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General information
The Effects of Neuromobilization in Patients With Shoulder Impingement Syndrome on Strength and Range of Motion.
The Effects of Neuromobilization in Patients With Shoulder Impingement Syndrome on Pain,Strength,Range of Motion and Functional disability Score
The Effects of Neuromobilization in Patients With Shoulder Impingement Syndrome on Strength and RangePain,Strength,Range of Motion. and Functional disability Score
The Effects of Neuromobilization in Patients With Shoulder Impingement Syndrome on Strength and Range of Motion.
The Effects of Neuromobilization in Patients With Shoulder Impingement Syndrome on Pain,Strength,Range of Motion and Functional disability Score.
The Effects of Neuromobilization in Patients With Shoulder Impingement Syndrome on Strength and RangePain,Strength,Range of Motion and Functional disability Score.
Primary outcomes
#1
Range of Motion Pain Intensity, strength
Pain Intensity
Range of Motion Pain Intensity, strength
before intervention, 5th and 11th week after intervention
before intervention, 5th week and 11th week after intervention
before intervention, 5th week and 11th week after intervention
Range of motion by Goniometry, Pain by Visual Analogue Scale and strength by Hand Held Dynamometer
Pain by Visual Analogue Scale
Range of motion by Goniometry, Pain by Visual Analogue Scale and strength by Hand Held Dynamometer
#2
empty
Range of motion
Range of motion
empty
Before intervention, on 5th week and on 11th week
Before intervention, on 5th week and on 11th week
empty
Measured by Goniometry
Measured by Goniometry
Secondary outcomes
#1
empty
Shoulder Strength
Shoulder Strength
empty
Before intervention, on 5th week and on 11th week
Before intervention, on 5th week and on 11th week
empty
Strength by Hand held dynamometer
Strength by Hand held dynamometer
#2
empty
Functional disability score
Functional disability score
empty
Before intervention, on 5th week and on 11th week
Before intervention, on 5th week and on 11th week
empty
UCLA Score
UCLA Score
Sponsors / Funding sources
#1
empty
Yes
1
Self
Social Security Hospital
SelfSocial Security Hospital
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: The University of Lahore
Name of organization / entity - Persian:
Full name of responsible person - English: Umair Ahmed
Full name of responsible person - Persian:
Position - English: Assistant Professor
Position - Persian:
Latest degree: master
Area of specialty/work:
Area of specialty/work title - English: Neuro Rehab
Area of specialty/work title - Persian:
Street address - English: Wapda Town
Street address - Persian:
City - English: Lahore
City - Persian:
Province: Punajb
Province - English: Punajb
Province - Persian:
contact.provinces_available:
Country: Pakistan
Postal code: 53720
Phone: N/A
Mobile: +92 321 2700817
Fax:
Email: umairahmedpt@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: The University of Lahore
Name of organization / entity - Persian:
Full name of responsible person - English: Hossein Karimi
Full name of responsible person - Persian:
Position - English: Professor
Position - Persian:
Latest degree: phd
Area of specialty/work:
Area of specialty/work title - English: Biomechanics
Area of specialty/work title - Persian:
Street address - English: Defence road
Street address - Persian:
City - English: Lahore
City - Persian:
Province: Punajb
Province - English: Punajb
Province - Persian:
contact.provinces_available:
Country: Pakistan
Postal code: 53720
Phone: N/A
Mobile: +98 912 109 6113
Fax:
Email: hkarimi.pt.uos08@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: The University of Lahore Name of organization / entity - Persian: Full name of responsible person - English: Umair AhmedHossein Karimi Full name of responsible person - Persian: Position - English: Assistant Professor Position - Persian: Latest degree: masterphd Area of specialty/work: Area of specialty/work title - English: Neuro RehabBiomechanics Area of specialty/work title - Persian: Street address - English: Wapda TownDefence road Street address - Persian: City - English: Lahore City - Persian: Province: Punajb Province - English: Punajb Province - Persian: contact.provinces_available: Country: Pakistan Postal code: 53720 Phone: N/A Mobile: +92 321 270081798 912 109 6113 Fax: Email: umairahmedpthkarimi.pt.uos08@gmail.com Web page address:
Protocol summary
Study aim
As neuromobilization was remained neglected in past therefore I decided to add neuromobilization for Shoulder impingement syndrome. The need is not only for investigation about this type of intervention but also recruiting appropriate sample size and age category for valid results.
Design
Randomized controlled trial
Settings and conduct
Social Security Hospital Gujranwala, Punjab, Pakistan. IRB Approved
Participants/Inclusion and exclusion criteria
80 participants
inclusion criteria
1)Positive Impingement Sign
2)Age Between 20-50 years
3)Patient with Positive Special Tests (Neers Test, Hawkins Kennedy Test, Empty Can Test)
exclusion criteria
Patients with co-morbidity such as Cervical Radiculopathy, Acromioclavicular Joint Pathology and Shoulder Dislocation/ Subluxation/ Fracture. Patients with history of Cervical, Shoulder of Upper Back Surgery
Intervention groups
Range of Motion Exercises, Stretching, Joint and tissue mobilization, Neural Mobilization Techniques, Motor Control Training, Strength Training. Shortwave diathermy/ Hot Pack, TENS, Ultrasound
Main outcome variables
Range of Motion Pain Intensity
General information
Reason for update
Acronym
NONE
IRCT registration information
IRCT registration number:IRCT20190121042445N1
Registration date:2019-02-19, 1397/11/30
Registration timing:prospective
Last update:2019-05-18, 1398/02/28
Update count:1
Registration date
2019-02-19, 1397/11/30
Registrant information
Name
Muhammad Akhtar
Name of organization / entity
University of Lahore,Lahore, Pakistan
Country
Pakistan
Phone
+92 55 3732032
Email address
a.hunjra@gmail.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2637-11-06, 2016/08/15
Expected recruitment end date
2639-06-21, 2018/03/31
Actual recruitment start date
2637-11-06, 2016/08/15
Actual recruitment end date
2639-06-21, 2018/03/31
Trial completion date
2639-06-21, 2018/03/31
Scientific title
The Effects of Neuromobilization in Patients With Shoulder Impingement Syndrome on Pain,Strength,Range of Motion and Functional disability Score.
Public title
The Effects of Neuromobilization in Patients With Shoulder Impingement Syndrome on Pain,Strength,Range of Motion and Functional disability Score
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Positive Impingement Sign
Age Between 20-50 years
Patient with Positive Special Tests (Neers Test, Hawkins Kennedy Test, Empty Can Test)
Exclusion criteria:
Patients with co-morbidity such as Cervical Radiculopathy,
Acromioclavicular Joint Pathology and Shoulder Dislocation/ Subluxation/ Fracture.
Patients with history of Cervical, Shoulder of Upper Back Surgery
Age
From 20 years old to 50 years old
Gender
Both
Phase
4
Groups that have been masked
Investigator
Sample size
Target sample size:
80
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Single blind randomized clinical trial.The sequence of assignment was determined using a computer generated random sequence table before the study. Individual, sequentially numbered index cards with the random assignment were prepared. The index cards were folded and placed in sealed, opaque envelopes. After the baseline examination, participants were randomly assigned to receive routine physiotherapy or routine physiotherapy plus neurombilization.
Blinding (investigator's opinion)
Single blinded
Blinding description
A single blind randomized clinical trial in which the investigator assessing the outcomes doesn’t know the identity of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
80 patients
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Board, University of Lahore
Street address
Raiwind road
City
Lahore
Postal code
53720
Approval date
2637-10-24, 2016/08/02
Ethics committee reference number
IRB-238-II
Health conditions studied
1
Description of health condition studied
patients suffering from shoulder impingement syndrome lead impairment of daily activities and reduction in work capacity. Most of patients have painful symptoms at night and during abduction which may affect the sleep and daily activities.Forty percent of the populations possibly suffer from shoulder pain at some point of their life time.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain Intensity
Timepoint
before intervention, 5th week and 11th week after intervention
Method of measurement
Pain by Visual Analogue Scale
2
Description
Range of motion
Timepoint
Before intervention, on 5th week and on 11th week
Method of measurement
Measured by Goniometry
Secondary outcomes
1
Description
Shoulder Strength
Timepoint
Before intervention, on 5th week and on 11th week
Method of measurement
Strength by Hand held dynamometer
2
Description
Functional disability score
Timepoint
Before intervention, on 5th week and on 11th week
Method of measurement
UCLA Score
Intervention groups
1
Description
Intervention group: Neuromobilization was applied using Butler’s recommendations.Procedure; Initially, the patient performed neural sliders and gradually progressed to neural tensioners. Neural sliders consisted of cervical lateral flexion movement, toward the involved side, simultaneously with elbow flexion and extension movements. While moving the head in to cervical lateral flexion the elbow was extended. When the elbow began to flex, the cervical spine was returned to neutral. Neural tensioners are the opposite of neural sliders. Neural tensioners are not a stretch and are performed to create tension in the nerve. The tension position is not held for a length of time, but is released by extending the elbow and returning the cervical spine to neutral once the patient had pushed slightly past the point of initially experiencing pain or discomfort. Neuromobilization technique was performed for 5 sec with 10 repetitions.
Category
Treatment - Other
2
Description
Control group: The routine physiotherapy includes pulsed Short wave diathermy, ultrasonic treatment, TENS and shoulder strengthening exercises for rotator cuff muscles and stretching exercises to regain flexibility.Joint and tissue mobilization, motor Control Training, strengthening and stretching exercises were performed for 5 sec with 10 repetitions.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Social Security Hospital
Full name of responsible person
Dr Waqar Zafar Bajwa
Street address
Model Town
City
Gujranwala
Postal code
52250
Phone
+92 55 9200152
Email
a.hunjra@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Social Security Hospital
Full name of responsible person
Muhammad Akhtar
Street address
Model Town
City
Gujranwala
Postal code
52250
Phone
+92 55 9200125
Email
a.hunjra@gmail.com
Grant name
N/A
Grant code / Reference number
N/A
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Social Security Hospital
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Hossein Karimi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biomechanics
Street address
Defence road
City
Lahore
Province
Punajb
Postal code
53720
Phone
N/A
Email
hkarimi.pt.uos08@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
PESSI
Full name of responsible person
Muhammad Akhtar
Position
Head Of Department
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Model Town
City
Gujranwala
Province
Punjab
Postal code
52250
Phone
N/A
Fax
Email
a.hunjra@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
PESSI
Full name of responsible person
Muhammad Akhtar
Position
HOD
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Model Town
City
Gujranwala
Province
Punjab
Postal code
52250
Phone
N/A
Email
a.hunjra@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The Effects of Neuromobilization in Patients With Shoulder Impingement Syndrome on Strength and Range of Motion.
When the data will become available and for how long
data will be available when my Ph.D study completed
To whom data/document is available
For academic institutions only
Under which criteria data/document could be used
People who will request for data
From where data/document is obtainable
through email address
What processes are involved for a request to access data/document