This research aims to effects of hold relax and spencer muscle energy technique in patients with adhesive capsulitis
Design
Two arm parallel group randomised trial with participant blinded. Randomisation was centralised and computerised with concealed randomisation sequence carried out at an external site
Settings and conduct
The study will be conducted in Allied Hospital Faisalabad. Outcome assessor will be blind as the outcome assessor will be the therapist from the concerned hospital and researcher and outcome assessor will be a different person
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
• age 30 above
• both gender included
• pain in the shoulder for at least 3 month
• subjects were clinically diagnosed with grade 2 adhesive capsulitis..
Exclusion Criteria:
• History of surgery on specified shoulder.
• History of any other pathological condition involving the shoulder.
Intervention groups
Both groups will receive baseline treatment protocol Movement with Mobilization in 3 sets and 15 repetitions each set and Ultrasonic Therapy for 10 minutes at 1.5 w/cm intensity and continuous mode. Group A will be given Spenser Muscle Energy Technique for 3 sets and 10 repetitions each set. Group B will be given Hold Relax Technique for 3 sets and 10 repetitions each set.
Main outcome variables
Pain,
Range of Motion in External Rotation,
Range of Motion in Abduction,
Range of Motion in Internal Rotation,
Functional Disability,
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230306057633N1
Registration date:2023-04-24, 1402/02/04
Registration timing:registered_while_recruiting
Last update:2023-04-24, 1402/02/04
Update count:0
Registration date
2023-04-24, 1402/02/04
Registrant information
Name
Muhammad Talha Hassan Javed
Name of organization / entity
Riphah International University Faisalabad
Country
Pakistan
Phone
+92 334 8196967
Email address
drtalhahassan97@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-09, 1401/12/18
Expected recruitment end date
2023-07-09, 1402/04/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effects of hold relax and spencer muscle energy technique in patients with adhesive capsulitis
Public title
Hold relax and spencer muscle energy technique in adhesive capsulitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 40 to 60 years
Both gender included
Pain in the shoulder for at least 3 month
Subjects were clinically diagnosed with grade 2 adhesive capsulitis.Painful and limited active and passive glenohumeral rom in capsular pattern (external rotation then abduction and then internal rotation) was considered diagnostic criteria for adhesive capsulitis.
Exclusion criteria:
History of Rotator cuff injury
History of any neurological deficit
History of surgery on specified shoulder.
History of pain or disorder of cervical spine, elbow, wrist and hand.
History of any other pathological condition involving the shoulder.
Hawkins-Kennedy test and empty can test were used to exclude other shoulder conditions
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization will be done with the computer generated method on random.org and the unit of randomization will be the simple individual randomization.
Blinding (investigator's opinion)
Single blinded
Blinding description
The blinding will be done by blinding the outcome assessor because outcome assessor and researcher will two different persons.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research and Ethical Committee
Street address
Adjacent Fish Farm, Satayana Rd, Faisalabad, Punjab
City
Faisalabad
Postal code
44000
Approval date
2023-03-10, 1401/12/19
Ethics committee reference number
REC-FSD-00319
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 intervention and 2, 4 weeks after intervention
Method of measurement
Pain will be measured by using Numeric Pain Rating Scale
Secondary outcomes
1
Description
Range of Motion at shoulder joint
Timepoint
Before intervention and 2, 4 weeks after intervention
Method of measurement
Range of motion at shoulder joint will be measured with the help of goniometer
2
Description
Functional Disability at shoulder joint
Timepoint
Before intervention and 2, 4 weeks after intervention
Method of measurement
Shoulder disability will be measured by using Shoulder Pain and Disability Index
Intervention groups
1
Description
Intervention group A will be Spenser muscle energy technique which will target shoulder muscles to improve pain, range of motion and functional disability
Category
Treatment - Other
2
Description
Intervention group B will be hold relax technique which will relax the tight muscles to improve pain, range of motion and disability of the shoulder.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Allied Hospital Faisalabad
Full name of responsible person
Dr. Sobia Nawaz
Street address
Dr. Tusi Rd, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Phone
+92 334 8196967
Email
info@pmc.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University Faisalabad
Full name of responsible person
Dr. Shahreen
Street address
Adjacent Fish Farm, Satayana Rd, Faisalabad, Punjab
City
Faislabad
Postal code
44000
Phone
+92 41 8777210
Email
contact@riphahfsd.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University Faisalabad
Proportion provided by this source
10
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 Faisalabad
Full name of responsible person
Muhammad Talha Hassan Javed
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
house P 228, street-3, Sanora Colony, Samanabad, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 325 4431141
Email
drtalhahassan97@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University Faisalabad
Full name of responsible person
Muhammad Talha Hassan Javed
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
house P 228, street-3, Sanora Colony, Samanabad, Faisalabad
City
faisalabad
Province
Punjab
Postal code
38000
Phone
+92 334 8196967
Email
drtalhahassan97@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University Faisalabad
Full name of responsible person
Muhammad Talha Hassan Javed
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
house P 228, street-3, Sanora Colony, Samanabad, Faisalabad
City
faisalabad
Province
Punjab
Postal code
38000
Phone
+92 334 8196967
Email
drtalhahassan97@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Sharing IPD may raise privacy and confidentiality concerns, especially when the data contains sensitive or personally identifiable information. There may be legal or ethical obligations to protect the privacy of the participants, and sharing their data could violate those obligations.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data set of IPD will be shared for primary outcomes only
When the data will become available and for how long
starting in July 2023
To whom data/document is available
Data set will be available for academic persons
Under which criteria data/document could be used
The documents will be used for further research purposes
From where data/document is obtainable
The data will be provided from email Id drtalhahassan97@gmail.com
What processes are involved for a request to access data/document
The applicant should send a email for requesting the documents and request will be followed within 72 hours