotation
2 secondary outcomes
Change in score on Shoulder Pain and Disability Index (SPADI)
Time frame: Change from baseline at 3 months
Axillary recess capsule thickness
Time frame: Change from baseline at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong Gyu Dong Gyu, M.D., Ph.D. principal investigator
College of medicine, Yeungnam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-articular steroid injection in people with Breast Neoplasm and Shoulder Capsulitis, run by Yeungnam University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion of shoulder joint (time frame: Change from baseline at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2022.