Protocol summary

Study aim
To compare the effects of Cyriax Manual Therapy versus Mulligan Technique on Clinical and Functional Outcomes in patient with Lateral Epicondylitis.
Design
Parallel group, double blinded, randomized controlled trial
Settings and conduct
The study would be double blinded as the participant and assessors of the study would be kept blind of the treatment group to which the patient will be allocated. The data will be collected from Physiotherapy Department, Gosha E Shifa Hospital, Lahore
Participants/Inclusion and exclusion criteria
Inclusion criteria: A Diagnosed Male and Female cases referred from Gosha E Shifa Hospital having age of 20 to 50 year are included in this study. Exclusion Criteria: the patient having any surgery or trauma of Elbow, Steroid injection for lateral epicondylitis, any Skin hypersensitivity or any Congenital deformity, Any Infection like Osteomyelitis, Ulcers, open wound or pathology of Shoulder Joint will be excluded.
Intervention groups
Group A participant will receive routine physical therapy as 10 minute TENS, 10 minute strengthening exercise of Extensor carpi longus,, 10 minute deep Friction Massage and Mill’s manipulation. Group B will receive Movement with Mobilization will applied on elbow in supine position, shoulder positioned as internal rotation, forearm pronation and elbow extension with 10 repetitions for 6 seconds with 15 seconds duration of rest, with routine physical therapy as 10 minute TENS, 10 minute strengthening exercise of Extensor carpi longus.
Main outcome variables
pain intensity, hand grip and functional activity

General information

Reason for update
Acronym
Nida Akbar Rajput
IRCT registration information
IRCT registration number: IRCT20200608047698N1
Registration date: 2020-07-21, 1399/04/31
Registration timing: registered_while_recruiting

Last update: 2020-07-21, 1399/04/31
Update count: 0
Registration date
2020-07-21, 1399/04/31
Registrant information
Name
Nida Akbar
Name of organization / entity
University of Lahore
Country
Pakistan
Phone
+92 233 837764
Email address
rajputnida75@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-15, 1398/12/25
Expected recruitment end date
2020-09-15, 1399/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Cyriax Manual Therapy Versus Mulligan Technique on clinical and functional outcomes in Patients with Lateral Epicondylitis
Public title
Lateral Epicondilitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed cases of Lateral Epicondylitis referred from Gosha E Shifa Hospital included Either genders minimum 20 years and maximum 50 year age
Exclusion criteria:
History of Any surgery/trauma of Elbow Steroid injection for lateral epicondylitis Skin hypersensitivity Any systematic disease like Rheumatoid arthritis, SLE Any Infection like Osteomyelitis, Ulcers, open wound Any Congenital deformity or pathology of Shoulder Joint
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
The patient having Diagnosed lateral epicondylitis will be recruited in the study by convenient sampling Technique
Blinding (investigator's opinion)
Double blinded
Blinding description
This will be double blind study as the assessor and participant will not be disclosed about the study group. The data will be collected by assessor and will be provided to the researcher.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of The University of Lahore "Institutional Review Board"
Street address
defence road campus,new campus ,The University of Lahore
City
lahore
Postal code
54000
Approval date
2020-03-06, 1398/12/16
Ethics committee reference number
IRB-UOL-FAHS/716-I/2020

Health conditions studied

1

Description of health condition studied
Lateral Epicondylitis
ICD-10 code
M77.1
ICD-10 code description
Lateral epicondylitis

Primary outcomes

1

Description
pain Intensity
Timepoint
before intervention and then on 4th week and 8th week
Method of measurement
Numeric Pain Rating Scale

2

Description
Grip strenght
Timepoint
before intervention and then on 4th week and 8th week
Method of measurement
Dynamometer

3

Description
Activities of daily living
Timepoint
before intervention and then on 4th week and 8th week
Method of measurement
Patient Rated Tennis Elbow Evaluation

Secondary outcomes

empty

Intervention groups

1

Description
In group A participant will receive routine physical therapy. Patient will recieve TENS Therapy for 10 minute, Afterward strengthening of Extensor carpi longus for 10 minutes, In the last patient will recieve Cyriax Techniques as Deep Friction Massage and Mill’s manipulation
Category
Rehabilitation

2

Description
Group B patient will receive Movement with Mobilization applied on elbow in supine position, shoulder positioned as internal rotation, forearm pronation and elbow extension with 10 repetitions for 6 seconds with 15 seconds duration of rest, While receive routine physical therapy as 10 minute TENS, 10 minute strengthening exercise of Extensor carpi longus for last 10 minute.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
The Physiotherapy Department, Gosha E Shifa Hospital, Lahore
Full name of responsible person
Mudassir Yaseen
Street address
759-A Block, Gulshan Ravi, Lahore
City
lahore
Postal code
0544
Phone
+92 42 37812194
Email
mudassaryasinpt@gmail.com
Web page address
http://www.grwtrust.org/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Lahore
Full name of responsible person
Dr Waqar Afzal PT
Street address
defence road Lahore
City
lahore
Postal code
54000
Phone
+92 51 4486422
Fax
+92 51 4486422
Email
waqarafazal621@gmail.com
Web page address
https://www.uol.www.uol.edu.pk
Grant name
student
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Academic support Only
Proportion provided by this source
20
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
Nida Akbar
Position
lecturer/physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
759-A Block, Gulshan Ravi, Lahore
City
lahore
Province
punjab
Postal code
0544
Phone
+92 331 3837764
Fax
Email
rajputnida75@gmail.com
Web page address
http://gswtrust.org/

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Nida Akbar Rajput
Position
lecturer/physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
759-A Block, Gulshan Ravi, Lahore
City
lahore
Province
punjab
Postal code
0544
Phone
+92 331 3837764
Email
rajputnida75@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Nida Akbar
Position
lecturer/Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
759-A Block, Gulshan Ravi, Lahore
City
lahore
Province
punjab
Postal code
0544
Phone
+92 331 3837764
Email
rajputnida75@gmail.com
Web page address
http://www.grwtrust.org/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Effects of Cyriax Manual Therapy versus Mulligan Technique on Clinical and Functional Outcomes in Patients with Lateral Epicondylitis
When the data will become available and for how long
after publication
To whom data/document is available
people working in academic institutes
Under which criteria data/document could be used
under the usage with terms in which journal is accessed /processed for publication
From where data/document is obtainable
Through email to Investigator rajputnida75@gmail.com
What processes are involved for a request to access data/document
It will be only used in confidential way for improving research and benefit of humanity can provide on request through email to Investigator rajputnida75@gmail.com
Comments
data can bee provided on request
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