Protocol summary

Study aim
The study will be conducted to investigate the best technique in increasing flexibility in post burn contractures in elbow joint
Design
This study will be a Randomized clinical trial with a sample size of 60 burn patients with contractures who had decreased muscle flexibility as a result of partial thickness burn. Data will be selected through convenient sampling from the Burn Unit Ward of Allied Hospital, Faisalabad. However, Informed consent will be taken from participants. Palpation, Visual analogue scale and goniometer will be used for pre and post-assessment. Sixty patients will be divided into two groups, thirty in each group. Group (1): received Muscle Energy Technique (MET), Group (2): received 20 sec of static stretching exercise. Measurements of elbow extension range of motion were conducted before treatment, post 5 days of treatment, and after 8 days of treatment.
Settings and conduct
Burn Unit Ward of Allied Hospital, Faisalabad
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 20-50 years Gender (both) 2nd degree deep and 3rd degree burns in elbow Patients with unilateral tight elbow flexors Superficial skin grafted individual Subjects not involved in any exercise activity at the start of the study Exclusion criteria: history of serious pathology (e.g. malignancy, inflammatory disorder, infection) history of cervical radiculopathy hand deformities fractured or dislocated elbow
Intervention groups
Sixty patients will be divided into two groups, thirty in each group. Group (1): received Muscle Energy Technique (MET), Group (2): received 20 sec of static stretching exercise.
Main outcome variables
Pain; Range of motion

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220930056062N6
Registration date: 2024-06-18, 1403/03/29
Registration timing: prospective

Last update: 2024-06-18, 1403/03/29
Update count: 0
Registration date
2024-06-18, 1403/03/29
Registrant information
Name
Kaiynat Shafique
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 334 6925051
Email address
kaiynatshafique@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-19, 1403/03/30
Expected recruitment end date
2024-07-29, 1403/05/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative analysis of efficacy of muscle energy technique and static stretching techniques in enhancing flexibility following burn contracture in elbow
Public title
Efficacy of muscle energy technique and static stretching techniques in burn contractures of elbow
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20-50 years Gender (both) 2nd degree deep and 3rd degree burns in elbow Patients with unilateral tight elbow flexors Superficial skin grafted individual Subjects not involved in any exercise activity at the start of the study
Exclusion criteria:
History of serious pathology (e.g. malignancy, inflammatory disorder, infection) Fractured or dislocated elbow Hand deformities History of cervical radiculopathy
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization through lottery method. Each participant will be asked to choose between two pieces of paper labeled "Group A" and "Group B." They will be assigned to treatment groups based on the paper they select.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients will be blind in this clinical trial
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Government College University Faisalabad
Street address
Gulberg Faisalabad
City
Faisalabad
Postal code
38000
Approval date
2024-05-01, 1403/02/12
Ethics committee reference number
5715

Health conditions studied

1

Description of health condition studied
Contracture, elbow
ICD-10 code
M24.52
ICD-10 code description
Contracture, elbow

Primary outcomes

1

Description
Pain
Timepoint
Assessment will be conducted before treatment, post 5 days of treatment and after 8 days of treatment
Method of measurement
Visual analogue scale

2

Description
Range of motion
Timepoint
Assessment will be conducted before treatment, post 5 days of treatment and after 8 days of treatment
Method of measurement
goniometer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Muscle Energy Technique
Category
Rehabilitation

2

Description
Intervention group 2: Static Stretching
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Allied Hospital faisalabad
Full name of responsible person
Rafia Imtiaz
Street address
Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 41 9210092
Email
rafiaimtiaz@gcuf.edu.pk

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Government College University Faisalabad
Full name of responsible person
Rafia Imtiaz
Street address
Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 41 9210023
Email
rafiaimtiaz@gcuf.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
It is a self funded study. All financial expenses are bear personally
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Government College University Faisalabd
Full name of responsible person
Rafia Imtiaz
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 9200876
Email
rafiaimtiaz@gcuf.edu.pk
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Government College University Faisalabad
Full name of responsible person
Rafia Imtiaz
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 9200886
Email
rafiaimtiaz@gcuf.edu.pk

Person responsible for updating data

Contact
Name of organization / entity
Government College University Faisalabad
Full name of responsible person
Rafia Imtiaz
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Fiasalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 9200886
Email
rafiaimtiaz@gcuf.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
Privacy concerns
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is 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
Comparative analysis of efficacy of muscle energy technique and static stretching techniques in enhancing flexibility following burn contracture in elbow
When the data will become available and for how long
Data from this trial will not be made publicly available. However, it may be accessible upon request. For inquiries regarding data access, please contact rafiaimtiaz@gcuf.edu.pk
To whom data/document is available
Data from this trial will not be made publicly available. However, it may be accessible upon request. For inquiries regarding data access, please contact rafiaimtiaz@gcuf.edu.pk.
Under which criteria data/document could be used
Data from this trial will not be made publicly available. However, it may be accessible upon request. For inquiries regarding data access, please contact rafiaimtiaz@gcuf.edu.pk.
From where data/document is obtainable
Data from this trial will not be made publicly available. However, it may be accessible upon request. For inquiries regarding data access, please contact rafiaimtiaz@gcuf.edu.pk.
What processes are involved for a request to access data/document
Data from this trial will not be made publicly available. However, it may be accessible upon request. For inquiries regarding data access, please contact rafiaimtiaz@gcuf.edu.pk.
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