- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Bat yam, Israel
- Bat yamon physical therapy
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Holon, Israel
- Holon Physiotherapy
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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.
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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
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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
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Neer test , empty can test, Hawkins Kennedy test
Periodo de tiempo: one year
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one year
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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shoulder muscle testing
Periodo de tiempo: one year
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one year
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: shlomo bierkenfeld, MD, Clalit Health Services
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- ק018/2015
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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