Protocol summary

Study aim
To compare the effect of using patellar strap and sports tape in football players with patellar tendinopathy.
Design
Randomized Controlled Trial, Parallel Group, Double Blind
Settings and conduct
The study will be conducted in Pakistan sports Board (PSB), Lahore Pakistan. Football players visiting PSB will be consented to participate in the study. The study will be single blind and the outcome accessor will be blinded by not knowing the details of the study groups. The Investigator will determine the information by the medical record number, assigned to each participant.
Participants/Inclusion and exclusion criteria
Inclusion criteria: • players with diagnosed case of patellar tendinopathy through ultrasound or mri. • players with age between 18 to 50 years of age. • players with pain in patellar tendon or its patellar or tibial insertion in one or both knees. • players having duration of symptoms exceeding 3 to 4 days.(12) exclusion criteria • players with acute knee pain due any pathology. • chronic joint pathology. • players with knee joint surgeries. • players with patellar tendon reconstructive surgery. • players who are unable to perform test due to any reason other than patellar tendinopathy
Intervention groups
Group 1: We will use Patellar Straps along with conventional method of rest, icing, elevation and compression . Group 2: We will use Sports tape in this group along with conventional method of rest, icing, elevation and compression.
Main outcome variables
Pain and functional performance of athlete

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220216054033N2
Registration date: 2022-04-29, 1401/02/09
Registration timing: prospective

Last update: 2022-04-29, 1401/02/09
Update count: 0
Registration date
2022-04-29, 1401/02/09
Registrant information
Name
Sufian Ahmed
Name of organization / entity
Riphah International University Islamabad Pakistan
Country
Pakistan
Phone
+92 334 4272734
Email address
sufianahmedghuman@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-15, 1401/02/25
Expected recruitment end date
2023-01-15, 1401/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Patellar Strap and Sports Tape on pain and functional performance in football players with Patellar Tendinopathy
Public title
Effect of Patellar Strap and Sports Tape on pain and functional performance in football players with Patellar Tendinopathy
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
players with diagnosed case of patellar tendinopathy through ultrasound or mri. players with age between 18 to 50 years of age. players with pain in patellar tendon or its patellar or tibial insertion in one or both knees. players having duration of symptoms exceeding 3 to 4 days
Exclusion criteria:
players with acute knee pain due any pathology. chronic joint pathology. players with knee joint surgeries. players with patellar tendon reconstructive surgery players who are unable to perform test due to any reason other than patellar tendinopathy
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 34
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the subjects using Purposive sampling the included cases will randomly allocated into two groups by simple random sampling using Gold Fish bowl method. Participants will be informed about their registration Number. The participants group will be masked as A & B by the Trainer/Assessor. Pre and post Data will be collected and analyzed by the data analyst. After analysis the Groups will be unmasked.
Blinding (investigator's opinion)
Single blinded
Blinding description
34 Participants will be involved in my study using Purposive Sampling Technique. 2 groups of 17 participants each will be made and will be randomized using systematic sampling. Outcome accessor will be blinded by not knowing the information about the groups of the study. The Investigator will determine the information by the medical record number, assigned to each participant.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Riphah International University
Street address
Quaid e Azam Industrial State
City
Lahore
Postal code
40050
Approval date
2022-12-27, 1401/10/06
Ethics committee reference number
029271

Health conditions studied

1

Description of health condition studied
Patellar Tendinopathy
ICD-10 code
M76.5
ICD-10 code description
Patellar tendinitis

Primary outcomes

1

Description
Reduction in pain of football player
Timepoint
Before intervention and 6 weeks after intervention
Method of measurement
For pain assessment: numeric pain rating scale for functional assessment

Secondary outcomes

1

Description
Increased functional outcome of the athlete
Timepoint
Before intervention and after 6 weeks of intervention
Method of measurement
Victorian institute of sports assessment: Questionnaire for Functional Performance Assessment.

Intervention groups

1

Description
Intervention group: Group 1, will include participants who will receive intervention in which patellar straps of different brands like Conwell, LiveUp, McDavid Knee Support Strap and CAMBIVO will be used to check its effectiveness on pain and functional performance.
Category
Rehabilitation

2

Description
Control group: In Group 2, it will include participants who will receive intervention of Sports tapes like Sports Rayon Zinc Oxide tape, Fastoplast Sports Tape, Dr. Sethi and Rigid White Tapes will be used along with conventional treatment method of rest, icing, compression and elevation
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Pakistan Sports Board
Full name of responsible person
Dr. Muhammad Hashim
Street address
Ferozpur Road Kalma Chowk
City
Lahore
Postal code
40050
Phone
+92 323 4071564
Email
tayyaba.mustafa123@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Hashim
Street address
Quadi azam Industrial State
City
Lahore
Postal code
40050
Phone
+92 323 4071564
Email
muhammad.hashim@riphah.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
Proportion provided by this source
1
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
Fatima Memorial Hospital
Full name of responsible person
Tayyaba Mustafa
Position
Lecturer
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
FMH Shadman
City
Lahore
Province
Punjab
Postal code
40050
Phone
+92 331 6267826
Email
tayyaba.mustafa123@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Hashim
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Quadi azam Industrial State Lahore
City
Lahore
Province
Punjab
Postal code
40050
Phone
+92 323 4071564
Email
muhammad.hashim@riphah.edu.pk

Person responsible for updating data

Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Hashim
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Quaid e azam industrial Estate Lahore
City
Lahore
Province
Punjab
Postal code
40050
Phone
+92 323 4071564
Email
muhammad.hashim@riphah.edu.pk

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
There is no further information
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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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