Ultrasonographic Assessment of Painful and Stiff Hemiplegic Shoulder in Terms of Adhesive Capsulitis

NCT04613648 | Terminated

• 1 other identifier: 2020-GOKAE-0356
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Adhesive Capsulitis of the Shoulder; Hemiplegia

Keywords

Shoulder; Hemiplegia; Adhesive capsulitis

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  Through study completion, an average of 3 year

Study Arms (3)

Group A

Painful and stiff hemiplegic side shoulders of stroke patients

Diagnostic Test: Imaging

Group B

Asymptomatic non-hemiplegic side shoulders of stroke patients

Diagnostic Test: Imaging

Group C

Non-dominant side shoulders of healthy volunteers

Diagnostic Test: Imaging

Interventions

Imaging DIAGNOSTIC_TEST

Ultrasonographic imaging of the shoulder

Group A; Group B; Group C

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subacute stroke patients with painful and stiff shoulder in the hemiplegic side, and healthy volunteers

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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,

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

İlker Şengül

Izmir, 35360, Turkey (Türkiye)

Location

Related Publications (20)

• 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.

  PMID: 21430513 BACKGROUND

• Hakuno A, Sashika H, Ohkawa T, Itoh R. Arthrographic findings in hemiplegic shoulders. Arch Phys Med Rehabil. 1984 Nov;65(11):706-11.

  PMID: 6497618 BACKGROUND

• Rizk 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.

  PMID: 6712451 BACKGROUND

• Lo 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.

  PMID: 14669184 BACKGROUND

• Tavora 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.

  PMID: 20797464 BACKGROUND

• Wilson 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.

  PMID: 26522903 BACKGROUND

• Manara 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.

  PMID: 25660242 BACKGROUND

• Wu 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.

  PMID: 32399538 BACKGROUND

• Lee 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.

  PMID: 19155379 BACKGROUND

• Idowu 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.

  PMID: 28382186 BACKGROUND

• Martinoli 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.

  PMID: 12640155 BACKGROUND

• Sabari 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.

  PMID: 9630143 BACKGROUND

• MacDermid 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.

  PMID: 10459526 BACKGROUND

• Ferreira-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.

  PMID: 21856077 BACKGROUND

• Bohannon 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.

  PMID: 3809245 BACKGROUND

• Brunnstrom S. Motor testing procedures in hemiplegia: based on sequential recovery stages. Phys Ther. 1966 Apr;46(4):357-75. doi: 10.1093/ptj/46.4.357. No abstract available.

  PMID: 5907254 BACKGROUND

• Homsi C, Bordalo-Rodrigues M, da Silva JJ, Stump XM. Ultrasound in adhesive capsulitis of the shoulder: is assessment of the coracohumeral ligament a valuable diagnostic tool? Skeletal Radiol. 2006 Sep;35(9):673-8. doi: 10.1007/s00256-006-0136-y. Epub 2006 May 25.

  PMID: 16724200 BACKGROUND

• Tamborrini G, Moller I, Bong D, Miguel M, Marx C, Muller AM, Muller-Gerbl M. The Rotator Interval - A Link Between Anatomy and Ultrasound. Ultrasound Int Open. 2017 Jun;3(3):E107-E116. doi: 10.1055/s-0043-110473. Epub 2017 Aug 23.

  PMID: 28845477 BACKGROUND

• Lee JC, Sykes C, Saifuddin A, Connell D. Adhesive capsulitis: sonographic changes in the rotator cuff interval with arthroscopic correlation. Skeletal Radiol. 2005 Sep;34(9):522-7. doi: 10.1007/s00256-005-0957-0. Epub 2005 Jul 6.

  PMID: 15999280 BACKGROUND

• Adey-Wakeling Z, Arima H, Crotty M, Leyden J, Kleinig T, Anderson CS, Newbury J; SEARCH Study Collaborative. Incidence and associations of hemiplegic shoulder pain poststroke: prospective population-based study. Arch Phys Med Rehabil. 2015 Feb;96(2):241-247.e1. doi: 10.1016/j.apmr.2014.09.007. Epub 2014 Sep 28.

  PMID: 25264111 BACKGROUND

MeSH Terms

Conditions

Bursitis; Hemiplegia

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• İlker Şengül, M.D.

  İzmir Katip Çelebi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: November 3, 2020
• Study Start: October 7, 2020
• Primary Completion: October 6, 2023
• Study Completion: October 6, 2023
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)