Protocol summary
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Study aim
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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.
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Design
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Randomized controlled trial
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Settings and conduct
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Social Security Hospital Gujranwala, Punjab, Pakistan. IRB Approved
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Range of Motion Exercises, Stretching, Joint and tissue mobilization, Neural Mobilization Techniques, Motor Control Training, Strength Training. Shortwave diathermy/ Hot Pack, TENS, Ultrasound
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Main outcome variables
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Range of Motion Pain Intensity
General information
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Reason for update
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Acronym
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NONE
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IRCT registration information
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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
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Registration date
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2019-02-19, 1397/11/30
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Registrant information
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Recruitment status
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Not yet recruiting
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Funding source
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Expected recruitment start date
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2637-11-06, 2016/08/15
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Expected recruitment end date
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2639-06-21, 2018/03/31
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Actual recruitment start date
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2637-11-06, 2016/08/15
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Actual recruitment end date
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2639-06-21, 2018/03/31
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Trial completion date
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2639-06-21, 2018/03/31
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Scientific title
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The Effects of Neuromobilization in Patients With Shoulder Impingement Syndrome on Pain,Strength,Range of Motion and Functional disability Score.
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Public title
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The Effects of Neuromobilization in Patients With Shoulder Impingement Syndrome on Pain,Strength,Range of Motion and Functional disability Score
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 50 years old
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Gender
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Both
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Phase
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4
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Groups that have been masked
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Sample size
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Target sample size:
80
Actual sample size reached:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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A single blind randomized clinical trial in which the investigator assessing the outcomes doesn’t know the identity of intervention.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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80 patients
Ethics committees
1
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Ethics committee
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Approval date
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2637-10-24, 2016/08/02
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Ethics committee reference number
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IRB-238-II
Health conditions studied
1
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Description of health condition studied
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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.
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Pain Intensity
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Timepoint
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before intervention, 5th week and 11th week after intervention
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Method of measurement
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Pain by Visual Analogue Scale
2
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Description
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Range of motion
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Timepoint
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Before intervention, on 5th week and on 11th week
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Method of measurement
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Measured by Goniometry
Secondary outcomes
1
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Description
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Shoulder Strength
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Timepoint
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Before intervention, on 5th week and on 11th week
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Method of measurement
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Strength by Hand held dynamometer
2
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Description
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Functional disability score
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Timepoint
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Before intervention, on 5th week and on 11th week
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Method of measurement
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UCLA Score
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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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.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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N/A
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Grant code / Reference number
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N/A
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Social Security Hospital
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Other
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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The Effects of Neuromobilization in Patients With Shoulder Impingement Syndrome on Strength and Range of Motion.
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When the data will become available and for how long
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data will be available when my Ph.D study completed
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To whom data/document is available
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For academic institutions only
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Under which criteria data/document could be used
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People who will request for data
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From where data/document is obtainable
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through email address
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What processes are involved for a request to access data/document
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my email address
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Comments
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N/A