Adhesive CapsulitisNCT07158255
Effects of Exercise on Adhesive Capsulitis
A study testing electrotherapy treatment and Exercise training in people with Adhesive Capsulitis and Exercise, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
Our study aims to investigate the effects of exercise training on pain, range of motion, functionality and shoulder architecture in patients with adhesive capsulitis. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Adhesive Capsulitis, Exercise, Ultrasonography
- What is being tested?
- electrotherapy treatment and Exercise training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Sep 2025to 15 Nov 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with adhesive capsulitis by a physician,
- Between the ages of 35-60,
- Not diagnosed with cervical disc herniation that could cause other shoulder pathologies,
- Not participating in an upper extremity-related physiotherapy program within the last 6 months,
- Volunteering individuals to participate in the study
Who cannot join
- Individuals who have undergone shoulder surgery consistent with any pathology,
- Individuals with a neurological history,
- Individuals diagnosed with diabetes mellitus (DM)
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
Hasan Kalyoncu University
Gaziantep, Gaziantep, (505) 090-5846
About this study
Official title: Effect of Exercise Training on Pain, Range of Motion, Functionality and Shoulder Architecture in Patients With Adhesive Capsulitis
Our study aims to investigate the effects of exercise training on pain, range of motion, functionality and shoulder architecture in patients with adhesive capsulitis.
Read the detailed description
Adhesive capsulitis (AC) is a common shoulder condition characterized by a gradual increase in spontaneous pain and a limitation in glenohumeral joint range of motion. Its pathophysiology, a pathological process of capsular fibrosis following synovial inflammation, is relatively well understood, but its cause remains unknown. The literature on the treatment of frozen shoulder, whose etiology remains unknown, provides evidence of the effectiveness of conservative treatment approaches such as physiotherapy, analgesics, and steroid injections. Early treatment success is achieved through pain reduction and increased function rather than achieving full range of motion. Pain with movement is minimal in primary frozen shoulder in Stage 1, while night pain accompanied by activity pain is also observed in Stages 2 and 3. Secondary frozen shoulder presents with similar pain, primarily caused by inflammation in the shoulder joint capsule. Increasing range of motion without pain suppression is quite difficult in patients with frozen shoulder. Although heat or electrotherapy methods are accepted to have theoretically positive effects on pain in treatment, it is difficult to determine the effect of a single method on the natural course of the disease. For this reason, therapeutic methods are generally applied in addition to manual therapy and therapeutic exercises. Thermal tools and stretching exercises are frequently used in physiotherapy to maintain and regain flexibility. Ultrasonography, which is among the clinical diagnostic methods performed in patients with adhesive capsulitis, has shown increased thickness, especially in the coracohumeral ligament, followed by fibrous changes in the supraspinatus tendon and long head of the biceps. The effectiveness of exercise training combined with electrotherapy on many factors has been frequently investigated in the literature. However, a review of the literature did not find any studies on the effects of exercise training given in adhesive capsulitis on shoulder architecture. The fact that ultrasonographic examination, an indispensable part of the diagnosis and treatment process, provides objective data on the effects of exercise will increase the quality of the study. In this context, our study; The aim of this study is to investigate the effects of exercise training on pain, range of motion, functionality and shoulder architecture in patients with adhesive capsulitis.
- Conditions
- Adhesive Capsulitis, Exercise, Ultrasonography
- Being tested
- electrotherapy treatment, Exercise training
- Keywords
- adhezsiv capsulitis, pain, range of motion, functionality, shoulder architecture, exercise
- Medical subject headings
- Bursitis, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrotherapy treatmentOther
Patients in the electrotherapy group will receive 15 sessions of TENS, hotpack, and ultrasound, 45 minutes each, 5 days a week, for 3 weeks. The treatment program is planned for 20 minutes of TENS, 15 minutes of hotpack, and 10 minutes of ultrasound.
Exercise trainingOther
In addition to electrotherapy, the patients in the study group will receive 15 sessions (45 minutes, 5 days a week, for 3 weeks) of exercise training consistent with the literature. Exercise training includes programs to increase joint range of motion and mobility at the pain threshold and to restore functionality. Following electrotherapy, upper extremity normal range of motion exercises, anterior and posterior capsule stretching exercises, pendulum exercises, wand exercises, isometric training in 3 planes, and isotonic strengthening exercises will be applied. Five exercises will be selected each day, performed under the supervision of a physiotherapist. A 2-minute rest period will be provided after each exercise, followed by a transition to the next exercise. Care will be taken to perform the exercises within the pain threshold and to ensure that the pain does not exceed a VAS score of 2.
| Study group | Role | What they receive |
|---|---|---|
| Exercise training group | Experimental | Patients in the study group will receive 15 sessions of exercise training (daily for 3 weeks). Exercise training includes programs to increase joint range of motion and mobility at the pain threshold and to restore functionality. Receives: Other: Exercise training |
| Control group | Active comparator | Patients in the control group will receive 15 sessions of electrotherapy treatment (TENS, US, Hotpack) Receives: Other: electrotherapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonographic Measurement
Thickness and density measurements of the coracohumeral ligament, supraspinatus tendon, infraspinatus tendon, long head of biceps and deltoid fascia, which constitute the shoulder architecture of the patients and are among the structures most affected by adhesive capsulitis, will be evaluated with an Ultrasound (Measured by 7.5-10 Mhz mobile ultrasound (ALEXUS A10HRL) device.
Measured: through of the study, average 3 weeks
The pain
Mc Gill Short Form will used to determine the type and severity of the pain. A short form of the McGill Pain Questionnaire (SF-MPQ) has been developed. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.
Measured: through of the study, average 3 weeks
Range of Motion
A Universal Goniometer will be used to assess normal range of motion. Measurements will be made regarding shoulder flexion, extension, abduction, adduction, internal and external rotation ranges of motion in three planes of the upper extremity shoulder joint, and the results will be recorded in degrees.
Measured: through of the study, average 3 weeks
Upper extremity functionality
The Questionnaire for Arm, Shoulder, and Hand Disabilities (Q-DASH) will be used to assess individuals' upper extremity functions. This questionnaire is a self-administered measurement tool with validated validity and reliability in Turkish. The validity and reliability of the Turkish version of the DASH questionnaire (DASH-T) was conducted in Turkey by Düger et al. in 2006. The questionnaire, consisting of 30 questions, assesses the individual's ability to perform functional activities (21 items), pain (5 items), and psychosocial aspects of the disease (4 items). The total score ranges from 0 to 100, with a higher score indicating better outcomes.
Measured: through of the study, average 3 weeks
Secondary outcomes (2)
Kinesiophobia
The Tampa Kinesiophobia Scale will be used to assess the fear of movement and movement avoidance in individuals diagnosed with adhesive capsulitis. The survey, whose validity and reliability study was conducted by Yılmaz et al. in 2011, consists of 17 descriptive questions. Each question uses a 4-point Likert-type scoring system (1=Strongly disagree, 2=Agree, 3=Disagree, 4=Strongly agree). Based on the responses, the individual receives a total score between 17 and 68. A high score on the scale indicates a high degree of kinesiophobia.
Measured: through of the study, average 3 weeks
The quality of Life
The European General Quality of Life Scale (EQ-5D) will be used to assess patients' quality of life. The EQ-5D general quality of life scale was developed in 1987 by the EuroQol group, the Western European Society for the Study of Quality of Life, and consists of two sections. The first section describes the current health profile in five subdimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses for each section have five options: "no problem," "mild problem," "moderate problem," "severe problem," and "extreme problem." The second section consists of a visual analog scale (VAS). In this section, individuals rate their current health status on a scale resembling a thermometer. Quality of life scores ranging from 0 to 100 are obtained from the visual analog scale. As the scale score increases, the perception of health increases in a positive direction.
Measured: through of the study, average 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start5 Sep 2025 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion15 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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
- Model description
- Participants were divided into two groups. Two different interventions were administered to each group. One group will receive electrotherapy and exercise therapy. The other group will receive electrotherapy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba GÖNEN, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158255
- Sponsor's protocol ID
- 2025/097
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yakut Y, Yakut E, Bayar K, Uygur F. Reliability and validity of the Turkish version short-form McGill pain questionnaire in patients with rheumatoid arthritis. Clin Rheumatol. 2007 Jul;26(7):1083-7. doi: 10.1007/s10067-006-0452-6. Epub 2006 Nov 15.
PubMed 17106618Do JG, Hwang JT, Yoon KJ, Lee YT. Correlation of Ultrasound Findings With Clinical Stages and Impairment in Adhesive Capsulitis of the Shoulder. Orthop J Sports Med. 2021 May 10;9(5):23259671211003675. doi: 10.1177/23259671211003675. eCollection 2021 May.
PubMed 33997079Liu J, Pan H, Bao Y, Huang L, Hu Y. The clinical utility of musculoskeletal ultrasonography in hemiplegic shoulder rehabilitation poststroke. Front Rehabil Sci. 2025 May 15;6:1576890. doi: 10.3389/fresc.2025.1576890. eCollection 2025.
PubMed 40443485Moleesaide A, Saengsuwan J, Sirasaporn P. Musculoskeletal ultrasound of the shoulder in patients with adhesive capsulitis. Biomed Rep. 2024 Oct 11;21(6):190. doi: 10.3892/br.2024.1878. eCollection 2024 Dec.
PubMed 39479361Nakano J, Yamabayashi C, Scott A, Reid WD. The effect of heat applied with stretch to increase range of motion: a systematic review. Phys Ther Sport. 2012 Aug;13(3):180-8. doi: 10.1016/j.ptsp.2011.11.003. Epub 2011 Dec 29.
PubMed 22814453Kelley MJ, Shaffer MA, Kuhn JE, Michener LA, Seitz AL, Uhl TL, Godges JJ, McClure PW. Shoulder pain and mobility deficits: adhesive capsulitis. J Orthop Sports Phys Ther. 2013 May;43(5):A1-31. doi: 10.2519/jospt.2013.0302. Epub 2013 Apr 30. No abstract available.
PubMed 23636125Kelley MJ, McClure PW, Leggin BG. Frozen shoulder: evidence and a proposed model guiding rehabilitation. J Orthop Sports Phys Ther. 2009 Feb;39(2):135-48. doi: 10.2519/jospt.2009.2916.
PubMed 19194024Hsu JE, Anakwenze OA, Warrender WJ, Abboud JA. Current review of adhesive capsulitis. J Shoulder Elbow Surg. 2011 Apr;20(3):502-14. doi: 10.1016/j.jse.2010.08.023. Epub 2010 Dec 16. No abstract available.
PubMed 21167743
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise Training on Pain, Range of Motion, Functionality and Shoulder Architecture in Patients With Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT07158255
- Acronym / sponsor ID
- 2025/097
- Conditions
- Adhesive Capsulitis, Exercise, Ultrasonography
- Keywords
- adhezsiv capsulitis, pain, range of motion, functionality, shoulder architecture, exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 5 Sep 2025 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 15 Nov 2025 (estimated)
- First posted
- 5 Sep 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.
Our study aims to investigate the effects of exercise training on pain, range of motion, functionality and shoulder architecture in patients with adhesive capsulitis.
Detailed description
Adhesive capsulitis (AC) is a common shoulder condition characterized by a gradual increase in spontaneous pain and a limitation in glenohumeral joint range of motion. Its pathophysiology, a pathological process of capsular fibrosis following synovial inflammation, is relatively well understood, but its cause remains unknown. The literature on the treatment of frozen shoulder, whose etiology remains unknown, provides evidence of the effectiveness of conservative treatment approaches such as physiotherapy, analgesics, and steroid injections. Early treatment success is achieved through pain reduction and increased function rather than achieving full range of motion. Pain with movement is minimal in primary frozen shoulder in Stage 1, while night pain accompanied by activity pain is also observed in Stages 2 and 3. Secondary frozen shoulder presents with similar pain, primarily caused by inflammation in the shoulder joint capsule. Increasing range of motion without pain suppression is quite difficult in patients with frozen shoulder. Although heat or electrotherapy methods are accepted to have theoretically positive effects on pain in treatment, it is difficult to determine the effect of a single method on the natural course of the disease. For this reason, therapeutic methods are generally applied in addition to manual therapy and therapeutic exercises. Thermal tools and stretching exercises are frequently used in physiotherapy to maintain and regain flexibility. Ultrasonography, which is among the clinical diagnostic methods performed in patients with adhesive capsulitis, has shown increased thickness, especially in the coracohumeral ligament, followed by fibrous changes in the supraspinatus tendon and long head of the biceps. The effectiveness of exercise training combined with electrotherapy on many factors has been frequently investigated in the literature. However, a review of the literature did not find any studies on the effects of exercise training given in adhesive capsulitis on shoulder architecture. The fact that ultrasonographic examination, an indispensable part of the diagnosis and treatment process, provides objective data on the effects of exercise will increase the quality of the study. In this context, our study; The aim of this study is to investigate the effects of exercise training on pain, range of motion, functionality and shoulder architecture in patients with adhesive capsulitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were divided into two groups. Two different interventions were administered to each group. One group will receive electrotherapy and exercise therapy. The other group will receive electrotherapy.
| Arm | Type | Receives |
|---|---|---|
| Exercise training group | Experimental | Other: Exercise trainingPatients in the study group will receive 15 sessions of exercise training (daily for 3 weeks). Exercise training includes programs to increase joint range of motion and mobility at the pain threshold and to restore functionality. |
| Control group | Active comparator | Other: electrotherapy treatmentPatients in the control group will receive 15 sessions of electrotherapy treatment (TENS, US, Hotpack) |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with adhesive capsulitis by a physician,
- Between the ages of 35-60,
- Not diagnosed with cervical disc herniation that could cause other shoulder pathologies,
- Not participating in an upper extremity-related physiotherapy program within the last 6 months,
- Volunteering individuals to participate in the study
Key exclusion criteria (3 listed)
- Individuals who have undergone shoulder surgery consistent with any pathology,
- Individuals with a neurological history,
- Individuals diagnosed with diabetes mellitus (DM)
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 |
|---|---|---|
| electrotherapy treatmentPatients in the electrotherapy group will receive 15 sessions of TENS, hotpack, and ultrasound, 45 minutes each, 5 days a week, for 3 weeks. The treatment program is planned for 20 minutes of TENS, 15 minutes of hotpack, and 10 minutes of ultrasound. | Other | Control group |
| Exercise trainingIn addition to electrotherapy, the patients in the study group will receive 15 sessions (45 minutes, 5 days a week, for 3 weeks) of exercise training consistent with the literature. Exercise training includes programs to increase joint range of motion and mobility at the pain threshold and to restore functionality. Following electrotherapy, upper extremity normal range of motion exercises, anterior and posterior capsule stretching exercises, pendulum exercises, wand exercises, isometric training in 3 planes, and isotonic strengthening exercises will be applied. Five exercises will be selected each day, performed under the supervision of a physiotherapist. A 2-minute rest period will be provided after each exercise, followed by a transition to the next exercise. Care will be taken to perform the exercises within the pain threshold and to ensure that the pain does not exceed a VAS score of 2. | Other | Exercise training group |
Primary outcome
Ultrasonographic Measurement
Time frame: through of the study, average 3 weeks
Thickness and density measurements of the coracohumeral ligament, supraspinatus tendon, infraspinatus tendon, long head of biceps and deltoid fascia, which constitute the shoulder architecture of the patients and are among the structures most affected by adhesive capsulitis, will be evaluated with an Ultrasound (Measured by 7.5-10 Mhz mobile ultrasound (ALEXUS A10HRL) device.
The pain
Time frame: through of the study, average 3 weeks
Mc Gill Short Form will used to determine the type and severity of the pain. A short form of the McGill Pain Questionnaire (SF-MPQ) has been developed. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.
Range of Motion
Time frame: through of the study, average 3 weeks
A Universal Goniometer will be used to assess normal range of motion. Measurements will be made regarding shoulder flexion, extension, abduction, adduction, internal and external rotation ranges of motion in three planes of the upper extremity shoulder joint, and the results will be recorded in degrees.
Upper extremity functionality
Time frame: through of the study, average 3 weeks
The Questionnaire for Arm, Shoulder, and Hand Disabilities (Q-DASH) will be used to assess individuals' upper extremity functions. This questionnaire is a self-administered measurement tool with validated validity and reliability in Turkish. The validity and reliability of the Turkish version of the DASH questionnaire (DASH-T) was conducted in Turkey by Düger et al. in 2006. The questionnaire, consisting of 30 questions, assesses the individual's ability to perform functional activities (21 items), pain (5 items), and psychosocial aspects of the disease (4 items). The total score ranges from 0 to 100, with a higher score indicating better outcomes.
2 secondary outcomes
Kinesiophobia
Time frame: through of the study, average 3 weeks
The quality of Life
Time frame: through of the study, average 3 weeks
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 5 Sep 2025.
- Results publication: PubMed 17106618Yakut Y, Yakut E, Bayar K, Uygur F. Reliability and validity of the Turkish version short-form McGill pain questionnaire in patients with rheumatoid arthritis. Clin Rheumatol. 2007 Jul;26(7):1083-7. doi: 10.1007/s10067-006-0452-6. Epub 2006 Nov 15.
- Results publication: PubMed 33997079Do JG, Hwang JT, Yoon KJ, Lee YT. Correlation of Ultrasound Findings With Clinical Stages and Impairment in Adhesive Capsulitis of the Shoulder. Orthop J Sports Med. 2021 May 10;9(5):23259671211003675. doi: 10.1177/23259671211003675. eCollection 2021 May.
- Results publication: PubMed 40443485Liu J, Pan H, Bao Y, Huang L, Hu Y. The clinical utility of musculoskeletal ultrasonography in hemiplegic shoulder rehabilitation poststroke. Front Rehabil Sci. 2025 May 15;6:1576890. doi: 10.3389/fresc.2025.1576890. eCollection 2025.
- Results publication: PubMed 39479361Moleesaide A, Saengsuwan J, Sirasaporn P. Musculoskeletal ultrasound of the shoulder in patients with adhesive capsulitis. Biomed Rep. 2024 Oct 11;21(6):190. doi: 10.3892/br.2024.1878. eCollection 2024 Dec.
- Results publication: PubMed 22814453Nakano J, Yamabayashi C, Scott A, Reid WD. The effect of heat applied with stretch to increase range of motion: a systematic review. Phys Ther Sport. 2012 Aug;13(3):180-8. doi: 10.1016/j.ptsp.2011.11.003. Epub 2011 Dec 29.
- Results publication: PubMed 23636125Kelley MJ, Shaffer MA, Kuhn JE, Michener LA, Seitz AL, Uhl TL, Godges JJ, McClure PW. Shoulder pain and mobility deficits: adhesive capsulitis. J Orthop Sports Phys Ther. 2013 May;43(5):A1-31. doi: 10.2519/jospt.2013.0302. Epub 2013 Apr 30. No abstract available.
- Results publication: PubMed 19194024Kelley MJ, McClure PW, Leggin BG. Frozen shoulder: evidence and a proposed model guiding rehabilitation. J Orthop Sports Phys Ther. 2009 Feb;39(2):135-48. doi: 10.2519/jospt.2009.2916.
- Results publication: PubMed 21167743Hsu JE, Anakwenze OA, Warrender WJ, Abboud JA. Current review of adhesive capsulitis. J Shoulder Elbow Surg. 2011 Apr;20(3):502-14. doi: 10.1016/j.jse.2010.08.023. Epub 2010 Dec 16. No abstract available.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrotherapy treatment and Exercise training in people with Adhesive Capsulitis and Exercise, run by Hasan Kalyoncu University 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 5 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: opening soon, as of the sponsor's last update on 5 Sep 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 Tuğba GÖNEN, Asisst. Prof. Dr. (505 090 58 46, tugba.badat@hku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasonographic Measurement (time frame: through of the study, average 3 weeks). The study lists 4 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 NCT07158255, which also lists 8 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 5 Sep 2025.