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Effects of Interferential current Therapy in addition to Routine Physical Therapy on Clinical and Physical Outcomes on Early postoperative Total Knee Arthroplasty

Protocol summary

Study aim
The aim of this study is to investigate the effectiveness of interferential current therapy on pain, edema, range of motion (ROM), basic functional mobility and knee stiffness in the early postoperative rehabilitation in total knee arthroplasty.
Design
Randomized Controlled Trial,After the synopsis is approved, the project will be conducted with in nine months,Non Probability Sampling Technique Sample Selection:
Settings and conduct
Study Setting: Bahria International Hospital, Lahore Binding: The trial will be single-blinded because the assessor will not know which group will get treatment. Assessment: Baseline and post-treatment information will be analyzed from each participant to determine the effectiveness of each treatment. After the week of treatment, a follow-up assessment will be conducted, and all results compared during treatment. A comparison of the pre-and post-treatment ranges also will be performed.
Participants/Inclusion and exclusion criteria
52 Participants included. Both male and female patients. Age between 45 to 65 years. Participants who has undergone total knee arthroplasty for the first time Patients who are not exposed to IFC treatment pre-operatively. Exclusion criteria: Patients with causes as: Infections, Deep Vein thrombosis(DVT), Cancer and Epilepsy. Bone and joint diseases or serious diseases affecting organ function. Any patient with pacemaker or any electrical stimulator device
Intervention groups
The experimental group used Interferential current therapy (IFC) in addition to conventional rehabilitation protocol. The control group received conventional rehabilitation training for the treatment of TKA. The same therapist will be employed to conduct each treatment for 20 minutes, twice a day, 3 times a week, for total of 1 week
Main outcome variables
Outcome measures: Clinical and physical outcomes (Pain, Edema,ROM and Basic Functional Mobility)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231108059998N1
Registration date: 2024-03-08, 1402/12/18
Registration timing: retrospective

Last update: 2024-03-08, 1402/12/18
Update count: 0
Registration date
2024-03-08, 1402/12/18
Registrant information
Name
Aqsa Aziz
Name of organization / entity
University of lahore
Country
Pakistan
Phone
+92 331 8446171
Email address
aqsaaziz26@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-10, 1402/03/20
Expected recruitment end date
2023-12-31, 1402/10/10
Actual recruitment start date
2023-06-10, 1402/03/20
Actual recruitment end date
2023-12-31, 1402/10/10
Trial completion date
2023-12-31, 1402/10/10
Scientific title
Effects of Interferential current Therapy in addition to Routine Physical Therapy on Clinical and Physical Outcomes on Early postoperative Total Knee Arthroplasty
Public title
Effects of Interferential Therapy in addition to Routine Physical Therapy on Clinical and Physical Outcomes on Early postoperative Total Knee Arthroplasty
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Both male and female patients. Age between 45 to 65 years. Patients who are not exposed to IFC treatment pre-operatively. Participants who has undergone total knee arthroplasty for the first time
Exclusion criteria:
Patients with causes as: Infections, Deep Vein thrombosis(DVT), Cancer and Epilepsy Bone and joint diseases or serious diseases affecting organ function. Any patient with pacemaker or any electrical stimulator device
Age
From 45 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Care provider
Sample size
Target sample size: 52
Actual sample size reached: 52
Randomization (investigator's opinion)
Randomized
Randomization description
The scratch card method of randomization will be used to divide the participants into experimental groups at random. Each participant will be given a unique number. After that, each group will be assigned an arbitrary number of members.
Blinding (investigator's opinion)
Single blinded
Blinding description
The trial will be single-blinded because the assessor will not know which group will get treatment.
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics committee- Faculty of Allied Health Sciences,The University of Lahore.
Street address
1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab
City
Lahore
Postal code
54590
Approval date
2023-11-30, 1402/09/09
Ethics committee reference number
Rec-UOL-651-01-2024

Health conditions studied

1

Description of health condition studied
Early post-operative Rehabilitation for total knee arthroplasty patients unilaterally.
ICD-10 code
Z96-65
ICD-10 code description
Z96-65

Primary outcomes

1

Description
Pain,Range of Motion,Edema and Basic Functional Mobility
Timepoint
Baseline and 1st week
Method of measurement
Pain - Faces Wong Baker Pain Rating Scale ,Range of Motion - Goniometer,Edema - Measuring Tape and AM-PAC 6 clicks in-patient questionnaire used for Basic Functional Mobility .

Secondary outcomes

empty

Intervention groups

1

Description
Intervention GroupA(IFC+Routine Physical Therapy) is exposed to Interferential Current therapy (Model no:ES-522 ITO Physiotherapy Low and Medium Frequency Electrical Stimulation device) in addition to conventional physical therapy. .Conventional rehabilitation training group exercises including Routine physical therapy: Range of motion exercises, ankle pumps ,SLR-straight leg raise , knee iso-metrics , Quadriceps strengthening(knee press), heel press ,hamstring strengthening (clamshell )and partial to complete weight bearing in knee extension with knee immobilizer using walking aids . Walkers, knee supports like immbolizier will use to train the patient’s body posture stepping and Gait training session will last for 20 minutes, twice a day,3 times a week for total of 1 week that is in-patient stay.
Category
Treatment - Devices

2

Description
Control GroupB(Routine Physical Therapy): Conventional rehabilitation training group exercises including Routine physical therapy: Range of motion exercises, ankle pumps ,SLR-straight leg raise , knee iso-metrics , Quadriceps strengthening(knee press), heel press ,hamstring strengthening (clamshell )and partial to complete weight bearing in knee extension with knee immobilizer using walking aids . Walkers, knee supports like immbolizier will use to train the patient’s body posture stepping and Gait training session will last for 20 minutes, twice a day,3 times a week for total of 1 week that is in-patient stay.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Bahria International Hospitals Lahore .
Full name of responsible person
Dr.Hafiz Ammar Qayyum
Street address
Takbeer Block Sector B Bahria Town, Lahore, Punjab
City
Lahore
Postal code
53720
Phone
+92 335 4454950
Email
ammarmalik00712@gmail.com
Web page address
https://www.google.com/url?sa=t&source=web&rct=j&opi=89978449&url=https://bahriainternationalhospital.com/%23:~:text%3DBahria%2520International%2520Hospital%2520Lahore%2520a,healthcare%2520provider%2520in%2520the%2520region.&ved=2ahUKEwi3jZK30IyEAxVN7QIHHcD-C1cQFnoECB4QBA&usg=AOvVaw1lUqm7gFfOJ52In9Sl9a2z

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University Of Lahore
Full name of responsible person
Dr Ayesha Jamil,Dr Aqsa Aziz
Street address
1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab
City
Lahore
Postal code
54000
Phone
+92 324 4481031
Email
ayeshabutt031@gmail.com
Web page address
https://www.google.com/url?sa=t&source=web&rct=j&opi=89978449&url=https://uol.edu.pk/contact-us/&ved=2ahUKEwikyeKp0oyEAxUR0wIHHcCXCsoQFnoECBwQAQ&usg=AOvVaw0-hG_bjJJYb7syMAmyXxUL
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
University of Lahore
Full name of responsible person
Aqsa Aziz
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 331 8446171
Email
aqsaaziz26@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University Of Lahore
Full name of responsible person
Dr Ayesha Jamil
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 324 4481031
Email
ayeshabutt031@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
University Of Lahore
Full name of responsible person
Dr Aqsa Aziz
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 331 8446171
Email
aqsaaziz26@gmail.com

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
Due to Confidentiality and research ethics
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
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
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