Calcific TendinitisNCT05272085

Comparison of the Efficiency of Ultrasound-Guided Lavage and Subacromial Bursa Injection in Calcific Tendinitis

A study testing Ultrasound Guided Lavage and Ultrasound Guided Subacromial Bursa Injection in people with Calcific Tendinitis and Calcific Tendinitis of Shoulder, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

It is aimed to compare in the early period the clinical and ultrasonographic findings in terms of the effectiveness of ultrasound-guided subacromial bursa injection with corticosteroid and ultrasound-guided lavage, which are the treatment options available in the literature for patients with calcific tendinitis who do… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Calcific Tendinitis, Calcific Tendinitis of Shoulder, Shoulder Pain
What is being tested?: Ultrasound Guided Lavage and Ultrasound Guided Subacromial Bursa Injection
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 9 Mar 2022to 30 Nov 2022
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Cases diagnosed with calcific tendinitis who did not benefit from conservative treatment
Cases with calcific deposits greater than 1 cm in direct radiography, ultrasonography, or magnetic resonance imaging
Cases between the ages of 18-75 whose informed consent was obtained for participation in the study

Who cannot join

Cases with radiculopathy ipsilateral to the affected shoulder
Cases with active inflammatory arthropathy of the affected shoulder
Cases with previous shoulder surgery
Cases with a history of humeral head, scapula, and clavicle fractures
Cases with neurological deficit affecting the upper extremity
Cases with uncontrolled diabetes mellitus and uncontrolled hypertension, uncompensated congestive heart failure, chronic renal failure, chronic liver disease, tumor and/or vascular disease, inflammatory and/or infectious diseases, currently active psychiatric disease

Show all 10Show fewer

Cases with a history of subacromial bursa injection, calcific lavage or shoulder joint injection in the last 3 months
Cases with a history of allergic reaction to the substance to be applied as local anesthetic
Pregnancy or lactation
Anticoagulant or antiagregant (antiplatelet) medication use that may interfere with the injection procedure.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Istanbul University- Cerrahpaşa
Istanbul, 34098

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of the Efficacy of Ultrasound-Guided Lavage and Subacromial Bursa Injection in Calcific Tendinitis: A Prospective, Randomized, Double-Blind Study

Read the detailed description

Calcific tendinitis is a disease that occurs with the precipitation of hydroxyapatite crystals on tendons and shoulder region is the most involved. In the shoulder region, calcific tendinitis can involve all rotator cuff tendons, most commonly the supraspinatus. It may progress with pain and functional limitation. The pain can increase with movement or can occur at rest and sleep. The prevalence of calcific tendinitis is between 2.7% and 20% in the general population. The most common age group is between 30 and 60. It can negatively affect the family and social life of the person and cause loss of workforce.

Especially in the treatment of patients with calcific tendinitis unresponsive to conservative treatment, ultrasound-guided corticosteroid injection in subacromial bursa and ultrasound-guided lavage are frequently used treatment options. However, there are very few studies in the literature comparing these two treatment methods as randomized controlled trials.

In this study, it is aimed to compare the effectiveness of ultrasound guided subacromial bursa injection and ultrasound guided lavage procedures on pain scores, functional scales, disability scales, direct radiography findings and ultrasonographic imaging findings.

Conditions: Calcific Tendinitis, Calcific Tendinitis of Shoulder, Shoulder Pain
Being tested: Ultrasound Guided Lavage, Ultrasound Guided Subacromial Bursa Injection
Keywords: Calcific tendinitis, Shoulder pain, Ultrasound-guided, Lavage, Barbotage, subacromial bursa injection
Medical subject headings: Rotator Cuff Tear Arthropathy, Shoulder Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ultrasound Guided LavageProcedure or surgery
Also called Ultrasound Guided Barbotage
After local anesthesia of subcutaneous tissue, lavage will be performed under the guidance of ultrasound using an 18-gauge needle with injectors filled with 4 ml of saline. The needle will be advanced to the center of the calcific deposit. The injector will be kept as parallel to the ground as possible. The plunger of the injector will be pushed with a gently pressure and then released. Calcific deposits are expected to be filled into the syringe along with saline. It is predicted that the clear saline will gradually turn white and become cloudy due to the incoming calcific deposits. When the color of the liquid becomes cloudy, the syringe will be removed without moving the needle, and a new syringe containing 4 ml saline will be placed in its place. Thus, the aspirated calcific deposits will not be reinjected. The same process will be repeated with a new saline filled syringe. After the procedure, 2 ml dexamethasone and 3 ml lidocaine will be injected in subacromial bursa.
Ultrasound Guided Subacromial Bursa InjectionProcedure or surgery
2 ml dexamethasone and 3 ml %2 lidocaine will be injected in the subacromial bursa using a 21-gauge needle under ultrasound guidance.

Study groups in NCT05272085
Study group	Role	What they receive
Ultrasound Guided Lavage Group	Active comparator	The physical examination, pain scoring, functional scale, disability scale, special tests, direct radiography findings and ultrasonographic imaging findings of the patients in this group before the treatment and 1 month after the treatment will be evaluated and will be recorded. Size of calcific deposits and Gartner classification will be evaluated on direct radiography. Size, shape, acoustic shadowing, power doppler activity of calcific deposits and other bursitis, tendinitis, ruptures, effusion in the shoulder will be evaluated on ultrasonographic imaging. Patients in this group will be treated with ultrasound-guided lavage. Receives: Procedure: Ultrasound Guided Lavage
Ultrasound Guided Subacromial Bursa Injection Group	Active comparator	The physical examination, pain scoring, functional scale, disability scale, special tests, direct radiography findings and ultrasonographic imaging findings of the patients in this group before the treatment and 1 month after the treatment will be evaluated and will be recorded. Size of calcific deposits and Gartner classification will be evaluated on direct radiography. Size, shape, acoustic shadowing, power doppler activity of calcific deposits and other bursitis, tendinitis, ruptures, effusion in the shoulder will be evaluated on ultrasonographic imaging. Patients in this group will be treated with ultrasound-guided subacromial bursa injection with corticosteroid and lidocaine. Receives: Procedure: Ultrasound Guided Subacromial Bursa Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of Range of Motion
The change in a participant's range of motion degree as measured by a goniometer (Passive Range of Motion and Active Range of Motion) from baseline to 1 month.
Measured: Baseline, 1 month
Clinical improvement measured by change in Numeric Rating Scale
A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. A patient selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing "worst possible pain"
Measured: Baseline, 1 hour, 1 month
Clinical improvement measured by change in Constant Shoulder Score
The constant shoulder score is a validated scale, measuring the shoulder function. It is an objective measurement independent of the shoulder pain. It is a 100-points scale composed of a number of individual parameters. The minimum score is 0, the maximum score is 100 points. The higher the score, the higher the quality of the function.
Measured: Baseline, 1 month
Clinical improvement measured by change in Quick Dash Score
Individual's ability to complete tasks, absorb forces, and severity of symptoms are measured by a 11 item Quick Dash questionnaire. At least 10 of the 11 items must be completed for a score to be calculated and the scores range from 0 (no disability) to 100 (most severe disability).
Measured: Baseline, 1 month
Clinical improvement measured by change in Shoulder Disability Questionnaire
This score measures the disability of the shoulder in daily life, work, social life.0 points indicate maximum well-being, 100 points indicate maximum disability
Measured: Baseline, 1 month
Change in Gartner Score of the Shoulder Calcifications on Direct Radiography
Radiological classification of calcifying tendinitis
Measured: Baseline, 1 month
Change in ultrasound scoring system presented by Chiou
This score includes size, shape (arc, fragmented, nodular, cystic), power doppler activity of calcific deposits.
Measured: Baseline, 1 month
Change in ultrasound classification system of calcific deposits presented by Farin
This classification includes acoustic shadowing of calcific deposits (well-defined shadow, faint shadow and no shadow)
Measured: Baseline, 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Mar 202230 Nov 2022

First posted9 Mar 2022
Study start9 Mar 2022
Primary completion30 Aug 2022
Study completion30 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Calcific TendinitisStudies of the same condition, open and under way.
More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
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: Participant
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05272085
Sponsor's protocol ID: IstanbulUC-NTugbayYildiran-01
Status last verified: Jan 2023
First submitted: 20 Feb 2022
Last updated: 31 Jan 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Louwerens JK, Sierevelt IN, van Hove RP, van den Bekerom MP, van Noort A. Prevalence of calcific deposits within the rotator cuff tendons in adults with and without subacromial pain syndrome: clinical and radiologic analysis of 1219 patients. J Shoulder Elbow Surg. 2015 Oct;24(10):1588-93. doi: 10.1016/j.jse.2015.02.024. Epub 2015 Apr 11.
PubMed 25870115
Sansone V, Maiorano E, Galluzzo A, Pascale V. Calcific tendinopathy of the shoulder: clinical perspectives into the mechanisms, pathogenesis, and treatment. Orthop Res Rev. 2018 Oct 3;10:63-72. doi: 10.2147/ORR.S138225. eCollection 2018.
PubMed 30774461
Sansone V, Consonni O, Maiorano E, Meroni R, Goddi A. Calcific tendinopathy of the rotator cuff: the correlation between pain and imaging features in symptomatic and asymptomatic female shoulders. Skeletal Radiol. 2016 Jan;45(1):49-55. doi: 10.1007/s00256-015-2240-3. Epub 2015 Aug 27.
PubMed 26306389
Greis AC, Derrington SM, McAuliffe M. Evaluation and nonsurgical management of rotator cuff calcific tendinopathy. Orthop Clin North Am. 2015 Apr;46(2):293-302. doi: 10.1016/j.ocl.2014.11.011. Epub 2015 Jan 27.
PubMed 25771323
de Witte PB, Selten JW, Navas A, Nagels J, Visser CP, Nelissen RG, Reijnierse M. Calcific tendinitis of the rotator cuff: a randomized controlled trial of ultrasound-guided needling and lavage versus subacromial corticosteroids. Am J Sports Med. 2013 Jul;41(7):1665-73. doi: 10.1177/0363546513487066. Epub 2013 May 21.
PubMed 23696211
Chiou HJ, Chou YH, Wu JJ, Hsu CC, Huang DY, Chang CY. Evaluation of calcific tendonitis of the rotator cuff: role of color Doppler ultrasonography. J Ultrasound Med. 2002 Mar;21(3):289-95; quiz 296-7. doi: 10.7863/jum.2002.21.3.289.
PubMed 11883540
Farin PU, Jaroma H. Sonographic findings of rotator cuff calcifications. J Ultrasound Med. 1995 Jan;14(1):7-14. doi: 10.7863/jum.1995.14.1.7.
PubMed 7707483
Gartner J, Heyer A. [Calcific tendinitis of the shoulder]. Orthopade. 1995 Jun;24(3):284-302. German.
PubMed 7617385
Zhang T, Duan Y, Chen J, Chen X. Efficacy of ultrasound-guided percutaneous lavage for rotator cuff calcific tendinopathy: A systematic review and meta-analysis. Medicine (Baltimore). 2019 May;98(21):e15552. doi: 10.1097/MD.0000000000015552.
PubMed 31124934
Lee S.H. (2020) Calcific Tendinitis Intervention. In: Peng P., Finlayson R., Lee S., Bhatia A. (eds) Ultrasound for Interventional Pain Management. Springer, Cham. https://doi.org/10.1007/978-3-030-18371-4_26

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Ultrasound-Guided Extracorporeal Shock Wave Therapy for Calcific Tendinitis
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The Effect of Doppler Ultrasound on Calcified Tendinitis
Calcific Tendinitis of Shoulder
Not yet recruiting
Paracetamol and Ibuprofen With or Without Famotidine for Calcific Tendinitis of the Shoulder
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RecruitingObservational study
A Novel Classification in Calcific Tendinitis of the Shoulder: Evaluating MRI Localization and Related Treatment Strategies
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All Calcific Tendinitis trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Efficacy of Ultrasound-Guided Lavage and Subacromial Bursa Injection in Calcific Tendinitis: A Prospective, Randomized, Double-Blind Study
ClinicalTrials.gov ID: NCT05272085
Acronym / sponsor ID: IstanbulUC-NTugbayYildiran-01
Conditions: Calcific Tendinitis, Calcific Tendinitis of Shoulder, Shoulder Pain
Keywords: Calcific tendinitis, Shoulder pain, Ultrasound-guided, Lavage, Barbotage, subacromial bursa injection
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Istanbul University - CerrahpasaUniversity, hospital or other
Study start: 9 Mar 2022 (actual)
Primary completion: 30 Aug 2022 (actual)
Study completion: 30 Nov 2022 (actual)
First posted: 9 Mar 2022 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Ultrasound Guided Lavage Group	Active comparator	Procedure: Ultrasound Guided LavageThe physical examination, pain scoring, functional scale, disability scale, special tests, direct radiography findings and ultrasonographic imaging findings of the patients in this group before the treatment and 1 month after the treatment will be evaluated and will be recorded. Size of calcific deposits and Gartner classification will be evaluated on direct radiography. Size, shape, acoustic shadowing, power doppler activity of calcific deposits and other bursitis, tendinitis, ruptures, effusion in the shoulder will be evaluated on ultrasonographic imaging. Patients in this group will be treated with ultrasound-guided lavage.
Ultrasound Guided Subacromial Bursa Injection Group	Active comparator	Procedure: Ultrasound Guided Subacromial Bursa InjectionThe physical examination, pain scoring, functional scale, disability scale, special tests, direct radiography findings and ultrasonographic imaging findings of the patients in this group before the treatment and 1 month after the treatment will be evaluated and will be recorded. Size of calcific deposits and Gartner classification will be evaluated on direct radiography. Size, shape, acoustic shadowing, power doppler activity of calcific deposits and other bursitis, tendinitis, ruptures, effusion in the shoulder will be evaluated on ultrasonographic imaging. Patients in this group will be treated with ultrasound-guided subacromial bursa injection with corticosteroid and lidocaine.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Cases diagnosed with calcific tendinitis who did not benefit from conservative treatment
Cases with calcific deposits greater than 1 cm in direct radiography, ultrasonography, or magnetic resonance imaging
Cases between the ages of 18-75 whose informed consent was obtained for participation in the study

Key exclusion criteria (10 listed)

Cases with radiculopathy ipsilateral to the affected shoulder
Cases with active inflammatory arthropathy of the affected shoulder
Cases with previous shoulder surgery
Cases with a history of humeral head, scapula, and clavicle fractures
Cases with neurological deficit affecting the upper extremity

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
Ultrasound Guided LavageAlso: Ultrasound Guided BarbotageAfter local anesthesia of subcutaneous tissue, lavage will be performed under the guidance of ultrasound using an 18-gauge needle with injectors filled with 4 ml of saline. The needle will be advanced to the center of the calcific deposit. The injector will be kept as parallel to the ground as possible. The plunger of the injector will be pushed with a gently pressure and then released. Calcific deposits are expected to be filled into the syringe along with saline. It is predicted that the clear saline will gradually turn white and become cloudy due to the incoming calcific deposits. When the color of the liquid becomes cloudy, the syringe will be removed without moving the needle, and a new syringe containing 4 ml saline will be placed in its place. Thus, the aspirated calcific deposits will not be reinjected. The same process will be repeated with a new saline filled syringe. After the procedure, 2 ml dexamethasone and 3 ml lidocaine will be injected in subacromial bursa.	Procedure or surgery	Ultrasound Guided Lavage Group
Ultrasound Guided Subacromial Bursa Injection2 ml dexamethasone and 3 ml %2 lidocaine will be injected in the subacromial bursa using a 21-gauge needle under ultrasound guidance.	Procedure or surgery	Ultrasound Guided Subacromial Bursa Injection Group

Primary outcome

Change of Range of Motion
Time frame: Baseline, 1 month
The change in a participant's range of motion degree as measured by a goniometer (Passive Range of Motion and Active Range of Motion) from baseline to 1 month.
Clinical improvement measured by change in Numeric Rating Scale
Time frame: Baseline, 1 hour, 1 month
A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. A patient selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing "worst possible pain"
Clinical improvement measured by change in Constant Shoulder Score
Time frame: Baseline, 1 month
The constant shoulder score is a validated scale, measuring the shoulder function. It is an objective measurement independent of the shoulder pain. It is a 100-points scale composed of a number of individual parameters. The minimum score is 0, the maximum score is 100 points. The higher the score, the higher the quality of the function.
Clinical improvement measured by change in Quick Dash Score
Time frame: Baseline, 1 month
Individual's ability to complete tasks, absorb forces, and severity of symptoms are measured by a 11 item Quick Dash questionnaire. At least 10 of the 11 items must be completed for a score to be calculated and the scores range from 0 (no disability) to 100 (most severe disability).
Clinical improvement measured by change in Shoulder Disability Questionnaire
Time frame: Baseline, 1 month
This score measures the disability of the shoulder in daily life, work, social life.0 points indicate maximum well-being, 100 points indicate maximum disability
Change in Gartner Score of the Shoulder Calcifications on Direct Radiography
Time frame: Baseline, 1 month
Radiological classification of calcifying tendinitis
Change in ultrasound scoring system presented by Chiou
Time frame: Baseline, 1 month
This score includes size, shape (arc, fragmented, nodular, cystic), power doppler activity of calcific deposits.
Change in ultrasound classification system of calcific deposits presented by Farin
Time frame: Baseline, 1 month
This classification includes acoustic shadowing of calcific deposits (well-defined shadow, faint shadow and no shadow)

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 31 Jan 2023.
Background: PubMed 25870115Louwerens JK, Sierevelt IN, van Hove RP, van den Bekerom MP, van Noort A. Prevalence of calcific deposits within the rotator cuff tendons in adults with and without subacromial pain syndrome: clinical and radiologic analysis of 1219 patients. J Shoulder Elbow Surg. 2015 Oct;24(10):1588-93. doi: 10.1016/j.jse.2015.02.024. Epub 2015 Apr 11.
Background: PubMed 30774461Sansone V, Maiorano E, Galluzzo A, Pascale V. Calcific tendinopathy of the shoulder: clinical perspectives into the mechanisms, pathogenesis, and treatment. Orthop Res Rev. 2018 Oct 3;10:63-72. doi: 10.2147/ORR.S138225. eCollection 2018.
Background: PubMed 26306389Sansone V, Consonni O, Maiorano E, Meroni R, Goddi A. Calcific tendinopathy of the rotator cuff: the correlation between pain and imaging features in symptomatic and asymptomatic female shoulders. Skeletal Radiol. 2016 Jan;45(1):49-55. doi: 10.1007/s00256-015-2240-3. Epub 2015 Aug 27.
Background: PubMed 25771323Greis AC, Derrington SM, McAuliffe M. Evaluation and nonsurgical management of rotator cuff calcific tendinopathy. Orthop Clin North Am. 2015 Apr;46(2):293-302. doi: 10.1016/j.ocl.2014.11.011. Epub 2015 Jan 27.
Background: PubMed 23696211de Witte PB, Selten JW, Navas A, Nagels J, Visser CP, Nelissen RG, Reijnierse M. Calcific tendinitis of the rotator cuff: a randomized controlled trial of ultrasound-guided needling and lavage versus subacromial corticosteroids. Am J Sports Med. 2013 Jul;41(7):1665-73. doi: 10.1177/0363546513487066. Epub 2013 May 21.
Background: PubMed 11883540Chiou HJ, Chou YH, Wu JJ, Hsu CC, Huang DY, Chang CY. Evaluation of calcific tendonitis of the rotator cuff: role of color Doppler ultrasonography. J Ultrasound Med. 2002 Mar;21(3):289-95; quiz 296-7. doi: 10.7863/jum.2002.21.3.289.
Background: PubMed 7707483Farin PU, Jaroma H. Sonographic findings of rotator cuff calcifications. J Ultrasound Med. 1995 Jan;14(1):7-14. doi: 10.7863/jum.1995.14.1.7.
Background: PubMed 7617385Gartner J, Heyer A. [Calcific tendinitis of the shoulder]. Orthopade. 1995 Jun;24(3):284-302. German.
Background: PubMed 31124934Zhang T, Duan Y, Chen J, Chen X. Efficacy of ultrasound-guided percutaneous lavage for rotator cuff calcific tendinopathy: A systematic review and meta-analysis. Medicine (Baltimore). 2019 May;98(21):e15552. doi: 10.1097/MD.0000000000015552.
BackgroundLee S.H. (2020) Calcific Tendinitis Intervention. In: Peng P., Finlayson R., Lee S., Bhatia A. (eds) Ultrasound for Interventional Pain Management. Springer, Cham. https://doi.org/10.1007/978-3-030-18371-4_26
Individual participant dataSharing planned: No

Related trials for Calcific Tendinitis

Recruiting
Ultrasound-Guided Extracorporeal Shock Wave Therapy for Calcific Tendinitis
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Recruiting
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Not yet recruiting
Paracetamol and Ibuprofen With or Without Famotidine for Calcific Tendinitis of the Shoulder
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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.

NURI TUGBAY YILDIRAN principal investigator

Istanbul University - Cerrahpasa

DENIZ PALAMAR study director

Istanbul University - Cerrahpasa

BILGE CAKIR study chair

Istanbul University - Cerrahpasa

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 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 31 Jan 2023. 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?

Change of Range of Motion (time frame: Baseline, 1 month). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05272085, which also lists 10 linked publications.

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 31 Jan 2023.