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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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History
# Registration date Revision Id
2 2023-08-11, 1402/05/20 275045
1 2023-03-01, 1401/12/10 257664
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  • General information

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    60
    2023-06-30, 1402/04/09
    2023-03-27, 1402/01/07
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    2023-04-03, 1402/01/14
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    2023-04-06, 1402/01/17
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    2023-07-03, 1402/04/12
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    Trial Complete

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Riphah International University, Lahore
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Fareeha Amjad
    Full name of responsible person - Persian:
    Position - English: Assistant Professor
    Position - Persian:
    Latest degree: master
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Riphah Quaid e Azam Campus, 28-M Quaid-e-Azam industrial Estate, kot lakhpat, Lahore
    Street address - Persian:
    City - English: Lahore
    City - Persian:
    Province: Punjab
    Province - English: Punjab
    Province - Persian:
    contact.provinces_available:
    Country: Pakistan
    Postal code: 54000
    Phone: +92 334 3372779
    Mobile: +92 334 3372779
    Fax:
    Email: fari_fairy22@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Riphah International University, Lahore
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Fareeha Amjad
    Full name of responsible person - Persian:
    Position - English: Assistant Professor
    Position - Persian:
    Latest degree: phd
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Riphah Quaid e Azam Campus, 28-M Quaid-e-Azam industrial Estate, kot lakhpat, Lahore
    Street address - Persian:
    City - English: Lahore
    City - Persian:
    Province: Punjab
    Province - English: Punjab
    Province - Persian:
    contact.provinces_available:
    Country: Pakistan
    Postal code: 54000
    Phone: +92 334 3372779
    Mobile: +92 334 3372779
    Fax:
    Email: fari_fairy22@yahoo.com
    Web page address:

Protocol summary

Study aim
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.
Design
This study will be a Randomized Clinical Trial, parallel-group, triple blinded
Settings and conduct
The trial would be conducted in Allied Hospital Faisalabad. It would be triple blinded, as the patients, assessor and the analyzer would be blinded
Participants/Inclusion and exclusion criteria
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
Intervention groups
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)
Main outcome variables
Pain Disability Range of Motion

General information

Reason for update
Trial Complete
Acronym
IRCT registration information
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
Registration date
2023-03-01, 1401/12/10
Registrant information
Name
Fareeha Amjad
Name of organization / entity
The University of Lahore
Country
Pakistan
Phone
+92 42 99200600
Email address
fari_fairy22@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-01, 1401/12/10
Expected recruitment end date
2023-03-27, 1402/01/07
Actual recruitment start date
2023-04-03, 1402/01/14
Actual recruitment end date
2023-04-06, 1402/01/17
Trial completion date
2023-07-03, 1402/04/12
Scientific title
Comparative Effects of Gong’s Mobilization and Mobilization with Movement on Pain, Range of Motion and Functional Disability in Patients with Adhesive Capsulitis
Public title
Comparative Effects of Gong’s Mobilization and Mobilization with Movement on Pain, Range of Motion and Functional Disability in Patients with Adhesive Capsulitis
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 40 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
As per the inclusion and exclusion criteria of the study, patients will be divided into two groups randomly by Random Number Generator table.
Blinding (investigator's opinion)
Triple blinded
Blinding description
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research and Ethical Review Committee
Street address
Riphah Quaid e Azam Campus, 28-M Quaid-e-Azam industrial Estate, kot lakhpat, Lahore
City
Lahore
Postal code
54000
Approval date
2023-01-02, 1401/10/12
Ethics committee reference number
REC/RCR & AHS/23/0112

Health conditions studied

1

Description of health condition studied
Adhesive Capsulitis of Shoulder
ICD-10 code
M75.0
ICD-10 code description
Adhesive capsulitis of shoulder

Primary outcomes

1

Description
Pain
Timepoint
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)
Method of measurement
Numeric Pain Rating Scale (NPRS)

2

Description
Range of Motion (ROM)
Timepoint
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)
Method of measurement
Universal Goniometer

3

Description
Disability
Timepoint
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)
Method of measurement
SPADI- Shoulder pain and disability index

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Treatment - Other

2

Description
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.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Allied Hospital
Full name of responsible person
Dr. Sobia Nawaz
Street address
Dr. Tusi Rd, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Phone
+92 41 9210082
Email
vcfmuf@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Riphah International University Lahore
Full name of responsible person
Dr. Fareeha Amjad
Street address
Riphah Quaid e Azam Campus, 28-M Quaid-e-Azam industrial Estate, kot lakhpat, Lahore
City
Lahore
Postal code
54000
Phone
+92 334 3372779
Email
fari_fairy22@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University Lahore
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Riphah International University, Lahore
Full name of responsible person
Hasha Asghar
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House No, P240, shadab colony jhang road faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 317 0070706
Email
drhashaasghar@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Riphah International University, Lahore
Full name of responsible person
Dr. Fareeha Amjad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Riphah Quaid e Azam Campus, 28-M Quaid-e-Azam industrial Estate, kot lakhpat, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 334 3372779
Email
fari_fairy22@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Riphah International University, Lahore
Full name of responsible person
Hasha Asghar
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House no P240, shadab Colony jhang Road, faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 317 0070706
Email
drhashaasghar@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
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Consent Form in its original format with no information about any participant study protocol- how the intervention was given to both groups
When the data will become available and for how long
Data would be available after the completion of the research at the end of 2023
To whom data/document is available
People working in an academic and clinical setting can have access to the above-mentioned information/documents
Under which criteria data/document could be used
Data can only be used for Research Purposes
From where data/document is obtainable
Data can be asked for at the following email address: drhashaasghar@gmail.com
What processes are involved for a request to access data/document
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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