Frozen ShoulderNCT05956171
The Effects of Two Different Treatment Protocols on Shoulder Function, Quality of Life, and Ultrasound Parameters in Patients With Frozen Shoulder
A study testing Intra-articular corticosteroid injection and Ultrasound Guided Hydrodilatation with corticosteroid injection in people with Frozen Shoulder and Shoulder Capsulitis, run by Istanbul University.
Trial summary
The goal of this interventional study is to compare the outcomes of two different injection aprroaches in patients with frozen shoulder. The main questions it aims to answer are: Is hydrodilatation better than intraarticular corticosteroid injection? Is there any prognostic factors that will help clinicians guide… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frozen Shoulder, Shoulder Capsulitis, Shoulder Pain
- What is being tested?
- Intra-articular corticosteroid injection and Ultrasound Guided Hydrodilatation with corticosteroid injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to Mar 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who fulfill the diagnostic criteria for frozen shoulder
- Agree to participate in the study
- Having the opportunity to follow up for at least 3 months
Who cannot join
- Refusing to participate in the study
- History of shoulder injection in the last 3 months
- Having diabetes mellitus
- Presence of comorbidities that contraindicate injection therapy, such as bleeding diathesis
- Known history of allergy or anaphylaxis to drugs used in treatment
Trial locations and contacts
No sites are listed yet.
About this study
The goal of this interventional study is to compare the outcomes of two different injection aprroaches in patients with frozen shoulder. The main questions it aims to answer are:
- Is hydrodilatation better than intraarticular corticosteroid injection?
- Is there any prognostic factors that will help clinicians guide their decision making when choosing between these two treatments?
Participans will receive an injection(cortcosteroid and local anesthetics alone or with hydrodilatation-corticosteroid and local anesthetics plus sterile saline solution) and then they will follow a rehabilitation program.
- Conditions
- Frozen Shoulder, Shoulder Capsulitis, Shoulder Pain
- Being tested
- Intra-articular corticosteroid injection, Ultrasound Guided Hydrodilatation with corticosteroid injection
- Keywords
- hydrodilatation, hydrodistension, ultrasound
- Medical subject headings
- Bursitis, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular corticosteroid injectionOther
5 ml blind intra-articular corticosteroid injection
Ultrasound Guided Hydrodilatation with corticosteroid injectionOther
15 ml intra-articular injection to shoulder via anterior approach under ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Guided Hydrodilatation with corticosteroid injection | Experimental | 15 ml intra-articular injection to shoulder via anterior approach under ultrasound guidance
Drugs:
* betamethasone dipropionate/ betamethasone sodium phosphate(diprospan) (5 mg+2mg/ml) (1 ml)
* prilocaine hydrochloride %2 (4 ml)
* Sodium chloride %0,9 (10 ml) Receives: Other: Ultrasound Guided Hydrodilatation with corticosteroid injection |
| Blind intra-articular corticosteroid injection | Active comparator | 5 ml intra-articular blind injection to shoulder via posterior approach
Drugs:
* betamethasone dipropionate/ betamethasone sodium phosphate(diprospan) (5 mg+2mg/ml) (1 ml)
* prilocaine hydrochloride %2 (4 ml) Receives: Other: Intra-articular corticosteroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline pain score on Visual Analog Scale(VAS)
Pain scored according to VAS; between 0(no pain) to 10(worst pain)
Measured: Baseline, 1 week, 1 month, 3 months
Change in Shoulder Pain and Disability Index(SPADI) scores
Scored between 0-10 ; 0 means no pain and disability and 10 means the worst pain and disability
Measured: Baseline, 1 month, 3 months
Secondary outcomes (7)
Change in Range of Movement(ROM)
Range of shoulder movements assessed with digital inclinometer in sittting and lying positions
Measured: Baseline, 1 week, 1 month, 3 months
Ultrasound Parameters
Coracohumeral ligament(CHL) thickness, axillary pouch(AP) thickness, elastography of deltoid muscle(anterior, middle, and posterior)
Measured: Baseline, 1 month, 3 months
Proprioception(Active position sense- joint position error)
Shoulder joint is positioned in 30 degree flexion and 15 degree internal and external rotation in lying position, patient is asked to position their joints and errors in degrees noted
Measured: Baseline, 3 months
Shoulder Strength
Measured with cybex isokinetic dinamometer, shoulder flexion/extension and shoulder internal/external rotation
Measured: Baseline, 3 months
Changes in Depression Score
measured by Beck's Depression Inventory(between 0 to 40), 0 means no depression and 40 means severe depression
Measured: Baseline, 1 months, 3 months
Changes in Life Quality Score
Items from the SF-36 (Short Form 36) survey, between 0(worst) to 100(best)
Measured: Baseline, 1 month, 3 months
Treatment Satisfaction
Global Improvement and Satisfaction Score, between 1 to 5, 1 very dissatisfied, and 5 very satisfied
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start1 Oct 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen ShoulderStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm study with one hydrodilatation group compared with the standart treatment group(cortisteroid injection)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatmanur Yegin, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956171
- Sponsor's protocol ID
- 2023/890
- Status last verified
- Oct 2023
- First submitted
- 14 Jul 2023
- Last updated
- 11 Oct 2023
- 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 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Two Different Treatment Protocols on Shoulder Function, Quality of Life, and Ultrasound Parameters in Patients With Frozen Shoulder
- ClinicalTrials.gov ID
- NCT05956171
- Acronym / sponsor ID
- 2023/890
- Conditions
- Frozen Shoulder, Shoulder Capsulitis, Shoulder Pain
- Keywords
- hydrodilatation, hydrodistension, ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 21 Jul 2023 (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 goal of this interventional study is to compare the outcomes of two different injection aprroaches in patients with frozen shoulder. The main questions it aims to answer are:
- Is hydrodilatation better than intraarticular corticosteroid injection?
- Is there any prognostic factors that will help clinicians guide their decision making when choosing between these two treatments?
Participans will receive an injection(cortcosteroid and local anesthetics alone or with hydrodilatation-corticosteroid and local anesthetics plus sterile saline solution) and then they will follow a rehabilitation program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm study with one hydrodilatation group compared with the standart treatment group(cortisteroid injection)
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Guided Hydrodilatation with corticosteroid injection | Experimental | Other: Ultrasound Guided Hydrodilatation with corticosteroid injection15 ml intra-articular injection to shoulder via anterior approach under ultrasound guidance Drugs: * betamethasone dipropionate/ betamethasone sodium phosphate(diprospan) (5 mg+2mg/ml) (1 ml) * prilocaine hydrochloride %2 (4 ml) * Sodium chloride %0,9 (10 ml) |
| Blind intra-articular corticosteroid injection | Active comparator | Other: Intra-articular corticosteroid injection5 ml intra-articular blind injection to shoulder via posterior approach Drugs: * betamethasone dipropionate/ betamethasone sodium phosphate(diprospan) (5 mg+2mg/ml) (1 ml) * prilocaine hydrochloride %2 (4 ml) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who fulfill the diagnostic criteria for frozen shoulder
- Agree to participate in the study
- Having the opportunity to follow up for at least 3 months
Key exclusion criteria (5 listed)
- Refusing to participate in the study
- History of shoulder injection in the last 3 months
- Having diabetes mellitus
- Presence of comorbidities that contraindicate injection therapy, such as bleeding diathesis
- Known history of allergy or anaphylaxis to drugs used in treatment
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 corticosteroid injection5 ml blind intra-articular corticosteroid injection | Other | Blind intra-articular corticosteroid injection |
| Ultrasound Guided Hydrodilatation with corticosteroid injection15 ml intra-articular injection to shoulder via anterior approach under ultrasound guidance | Other | Ultrasound Guided Hydrodilatation with corticosteroid injection |
Primary outcome
Change from baseline pain score on Visual Analog Scale(VAS)
Time frame: Baseline, 1 week, 1 month, 3 months
Pain scored according to VAS; between 0(no pain) to 10(worst pain)
Change in Shoulder Pain and Disability Index(SPADI) scores
Time frame: Baseline, 1 month, 3 months
Scored between 0-10 ; 0 means no pain and disability and 10 means the worst pain and disability
7 secondary outcomes
Change in Range of Movement(ROM)
Time frame: Baseline, 1 week, 1 month, 3 months
Ultrasound Parameters
Time frame: Baseline, 1 month, 3 months
Proprioception(Active position sense- joint position error)
Time frame: Baseline, 3 months
Shoulder Strength
Time frame: Baseline, 3 months
Changes in Depression Score
Time frame: Baseline, 1 months, 3 months
Changes in Life Quality Score
Time frame: Baseline, 1 month, 3 months
Treatment Satisfaction
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-articular corticosteroid injection and Ultrasound Guided Hydrodilatation with corticosteroid injection in people with Frozen Shoulder and Shoulder Capsulitis, run by Istanbul University.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatmanur Yegin (0905462729955, fatmanur.yegin@istanbul.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline pain score on Visual Analog Scale(VAS) (time frame: Baseline, 1 week, 1 month, 3 months). The study lists 2 primary outcomes in all. 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 11 Oct 2023.