- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT02440477
The Effect of Changing Posture in Sitting on Selected Clinical Shoulder Tests (EOCPIS)
The Effect of Changing Posture in Sitting on Selected Clinical Shoulder Tests in Patients With Rotator Cuff Degenerative Tears
Background: Shoulder pain is the third most common musculoskeletal problem accounting almost 21% of all musculoskeletal complaints. Symptomatic Rotator cuff degenerative tears (RCDT) are mostly common above the age of 40. Deviations of posture in the upper quadrant such as, slouched posture and forward head position, have been linked repeatedly to rotator cuff diseases, altered scapular kinematics and changes in the acromiohumeral distance (AHD). No study yet examined the effect of changing posture in sitting on the output of shoulder clinical tests, in patients with RCDT.
Objectives: The primary objective of the study is to examine the effect of changing posture in sitting on selected clinical shoulder tests in patients with rotator cuff degenerative tears (RCDT) Study design: A single blinded controlled clinical trial Methods: A total of 100 subjects (Patients referred to physiotherapy outpatient clinics of Clalit Healthcare Services in Holon and Hertzlyia) will be included in this study and divided into 2 groups: 50 subjects with shoulder pain who are diagnosed with RCDT by ultrasound and a control group of 50 volunteering subjects without any pain in the upper quadrant. All patients will be measured for their body weight and height and their hand dominance will be notified. Following reliability trials on the first 10 subjects, all subjects will be tested for pain provocation and level of pain (VAS) in both shoulders with 3 commonly used clinical shoulder tests for the diagnosis of rotator cuff diseases (Empty can - sensitivity=94%, specificity = 46% Neer test - sensitivity = 72%, specificity = 60%, and Hawkins-Kennedy test - sensitivity = 79%, specificity = 59% ) in 3 sitting postures; normal resting posture, slouched posture, and upright posture with scapular retraction as described by Kalra et al (2010). In addition, the rotator cuff muscle strength tests during shoulder abduction, internal rotation and external rotation will be measured for the 2 shoulders using a hand-held dynamometer.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
Opintotyyppi
Ilmoittautuminen (Odotettu)
Yhteystiedot ja paikat
Opiskelupaikat
-
-
-
Bat yam, Israel
- Bat yamon physical therapy
-
Holon, Israel
- Holon Physiotherapy
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
Inclusion Criteria:
- Patients aged over 40 years.
- Patients with partial rotator cuff degenerative tears that were diagnosed by ultrasound.
Exclusion Criteria:
- Recent trauma to the upper quadrant.
- Patients with spondyloarthropaties and or rheumatological diseases
- Any oncological disease.
- Any surgery or fractures in the upper quadrant.
- Systemic vascular pathology.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
|---|---|
|
partial rotator cuff tears
50 subjects with shoulder pain who are diagnosed with partial rotator cuff degenrative tears by ultrasound.
All patients will be measured for their body weight and height and their hand dominance will be notified.
Following reliability trials on the first 10 subjects, all subjects will be tested for pain provocation and level of pain (VAS) in both shoulders with 3 commonly used clinical shoulder tests for the diagnosis of rotator cuff diseases Empty can ,Neer test and Hawkins-Kennedy test in 3 sitting postures; normal resting posture, slouched posture, and upright posture with scapular retraction.
In addition, the rotator cuff muscle strength tests during shoulder abduction, internal rotation and external rotation will be measured for the 2 shoulders using a hand-held dynamometer.
|
Three clinical shoulder tests (Neer impingement sign,Hawkins-kennedy, empty can) performed in three different sitting positions: normal resting posture, slouched posture, and upright posture with scapular retraction and shoulder.
and in addition shoulder muscle strength test with handheld dynamometer
|
|
control group
50 volunteering subjects without any pain in the upper quadrant.All patients will be measured for their body weight and height and their hand dominance will be notified.
Following reliability trials on the first 10 subjects, all subjects will be tested for pain provocation and level of pain (VAS) in both shoulders with 3 commonly used clinical shoulder tests for the diagnosis of rotator cuff diseases Empty can ,Neer test and Hawkins-Kennedy test in 3 sitting postures; normal resting posture, slouched posture, and upright posture with scapular retraction.
In addition, the rotator cuff muscle strength tests during shoulder abduction, internal rotation and external rotation will be measured for the 2 shoulders using a hand-held dynamometer.
|
Three clinical shoulder tests (Neer impingement sign,Hawkins-kennedy, empty can) performed in three different sitting positions: normal resting posture, slouched posture, and upright posture with scapular retraction and shoulder.
and in addition shoulder muscle strength test with handheld dynamometer
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
|
Neer test , empty can test, Hawkins Kennedy test
Aikaikkuna: one year
|
one year
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
|
shoulder muscle testing
Aikaikkuna: one year
|
one year
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: shlomo bierkenfeld, MD, Clalit health services
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- Kalra N, Seitz AL, Boardman ND 3rd, Michener LA. Effect of posture on acromiohumeral distance with arm elevation in subjects with and without rotator cuff disease using ultrasonography. J Orthop Sports Phys Ther. 2010 Oct;40(10):633-40. doi: 10.2519/jospt.2010.3155.
- Tempelhof S, Rupp S, Seil R. Age-related prevalence of rotator cuff tears in asymptomatic shoulders. J Shoulder Elbow Surg. 1999 Jul-Aug;8(4):296-9. doi: 10.1016/s1058-2746(99)90148-9.
- Seitz AL, McClure PW, Finucane S, Boardman ND 3rd, Michener LA. Mechanisms of rotator cuff tendinopathy: intrinsic, extrinsic, or both? Clin Biomech (Bristol, Avon). 2011 Jan;26(1):1-12. doi: 10.1016/j.clinbiomech.2010.08.001. Epub 2010 Sep 16.
- Hegedus EJ, Goode A, Campbell S, Morin A, Tamaddoni M, Moorman CT 3rd, Cook C. Physical examination tests of the shoulder: a systematic review with meta-analysis of individual tests. Br J Sports Med. 2008 Feb;42(2):80-92; discussion 92. doi: 10.1136/bjsm.2007.038406. Epub 2007 Aug 24.
- Kebaetse M, McClure P, Pratt NA. Thoracic position effect on shoulder range of motion, strength, and three-dimensional scapular kinematics. Arch Phys Med Rehabil. 1999 Aug;80(8):945-50. doi: 10.1016/s0003-9993(99)90088-6.
- Hawkins RJ, Kennedy JC. Impingement syndrome in athletes. Am J Sports Med. 1980 May-Jun;8(3):151-8. doi: 10.1177/036354658000800302.
- Neer CS 2nd. Impingement lesions. Clin Orthop Relat Res. 1983 Mar;(173):70-7. No abstract available.
- Urwin M, Symmons D, Allison T, Brammah T, Busby H, Roxby M, Simmons A, Williams G. Estimating the burden of musculoskeletal disorders in the community: the comparative prevalence of symptoms at different anatomical sites, and the relation to social deprivation. Ann Rheum Dis. 1998 Nov;57(11):649-55. doi: 10.1136/ard.57.11.649.
- Ludewig PM, Reynolds JF. The association of scapular kinematics and glenohumeral joint pathologies. J Orthop Sports Phys Ther. 2009 Feb;39(2):90-104. doi: 10.2519/jospt.2009.2808.
- Bullock MP, Foster NE, Wright CC. Shoulder impingement: the effect of sitting posture on shoulder pain and range of motion. Man Ther. 2005 Feb;10(1):28-37. doi: 10.1016/j.math.2004.07.002.
- Cutti AG, Veeger HE. Shoulder biomechanics: today's consensus and tomorrow's perspectives. Med Biol Eng Comput. 2009 May;47(5):463-6. doi: 10.1007/s11517-009-0487-3. Epub 2009 Apr 25.
- Lugo R, Kung P, Ma CB. Shoulder biomechanics. Eur J Radiol. 2008 Oct;68(1):16-24. doi: 10.1016/j.ejrad.2008.02.051. Epub 2008 Jun 3.
- Lewis JS. Subacromial impingement syndrome: a musculoskeletal condition or a clinical illusion? Physical Therapy Reviews.2011; 16(5): 1-12.
- Donatelli R. Physical Therapy of the Shoulder (Clinics in Physical Therapy). 4th ed. New York, NY: Churchill-Livingstone; 2004.
- Greenfield B, Catlin PA, Coats PW, Green E, McDonald JJ, North C. Posture in patients with shoulder overuse injuries and healthy individuals. J Orthop Sports Phys Ther. 1995 May;21(5):287-95. doi: 10.2519/jospt.1995.21.5.287.
- Culham E, Peat M. Functional anatomy of the shoulder complex. J Orthop Sports Phys Ther. 1993 Jul;18(1):342-50. doi: 10.2519/jospt.1993.18.1.342.
- Lukasiewicz AC, McClure P, Michener L, Pratt N, Sennett B. Comparison of 3-dimensional scapular position and orientation between subjects with and without shoulder impingement. J Orthop Sports Phys Ther. 1999 Oct;29(10):574-83; discussion 584-6. doi: 10.2519/jospt.1999.29.10.574.
- Schellingerhout JM, Verhagen AP, Thomas S, Koes BW. Lack of uniformity in diagnostic labeling of shoulder pain: time for a different approach. Man Ther. 2008 Dec;13(6):478-83. doi: 10.1016/j.math.2008.04.005. Epub 2008 Jun 13.
- Hughes PC, Taylor NF, Green RA. Most clinical tests cannot accurately diagnose rotator cuff pathology: a systematic review. Aust J Physiother. 2008;54(3):159-70. doi: 10.1016/s0004-9514(08)70022-9.
- Lewis JS, Tennent TD. How effective are diagnostic tests for the assessment of rotator cuff disease of the shoulder? In: MacAuley D, Best TM, editors. Evidence based Sports Medicine. 2nd ed. London: Blackwell Publishing. 2007; 327-59.
- Jobe FW, Moynes DR. Delineation of diagnostic criteria and a rehabilitation program for rotator cuff injuries. Am J Sports Med. 1982 Nov-Dec;10(6):336-9. doi: 10.1177/036354658201000602.
- Kim E, Jeong HJ, Lee KW, Song JS. Interpreting positive signs of the supraspinatus test in screening for torn rotator cuff. Acta Med Okayama. 2006 Aug;60(4):223-8. doi: 10.18926/AMO/30715.
- Michener LA, Kalra N, Pinkstaff S, Ericksen J,Boardman N. Measurement of the subacromial space using ultrasonography. Journal of Athletic Training.2007;42:126.
- Woo S.L. An K.N. Frank C.B. Livesay G.A. Ma, C.B. Zeminski J. Anatomy, biology, and biomechanics of tendon and ligament. 2000 In: Buckwalter, J., Einhorn, T.,Simon, S. (Eds.), Orthopaedic Basic Science. American Academy of Orthopaedic Surgeons, Park Ridge.
- Kumagai J, Sarkar K, Uhthoff HK. The collagen types in the attachment zone of rotator cuff tendons in the elderly: an immunohistochemical study. J Rheumatol. 1994 Nov;21(11):2096-100.
- Palstanga N, Field D, Soamnes R. Anatomy and human movement, structure and function, third edition. Butterworth-Heinman Ltd. 1991: 88-101
- Magee DJ. Orthopedic Physical Assessment: 5th Edition. St. Louis, MO: Saunders Elsevier; 2008.
- Kendall FP, Kendall McCreary E, Rodgers MM, Romani WA. Muscles: Testing and Function, with Posture and Pain 5th edition. LWW; 2005.
- Weisman A, Masharawi Y. Does Altering Sitting Posture Have a Direct Effect on Clinical Shoulder Tests in Individuals With Shoulder Pain and Rotator Cuff Degenerative Tears? Phys Ther. 2019 Feb 1;99(2):194-202. doi: 10.1093/ptj/pzy111.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Odotettu)
Opintojen valmistuminen (Odotettu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muut tutkimustunnusnumerot
- ק018/2015
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
Kliiniset tutkimukset Kiertäjämansetin osittainen repeytyminen
-
Voll Medical Technologies Ltd.Rekrytointi
-
Ataturk UniversityRekrytointiMassiivinen Rotator Cuff TearTurkki (Türkiye)
-
OrthoSpace Ltd.LopetettuTäyspaksuinen Rotator Cuff TearYhdistynyt kuningaskunta
-
Orthofix Inc.LopetettuTäyspaksuinen Rotator Cuff TearYhdysvallat
-
Orlando Health, Inc.ValmisTäyspaksuinen Rotator Cuff TearYhdysvallat
-
Laval UniversityTuntematonTäyspaksuinen Rotator Cuff TearKanada
-
University of Missouri-ColumbiaValmisOlkapään nivelrikko | Mansetin kyynelartropatia | Massiivinen Rotator Cuff TearYhdysvallat
-
Taichung Veterans General HospitalAktiivinen, ei rekrytointiRotator Cuff Tear | Rotator Cuff tendinopatiaTaiwan
-
Arthrex, Inc.RekrytointiRotator Cuff Tear ArthropathyYhdysvallat
-
Gülçe İrem YalçınkayaAktiivinen, ei rekrytointi
Kliiniset tutkimukset clinical shoulder tests
-
University of VigoValmisOlkapääkipu | Urheilun fysioterapiaEspanja
-
Guna S.p.aValmisRotaattorimansetin vammat | Tendinopatia | Rotator Cuff Tendinitis | Syndrooma Rotator Cuff | Jänteet, Rotator CuffItalia
-
CHU de ReimsValmis
-
Smith & Nephew, Inc.LopetettuNiveltulehdus | Nivelreuma | Avaskulaarinen nekroosi | Nivelten epävakaus | Murtuma | Kipu, olkapää | Niveltulehdus, rappeuttava | Muiden nivelten trauman jälkeinen niveltulehdus, olkapääalue | Olkapään ja siihen liittyvien sairauksien rotator Cuff -oireyhtymä | Niveltrauma | Dislokaatio, olkapääYhdysvallat
-
Madigan Army Medical CenterTelemedicine & Advanced Technology Research Center; Analytics4Medicine, LLCLopetettu
-
National Cheng-Kung University HospitalValmis
-
University of North Carolina, Chapel HillNational Institute of Environmental Health Sciences (NIEHS)Valmis
-
Linkoeping UniversityAktiivinen, ei rekrytointiSydäninfarkti | HaurasRuotsi
-
University of SaskatchewanNovartis; Lung Association of SaskatchewanTuntematonKeuhkosairaus, krooninen obstruktiivinenKanada
-
Anabela Correia MartinsSensing Future Technologies; Fraunhofer Portugal Research Center for Assistive...TuntematonSatunnaiset putouksetPortugali