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Scapular Upward Rotation Focused Treatment for Patient With Shoulder Impingement Syndrome and a Positive Scapular Assistance Test

Primary Purpose

Subacromial Pain Syndrome, Impingement Syndrome, Scapular Dyskinesis

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
exercise
manual therapy
Sponsored by
Meuhedet. Healthcare Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacromial Pain Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • MeuhedetRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

intervention group

control group

Arm Description

Participants in the intervention group will receive 12 treatment sessions over a 6-week period. Three sessions during the first 2 weeks, 2 sessions per week during weeks 3 and 4 , and one session during weeks 5 and 6. Each session will be 30 minutes including 10 minutes of manual therapy and 20 minutes for review and/or modification of the exercise program. The manual therapy will include trigger point manual therapy. The exercise program will include 2 scapular and rotator cuff strengthening exercises emphasizing scapular upward rotation and posterior tilt and one additional flexibility exercise. These exercise will be repeated at home on the days in between the therapy sessions.

Participants in the control group will receive 12 treatment sessions over a 6-week period. Three sessions during the first 2 weeks, 2 sessions per week during weeks 3 and 4 , and one session during weeks 5 and 6. Each session will be 30 minutes including 10 minutes of manual therapy and 20 minutes for review and/or modification of the exercise program. The manual therapy will include trigger point manual therapy, posterior shoulder stretching, and mobilization-with-movement into shoulder elevation. The exercise program will include 2 exercises focusing on scapular and rotator cuff strengthening without a special emphasis on scapular upward rotation as well as one additional flexibility exercise. These exercises will be performed at home on the days on between the therapy sessions.

Outcomes

Primary Outcome Measures

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
Numeric pain Rating Scale (NPRS), 0 - 10
each participant will receive the NPRS questioner higher score means greater pain

Secondary Outcome Measures

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
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
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

Full Information

First Posted
December 20, 2020
Last Updated
September 14, 2021
Sponsor
Meuhedet. Healthcare Organization
Collaborators
Ariel University
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1. Study Identification

Unique Protocol Identification Number
NCT04813757
Brief Title
Scapular Upward Rotation Focused Treatment for Patient With Shoulder Impingement Syndrome and a Positive Scapular Assistance Test
Official Title
Scapular Upward Rotation Focused Treatment for Patients With Shoulder Impingement Syndrome and a Positive Scapular Assistance Test
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meuhedet. Healthcare Organization
Collaborators
Ariel University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Pain Syndrome, Impingement Syndrome, Scapular Dyskinesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
ParticipantOutcomes Assessor
Masking Description
We assume participants will not be able to differentiate between the upward rotation focused intervention and the control intervention. Furthermore, the examiner performing baseline and outcome assessment will be unaware of the group allocation while performing these assessments.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
Participants in the intervention group will receive 12 treatment sessions over a 6-week period. Three sessions during the first 2 weeks, 2 sessions per week during weeks 3 and 4 , and one session during weeks 5 and 6. Each session will be 30 minutes including 10 minutes of manual therapy and 20 minutes for review and/or modification of the exercise program. The manual therapy will include trigger point manual therapy. The exercise program will include 2 scapular and rotator cuff strengthening exercises emphasizing scapular upward rotation and posterior tilt and one additional flexibility exercise. These exercise will be repeated at home on the days in between the therapy sessions.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Participants in the control group will receive 12 treatment sessions over a 6-week period. Three sessions during the first 2 weeks, 2 sessions per week during weeks 3 and 4 , and one session during weeks 5 and 6. Each session will be 30 minutes including 10 minutes of manual therapy and 20 minutes for review and/or modification of the exercise program. The manual therapy will include trigger point manual therapy, posterior shoulder stretching, and mobilization-with-movement into shoulder elevation. The exercise program will include 2 exercises focusing on scapular and rotator cuff strengthening without a special emphasis on scapular upward rotation as well as one additional flexibility exercise. These exercises will be performed at home on the days on between the therapy sessions.
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
manual therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Disability of the Arm, Shoulder and Hand (DASH) questionnaire
Description
each participant will receive the Disability of the Arm shoulder and hand questioner. score is from 0 -100 a higher score is greater disability
Time Frame
pre intervention
Title
Numeric pain Rating Scale (NPRS), 0 - 10
Description
each participant will receive the NPRS questioner higher score means greater pain
Time Frame
pre intervention
Secondary Outcome Measure Information:
Title
Active shoulder flexion
Description
in standing position the patient will elevate the arm in the sagittal plane, the range of motion will be measured by goniometer
Time Frame
pre intervention
Title
active shoulder abduction
Description
in standing position the patient will elevate the arm in the frontal plane, the range of motion will be measured by goniometer
Time Frame
pre intervention
Title
scapular posterior tilt
Description
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
Time Frame
pre intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrey Maizles
Phone
0547664393
Email
maizles1@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alon Rabin, PHD
Phone
0523581550
Email
alonrabin@gmail.com
Facility Information:
Facility Name
Meuhedet
City
Ashdod
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koni Ben-Simon, B.P.T
Phone
0522763304
First Name & Middle Initial & Last Name & Degree
Emma Kabakov, M.D

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Scapular Upward Rotation Focused Treatment for Patient With Shoulder Impingement Syndrome and a Positive Scapular Assistance Test

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