Shoulder PainNCT06888791
US-guided Hydro Dissection vs Fluoroscopy-guided Hydro Dissection for Adhesive Capsulitis
A study testing US-guided Hydro Dissection and Fluoroscopy-guided Hydro Dissection in people with Shoulder Pain, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the differences in joint range of motion, Visual Analog Scale (VAS) scores, and the Shoulder Pain and Disability Index (SPADI) outcomes in patients with adhesive capsulitis (frozen shoulder) who undergo hydrodilatation therapy with either ultrasound (USG) or fluoroscopy guidance, in… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- US-guided Hydro Dissection and Fluoroscopy-guided Hydro Dissection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Feb 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of frozen shoulder disease
- VAS>5
Who cannot join
- Other shoulder diseases that may cause shoulder pain (Rotator cuff tear, clavicle fracture, etc.)
- Allergy to local anesthetics
- History of shoulder surgery in the last 12 months
- Pregnancy
- Coagulopathy or antiplatelet use
- The patient has a mental illness that prevents decision-making
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Diskapi Training and Research Hospital
Ankara, 06500
Gokhan YILDIZ, +905059272589 ext. TR, gkoyldz@gmial.com
About this study
Official title: Is Hydro Dissection Treatment More Successful With Ultrasonography or Fluoroscopy in the Management of Adhesive Capsulitis?
This study aims to evaluate the differences in joint range of motion, Visual Analog Scale (VAS) scores, and the Shoulder Pain and Disability Index (SPADI) outcomes in patients with adhesive capsulitis (frozen shoulder) who undergo hydrodilatation therapy with either ultrasound (USG) or fluoroscopy guidance, in addition to a suprascapular nerve block.
Read the detailed description
Adhesive capsulitis is a common condition characterized by painful restriction of both active and passive glenohumeral movement, especially when joint degeneration alone is insufficient to explain the limitation. The condition is more prevalent in women and has a strong correlation with diabetes mellitus and thyroid dysfunction. The prevalence in the general population is approximately 3-5%, but it can reach up to 20% in diabetic patients.
The primary goals of treatment are to alleviate pain, improve mobility, shorten symptom duration, and facilitate a return to normal activities. The suprascapular nerve is a major sensory nerve for the posterior and superior aspects of the shoulder and is an accessible target for blockade. Conditions in which suprascapular nerve block is used include chronic shoulder pain syndromes such as rheumatoid arthritis, glenohumeral osteoarthritis, post-stroke shoulder pain, motor neuron disease-related shoulder pain, and various rotator cuff disorders.
Hydrodilatation therapy works by releasing the contracted joint capsule and reducing fibrosis, while corticosteroids exert strong anti-inflammatory effects throughout the shoulder joint. The high-pressure transmission mechanism used in hydrodilatation enhances the distribution of corticosteroids throughout the glenohumeral joint capsule. The procedure involves injecting fluid into the joint cavity under radiological guidance using either ultrasound or fluoroscopy.
This study aims to determine whether performing hydrodilatation under ultrasound versus fluoroscopy guidance in addition to suprascapular nerve block leads to differences in joint range of motion, VAS scores, and SPADI disability index outcomes in patients diagnosed with adhesive capsulitis. Assessments will be performed before the procedure, on the day of the procedure, and at the 3rd month
- Conditions
- Shoulder Pain
- Being tested
- US-guided Hydro Dissection, Fluoroscopy-guided Hydro Dissection
- Keywords
- Nerve Block, Fluoroscopy, Pain Management
- Medical subject headings
- Shoulder Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US-guided Hydro DissectionProcedure or surgery
All procedures are performed under sterile conditions. The patient is seated in a sitting position with the physician behind the patient, the shoulder joint and the surrounding area is cleaned extensively with 10% povidone iodine. The probe is placed in the posterior lateral region of the shoulder, below the level of the scapular spine. The posterior labrum is observed as a triangular hyperechoic structure extending from the glenoid to the humeral head. A 22 G spinal needle is inserted approximately 1 cm medial to the probe along the axis of the spina scapula and 8 mg (2 mL) dexamethasone, 80 mg (4 mL) 2% lidocaine, 14 mL 0.9% saline is slowly injected into the joint in a total of 20 mL into the glenohumeral region. For suprascapular nerve block, 2 ml 0.5% bupivacaine + 2 ml 0.9% saline is administered. Patients are followed up in the recovery unit for 30 minutes after the procedure.
Fluoroscopy-guided Hydro DissectionProcedure or surgery
The patient is placed on the scope table in supine position and the shoulder joint is cleaned with 10% povidone iodine. The acromioclavicular joint and the glenohumeral joint are visualized using C-arm fluoroscopy with anteroposterior view. The acromioclavicular joint is marked as the entry point to the shoulder joint. After the skin and subcutaneous tissue is anesthetized with 1 cc 2% lidocaine with a 27 G needle, a 22 G spinal needle is inserted through the acromioclavicular joint and the needle is directed towards the glenohumeral joint. With 1 ml of contrast medium, the localization of the needle is confirmed. After appropriate spread of contrast agent, 8 mg (2 mL) dexamethasone, 80 mg (4 mL) 2% lidocaine, 14 mL 0.9% saline are administered into the joint in a total of 20 mL. For US-guided suprascapular nerve block, 2 ml 0.5% bupivacaine + 2 ml 0.9% saline is administered. Patients are followed up in the recovery unit for 30 minutes after the procedure.
| Study group | Role | What they receive |
|---|---|---|
| US-guided Hydro Dissection | Active comparator | US-guided hydro dissection for adhesive capsulitis Receives: Procedure: US-guided Hydro Dissection |
| Fluoroscopy-guided Hydro Dissection | Active comparator | Fluoroscopy-guided hydro dissection for adhesive capsulitis Receives: Procedure: Fluoroscopy-guided Hydro Dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS)
VAS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)
Measured: Change from baseline to 1st and 3rd month after treatment
Secondary outcomes (1)
Shoulder Pain and Disability Index (SPADI)
SPADI is a self-report questionnaire developed to evaluate patients with shoulder problems. The pain subscale has 5-items and the disability subscale has 8-items.The total score ranges from 0 to 100, with higher scores indicating better outcomes.
Measured: Change from baseline to 1st and 3rd month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start25 Feb 2025
- Primary completion25 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damla Yürük, Diskapi Teaching and Research Hospital
- Investigators
- Gevher Rabia Genc Perdecioğlu, Study chair, Diskapi TRH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888791
- Sponsor's protocol ID
- US-guided vs fluoro-guided HD
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Hydro Dissection Treatment More Successful With Ultrasonography or Fluoroscopy in the Management of Adhesive Capsulitis?
- ClinicalTrials.gov ID
- NCT06888791
- Acronym / sponsor ID
- US-guided vs fluoro-guided HD
- Conditions
- Shoulder Pain
- Keywords
- Nerve Block, Fluoroscopy, Pain Management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 25 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 21 Mar 2025 (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.
This study aims to evaluate the differences in joint range of motion, Visual Analog Scale (VAS) scores, and the Shoulder Pain and Disability Index (SPADI) outcomes in patients with adhesive capsulitis (frozen shoulder) who undergo hydrodilatation therapy with either ultrasound (USG) or fluoroscopy guidance, in addition to a suprascapular nerve block.
Detailed description
Adhesive capsulitis is a common condition characterized by painful restriction of both active and passive glenohumeral movement, especially when joint degeneration alone is insufficient to explain the limitation. The condition is more prevalent in women and has a strong correlation with diabetes mellitus and thyroid dysfunction. The prevalence in the general population is approximately 3-5%, but it can reach up to 20% in diabetic patients.
The primary goals of treatment are to alleviate pain, improve mobility, shorten symptom duration, and facilitate a return to normal activities. The suprascapular nerve is a major sensory nerve for the posterior and superior aspects of the shoulder and is an accessible target for blockade. Conditions in which suprascapular nerve block is used include chronic shoulder pain syndromes such as rheumatoid arthritis, glenohumeral osteoarthritis, post-stroke shoulder pain, motor neuron disease-related shoulder pain, and various rotator cuff disorders.
Hydrodilatation therapy works by releasing the contracted joint capsule and reducing fibrosis, while corticosteroids exert strong anti-inflammatory effects throughout the shoulder joint. The high-pressure transmission mechanism used in hydrodilatation enhances the distribution of corticosteroids throughout the glenohumeral joint capsule. The procedure involves injecting fluid into the joint cavity under radiological guidance using either ultrasound or fluoroscopy.
This study aims to determine whether performing hydrodilatation under ultrasound versus fluoroscopy guidance in addition to suprascapular nerve block leads to differences in joint range of motion, VAS scores, and SPADI disability index outcomes in patients diagnosed with adhesive capsulitis. Assessments will be performed before the procedure, on the day of the procedure, and at the 3rd month
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| US-guided Hydro Dissection | Active comparator | Procedure: US-guided Hydro DissectionUS-guided hydro dissection for adhesive capsulitis |
| Fluoroscopy-guided Hydro Dissection | Active comparator | Procedure: Fluoroscopy-guided Hydro DissectionFluoroscopy-guided hydro dissection for adhesive capsulitis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of frozen shoulder disease
- VAS>5
Key exclusion criteria (6 listed)
- Other shoulder diseases that may cause shoulder pain (Rotator cuff tear, clavicle fracture, etc.)
- Allergy to local anesthetics
- History of shoulder surgery in the last 12 months
- Pregnancy
- Coagulopathy or antiplatelet use
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 |
|---|---|---|
| US-guided Hydro DissectionAll procedures are performed under sterile conditions. The patient is seated in a sitting position with the physician behind the patient, the shoulder joint and the surrounding area is cleaned extensively with 10% povidone iodine. The probe is placed in the posterior lateral region of the shoulder, below the level of the scapular spine. The posterior labrum is observed as a triangular hyperechoic structure extending from the glenoid to the humeral head. A 22 G spinal needle is inserted approximately 1 cm medial to the probe along the axis of the spina scapula and 8 mg (2 mL) dexamethasone, 80 mg (4 mL) 2% lidocaine, 14 mL 0.9% saline is slowly injected into the joint in a total of 20 mL into the glenohumeral region. For suprascapular nerve block, 2 ml 0.5% bupivacaine + 2 ml 0.9% saline is administered. Patients are followed up in the recovery unit for 30 minutes after the procedure. | Procedure or surgery | US-guided Hydro Dissection |
| Fluoroscopy-guided Hydro DissectionThe patient is placed on the scope table in supine position and the shoulder joint is cleaned with 10% povidone iodine. The acromioclavicular joint and the glenohumeral joint are visualized using C-arm fluoroscopy with anteroposterior view. The acromioclavicular joint is marked as the entry point to the shoulder joint. After the skin and subcutaneous tissue is anesthetized with 1 cc 2% lidocaine with a 27 G needle, a 22 G spinal needle is inserted through the acromioclavicular joint and the needle is directed towards the glenohumeral joint. With 1 ml of contrast medium, the localization of the needle is confirmed. After appropriate spread of contrast agent, 8 mg (2 mL) dexamethasone, 80 mg (4 mL) 2% lidocaine, 14 mL 0.9% saline are administered into the joint in a total of 20 mL. For US-guided suprascapular nerve block, 2 ml 0.5% bupivacaine + 2 ml 0.9% saline is administered. Patients are followed up in the recovery unit for 30 minutes after the procedure. | Procedure or surgery | Fluoroscopy-guided Hydro Dissection |
Primary outcome
Visual analog scale (VAS)
Time frame: Change from baseline to 1st and 3rd month after treatment
VAS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)
1 secondary outcome
Shoulder Pain and Disability Index (SPADI)
Time frame: Change from baseline to 1st and 3rd month after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
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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.
Gevher Rabia Genc Perdecioğlu study chair
Diskapi TRH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing US-guided Hydro Dissection and Fluoroscopy-guided Hydro Dissection in people with Shoulder Pain, run by Diskapi Teaching 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 2 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: looking for participants now, as of the sponsor's last update on 21 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AYSE BETUL ACAR (+905326685180 ext. TR, betulbozann@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (VAS) (time frame: Change from baseline to 1st and 3rd month after treatment). 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 21 Mar 2025; AzTrials last refreshed its copy on 27 Oct 2026.