Protocol summary

Study aim
To Find The Effects Of Shoulder Joint Mobilization With Movement With And Without Scapular Mobilization On Pain,Range Of Motion And Function In Adhesive Capsulitis.
Design
Two parallel groups ,Double blinded ,Randomized Controlled Trial.
Settings and conduct
DHQ TEACHING HOSPITAL SARGODHA, Outcome assessor and participant will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: • Age 40-65 yrs with complaint of shoulder pain for last 3 months. • both genders. • NPRS score ≤ 6 screened written informed consent. • Diabetes and hypertension. • unilateral shoulder must have not move more then 90 degrees of abduction and 50% decreased external rotation as compared to normal side/normal ROMS values. Exclusion criteria: • Inflammatory Pathologies such as Rotator cuff tendinitis,rheumatoid arthritis. • Trauma. • Shoulder Surgeries,Malignancy . • Neurological disorders of upper extremity • Cervical or thoracic problem having cervical rib. • Intra articular injection in glenohumeral joint during last 03 months.
Intervention groups
Intervention Group A:Shoulder Joint Mobilization With Movement. Intervention Group B:Shoulder Joint Mobilization With Movement With Scapular Mobilization.
Main outcome variables
Pain intensity will be measured by NPRS. ROM of shoulder measured by universal Goniometer. Functional Disability by Shoulder Pain And Disability Index (SPADI).

General information

Reason for update
Acronym
ESJMWMAWOSMPRFAC
IRCT registration information
IRCT registration number: IRCT20200316046796N1
Registration date: 2020-07-30, 1399/05/09
Registration timing: prospective

Last update: 2020-07-30, 1399/05/09
Update count: 0
Registration date
2020-07-30, 1399/05/09
Registrant information
Name
Safa Khalid
Name of organization / entity
Riphah International University Lahore Campus
Country
Pakistan
Phone
+92 48 3254512
Email address
khalid.safa93@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-01, 1399/05/11
Expected recruitment end date
2020-11-01, 1399/08/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects Of Shoulder Joint Mobilization With Movement With And Without Scapular Mobilization On Pain,Range Of Motion And Function In Adhesive Capsulitis.
Public title
Effects Of Shoulder Joint Mobilization With Movement With And Without Scapular Mobilization On Pain,Range Of Motion And Function In Adhesive Capsulitis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 40-65 yrs with complaint of shoulder pain for last 3 months. both genders. NPRS score ≤ 6 screened written informed consent. Diabetes and hypertension. unilateral shoulder must have not move more then 90 degrees of abduction and 50% decreased external rotation as compared to normal side/normal ROMS values.
Exclusion criteria:
inflammatory pathologies such as rotator cuff tendinitis,rheumatoid arthritis. trauma. shoulder surgeries,malignancy. neurological disorders of upper extremity. cervical or thoracic problem having cervical rib. intra articular injection in glenohumeral joint during last 03 months.
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 38
Randomization (investigator's opinion)
Randomized
Randomization description
Written informed consent will be taken and list will be formed by Computer Generated Random Number Table method by using Epitool Calculator.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double Blinded:Participants and Outcome Assessor (Physicians,Nurses,Physiotherapist etc) will be blinded.Data safety will be ensured by assigning Specific Identity numbers and all consent reading forms will be placed in locker to blind the Outcome Assessor.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Secretary Ethical Review Committee, Riphah College Of Rehabilitation And Allied Health Sciences
Street address
28-M Quaid-e-Azam Industrial Estate,Kot Lakhpat,Lahore
City
Lahore
Postal code
54000
Approval date
2020-02-08, 1398/11/19
Ethics committee reference number
REC/RCRS/20/1037

Health conditions studied

1

Description of health condition studied
Adhesive Capsulitis
ICD-10 code
M75.00
ICD-10 code description
Adhesive capsulitis of unspecified shoulder

Primary outcomes

1

Description
Pain
Timepoint
Before start of intervention and at the end of 3 weeks of intervention.
Method of measurement
Numeric Pain Rating Scale ( NPRS).

2

Description
Range Of Motion.
Timepoint
Before start of intervention and at the end of 3 weeks of intervention.
Method of measurement
Universal Goniometer.

Secondary outcomes

1

Description
Functional Disability of Shoulder.
Timepoint
Before start of intervention and at the end of 3 weeks of intervention.
Method of measurement
Shoulder Pain And Disability Index (SPADI).

Intervention groups

1

Description
Intervention group:Shoulder Joint Mobilization With Movement three sets of 10 Repetitions will be applied .This Group will receive total 6 sessions of interventions (2 sessions/week) in 3 weeks.
Category
Treatment - Other

2

Description
Intervention group:Shoulder Joint Mobilization With Movement With Scapular Mobilization three sets of 10 Repetitions will be applied This group will receive total 6 sessions of interventions (2 sessions/week) in 3 weeks and this group in addition also will receive 10 sets of scapular mobilizations as well.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
DHQ TEACHING HOSPITAL SARGODHA
Full name of responsible person
Safa Khalid
Street address
DHQ Teaching Hospital Sargodha Khushab Road، Sargodha, Punjab
City
Sargodha
Postal code
40100
Phone
+92 48 3254512
Email
khalid.safa93@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Salman Bashir
Street address
28-M Quaid-e-Azam Industrial Estate,Kot Lakhpat,Lahore
City
Lahore
Postal code
54000
Phone
+92 42 35126110
Email
chistisalman@yahoo.com
Grant name
Educational
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University
Proportion provided by this source
20
Public or private sector
Private
Domestic or foreign origin
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
PK
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Salman Bashir
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
28-M Quaid-e-Azam Industrial Estate,Kot Lakhpat,Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35126110
Email
chistisalman@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Salman Bashir
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
28-M Quaid-e-Azam Industrial Estate,Kot Lakhpat,Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35126110
Email
chistisalman@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Safa Khalid
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
28-M Quaid-e-Azam Industrial Estate,Kot Lakhpat,Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35126110
Email
khalid.safa93@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...