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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04813757
Other study ID # 03-06-11-19
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2020
Est. completion date December 2022

Study information

Verified date September 2021
Source Meuhedet. Healthcare Organization
Contact Andrey Maizles
Phone 0547664393
Email maizles1@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Altered scapular movement is a common impairment among patients with subacromial impingement syndrome (SAIS). Nevertheless scapular focused interventions have resulted in conflicting findings among this population. One possible reason for this is the inability to identify patients with SAIS who will respond favorably to a scapular focused intervention. The scapular assistance test (SAT) may be one possible indicator of patients most likely to benefit from a scapular focused intervention, particularly one that emphasizes scapular upward rotation. The purpose of this study is to examine targeted upward rotation intervention in patients demonstrating a positive Scapular Assistance test.


Description:

Background: Patients with SAIS are commonly referred to physical therapy. A common impairment among patients with SAIS is altered scapular movement, characterized by insufficient upward rotation and posterior tilt. These deficits are believed to decrease the subacromial space and diminish length -tension relationship among the deltoid and rotator cuff musculature. The scapular assistance test (SAT) is a physical examination manoeuvre aimed to detect patients in whom insufficient scapular upward rotation and posterior tilt contribute to the generation of shoulder symptoms. The SAT may, therefore, serve as an indication for the need of scapular focused intervention. Given the inconsistent results of scapular focused interventions among patients with SAIS, the purpose of this study is to assess the outcome of a scapular-focused intervention, particularly geared toward increasing scapular upward rotation, among patients with SAIS that exhibit a positive SAT as well. Methods: Fifty patients with SAIS and a positive SAT referred to the "Meuhedet" outpatient physical therapy clinic in Ashdod will be recruited for this study. Following baseline assessment, patients will be randomized into 12 sessions over a 6-week period. The intervention group will receive manual therapy and an exercise program focused on increasing scapular upward rotation while the control group will receive manual therapy and an exercise program focused on scapular muscle an rotator cuff strengthening with no special emphasis on scapular upward rotation. Repeated measures analysis of covariance will be conducted to detect differences in pain intensity, shoulder -related disability and scapular upward rotation following the intervention


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Unilateral shoulder pain for =1 month - A diagnosis of SAIS as determined by having 3 or ore positive tests out of: Neer test, Hawkins test, Painful arc, Jobe test, external rotation resistance test. - A positive SAT Exclusion criteria: - Cervical spine involvement as evidenced by reproduction of symptoms with neck movement - Massive rotator cuff tear as evidenced by pseudoparalysis - Previous history of a fracture or surgery within the involved shoulder. - Limited passive range of motion by =50% or more compared with uninvolved side in - 2 planes of motion (i.e. flexion, external rotation) - A history of shoulder dislocation or subluxation - A history of Rheumatoid arthritis, CVA, fibromyalgia - Current pregnancy - Population with special needs - Pending disability claim / litigation procedure associated with shoulder complaint.

Study Design


Intervention

Other:
exercise
each group will perform 2 shoulder strength exercise at the therapy session and 3 exercise at home session-2 strength exercise and one stretching exercise. they will perform the exercises 5 times per week
manual therapy
on each treatment session both group will receive 15 minutes of manual therapy which will include: massage,3-4 trigger point treatment posterior capsule stretch and mobilization with movement

Locations

Country Name City State
Israel Meuhedet Ashdod

Sponsors (2)

Lead Sponsor Collaborator
Meuhedet. Healthcare Organization Ariel University

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Disability of the Arm, Shoulder and Hand (DASH) questionnaire each participant will receive the Disability of the Arm shoulder and hand questioner. score is from 0 -100 a higher score is greater disability pre intervention
Primary Numeric pain Rating Scale (NPRS), 0 - 10 each participant will receive the NPRS questioner higher score means greater pain pre intervention
Secondary Active shoulder flexion in standing position the patient will elevate the arm in the sagittal plane, the range of motion will be measured by goniometer pre intervention
Secondary active shoulder abduction in standing position the patient will elevate the arm in the frontal plane, the range of motion will be measured by goniometer pre intervention
Secondary scapular posterior tilt in standing position the scapular posterior tilt willl be measured by digital inclinometer which will be placed on the medial border of the scapula. the posterior tilt will be measured in 90 and 120 degree of forward flexion pre intervention
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