To compare the effect of Specific inferior capsular stretching and Mobilization with movement in Adhesive capsulitis.
Design
Two groups, single blinded, Randomised controlled trial.
Settings and conduct
Max Rehab Center of Riphah College of Rehabilitation & Allied Health Sciences. Data safety of this single blinded trial (Outcome Assessor Blind) will be ensured by assigning the participants different Specific identity numbers. All consent, reading forms will be placed in locker to blind the assessor.
Participants/Inclusion and exclusion criteria
Inclusion: 1. Both gender (male and females) 2. Patient Aged 40-60 years . 3. Shoulder pain at night that often disturb sleep.4. Difficulty in reaching behind the back.5. Reduced arm swing with walking.6. Stiff and painful shoulder more than 1 month.7. Minimum 50% of restriction in abduction & external rotation of shoulder joint. Exclusion: 1. Recent trauma in and around shoulder joint.2. History of shoulder subluxation, dislocation, or ligamentous injury.3. Intrinsic glenohumeral pathology as GH arthritis.4. Previous surgeries. 5. Subjects with diabetes.6. Surgical release of capsule.7. Subjects on steroids or NSAIDs
Intervention groups
Intervention Group A Mobilization with movement
Intervention Group B Specific inferior capsular stretching
Main outcome variables
Numeric Pain Rating Scale(NPRS) for Pain , Shoulder Pain and Disability Index (SPADI) for Pain and function and Universal Goniometry for Range of motion.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200921048785N1
Registration date:2020-10-25, 1399/08/04
Registration timing:registered_while_recruiting
Last update:2020-10-25, 1399/08/04
Update count:0
Registration date
2020-10-25, 1399/08/04
Registrant information
Name
Samina Kousar
Name of organization / entity
Riphah International University, Islamabad, Pakistan
Country
Pakistan
Phone
+92 42 32185426
Email address
saminakousar779@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-01, 1399/07/10
Expected recruitment end date
2020-11-10, 1399/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Specific Inferior Capsular stretching and Mobilization with movement in Adhesive Capsulitis
Public title
Effects of Specific inferior capsular stretching and Mobilization with movement in Adhesive capsulitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both male and female patients will be included
Patients with frozen shoulder aged 40-60 years will be recruited
Shoulder pain at night that often disturb sleep
Difficulty in reaching behind the back
Reduced arm swing with walking
Stiff and painful shoulder more than 1 month
Minimum 50% of restriction in abduction & external rotation of shoulder joint
Exclusion criteria:
Recent trauma in and around shoulder joint
History of shoulder subluxation, dislocation, or ligamentous injury
Intrinsic glenohumeral pathology as GH arthritis
Previous surgeries
Subjects with diabetes
Surgical release of capsule
Subjects on steroids or NSAIDs
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Once the above mentioned inclusion and exclusion criteria will be take into account, potential participants will be considered. Written informed consent will be taken. After enrollment into study, patient will be allocated either to Group A or Group B by Lottery method. No. of Chits will be equal to the total Sample Size. Odd numbers will be allocated to Group A and Even numbers will be allocated to Group B. Each patient will be requested to draw a chit from the box and after that patient will be recruited into either A or B group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome Assessor Blind: Data safety will be ensured by assigning the participants different Specific identity numbers. All consent, reading forms will be placed in locker to blind the 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/20/1045
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/Frozen shoulder/Periarthritis of shoulder
Primary outcomes
1
Description
Pain
Timepoint
Baseline, Before 1st treatment session and after 12th treatment session of total 6 weeks treatment plan (pre/post)
Method of measurement
Numeric Pain Rating Scale
2
Description
Range of motion
Timepoint
Baseline, Before 1st treatment session and after 12th treatment session of total 6 weeks treatment plan (pre/post)
Method of measurement
Goniometer
Secondary outcomes
1
Description
Pain & Function
Timepoint
Baseline, Before 1st treatment session and after 12th treatment session of total 6 weeks of treatment plan (pre/post)
Method of measurement
Shoulder Pain and Disability Index (SPADI)
Intervention groups
1
Description
Intervention group: Group A receiving Mobilization with movement
Category
Treatment - Other
2
Description
Intervention group: Group B receiving Specific inferior capsular stretching
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Max Rehab Center,Lahore, Pakistan
Full name of responsible person
Dr. Rabiya Noor
Street address
393-D3, Wapda Town, Lahore
City
Lahore
Postal code
54000
Phone
+92 42 35126110
Email
rabiya.noor@riphah.edu.pk
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
REC/RCRS/20/1045
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
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
Full name of responsible person
Dr. Rabiya Noor
Position
Assistant 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
rabiya.noor@riphah.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Dr. Rabiya Noor
Position
Assistant 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
rabiya.noor@riphah.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Dr. Rabiya Noor
Position
Assistant 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
rabiya.noor@riphah.edu.pk
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