The aim of the study is compare the effect of Alfredson vs Silbernagel eccentric protocol on clinical outcomes in Amateur players with Achilles tendinopathy
Design
A single blinded randomized controlled trial, conducted on 72 patients, equally divided into two groups, single centered study.
Settings and conduct
The university of Lahore teaching hospital, single blinded study.
Participants/Inclusion and exclusion criteria
Age of 18-40 years, Both male and female with Grade 1, Grade 2 – Tendinopathy (grade 1 represents a normal tendon; grade 2 an enlarged tendon) and Clinical diagnosis of Achilles tendinopathy. Arc test, Thompson test, RLH test are diagnostic tests are included.
Achilles tendon rupture, History of invasive intervention for AT on more painful side, Diagnosed systemic inflammatory conditions (e.g. rheumatoid arthritis, ankylosing spondylitis),Any other lower limb pathology are excluded.
Intervention groups
72 patients will be randomly divided into control and experimental groups. The control group will receive Alfredson eccentric protocol while the experimental group will receive Silbernagel eccentric protocol.
Main outcome variables
Pain, Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231017059755N1
Registration date:2024-05-09, 1403/02/20
Registration timing:retrospective
Last update:2024-05-09, 1403/02/20
Update count:0
Registration date
2024-05-09, 1403/02/20
Registrant information
Name
Mehak Amjad
Name of organization / entity
The University of Lahore
Country
Pakistan
Phone
+92 314 4976133
Email address
mehak.amjad@admin.uol.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-18, 1402/06/27
Expected recruitment end date
2023-12-16, 1402/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Alfredson vs Silbernagel eccentric protocol on clinical outcomes in Amateur players with Achilles tendinopathy
Public title
Effect of Alfredson vs Silbernagel eccentric protocol on clinical outcomes in Amateur players with Achilles tendinopathy
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18-40 years
Both male and female
Grade 1, Grade 2 – Tendinopathy (grade 1 represents a normal tendon; grade 2 an enlarged tendon).
Clinical diagnosis of Achilles tendinopathy
Arc test, Thompson test, RLH test are diagnostic tests
Exclusion criteria:
Achilles tendon rupture
History of invasive intervention for AT on more painful side
Diagnosed systemic inflammatory conditions (e.g. rheumatoid arthritis, ankylosing spondylitis)
Any other lower limb pathology
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
The mechanics of randomization play a crucial role in ensuring unbiased comparisons between the two interventions. The method of randomization refers to the technique used to allocate participants to the different treatment groups is :
Simple Randomization: A basic method where each participant has an equal chance of being assigned to the protocol group.
Tool can be used for randomization is Random Number Tables
in which each number has an equal chance of being selected. These tables can use to assign participants randomly.
The random sequence is built based on the chosen method of randomization. For simple randomization, a list of random numbers can be generated.
Blinding (investigator's opinion)
Single blinded
Blinding description
An independent assessor, who will be a senior and experienced physiotherapist and further will not be the part of study will perform the assessment of patients
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional review board
Street address
1-km, Defence Road, Off Bhobatian Chowk , Lahore
City
Lahore
Postal code
51000
Approval date
2023-09-14, 1402/06/23
Ethics committee reference number
REC-UOL-529-09-2023
Health conditions studied
1
Description of health condition studied
Achilles tendinopathy
ICD-10 code
M76. 60
ICD-10 code description
used to indicate a diagnosis for reimbursement purposes
Primary outcomes
1
Description
Pain
Timepoint
Before intervention and after 4 weeks of intervention
Method of measurement
Numerical pain rating scale (NPRS)
Secondary outcomes
1
Description
Pain, Quality of life
Timepoint
Before intervention and after 4 weeks of intervention
Method of measurement
Victorian Institute of Sport Assessment (VISA-A), The Achilles tendon Total Rupture Score (ATRS)
Intervention groups
1
Description
Group A: Patients will be instructed about the treatment procedures. The Alfredson isolated eccentric exercise program, which comprises 4 weeks of eccentric heel-drops on the injured limb, with the use of the uninjured limb to concentrically return to the start position. Exercises will be performed twice daily, for three sets of 15 repetitions, both with a straight and bent knee (i.e. 180 repetitions each day). Non-disabling pain during the exercises will be permitted, and load added gradually in a backpack (in steps of 5 kg) when exercises can be performed without pain.
Category
Other
2
Description
Group B: This group will receive Silbernagel protocol comprises various concentric and eccentric heel raise exercises, which are performed both on two legs and one leg, with three sets of 15 repetitions. The duration of the program is also 4 weeks, and non-disabling pain during the exercises is also permitted, but contrary to the Alfredson program, exercises are performed only once daily. Progression is made by changing from bipedal to unipedal exercises, by progressing from concentric-eccentric to purely eccentric loading, by adding weight in a backpack (in steps of 5 kg when pain did not exceed 5 on a 0–10 numerical rating scale), and finally by using fast-rebounding and plyometric exercises
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
The University of Lahore Teaching Hospital
Full name of responsible person
Mehak Amjad
Street address
1-km, Defence Road, Off Bhobatian Chowk , Lahore
City
Lahore
Postal code
54000
Phone
+92 302 6965902
Email
mehakamir50@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Lahore
Full name of responsible person
Mehak Amjad
Street address
university of Lahore
City
Lahore
Postal code
54000
Phone
+92 302 6965902
Email
mehakamir50@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The University of Lahore
Proportion provided by this source
100
Public or private sector
Public
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, Pakistan
Full name of responsible person
Mehak Amjad
Position
Officer
Latest degree
Bachelor
Other areas of specialty/work
Administration
Street address
The university of Lahore main campus near bhobatian chowk
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 302 6965902
Email
mehakamir50@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The university of Lahore
Full name of responsible person
Mehak Amjad
Position
Officer
Latest degree
Bachelor
Other areas of specialty/work
Administration
Street address
1-km, Defence Road, Off Bhobatian Chowk , Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 302 6965902
Email
mehakamir50@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Mehak Amjad
Position
Officer
Latest degree
Bachelor
Other areas of specialty/work
Administration
Street address
1-km, Defence Road, Off Bhobatian Chowk , Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 302 6965902
Email
mehakamir50@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
All collected identified IPD
When the data will become available and for how long
Data will be available after the completion of study and will remain available till 6 months
To whom data/document is available
Data will be available for other people almost 6 months after the completion of study
Under which criteria data/document could be used
The data/document could be used by communicating with the principle investigator "Mehak Amjad" on email address "mehakamir50@gmail.com".
From where data/document is obtainable
Mehak Amjad, mehakamir50@gmail.com
What processes are involved for a request to access data/document
The data/document can be accessed through communicating with the principle investigator "Mehak Amjad" on email address "mehakamir50@gmail.com".