NCT02440477

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

March 3, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

May 7, 2015

Last Update Submit

March 2, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Neer test , empty can test, Hawkins Kennedy test

    one year

Secondary Outcomes (1)

  • shoulder muscle testing

    one year

Study Arms (2)

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.

Other: clinical shoulder tests

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.

Other: clinical shoulder tests

Interventions

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 grouppartial rotator cuff tears

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged over 40 years with partial rotator cuff degenerative tears that were diagnosed by ultrasound.

You may qualify if:

  • Patients aged over 40 years.
  • Patients with partial rotator cuff degenerative tears that were diagnosed by ultrasound.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bat yamon physical therapy

Bat Yam, Israel, Israel

Location

Holon Physiotherapy

Holon, Israel, Israel

Location

Related Publications (29)

  • 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.

    PMID: 9924205BACKGROUND
  • 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.

    PMID: 20710092BACKGROUND
  • 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.

    PMID: 15681266BACKGROUND
  • 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.

    PMID: 19396486BACKGROUND
  • 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.

    PMID: 18511227BACKGROUND
  • Lewis JS. Subacromial impingement syndrome: a musculoskeletal condition or a clinical illusion? Physical Therapy Reviews.2011; 16(5): 1-12.

    BACKGROUND
  • 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.

    PMID: 10453773BACKGROUND
  • Donatelli R. Physical Therapy of the Shoulder (Clinics in Physical Therapy). 4th ed. New York, NY: Churchill-Livingstone; 2004.

    BACKGROUND
  • Neer CS 2nd. Impingement lesions. Clin Orthop Relat Res. 1983 Mar;(173):70-7. No abstract available.

    PMID: 6825348BACKGROUND
  • 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.

    PMID: 7787853BACKGROUND
  • 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.

    PMID: 8348135BACKGROUND
  • 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.

    PMID: 19194022BACKGROUND
  • 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.

    PMID: 10560066BACKGROUND
  • 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.

    PMID: 17720798BACKGROUND
  • 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.

    PMID: 18555732BACKGROUND
  • 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.

    PMID: 18721119BACKGROUND
  • 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.

    PMID: 10471998BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 7180952BACKGROUND
  • Hawkins RJ, Kennedy JC. Impingement syndrome in athletes. Am J Sports Med. 1980 May-Jun;8(3):151-8. doi: 10.1177/036354658000800302.

    PMID: 7377445BACKGROUND
  • 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.

    PMID: 16943859BACKGROUND
  • Michener LA, Kalra N, Pinkstaff S, Ericksen J,Boardman N. Measurement of the subacromial space using ultrasonography. Journal of Athletic Training.2007;42:126.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 7869316BACKGROUND
  • Seitz AL, McClure PW, Finucane S, Boardman ND 3rd, Michener LA. Mechanisms of rotator cuff tendinopathy: intrinsic, extrinsic, or both? Clin Biomech (Bristol). 2011 Jan;26(1):1-12. doi: 10.1016/j.clinbiomech.2010.08.001. Epub 2010 Sep 16.

    PMID: 20846766BACKGROUND
  • Palstanga N, Field D, Soamnes R. Anatomy and human movement, structure and function, third edition. Butterworth-Heinman Ltd. 1991: 88-101

    BACKGROUND
  • Magee DJ. Orthopedic Physical Assessment: 5th Edition. St. Louis, MO: Saunders Elsevier; 2008.

    BACKGROUND
  • Kendall FP, Kendall McCreary E, Rodgers MM, Romani WA. Muscles: Testing and Function, with Posture and Pain 5th edition. LWW; 2005.

    BACKGROUND
  • 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.

Study Officials

  • shlomo bierkenfeld, MD

    Clalit Health Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2015

First Posted

May 12, 2015

Study Start

July 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

March 3, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will share

Locations