Comparative effectiveness of spencer technique versus isotonic stretching on pain, Range of Motion, and Shoulder Disability in patients with stage-II Adhesive Capsulitis.
The trial is conducted in Allied Hospital Faisalabad. Subjects are chosen according to inclusion criteria. Subjects are blinded as they don't know their treatment protocol and group.
Participants/Inclusion and exclusion criteria
Inclusion Criteria
• Patients aged between 40-60 years
• Gender included both male and female.
• Patients having frozen shoulder of stage 2.
• Patient having restricted ROM.
Exclusion Criteria
• Patient with recent history of surgery.
• Patient with Rheumatoid arthritis
• Patient with history of any trauma/fracture of shoulder region.
• Subject with neurological deficit
Intervention groups
Both groups will receive baseline treatment protocol capsular stretching of shoulder joint and isometric strengthening exercise of flexor, extensor, abductors, adductors, external rotators, internal rotators. Group A will be given Spenser Technique for 1 set of 10 repetitions. Group B will be given isotonic stretching for 1 set with 5 repetitions.
Main outcome variables
Pain, Range of Motion, Shoulder Disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230518058222N1
Registration date:2023-06-12, 1402/03/22
Registration timing:registered_while_recruiting
Last update:2023-06-12, 1402/03/22
Update count:0
Registration date
2023-06-12, 1402/03/22
Registrant information
Name
Rida E Fatima
Name of organization / entity
Riphah International University Faisalabad
Country
Pakistan
Phone
+92 321 6002890
Email address
ridaefatima234@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-29, 1402/03/08
Expected recruitment end date
2023-09-09, 1402/06/18
Actual recruitment start date
2023-05-29, 1402/03/08
Actual recruitment end date
2023-09-09, 1402/06/18
Trial completion date
2023-09-09, 1402/06/18
Scientific title
Comparative effectiveness of spencer technique versus isotonic stretching on pain, Range of Motion, and Shoulder Disability in patients with stage-II Adhesive Capsulitis.
Public title
spencer technique and isotonic stretching in stage-II Adhesive Capsulitis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
• Patients aged between 40-60 years.
• Gender included both male and female.
• Patients having frozen shoulder of stage-II.
• Patient having restricted ROM.
Exclusion criteria:
• Patient with recent history of surgery.
• Patient with Rheumatoid arthritis.
• Patient with history of any trauma/fracture of shoulder region.
• Patient with neurological deficit.
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
62
Actual sample size reached:
52
Randomization (investigator's opinion)
Randomized
Randomization description
We did randomization by computer generator method Random allocation software.
Unit of randomization is individual.
Type of randomization is simple randomization.
Software name is random allocation software.
Blinding (investigator's opinion)
Single blinded
Blinding description
In our study participants are blinded that's why it is single blinded study .participants are unaware of interventions group. They didn't know which group of intervention they received.
Investigator, healthcare provider, Data collector, outcome assessor they all are not blinded,
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Riphah International University faisalabad
Street address
Riphah international University near fish farm satyana road Faisalabad
City
Faisalabad
Postal code
38000
Approval date
2023-05-29, 1402/03/08
Ethics committee reference number
RCRAHS/REC/23/39
Health conditions studied
1
Description of health condition studied
Stage -II Adhesive Capsulitis
ICD-10 code
M75.0
ICD-10 code description
Adhesive Capsulitis of unspecified shoulder
Primary outcomes
1
Description
Pain
Timepoint
Before intervention and 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 4 weeks after intervention
Method of measurement
Range of motion at shoulder joint will be measured by using goniometer
2
Description
Shoulder Disability
Timepoint
Before intervention and 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: Intervention group A is the Spencer technique which target shoulder muscles to improve pain, range of motion and shoulder disability. the dosage was one sets of each 10-15 repetitions within pain-free range.
Category
Treatment - Other
2
Description
Intervention group: Intervention group B is the isotonic stretching which relax the tight muscles to improve pain, range of motion and shoulder disability. The dosage was one sets of each 5 repetitions
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
Faisalabd
Postal code
38000
Phone
+92 41 9210082
Email
info@pmc.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University Faislabad
Full name of responsible person
Dr. Sahreen Anwar
Street address
Adjacent Fish Farm, Satayana Road, Faisalabad.
City
Faisalabad
Postal code
38000
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 Faislabad
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
Rida E Fatima
Position
Lacturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
house no. 692-B People's Colony#1 Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 321 6002890
Email
Ridaefatima234@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University Faislabad
Full name of responsible person
Rida E Fatima
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House no. 692-B People's Colony#1, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 321 6002890
Email
Ridaefatima234@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University Faisalabad
Full name of responsible person
Rida E Fatima
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House no. 692-B people's colony#1, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 321 6002890
Fax
Email
Ridaefatima234@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 September 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 ridaefatima234@gmail.com
What processes are involved for a request to access data/document
The applicant should send an email for requesting the documents and request will be followed within 72 hours.