The Effect of Changing Posture in Sitting on Selected Clinical Shoulder Tests

Partial Tear of Rotator Cuff Clinical Trial

— EOCPIS  

Official title:

The Effect of Changing Posture in Sitting on Selected Clinical Shoulder Tests in Patients With Rotator Cuff Degenerative Tears

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02440477
• Other study ID #: ?018/2015
• Status: Active, not recruiting
• Phase: N/A
• First received: May 7, 2015
• Last updated: March 2, 2017
• Start date: July 1, 2015
• Est. completion date: April 1, 2017

Study information

• Verified date: February 2017
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Quality assurance - "clalit" health services will provide ongoing auditing and monitoring of the study. data checks will be also examined by "clalit health services". the investigators are obliged to enter all the data into logs provided upfront by the organisation. All the data obtained will be stored in an original folder intended for inspection and all encounters with volunteers will be documented in the computerized medical file of the volunteers. Standard operating procedures will be followed by the regulations expected by "clalit" health services and the Israeli ministry of health. After the first 10 volunteers of the study a reliability and validity statistical analysis will be made to assess the sample size estimated. Missing, unavailable, "non-reported" or uninterpretable data will be excluded from the final analysis.Data will be analyzed using the Statistical Package for the Social Sciences Version 15 (SPSS Inc., Chicago, IL, USA). Results of measurements of each test will be analyzed for mean, standard deviation (SD) and range. Categorical variables will be described percentiles/median. Changes of variables in the same subject will be analyzed using a paired T test for continuous variables and Mann-Whitney test for categorical variables. In addition, the correlations between variables will be calculated using ICC. P values smaller than 0.05 (p<0.05) will be considered significant

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: April 1, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. Patients aged over 40 years.

2. Patients with partial rotator cuff degenerative tears that were diagnosed by ultrasound.

Exclusion Criteria:

1. Recent trauma to the upper quadrant.

2. Patients with spondyloarthropaties and or rheumatological diseases

3. Any oncological disease.

4. Any surgery or fractures in the upper quadrant.

5. Systemic vascular pathology.

Related Conditions & MeSH terms

• Partial Tear of Rotator Cuff

Intervention

Other:
• clinical shoulder tests
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

Locations

Country	Name	City	State
Israel	Bat yamon physical therapy	Bat yam
Israel	Holon Physiotherapy	Holon

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neer test , empty can test, Hawkins Kennedy test		one year
Secondary	shoulder muscle testing		one year