To compare the impact of stretching exercises with and without kinesiotaping on pain levels, disability, and range of motion in shoulder flexion among dentists with rounded shoulders.
Design
A double blinded, randomized clinical trial with sample size of 58 patients, enrolled between January 2024 & September 2024
Settings and conduct
Double blinded study conducted at physiotherapy OPD of Ibne Siena Hospital & Research Institute, Multan.
patient and assessor are blind
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1)Patients with rounded shoulders diagnosed by physiotherapist. Calculate scapular index using formula (CP to SN)/(PLA to TS) *100
2) Both males and females
3) Age group 30-50 years
4) Patients with shoulder flexion limitation.
5) Patients with shoulder pain are included in the study
6) Dentists who treat more than 8 patients daily
7) Evidence of shoulder pain induced limitations in activities of daily life
8) Mobile Screen time should be less than 04 hours per day
Exclusion criteria:
1) Individuals with frozen shoulder
2) Individuals with shoulder injury
3) Fracture or shoulder joint dislocation
4) Individuals with diabetic neuropathy
5) Neurological disorders like epilepsy or surgical procedures
Intervention groups
Along with standard physical therapy kinesio-taping with approximately 50 to 60% stretch. 1st kinesiology tape applied from anterior aspect of acromion to spinous process of T10 vertebra. 2nd kinesiology tape was applied to same area with 50% overlay. Taping applied after every 3 days for 24 hours. Sessions given twice a week for 4 weeks lasting 30–40 minutes.
Main outcome variables
Pain
disability
Shoulder flexion range
General information
Reason for update
Acronym
KT, RS
IRCT registration information
IRCT registration number:IRCT20240721062493N1
Registration date:2024-09-26, 1403/07/05
Registration timing:retrospective
Last update:2024-09-26, 1403/07/05
Update count:0
Registration date
2024-09-26, 1403/07/05
Registrant information
Name
Anum Fatima
Name of organization / entity
The University of Lahore
Country
Pakistan
Phone
+92 308 4784771
Email address
anum.fatyma2@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-01, 1402/10/11
Expected recruitment end date
2024-08-24, 1403/06/03
Actual recruitment start date
2024-01-24, 1402/11/04
Actual recruitment end date
2024-09-25, 1403/07/04
Trial completion date
2024-09-25, 1403/07/04
Scientific title
STRETCHING EXERCISES AND KINESIOTAPING ON PAIN AND DISABILITY AMONG DENTISTS WITH ROUNDED SHOULDERS
Public title
STRETCHING EXERCISES AND KINESIOTAPING ON PAIN AND DISABILITY AMONG DENTISTS WITH ROUNDED SHOULDERS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
dentists with shoulder pain and rounded shoulders diagnosed by scapular index
both male and females
Patients with shoulder flexion limitation
Dentists who treat more than 8 patients daily
Mobile Screen time should be less than 04 hours per day
age 30-50
Exclusion criteria:
Individuals with frozen shoulder
Individuals with shoulder injury
Fracture or shoulder joint dislocation
Individuals with diabetic neuropathy
Neurological disorders like epilepsy or surgical procedures
Age
From 30 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
58
Actual sample size reached:
58
Randomization (investigator's opinion)
Randomized
Randomization description
randomized according to serial numbers assigned by hospital. All participants having even serial number were assigned to experimental group while all odd serial numbers were allocated in control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study was double blinded. The assessor and patient were unaware of the treatment given to both groups.
Placebo
Not used
Assignment
Parallel
Other design features
Data was collected at baseline and 4th week (assessment).
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of University of Lahore
Street address
1km Defence Road, near bhuptian chowk, Lahore, Punjab
City
Lahore
Postal code
54000
Approval date
2024-05-05, 1403/02/16
Ethics committee reference number
REC-UOL-666-03-2024
Health conditions studied
1
Description of health condition studied
Shoulder pain
ICD-10 code
M25.51
ICD-10 code description
Pain in joint, Dislocations, sprains and strains involving other combinations of body regions
Primary outcomes
1
Description
pain
Timepoint
Data was collected at baseline before intervention and in 4th week after intervention.
Method of measurement
Numerical Pain Rating Scale
2
Description
Range of motion of Shoulder flexion
Timepoint
Data was collected at baseline before intervention and in 4th week after intervention.
Method of measurement
Goniometer
3
Description
Disability of Shoulder joint
Timepoint
Data was collected at baseline before intervention and in 4th week after intervention.
Method of measurement
Shoulder Pain and Disability Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Category
Treatment - Devices
2
Description
Control group:
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibne Siena hospital and research institute, Multan.
Full name of responsible person
Dr. Usman Khalid
Street address
Multan Southern Bypass, Jahangirabad Shah Rukn-e-Alam Town
City
Multan
Postal code
60000
Phone
+92 331 7157977
Email
dr.usman_khalid@yahoo.com
Web page address
https://ibn-e-siena.org.pk/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Lahore
Full name of responsible person
Prof. Dr. Ashfaq Ahmad
Street address
1km Defence Road, near bhuptian chowk, Lahore, Punjab
City
Lahore
Postal code
54000
Phone
+92 42 111 865 865
Email
info@uol.edu.pk
Web page address
https://uol.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of 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
The University of Lahore
Full name of responsible person
Anum Fatima
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House no. F-200, Street no. 23, Ali Block, Buch Executive Villas, Multan
City
Multan
Province
punjab
Postal code
60000
Phone
+92 308 4784771
Email
anum.fatyma2@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Dr Hira Shafiq
Position
Senior Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
1km Defence Road, near bhuptian chowk, Lahore, Punjab
City
Lahore
Province
punjab
Postal code
54000
Phone
+92 337 8638378
Email
anum.fatyma2@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Anum Fatima
Position
student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House# F-200, Street#23, Buch Executive Villas, Multan
City
Multan
Province
punjab
Postal code
60000
Phone
+92 308 4784771
Email
anum.fatyma2@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
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic data and data related to final outcome will be shared by maintaining the confidentiality
When the data will become available and for how long
data will be available from march 2024 to august 2024 after the 6 months of publication data sharing plan for a clinical trial (i.e. what data will be shared and under what conditions) will be publically available at the third party site that shares data with and meets the data requirements of WHO's international clinical trials registry platform, this occurs before the first participant is enrolled
To whom data/document is available
Dr Hira Shafiq (corresponding author) senior lecturer at the university of lahore
Under which criteria data/document could be used
for research purpose
From where data/document is obtainable
to corresponding author of the study, Dr Hira Shafiq and can contact on +92 . Can visit these research engines, you can easily find my study here https://scholar.google.com
What processes are involved for a request to access data/document
open-access and there is traditional public data release where anyone can get access to the data with no registration or conditions. The request will be reviewed by director InCharge and in case of eligibility, it would be shared in 2 weeks