Adhesive Capsulitis of the ShoulderNCT04613648
Ultrasonographic Assessment of Painful and Stiff Hemiplegic Shoulder in Terms of Adhesive Capsulitis
An observational study of Adhesive Capsulitis of the Shoulder and Hemiplegia, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
Although a relationship has been reported between stroke and adhesive capsulitis, it is controversial whether the underlying cause of the capsular changes seen in hemiplegic shoulder pain is true adhesive capsulitis. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adhesive Capsulitis of the Shoulder, Hemiplegia
- What is being tested?
- Imaging
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Oct 2020to 6 Oct 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subacute stroke patients with painful and stiff shoulder in the hemiplegic side, and healthy volunteers
Who may be able to join
- First stroke
- Stroke duration from 1 month to 6 months
- To be able to communicate well
- Presence of hemiplegic side shoulder pain
- Limitation of passive glenohumeral joint abduction on the hemiplegic side
- Limitation of passive glenohumeral joint external rotation of the hemiplegic side
Who cannot join
- Stroke duration <1 month or > 6 months
- Only presence of one of the pain or stiffness in the hemiplegic side shoulder
- History of pre-stroke shoulder pain independent from the side of shoulder
- Pain and / or stiffness in the non-hemiplegic side shoulder
- History of shoulder injury (independent from the side)
- History of upper extremity surgery (independent from the side)
Show all 11Show fewer
- Weakness in both upper extremities
- Existence of non-stroke diseases (osteoarthritis, inflammatory arthritis, etc.) that may cause restriction in the shoulder joint
- Inability to communicate properly
- <40 years old
- Hand pain and/or swelling in addition to shoulder pain and stiffness,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasonographic Assessment of Painful and Stiff Hemiplegic Shoulder in Subacute Stroke Patients in Terms of Adhesive Capsulitis
Although a relationship has been reported between stroke and adhesive capsulitis, it is controversial whether the underlying cause of the capsular changes seen in hemiplegic shoulder pain is true adhesive capsulitis. Although there has been a limited number of studies, ultrasound, which has been reported as a sensitive and specific method in the diagnosis of true (idiopathic) adhesive capsulitis, has not yielded similar results to arthrography and MRI in demonstrating fibrotic and adhesive changes in the glenohumeral capsule in stroke patients with hemiplegic shoulder pain. This study aims to investigate ultrasonographic structural changes that may be associated with adhesive capsulitis in subacute stroke patients with painful and stiff hemiplegic side shoulder.
Read the detailed description
Hemiplegic shoulder pain is one of the commonly seen complications of a stroke. Limitation of shoulder joint movement is added to hemiplegic shoulder pain in time. Therefore, adhesive capsulitis is one of the differential diagnoses that come to mind first in patients with hemiplegic shoulder pain and stiffness. Indeed, in arthrographic and magnetic resonance imaging (MRI) studies, it has been reported that adhesive capsulitis (or more accurately, capsular changes), is quite frequent.
Although a relationship has been reported between stroke and adhesive capsulitis, it is controversial whether the underlying cause of the capsular changes seen in hemiplegic shoulder pain is true adhesive capsulitis. Although these capsular changes and joint limitations in patients with hemiplegic shoulder pain may theoretically be related to idiopathic adhesive capsulitis, secondary causes including spasticity, contracture, fibrosis due to lack of movement, rotator cuff lesions, and glenohumeral subluxation have also been emphasized as a cause of the capsular restriction. Although there have been a limited number of studies, ultrasound, which has been reported as a sensitive and specific method in the diagnosis of true (idiopathic) adhesive capsulitis, has not yielded similar results to arthrography and MRI in demonstrating fibrotic and adhesive changes in the glenohumeral capsule in stroke patients with hemiplegic shoulder pain and stiffness. Because ultrasonographic examinations are mostly focused on rotator cuff tendons, bicipital tendon, and subacromial bursa, lack of detailed examination in terms of adhesive capsulitis may be one of the underlying reasons for this inconsistency. In this context, this study aims to investigate ultrasonographic structural changes that may be associated with adhesive capsulitis in subacute stroke patients with painful and stiff hemiplegic side shoulder.
- Conditions
- Adhesive Capsulitis of the Shoulder, Hemiplegia
- Being tested
- Imaging
- Keywords
- Shoulder, Hemiplegia, Adhesive capsulitis
- Medical subject headings
- Bursitis, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImagingDiagnostic test
Ultrasonographic imaging of the shoulder
| Study group | Role | What they receive |
|---|---|---|
| Group A | Painful and stiff hemiplegic side shoulders of stroke patients Receives: Diagnostic Test: Imaging | |
| Group B | Asymptomatic non-hemiplegic side shoulders of stroke patients Receives: Diagnostic Test: Imaging | |
| Group C | Non-dominant side shoulders of healthy volunteers Receives: Diagnostic Test: Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coracohumeral ligament thickness
The thickness in mm of the thickest part of the coracohumeral ligament on the axial-oblique plane with the shoulder in the neutral position
Measured: Through study completion, an average of 3 year
Soft tissue composition of the rotator interval
The presence of soft tissue increase (hypoechogenic compared to the biceps tendon and hyperechogenic compared to the joint fluid around the biceps tendon) in the imaging of the rotator interval on the transverse oblique plane
Measured: Through study completion, an average of 3 year
Vascularity in the rotator interval
The presence of increased vascularity in the color Doppler sonographic imaging of the rotator interval on the transverse oblique plane
Measured: Through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start7 Oct 2020
- Primary completion6 Oct 2023
- Study completion6 Oct 2023
Why it stopped: The study was stopped because the sample size calculated a priori could not be reached within the study period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Adhesive Capsulitis of the ShoulderStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ilker şengül, Izmir Katip Celebi University
- Investigators
- İlker Şengül, M.D., Principal investigator, İzmir Katip Çelebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613648
- Sponsor's protocol ID
- 2020-GOKAE-0356
- Status last verified
- Mar 2024
- First submitted
- 22 Oct 2020
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kalichman L, Ratmansky M. Underlying pathology and associated factors of hemiplegic shoulder pain. Am J Phys Med Rehabil. 2011 Sep;90(9):768-80. doi: 10.1097/PHM.0b013e318214e976.
PubMed 21430513Hakuno A, Sashika H, Ohkawa T, Itoh R. Arthrographic findings in hemiplegic shoulders. Arch Phys Med Rehabil. 1984 Nov;65(11):706-11.
PubMed 6497618Rizk TE, Christopher RP, Pinals RS, Salazar JE, Higgins C. Arthrographic studies in painful hemiplegic shoulders. Arch Phys Med Rehabil. 1984 May;65(5):254-6.
PubMed 6712451Lo SF, Chen SY, Lin HC, Jim YF, Meng NH, Kao MJ. Arthrographic and clinical findings in patients with hemiplegic shoulder pain. Arch Phys Med Rehabil. 2003 Dec;84(12):1786-91. doi: 10.1016/s0003-9993(03)00408-8.
PubMed 14669184Tavora DG, Gama RL, Bomfim RC, Nakayama M, Silva CE. MRI findings in the painful hemiplegic shoulder. Clin Radiol. 2010 Oct;65(10):789-94. doi: 10.1016/j.crad.2010.06.001. Epub 2010 Jul 21.
PubMed 20797464Wilson RD, Chae J. Hemiplegic Shoulder Pain. Phys Med Rehabil Clin N Am. 2015 Nov;26(4):641-55. doi: 10.1016/j.pmr.2015.06.007. Epub 2015 Sep 9.
PubMed 26522903Manara JR, Taylor J, Nixon M. Management of shoulder pain after a cerebrovascular accident or traumatic brain injury. J Shoulder Elbow Surg. 2015 May;24(5):823-9. doi: 10.1016/j.jse.2014.12.003. Epub 2015 Feb 3.
PubMed 25660242Wu H, Tian H, Dong F, Liang W, Song D, Zeng J, Ding Z, Shi Y, Luo H, Xu J. The role of grey-scale ultrasound in the diagnosis of adhesive capsulitis of the shoulder: a systematic review and meta-analysis. Med Ultrason. 2020 Sep 5;22(3):305-312. doi: 10.11152/mu-2430. Epub 2020 Apr 14.
PubMed 32399538Lee IS, Shin YB, Moon TY, Jeong YJ, Song JW, Kim DH. Sonography of patients with hemiplegic shoulder pain after stroke: correlation with motor recovery stage. AJR Am J Roentgenol. 2009 Feb;192(2):W40-4. doi: 10.2214/AJR.07.3978.
PubMed 19155379Idowu BM, Ayoola OO, Adetiloye VA, Komolafe MA. Sonographic Evaluation of Structural Changes in Post-Stroke Hemiplegic Shoulders. Pol J Radiol. 2017 Mar 13;82:141-148. doi: 10.12659/PJR.899684. eCollection 2017.
PubMed 28382186Martinoli C, Bianchi S, Prato N, Pugliese F, Zamorani MP, Valle M, Derchi LE. US of the shoulder: non-rotator cuff disorders. Radiographics. 2003 Mar-Apr;23(2):381-401; quiz 534. doi: 10.1148/rg.232025100.
PubMed 12640155Sabari JS, Maltzev I, Lubarsky D, Liszkay E, Homel P. Goniometric assessment of shoulder range of motion: comparison of testing in supine and sitting positions. Arch Phys Med Rehabil. 1998 Jun;79(6):647-51. doi: 10.1016/s0003-9993(98)90038-7.
PubMed 9630143MacDermid JC, Chesworth BM, Patterson S, Roth JH. Intratester and intertester reliability of goniometric measurement of passive lateral shoulder rotation. J Hand Ther. 1999 Jul-Sep;12(3):187-92. doi: 10.1016/s0894-1130(99)80045-3.
PubMed 10459526Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.
PubMed 21856077Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.
PubMed 3809245
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Assessment of Painful and Stiff Hemiplegic Shoulder in Subacute Stroke Patients in Terms of Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT04613648
- Acronym / sponsor ID
- 2020-GOKAE-0356
- Conditions
- Adhesive Capsulitis of the Shoulder, Hemiplegia
- Keywords
- Shoulder, Hemiplegia, Adhesive capsulitis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was stopped because the sample size calculated a priori could not be reached within the study period.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 6 Oct 2023 (actual)
- Study completion
- 6 Oct 2023 (actual)
- First posted
- 3 Nov 2020 (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.
Although a relationship has been reported between stroke and adhesive capsulitis, it is controversial whether the underlying cause of the capsular changes seen in hemiplegic shoulder pain is true adhesive capsulitis. Although there has been a limited number of studies, ultrasound, which has been reported as a sensitive and specific method in the diagnosis of true (idiopathic) adhesive capsulitis, has not yielded similar results to arthrography and MRI in demonstrating fibrotic and adhesive changes in the glenohumeral capsule in stroke patients with hemiplegic shoulder pain. This study aims to investigate ultrasonographic structural changes that may be associated with adhesive capsulitis in subacute stroke patients with painful and stiff hemiplegic side shoulder.
Detailed description
Hemiplegic shoulder pain is one of the commonly seen complications of a stroke. Limitation of shoulder joint movement is added to hemiplegic shoulder pain in time. Therefore, adhesive capsulitis is one of the differential diagnoses that come to mind first in patients with hemiplegic shoulder pain and stiffness. Indeed, in arthrographic and magnetic resonance imaging (MRI) studies, it has been reported that adhesive capsulitis (or more accurately, capsular changes), is quite frequent.
Although a relationship has been reported between stroke and adhesive capsulitis, it is controversial whether the underlying cause of the capsular changes seen in hemiplegic shoulder pain is true adhesive capsulitis. Although these capsular changes and joint limitations in patients with hemiplegic shoulder pain may theoretically be related to idiopathic adhesive capsulitis, secondary causes including spasticity, contracture, fibrosis due to lack of movement, rotator cuff lesions, and glenohumeral subluxation have also been emphasized as a cause of the capsular restriction. Although there have been a limited number of studies, ultrasound, which has been reported as a sensitive and specific method in the diagnosis of true (idiopathic) adhesive capsulitis, has not yielded similar results to arthrography and MRI in demonstrating fibrotic and adhesive changes in the glenohumeral capsule in stroke patients with hemiplegic shoulder pain and stiffness. Because ultrasonographic examinations are mostly focused on rotator cuff tendons, bicipital tendon, and subacromial bursa, lack of detailed examination in terms of adhesive capsulitis may be one of the underlying reasons for this inconsistency. In this context, this study aims to investigate ultrasonographic structural changes that may be associated with adhesive capsulitis in subacute stroke patients with painful and stiff hemiplegic side shoulder.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Diagnostic Test: ImagingPainful and stiff hemiplegic side shoulders of stroke patients |
| Group B | – | Diagnostic Test: ImagingAsymptomatic non-hemiplegic side shoulders of stroke patients |
| Group C | – | Diagnostic Test: ImagingNon-dominant side shoulders of healthy volunteers |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subacute stroke patients with painful and stiff shoulder in the hemiplegic side, and healthy volunteers
Key inclusion criteria (6 listed)
- First stroke
- Stroke duration from 1 month to 6 months
- To be able to communicate well
- Presence of hemiplegic side shoulder pain
- Limitation of passive glenohumeral joint abduction on the hemiplegic side
Key exclusion criteria (11 listed)
- Stroke duration <1 month or > 6 months
- Only presence of one of the pain or stiffness in the hemiplegic side shoulder
- History of pre-stroke shoulder pain independent from the side of shoulder
- Pain and / or stiffness in the non-hemiplegic side shoulder
- History of shoulder injury (independent from the side)
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 |
|---|---|---|
| ImagingUltrasonographic imaging of the shoulder | Diagnostic test | Group A, Group B, Group C |
Primary outcome
Coracohumeral ligament thickness
Time frame: Through study completion, an average of 3 year
The thickness in mm of the thickest part of the coracohumeral ligament on the axial-oblique plane with the shoulder in the neutral position
Soft tissue composition of the rotator interval
Time frame: Through study completion, an average of 3 year
The presence of soft tissue increase (hypoechogenic compared to the biceps tendon and hyperechogenic compared to the joint fluid around the biceps tendon) in the imaging of the rotator interval on the transverse oblique plane
Vascularity in the rotator interval
Time frame: Through study completion, an average of 3 year
The presence of increased vascularity in the color Doppler sonographic imaging of the rotator interval on the transverse oblique plane
Results and safety
The study was stopped early (reason given: The study was stopped because the sample size calculated a priori could not be reached within the study period.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Background: PubMed 21430513Kalichman L, Ratmansky M. Underlying pathology and associated factors of hemiplegic shoulder pain. Am J Phys Med Rehabil. 2011 Sep;90(9):768-80. doi: 10.1097/PHM.0b013e318214e976.
- Background: PubMed 6497618Hakuno A, Sashika H, Ohkawa T, Itoh R. Arthrographic findings in hemiplegic shoulders. Arch Phys Med Rehabil. 1984 Nov;65(11):706-11.
- Background: PubMed 6712451Rizk TE, Christopher RP, Pinals RS, Salazar JE, Higgins C. Arthrographic studies in painful hemiplegic shoulders. Arch Phys Med Rehabil. 1984 May;65(5):254-6.
- Background: PubMed 14669184Lo SF, Chen SY, Lin HC, Jim YF, Meng NH, Kao MJ. Arthrographic and clinical findings in patients with hemiplegic shoulder pain. Arch Phys Med Rehabil. 2003 Dec;84(12):1786-91. doi: 10.1016/s0003-9993(03)00408-8.
- Background: PubMed 20797464Tavora DG, Gama RL, Bomfim RC, Nakayama M, Silva CE. MRI findings in the painful hemiplegic shoulder. Clin Radiol. 2010 Oct;65(10):789-94. doi: 10.1016/j.crad.2010.06.001. Epub 2010 Jul 21.
- Background: PubMed 26522903Wilson RD, Chae J. Hemiplegic Shoulder Pain. Phys Med Rehabil Clin N Am. 2015 Nov;26(4):641-55. doi: 10.1016/j.pmr.2015.06.007. Epub 2015 Sep 9.
- Background: PubMed 25660242Manara JR, Taylor J, Nixon M. Management of shoulder pain after a cerebrovascular accident or traumatic brain injury. J Shoulder Elbow Surg. 2015 May;24(5):823-9. doi: 10.1016/j.jse.2014.12.003. Epub 2015 Feb 3.
- Background: PubMed 32399538Wu H, Tian H, Dong F, Liang W, Song D, Zeng J, Ding Z, Shi Y, Luo H, Xu J. The role of grey-scale ultrasound in the diagnosis of adhesive capsulitis of the shoulder: a systematic review and meta-analysis. Med Ultrason. 2020 Sep 5;22(3):305-312. doi: 10.11152/mu-2430. Epub 2020 Apr 14.
- Background: PubMed 19155379Lee IS, Shin YB, Moon TY, Jeong YJ, Song JW, Kim DH. Sonography of patients with hemiplegic shoulder pain after stroke: correlation with motor recovery stage. AJR Am J Roentgenol. 2009 Feb;192(2):W40-4. doi: 10.2214/AJR.07.3978.
- Background: PubMed 28382186Idowu BM, Ayoola OO, Adetiloye VA, Komolafe MA. Sonographic Evaluation of Structural Changes in Post-Stroke Hemiplegic Shoulders. Pol J Radiol. 2017 Mar 13;82:141-148. doi: 10.12659/PJR.899684. eCollection 2017.
- Background: PubMed 12640155Martinoli C, Bianchi S, Prato N, Pugliese F, Zamorani MP, Valle M, Derchi LE. US of the shoulder: non-rotator cuff disorders. Radiographics. 2003 Mar-Apr;23(2):381-401; quiz 534. doi: 10.1148/rg.232025100.
- Background: PubMed 9630143Sabari JS, Maltzev I, Lubarsky D, Liszkay E, Homel P. Goniometric assessment of shoulder range of motion: comparison of testing in supine and sitting positions. Arch Phys Med Rehabil. 1998 Jun;79(6):647-51. doi: 10.1016/s0003-9993(98)90038-7.
- Individual participant dataSharing planned: No
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.
İlker Şengül, M.D. principal investigator
İzmir Katip Çelebi University
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 and Hemiplegia, run by Izmir Katip Celebi 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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 18 Mar 2024. 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 was stopped early (reason given: The study was stopped because the sample size calculated a priori could not be reached within the study period.). Results are not available in the source record.
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?
Coracohumeral ligament thickness (time frame: Through study completion, an average of 3 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04613648, which also lists 20 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 18 Mar 2024.