Adhesive Capsulitis of the ShoulderNCT07905326
Muscle Architecture, Stiffness, and Neuromuscular Activation in Unilateral Adhesive Capsulitis
An observational study of Adhesive Capsulitis of the Shoulder, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study examined muscle structure, stiffness, and activation in adults aged 40 to 70 years with unilateral adhesive capsulitis. Thirty-two participants completed a single assessment of both shoulders using ultrasound, shear-wave elastography, surface electromyography, and shoulder-function… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Adhesive Capsulitis of the Shoulder
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Aug 2024to 10 Nov 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 40-70 years with unilateral adhesive capsulitis, consecutively recruited from the Orthopedics and Traumatology outpatient clinic at Ankara Etlik City Hospital, Ankara, Türkiye. Thirty-two participants were enrolled and completed the single-session assessment.
Who may be able to join
- Age 40-70 years.
- Unilateral adhesive capsulitis meeting the study diagnostic criteria.
- Shoulder pain for more than 3 months.
- Restriction of active and passive forward flexion to <100°, external rotation to <10°, and internal rotation to below the L5 spinous level.
- No abnormality on standard anteroposterior and axillary radiographs.
- Asymptomatic contralateral shoulder with full active range of motion and no history of shoulder surgery, fracture, dislocation, or adhesive capsulitis.
- Ability to understand instructions, perform resisted shoulder tasks and maximal voluntary contractions, and complete questionnaires.
Who cannot join
- Bilateral adhesive capsulitis.
- Full- or partial-thickness rotator cuff tear on ultrasound, calcific tendinitis, or glenohumeral osteoarthritis.
- Previous shoulder surgery or fracture on either side.
- Corticosteroid injection, hydrodilatation, or manipulation under anesthesia of the affected shoulder within the previous 3 months.
- Neurologic disorder affecting the upper limbs or neuromuscular disease.
- Inflammatory arthritis or systemic disease affecting muscle properties.
- Skin lesions or allergy precluding electrode placement or ultrasound gel application.
- Cognitive impairment preventing cooperation with the testing protocol.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences
Ankara, Kecioren, 06010
About this study
Official title: Muscle Architecture, Stiffness, and Neuromuscular Activation of the Rotator Cuff and Deltoid in Unilateral Adhesive Capsulitis: A Prospective Bilateral Ultrasound, Shear-Wave Elastography, and Surface Electromyography Study
This prospective observational study examined muscle structure, stiffness, and activation in adults aged 40 to 70 years with unilateral adhesive capsulitis. Thirty-two participants completed a single assessment of both shoulders using ultrasound, shear-wave elastography, surface electromyography, and shoulder-function questionnaires. The affected shoulder was compared with the asymptomatic contralateral shoulder, and affected-side findings were compared between pain-dominant (freezing) and stiffness-dominant (frozen) phases. The study did not assign a treatment or intervention.
Read the detailed description
This was a prospective, single-center observational study with a cross-sectional assessment and within-participant comparison of the affected and asymptomatic contralateral shoulders. Adults aged 40-70 years with unilateral adhesive capsulitis were recruited consecutively from the Department of Orthopedics and Traumatology outpatient clinic at Ankara Etlik City Hospital, Ankara, Türkiye, from July 2024 through February 2026. Thirty-two participants completed all assessments.
Participants were classified as being in the freezing phase (visual analog scale pain score 6-10; n=15) or frozen phase (score 0-5; n=17). No treatment was assigned by the study. Bilateral ultrasound was used to measure muscle thickness, fascicle length, physiological cross-sectional area, and pennation angle of the supraspinatus, infraspinatus, teres minor, and anterior, middle, and posterior deltoid. Shear-wave elastography was used to measure muscle Young's modulus. Surface electromyography was recorded during dumbbell scaption and normalized to maximal voluntary isometric contraction.
Shoulder function was assessed with the Constant-Murley Score, UCLA Shoulder Scale, ASES, DASH, QuickDASH, and Oxford Shoulder Score. Primary analyses compared the affected and contralateral shoulders. Secondary analyses compared affected-side measures between phases and examined associations between muscle measures and function scores. All assessments were performed in a single session before initiation of any new treatment.
- Conditions
- Adhesive Capsulitis of the Shoulder
- Keywords
- Frozen shoulder, Adhesive capsulitis, Rotator cuff, Deltoid, Muscle architecture, Shear-wave elastography, Surface electromyography
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Freezing Phase | Participants with unilateral adhesive capsulitis classified in the freezing phase based on a visual analog scale pain score of 6-10. Actual enrollment: 15 participants. | |
| Frozen Phase | Participants with unilateral adhesive capsulitis classified in the frozen phase based on a visual analog scale pain score of 0-5. Actual enrollment: 17 participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Side-to-Side Difference in Muscle Thickness
Ultrasound muscle thickness (cm) in the supraspinatus, infraspinatus, teres minor, and anterior, middle, and posterior deltoid; compare the affected shoulder with the asymptomatic contralateral shoulder.
Measured: Baseline (single assessment at the initial study visit)
Side-to-Side Difference in Fascicle Length
Ultrasound fascicle length (cm) in the supraspinatus, infraspinatus, teres minor, and anterior, middle, and posterior deltoid; compare the affected shoulder with the asymptomatic contralateral shoulder.
Measured: Baseline (single assessment at the initial study visit)
Side-to-Side Difference in Physiological Cross-Sectional Area
Ultrasound-derived physiological cross-sectional area (PCSA; cm²) for the supraspinatus, infraspinatus, teres minor, and deltoid subregions; compare the affected shoulder with the contralateral shoulder.
Measured: Baseline (single assessment at the initial study visit)
Side-to-Side Difference in Pennation Angle
Ultrasound pennation angle (degrees) for the supraspinatus, infraspinatus, teres minor, and deltoid subregions; compare the affected shoulder with the contralateral shoulder.
Measured: Baseline (single assessment at the initial study visit)
Side-to-Side Difference in Shear-Wave Elastography Stiffness
Mean Young's modulus (kPa) from three acquisitions for each muscle; compare the affected shoulder with the asymptomatic contralateral shoulder.
Measured: Baseline (single assessment at the initial study visit)
Side-to-Side Difference in Normalized Surface EMG Activation
Mean root-mean-square amplitude during dumbbell scaption, normalized to maximal voluntary isometric contraction (%MVIC), for the supraspinatus, infraspinatus, teres minor, and deltoid subregions; compare the affected shoulder with the contralateral shoulder.
Measured: Baseline (single assessment at the initial study visit)
Secondary outcomes (2)
Difference in Affected-Side Muscle Parameters Between Disease Phases
Compare affected-side muscle architecture, shear-wave elastography stiffness, and normalized EMG parameters between the freezing phase (VAS 6-10; n=15) and frozen phase (VAS 0-5; n=17).
Measured: Baseline (single assessment at the initial study visit)
Association Between Affected-Side Muscle Parameters and Shoulder Function
Assess correlations between affected-side muscle architecture, shear-wave elastography stiffness, normalized EMG, and the Constant-Murley Score, UCLA Shoulder Scale, ASES, DASH, QuickDASH, and Oxford Shoulder Score.
Measured: Baseline (single assessment at the initial study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start24 Aug 2024
- Primary completion10 Oct 2024
- Study completion10 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive Capsulitis of the ShoulderStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, caglar soylu, Ankara Yildirim Beyazıt University
- Investigators
- Ali Şahin, MD, Principal investigator, Acibadem Ankara HospitalYasin Erdogan, MD, Study chair, Ankara Etlik City HospitalYunus Kesik, MD, Study chair, Ankara Etlik City HospitalNecmiye Un Yildirim, PT, PhD, Study chair, Saglik Bilimleri UniversitesiAhmet Firat, MD, Study chair, VM Medical Park Ankara Hospital; Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905326
- Sponsor's protocol ID
- AEŞH-BADEK-2024-625
- Other IDs
- AEŞH-BADEK-2024-625
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participants' privacy and confidentiality. Only aggregate data are reported.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Architecture, Stiffness, and Neuromuscular Activation of the Rotator Cuff and Deltoid in Unilateral Adhesive Capsulitis: A Prospective Bilateral Ultrasound, Shear-Wave Elastography, and Surface Electromyography Study
- ClinicalTrials.gov ID
- NCT07905326
- Acronym / sponsor ID
- AEŞH-BADEK-2024-625
- Conditions
- Adhesive Capsulitis of the Shoulder
- Keywords
- Frozen shoulder, Adhesive capsulitis, Rotator cuff, Deltoid, Muscle architecture, Shear-wave elastography, Surface electromyography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 24 Aug 2024 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 Nov 2024 (actual)
- First posted
- 29 Oct 2026 (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 prospective observational study examined muscle structure, stiffness, and activation in adults aged 40 to 70 years with unilateral adhesive capsulitis. Thirty-two participants completed a single assessment of both shoulders using ultrasound, shear-wave elastography, surface electromyography, and shoulder-function questionnaires. The affected shoulder was compared with the asymptomatic contralateral shoulder, and affected-side findings were compared between pain-dominant (freezing) and stiffness-dominant (frozen) phases. The study did not assign a treatment or intervention.
Detailed description
This was a prospective, single-center observational study with a cross-sectional assessment and within-participant comparison of the affected and asymptomatic contralateral shoulders. Adults aged 40-70 years with unilateral adhesive capsulitis were recruited consecutively from the Department of Orthopedics and Traumatology outpatient clinic at Ankara Etlik City Hospital, Ankara, Türkiye, from July 2024 through February 2026. Thirty-two participants completed all assessments.
Participants were classified as being in the freezing phase (visual analog scale pain score 6-10; n=15) or frozen phase (score 0-5; n=17). No treatment was assigned by the study. Bilateral ultrasound was used to measure muscle thickness, fascicle length, physiological cross-sectional area, and pennation angle of the supraspinatus, infraspinatus, teres minor, and anterior, middle, and posterior deltoid. Shear-wave elastography was used to measure muscle Young's modulus. Surface electromyography was recorded during dumbbell scaption and normalized to maximal voluntary isometric contraction.
Shoulder function was assessed with the Constant-Murley Score, UCLA Shoulder Scale, ASES, DASH, QuickDASH, and Oxford Shoulder Score. Primary analyses compared the affected and contralateral shoulders. Secondary analyses compared affected-side measures between phases and examined associations between muscle measures and function scores. All assessments were performed in a single session before initiation of any new treatment.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Freezing Phase | – | –Participants with unilateral adhesive capsulitis classified in the freezing phase based on a visual analog scale pain score of 6-10. Actual enrollment: 15 participants. |
| Frozen Phase | – | –Participants with unilateral adhesive capsulitis classified in the frozen phase based on a visual analog scale pain score of 0-5. Actual enrollment: 17 participants. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 40-70 years with unilateral adhesive capsulitis, consecutively recruited from the Orthopedics and Traumatology outpatient clinic at Ankara Etlik City Hospital, Ankara, Türkiye. Thirty-two participants were enrolled and completed the single-session assessment.
Key inclusion criteria (7 listed)
- Age 40-70 years.
- Unilateral adhesive capsulitis meeting the study diagnostic criteria.
- Shoulder pain for more than 3 months.
- Restriction of active and passive forward flexion to <100°, external rotation to <10°, and internal rotation to below the L5 spinous level.
- No abnormality on standard anteroposterior and axillary radiographs.
Key exclusion criteria (8 listed)
- Bilateral adhesive capsulitis.
- Full- or partial-thickness rotator cuff tear on ultrasound, calcific tendinitis, or glenohumeral osteoarthritis.
- Previous shoulder surgery or fracture on either side.
- Corticosteroid injection, hydrodilatation, or manipulation under anesthesia of the affected shoulder within the previous 3 months.
- Neurologic disorder affecting the upper limbs or neuromuscular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Side-to-Side Difference in Muscle Thickness
Time frame: Baseline (single assessment at the initial study visit)
Ultrasound muscle thickness (cm) in the supraspinatus, infraspinatus, teres minor, and anterior, middle, and posterior deltoid; compare the affected shoulder with the asymptomatic contralateral shoulder.
Side-to-Side Difference in Fascicle Length
Time frame: Baseline (single assessment at the initial study visit)
Ultrasound fascicle length (cm) in the supraspinatus, infraspinatus, teres minor, and anterior, middle, and posterior deltoid; compare the affected shoulder with the asymptomatic contralateral shoulder.
Side-to-Side Difference in Physiological Cross-Sectional Area
Time frame: Baseline (single assessment at the initial study visit)
Ultrasound-derived physiological cross-sectional area (PCSA; cm²) for the supraspinatus, infraspinatus, teres minor, and deltoid subregions; compare the affected shoulder with the contralateral shoulder.
Side-to-Side Difference in Pennation Angle
Time frame: Baseline (single assessment at the initial study visit)
Ultrasound pennation angle (degrees) for the supraspinatus, infraspinatus, teres minor, and deltoid subregions; compare the affected shoulder with the contralateral shoulder.
Side-to-Side Difference in Shear-Wave Elastography Stiffness
Time frame: Baseline (single assessment at the initial study visit)
Mean Young's modulus (kPa) from three acquisitions for each muscle; compare the affected shoulder with the asymptomatic contralateral shoulder.
Side-to-Side Difference in Normalized Surface EMG Activation
Time frame: Baseline (single assessment at the initial study visit)
Mean root-mean-square amplitude during dumbbell scaption, normalized to maximal voluntary isometric contraction (%MVIC), for the supraspinatus, infraspinatus, teres minor, and deltoid subregions; compare the affected shoulder with the contralateral shoulder.
2 secondary outcomes
Difference in Affected-Side Muscle Parameters Between Disease Phases
Time frame: Baseline (single assessment at the initial study visit)
Association Between Affected-Side Muscle Parameters and Shoulder Function
Time frame: Baseline (single assessment at the initial study visit)
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 29 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participants' privacy and confidentiality. Only aggregate data are reported.
Related trials for Adhesive Capsulitis of the Shoulder
Not yet recruiting
Effects of Clinic Versus mHealth Application-Based Shoulder Rehabilitation in Patients With Adhesive Capsulitis
Adhesive Capsulitis
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
Not yet recruiting
Effects of Posterior Capsular Stretching With and Without Dynamic Neuromuscular Stabilization Exercises in Frozen Shoulder
Frozen Shoulder
RecruitingPhase 4
Ultrasound-Guided Intra-Articular vs Gluteal Intramuscular Corticosteroid Injection for Frozen 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.
Ali Şahin, MD principal investigator
Acibadem Ankara Hospital
Yasin Erdogan, MD study chair
Ankara Etlik City Hospital
Yunus Kesik, MD study chair
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adhesive Capsulitis of the Shoulder, run by Ankara Yildirim Beyazıt 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 7 inclusion and 8 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 29 Oct 2026. 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?
Side-to-Side Difference in Muscle Thickness (time frame: Baseline (single assessment at the initial study visit)). The study lists 6 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 29 Oct 2026.