Protocol summary
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Study aim
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To compare the effects of Gong’s Mobilization and Mobilization with Movement on pain,
range of motion and functional disability in patients with adhesive capsulitis.
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Design
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This study will be a Randomized Clinical Trial, parallel-group, triple blinded
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Settings and conduct
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The trial would be conducted in Allied Hospital Faisalabad. It would be triple blinded, as the patients, assessor and the analyzer would be blinded
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Participants/Inclusion and exclusion criteria
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INCLUSION CRITERIA
• Male & female patients
• Age group 40 to 60 years
• Subjects clinically diagnosed with grade 2 adhesive capsulitis.
• Painful and limited active and passive glenohumeral ROM >25% in a capsular pattern
• Pain in the shoulder for at least 3 months.
EXCLUSION CRITERIA
• History of surgery on affected shoulder.
• History of fracture around shoulder complex.
• History of pain or disorders of the cervical spine, elbow, wrist, or hand.
• History of any other pathological conditions involving the shoulder
History of neurological deficits limiting shoulder during activities of daily living
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Intervention groups
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Group A will be given Gongs Mobilization along with ultrasonic therapy.
Group B will be given Mobilization with Movement technique along with ultrasonic therapy.
For common treatment, both the groups will receive Ultrasound with a dosage of 1 MHz
in frequency, at continuous mode and 1.5 W/ cm2 of intensity for 10 minutes of treatment.
Codman Pendulum Exercise will be taught as home plan for both groups as a common
treatment.Total intervention protocol will be given for four weeks of duration, 3 sessions per week with
total 12 sessions. Outcomes will be assessed at baseline, at the end of 2 week (6th session) and
at the end of 4th week (12th session)
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Main outcome variables
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Pain
Disability
Range of Motion
General information
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Reason for update
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Trial Complete
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190717044238N4
Registration date:
2023-03-01, 1401/12/10
Registration timing:
prospective
Last update:
2023-08-12, 1402/05/21
Update count:
1
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Registration date
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2023-03-01, 1401/12/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-03-01, 1401/12/10
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Expected recruitment end date
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2023-03-27, 1402/01/07
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Actual recruitment start date
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2023-04-03, 1402/01/14
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Actual recruitment end date
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2023-04-06, 1402/01/17
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Trial completion date
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2023-07-03, 1402/04/12
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Scientific title
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Comparative Effects of Gong’s Mobilization and Mobilization with Movement on Pain, Range of Motion and Functional Disability in Patients with Adhesive Capsulitis
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Public title
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Comparative Effects of Gong’s Mobilization and Mobilization with Movement on Pain, Range of Motion and Functional Disability in Patients with Adhesive Capsulitis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Male & female patients
Age group 40 to 60 years
Subjects clinically diagnosed with grade 2 adhesive capsulitis
Painful and limited active and passive glenohumeral ROM >25% in capsular pattern (limited external rotation then abduction and then flexion
Pain in the shoulder for at least 3 months
Exclusion criteria:
History of surgery on effected shoulder.
History of fracture around shoulder complex.
History of pain or disorders of the cervical spine, elbow, wrist, or hand.
History of any other pathological conditions involving the shoulder (rotator cuff tear, tendinitis, etc.) Hawkins-Kennedy test, empty can test will be used to exclude other shoulder conditions.
History of neurological deficits limiting shoulder during activities of daily living
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Age
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From 40 years old to 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
60
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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As per the inclusion and exclusion criteria of the study, patients will be divided into two groups
randomly by Random Number Generator table.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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The patients taking part in the study would be blinded, they would not be able to know the group they have been allocated to, either Gongs or Mobilization with Movement, The assessor of the outcomes would be blinded and lastly, our data analyzer would be blinded too, making it a triple blinded clinical trial.
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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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Ethics committees
1
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Ethics committee
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Approval date
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2023-01-02, 1401/10/12
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Ethics committee reference number
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REC/RCR & AHS/23/0112
Health conditions studied
1
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Description of health condition studied
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Adhesive Capsulitis of Shoulder
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ICD-10 code
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M75.0
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ICD-10 code description
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Adhesive capsulitis of shoulder
Primary outcomes
1
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Description
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Pain
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Timepoint
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Total intervention protocol will be given for four weeks of duration, 3 sessions per week with total 12 sessions. Outcomes will be assessed at baseline, at the end of 2 week (6th session) and at the end of 4th week (12th session)
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Method of measurement
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Numeric Pain Rating Scale (NPRS)
2
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Description
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Range of Motion (ROM)
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Timepoint
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Total intervention protocol will be given for four weeks of duration, 3 sessions per week with total 12 sessions. Outcomes will be assessed at baseline, at the end of 2 week (6th session) and at the end of 4th week (12th session)
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Method of measurement
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Universal Goniometer
3
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Description
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Disability
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Timepoint
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Total intervention protocol will be given for four weeks of duration, 3 sessions per week with total 12 sessions. Outcomes will be assessed at baseline, at the end of 2 week (6th session) and at the end of 4th week (12th session)
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Method of measurement
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SPADI- Shoulder pain and disability index
Intervention groups
1
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Description
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Intervention group 1: Gong's Mobilization. Procedure: Gong’s mobilization will be performed in a sitting/side-lying position.• The therapist will stand on the unaffected side of the subject and will place one hand on the affected side of the patient, pushing the humeral head in an anterior to a posterior direction, parallel to the joint plain.• Simultaneously the subject will be asked to quickly and powerfully perform the restricted movement (Abduction). During the above-mentioned movement, the therapist will keep pressing the humeral head along the long axis of the humerus. The therapist will follow the movement of the subject’s shoulder when they will be performing abduction. The speed of the movement is kept constant by the therapist from the beginning until the end range maintaining little distraction throughout the movement. At the end range of movement, the therapist will accelerate the movement. The procedure will be performed in 3 sets of 10 repetitions each and the technique will be applied 3 days a week for 4 weeks.
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Category
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Treatment - Other
2
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Description
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Intervention group 2: Mobilization with Movement -----Procedure (for improving shoulder abduction): Patient position: sitting on a chair with effected shoulder by the side and head in neutral position.• Therapist position and procedure: therapist will stand posterolateral to the affected side, placing the belt across the humeral head and to his waist.• Leaning backward, therapist will apply a posterolateral glide and patient will actively perform shoulder abduction, then overpressure will be applied.• will Therapist maintain the posterolateral glide throughout and return to neutral. Therapist will ensure that the movement is pain free.• The intervention will be given in 3 sets of 10 repetitions each------------ Procedure(for improving Internal Rotation and External Rotation): Patient position: supine lying with scapula at the edge of the plinth• Therapist position: standing lateral to the affected joint.• Hand placement: patients shoulder and elbow will be placed at 90 degrees of flexion. Therapist will grasp distal humerus with both hands.• Belt placement: Belt will be secured around therapist waist and should be parallel to floor and perpendicular to humerus. Therapist will distract the joint laterally and will ask the patient to perform external and internal rotation actively and passive overpressure would be applied at end range.• The procedure will be performed in 3 sets of 10 repetitions each and the technique will be applied 3 days a week for 4 weeks.
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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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Grant code / Reference number
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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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Riphah International University Lahore
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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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Academic
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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No - There is not a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is 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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Yes - There is a plan to make this available
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Title and more details about the data/document
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Consent Form in its original format with no information about any participant
study protocol- how the intervention was given to both groups
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When the data will become available and for how long
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Data would be available after the completion of the research at the end of 2023
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To whom data/document is available
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People working in an academic and clinical setting can have access to the above-mentioned information/documents
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Under which criteria data/document could be used
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Data can only be used for Research Purposes
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From where data/document is obtainable
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Data can be asked for at the following email address: drhashaasghar@gmail.com
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What processes are involved for a request to access data/document
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One can ask for data at the given email address and it would be provided after knowing the general implications of sharing that particular data.
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Comments
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