The Effect of Thoracic Mulligan Mobilization on Sub-acromial Impingement Syndrome (SAIS)
Primary Purpose
Shoulder Impingement Syndrome
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
mulligan thoracic Sustained Natural Apophyseal Glides
traditional treatments
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Impingement Syndrome focused on measuring SUBACROMIAL IMPINGEMENT SYNDROME, mulligan thoracic sustained natural apophyseal glides, Acromiohumeral distance or subacromial space
Eligibility Criteria
Inclusion Criteria:
- Patients referred as sub-acromial impingement syndrome (stage 2) according to neer's classification.
- Have +ve Neer's sign, +ve Hawkins and Kennedy test and +ve Empty and full can tests.
- selected from both genders.
- Aged from 25 to 40 years old.
- Have restricted thoracic extension motion ( +ve occiput to wall test).
Exclusion Criteria:
- History of shoulder adhesive capsulitis
- Rotator cuff tendon tear/rupture (stage 3).
- Shoulder dislocation, subluxation and fractures.
- History of cervical, shoulder, upper back surgery.
- Any spinal deformities such as scoliosis, kyphosis and rounded shoulder.
- Diabetes mellitus.
- Radiculopathy.
- History of breast cancer.
- Previous stroke or Shoulder hand syndrome.
- Ligamentous Laxity.
Sites / Locations
- faculty of physical therapy - Cairo university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
mulligan group
exercising group
Arm Description
Patients in the study group will treated with SNAGS techniques on thoracic spine with traditional treatment consist of ice application, supervised exercises (stretching and strengthening exercise) for 3 times/week for one month.
will receive only traditional treatment (ice application and supervised exercise ) for 3 times/week for one month.
Outcomes
Primary Outcome Measures
Pain by Visual analogue scale
the patient asked to choose from scale from zero (no pain) to 10 (worst pain) to detect his/her intensity of pain.
Range of motion of shoulder joint by universal goniometer.
for flexion stationary Arm of the goniometer was aligned with the lateral border of the scapula (mid axillary arm), and the moving arm was aligned with the humerus.
for abduction the fulcrum was placed at the mid point of the posterior aspect of the glenohumeral joint, stationary arm was parallel to the trunk, and the moving arm was parallel to the longitudinal axis of the humerus. for internal and external rotation patient was in supine with the hips and knees flexed approximately 45°.The tested arm was supported on the table in 90° of abduction, elbow flexed 90°, and the wrist in neutral position.
the fulcrum was placed on the olecranon, stationary arm Placed perpendicular to the floor, and the moving arm parallel with the forearm.
Shoulder pain and disability index
the patients will asked to answer the questions on index . And then creating a percentage of pain and disability with higher scores indicating more severe limitation. The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).
Minimum Detectable Change (90% confidence) = 13 points
The sub-acromial space by radiograph X ray
measure the size of sub-acromial space
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04801732
Brief Title
The Effect of Thoracic Mulligan Mobilization on Sub-acromial Impingement Syndrome
Acronym
SAIS
Official Title
The Effect of Mulligan Thoracic Sustained Natural Apophyseal Glides on Sub-acromial Impingement Syndrome.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo 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
This study was conducted to investigate the effect of mulligan thoracic sustained natural apophyseal glide on patients diagnosed as sub acromial impingement syndrome and its effect on shoulder range of motion, pain, function and disability of affected shoulder joint and size of sub acromial space, Half of the patients will treated with traditional treatment and mulligan thoracic SNAGS technique, while the other half will treated with traditional treatment only.
Detailed Description
Forty patients with sub-acromial impingement syndrome will participate in this study. Intervention for the both group consisted of 12 session (3 times per week ) for one month. Subjects will be divided randomly and allocated into two groups , study group will received supervised exercise and mulligan thoracic SNAGS technique and the control group will received supervised exercise (stretching and strengthening exercises). both group will assessed by x ray to measure sub-acromial space , visual analogue scale for pain , The Shoulder Pain and Disability Index for shoulder function and goniometer for shoulder flexion, abduction ,external and internal rotation range of motion before and after treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome
Keywords
SUBACROMIAL IMPINGEMENT SYNDROME, mulligan thoracic sustained natural apophyseal glides, Acromiohumeral distance or subacromial space
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled study design were the recruited patients will randomly allocated into two groups control group and study group by Closed Envelope method of randomization. The treatment for all patients in both groups will conducted 3 times per week for one month .The study group (A): will receive SNAGS techniques on thoracic spine with traditional treatment consist of ice application, supervised exercises (stretching and strengthening exercise) and the study group(B) will receive only traditional treatment (ice or application and supervised exercise). All patients will be diagnosed as stage II according to Neer's classification recruited from orthopedic clinic from both sexes who met all the inclusion criteria and will be informed about the study procedure and signed the informed consent prepared for this study.
Masking
Participant
Masking Description
Patients will randomly assigned into two groups without being informed whether they are in the control or the study(experimental) group.
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mulligan group
Arm Type
Experimental
Arm Description
Patients in the study group will treated with SNAGS techniques on thoracic spine with traditional treatment consist of ice application, supervised exercises (stretching and strengthening exercise) for 3 times/week for one month.
Arm Title
exercising group
Arm Type
Active Comparator
Arm Description
will receive only traditional treatment (ice application and supervised exercise ) for 3 times/week for one month.
Intervention Type
Other
Intervention Name(s)
mulligan thoracic Sustained Natural Apophyseal Glides
Intervention Description
Extension Thoracic Sustained Natural Apophyseal Glides :
Patient position: The patient sits astride the end of the table with hands placed behind the neck to protract the scapulae allowing access to the mid thoracic spine for the therapist's hand.
Therapist position: Therapist stands on their most efficient side for a centrally applied Sustained Natural Apophyseal Glides.
Therapist grasp: The therapist's mobilizing hand (ulnar border) will apply a cephalad glide in line with the facet joint plane of the involved spinal level and the other arm holds the thoracic wall above the level to be mobilized.
Traction is applied prior to glide, which is achieved by therapist knee extension
Repetitions: Three sets of ten repetitions will be done after a trial for the patient to be familial with the technique.
and traditional treatment.
Intervention Type
Other
Intervention Name(s)
traditional treatments
Intervention Description
includes: Ice pack and Pendulum exercise and shoulder range of motion (elevation, depression, flexion, abduction, rotations).Stretching exercise for internal rotators and posterior capsule.
Strengthening exercise will be isometric in nature include external shoulder rotators, internal rotators, biceps, deltoid, and scapular stabilizers (rhomboids, trapezius, serratus anterior, Latissimus Dorsi , and pectoralis major muscles).
Primary Outcome Measure Information:
Title
Pain by Visual analogue scale
Description
the patient asked to choose from scale from zero (no pain) to 10 (worst pain) to detect his/her intensity of pain.
Time Frame
changes from baseline to before treatment and changes before treatment to immediately after treatment
Title
Range of motion of shoulder joint by universal goniometer.
Description
for flexion stationary Arm of the goniometer was aligned with the lateral border of the scapula (mid axillary arm), and the moving arm was aligned with the humerus.
for abduction the fulcrum was placed at the mid point of the posterior aspect of the glenohumeral joint, stationary arm was parallel to the trunk, and the moving arm was parallel to the longitudinal axis of the humerus. for internal and external rotation patient was in supine with the hips and knees flexed approximately 45°.The tested arm was supported on the table in 90° of abduction, elbow flexed 90°, and the wrist in neutral position.
the fulcrum was placed on the olecranon, stationary arm Placed perpendicular to the floor, and the moving arm parallel with the forearm.
Time Frame
changes from baseline to before treatment and changes before treatment to immediately after treatment
Title
Shoulder pain and disability index
Description
the patients will asked to answer the questions on index . And then creating a percentage of pain and disability with higher scores indicating more severe limitation. The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).
Minimum Detectable Change (90% confidence) = 13 points
Time Frame
changes from baseline to before treatment and changes before treatment to immediately after treatment
Title
The sub-acromial space by radiograph X ray
Description
measure the size of sub-acromial space
Time Frame
changes from baseline to before treatment and changes before treatment to immediately after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients referred as sub-acromial impingement syndrome (stage 2) according to neer's classification.
Have +ve Neer's sign, +ve Hawkins and Kennedy test and +ve Empty and full can tests.
selected from both genders.
Aged from 25 to 40 years old.
Have restricted thoracic extension motion ( +ve occiput to wall test).
Exclusion Criteria:
History of shoulder adhesive capsulitis
Rotator cuff tendon tear/rupture (stage 3).
Shoulder dislocation, subluxation and fractures.
History of cervical, shoulder, upper back surgery.
Any spinal deformities such as scoliosis, kyphosis and rounded shoulder.
Diabetes mellitus.
Radiculopathy.
History of breast cancer.
Previous stroke or Shoulder hand syndrome.
Ligamentous Laxity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shimaa T Abu EL-Kasem, PhD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
faculty of physical therapy - Cairo university
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
These data are case sensitive and considered confidential regarding my supervisors' and study directors' opinion, So, upon their request i prefer to not share individual participant data with other researchers
Learn more about this trial
The Effect of Thoracic Mulligan Mobilization on Sub-acromial Impingement Syndrome
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