Adhesive CapsulitisNCT06202963
Has Ultrasound-guided Hydrorelease of Coracohumeral Ligamet Additional Benefit in Patients With Adhesive Capsulitis Receiving Ultrasound-guided Shoulder Hyrodilatation?
A study testing Triamcinolone Acetonide in people with Adhesive Capsulitis, run by Haydarpasa Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this study is to detect if there is an additional benefit to performing ultrasound-guided hydrorelease of the coracohumeral ligament in patients with adhesive capsulitis of the shoulder receiving ultrasound-guided hydrodilatation. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Triamcinolone Acetonide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Dec 2023to 15 Mar 2025
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between the ages of 30 and 70 who have complained of shoulder pain and limitation in the shoulder for at least 3 months and have been diagnosed with adhesive capsulitis by clinical examination will be included in the study.
Who cannot join
- A history of physical therapy or injections for the shoulder joint within the previous three months,
- The existence of a neurological condition or surgical history that could impair upper limb functions,
- Being a breastfeeding or pregnant woman,
- Mental illnesses and cognitive impairments that impair cooperation
- Diabetes mellitus with unregulated glucose levels
- Presence of Cancer
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Science University Haydarpasa Numune Research and Training Hospital
Istanbul, Uskudar, 34668
About this study
The goal of this study is to detect if there is an additional benefit to performing ultrasound-guided hydrorelease of the coracohumeral ligament in patients with adhesive capsulitis of the shoulder receiving ultrasound-guided hydrodilatation.
Read the detailed description
This study is organised as double-blind, randomised controlled trial. Written informed consent will be taken from all the patients participating to the study.
Inclusion Criteria
Patients between the ages of 30 and 70, who have complaints of shoulder pain and limitation in the shoulder for at least 3 months and are diagnosed with Adhesive Capsulitis by clinical examination, will be included in the study.
Exlusion Criteria
- A history of physical therapy or injections for the shoulder joint within the previous three months,
- The existence of a neurological condition or surgical history that could impair upper limb functions,
- Being a breastfeeding or pregnant woman,
- Mental illnesses and cognitive impairments that impair cooperation
- Diabetes mellitus with unregulated glucose levels
- Presenece of Cancer
Patients included in the study will be divided into two groups by block randomization.
In group 1, hydrodilatation will be performed with intra-articular 40 mg triamcinolone, lidocaine, and physiological saline through a posterior approach to the shoulder, guided by ultrasonographic imaging. Fluid injection will continue until distension is observed in the shoulder joint capsule by ultrasonography. The amount of fluid given will be recorded.
The second group will undergo hydrodilatation with intra-articular 40 mg triamcinolone, lidocaine, and physiological saline through a posterior approach to the shoulder, guided by ultrasonographic imaging. Additionally, with ultrasonographic evaluation, 2 cc of physiological saline will be injected into the corocohumeral ligament.
All the patients will be evaluated by a doctor who is blind to the study groups. Demographic information, history of shoulder pain, presence of chronic diseases, pain severity measured by VAS during resting,activity and sleep will be recorded. Physical examination including shoulder range of motion, will be evaluated. Shoulder Disability Index will be used for evaluating the functional status of shoulder. They will be evaluated before and immediately after injection, 1 week later, 1 month and 3 months after injection with VAS, shoulder range of motion and Shoulder Disability Index.
- Conditions
- Adhesive Capsulitis
- Being tested
- Triamcinolone Acetonide
- Keywords
- Adhesive Capsulitis, Coracohumeral ligament, Hydrorelease, Hydrodilatation
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone AcetonideDrug
Also called lidocaine, serum physiologic
- group will receive ultrasound-guided hydrodilatation
- group will receive ultarsound-guided coracohumeral hydrorelease in addition to the ultrasound-guided hydrodilaltation of shoulder
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | In group 1, hydrodilatation will be performed with intra-articular 40 mg triamcinolone, lidocaine, and physiological saline through a posterior approach to the shoulder, guided by ultrasonographic imaging. Fluid injection will continue until distension is observed in the shoulder joint capsule by ultrasonography. The amount of fluid given will be recorded. Receives: Drug: Triamcinolone Acetonide |
| Group 2 | Active comparator | The second group will undergo hydrodilatation with intra-articular 40 mg triamcinolone, lidocaine, and physiological saline through a posterior approach to the shoulder, guided by ultrasonographic imaging. The amount of fluid given will be recorded. Additionally, with ultrasonographic evaluation, 2 cc of physiological saline will be injected into the corocohumeral ligament. Receives: Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analouge Scale (VAS)
Pain Severity
Measured: Before and immediately after injection, 1 week,1 month and 2 moths after injection
Shoulder Range of Motion
Shoulder Limitation
Measured: Before and immediately after injection, 1 week,1 month and 2 moths after injection
Shoulder Disability Index
Shouler Disability
Measured: Before injection, 1 week,1 month and 2 moths after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start18 Dec 2023
- Primary completion15 Mar 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive CapsulitisStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haydarpasa Numune Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel süzen Özbayrak, Haydarpasa Numune Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202963
- Sponsor's protocol ID
- HNEAH-KAEK/KK/2023/210
- Status last verified
- Mar 2025
- First submitted
- 2 Jan 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Has Ultrasound-guided Hydrorelease of Coracohumeral Ligamet Additional Benefit in Patients With Adhesive Capsulitis Receiving Ultrasound-guided Shoulder Hyrodilatation?
- ClinicalTrials.gov ID
- NCT06202963
- Acronym / sponsor ID
- HNEAH-KAEK/KK/2023/210
- Conditions
- Adhesive Capsulitis
- Keywords
- Adhesive Capsulitis, Coracohumeral ligament, Hydrorelease, Hydrodilatation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Haydarpasa Numune Training and Research HospitalUniversity, hospital or other
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 12 Jan 2024 (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 study is to detect if there is an additional benefit to performing ultrasound-guided hydrorelease of the coracohumeral ligament in patients with adhesive capsulitis of the shoulder receiving ultrasound-guided hydrodilatation.
Detailed description
This study is organised as double-blind, randomised controlled trial. Written informed consent will be taken from all the patients participating to the study.
Inclusion Criteria
Patients between the ages of 30 and 70, who have complaints of shoulder pain and limitation in the shoulder for at least 3 months and are diagnosed with Adhesive Capsulitis by clinical examination, will be included in the study.
Exlusion Criteria
- A history of physical therapy or injections for the shoulder joint within the previous three months,
- The existence of a neurological condition or surgical history that could impair upper limb functions,
- Being a breastfeeding or pregnant woman,
- Mental illnesses and cognitive impairments that impair cooperation
- Diabetes mellitus with unregulated glucose levels
- Presenece of Cancer
Patients included in the study will be divided into two groups by block randomization.
In group 1, hydrodilatation will be performed with intra-articular 40 mg triamcinolone, lidocaine, and physiological saline through a posterior approach to the shoulder, guided by ultrasonographic imaging. Fluid injection will continue until distension is observed in the shoulder joint capsule by ultrasonography. The amount of fluid given will be recorded.
The second group will undergo hydrodilatation with intra-articular 40 mg triamcinolone, lidocaine, and physiological saline through a posterior approach to the shoulder, guided by ultrasonographic imaging. Additionally, with ultrasonographic evaluation, 2 cc of physiological saline will be injected into the corocohumeral ligament.
All the patients will be evaluated by a doctor who is blind to the study groups. Demographic information, history of shoulder pain, presence of chronic diseases, pain severity measured by VAS during resting,activity and sleep will be recorded. Physical examination including shoulder range of motion, will be evaluated. Shoulder Disability Index will be used for evaluating the functional status of shoulder. They will be evaluated before and immediately after injection, 1 week later, 1 month and 3 months after injection with VAS, shoulder range of motion and Shoulder Disability Index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Triamcinolone AcetonideIn group 1, hydrodilatation will be performed with intra-articular 40 mg triamcinolone, lidocaine, and physiological saline through a posterior approach to the shoulder, guided by ultrasonographic imaging. Fluid injection will continue until distension is observed in the shoulder joint capsule by ultrasonography. The amount of fluid given will be recorded. |
| Group 2 | Active comparator | Drug: Triamcinolone AcetonideThe second group will undergo hydrodilatation with intra-articular 40 mg triamcinolone, lidocaine, and physiological saline through a posterior approach to the shoulder, guided by ultrasonographic imaging. The amount of fluid given will be recorded. Additionally, with ultrasonographic evaluation, 2 cc of physiological saline will be injected into the corocohumeral ligament. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients between the ages of 30 and 70 who have complained of shoulder pain and limitation in the shoulder for at least 3 months and have been diagnosed with adhesive capsulitis by clinical examination will be included in the study.
Key exclusion criteria (6 listed)
- A history of physical therapy or injections for the shoulder joint within the previous three months,
- The existence of a neurological condition or surgical history that could impair upper limb functions,
- Being a breastfeeding or pregnant woman,
- Mental illnesses and cognitive impairments that impair cooperation
- Diabetes mellitus with unregulated glucose levels
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 |
|---|---|---|
| Triamcinolone AcetonideAlso: lidocaine, serum physiologic1. group will receive ultrasound-guided hydrodilatation 2. group will receive ultarsound-guided coracohumeral hydrorelease in addition to the ultrasound-guided hydrodilaltation of shoulder | Drug | Group 1, Group 2 |
Primary outcome
Visual Analouge Scale (VAS)
Time frame: Before and immediately after injection, 1 week,1 month and 2 moths after injection
Pain Severity
Shoulder Range of Motion
Time frame: Before and immediately after injection, 1 week,1 month and 2 moths after injection
Shoulder Limitation
Shoulder Disability Index
Time frame: Before injection, 1 week,1 month and 2 moths after injection
Shouler Disability
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 2 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Adhesive Capsulitis
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Effects of Clinic Versus mHealth Application-Based Shoulder Rehabilitation in Patients With Adhesive Capsulitis
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Effects of Posterior Capsular Stretching With and Without Dynamic Neuromuscular Stabilization Exercises in Frozen Shoulder
Frozen Shoulder
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Spencer vs. Ola Grimsby Techniques With Scapular Motor Training in Idiopathic Adhesive Capsulitis
Idiopathic Adhesive Capsulitis
Not yet recruitingPhase 4
OMT for Adhesive Capsulitis
Adhesive Capsulitis of the Shoulder, Frozen Shoulder
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triamcinolone Acetonide in people with Adhesive Capsulitis, run by Haydarpasa Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 6 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 2 Apr 2025. 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 Turkey (Türkiye). 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?
Visual Analouge Scale (VAS) (time frame: Before and immediately after injection, 1 week,1 month and 2 moths after injection). The study lists 3 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 2 Apr 2025.