To determine the comparative effectiveness of pulse and continuous mode of therapeutic ultrasound in grade I & grade II osteoarthritis of knee joint in terms of pain, range of motion, activity level and functional independence.
Design
Randomised, double blinded, two phase study with two intervention groups observed at the same time.
Settings and conduct
Study is double blinded with participant and outcome assessor blinding. Study will be conducted in Mayo Hospital Lahore, Pakistan
Participants/Inclusion and exclusion criteria
Participants with age between 50 and 65 with diagnosed osteoarthritis of knee joint in grade 1 and grade 2 of Kellgen and Lawrence classification are included in the study. Participants with cancer, NSAIDS or thrombophlebitis are excluded from the study.
Intervention groups
There are two intervention groups. Continuous mode of ultrasound and Pulsed mode of ultrasound.
Main outcome variables
Pain, range of motion, activity level and functional independence.
General information
Reason for update
Acronym
OA (Osteoarthritis)
IRCT registration information
IRCT registration number:IRCT20220513054841N1
Registration date:2023-05-19, 1402/02/29
Registration timing:prospective
Last update:2023-05-19, 1402/02/29
Update count:0
Registration date
2023-05-19, 1402/02/29
Registrant information
Name
Maheen Shad
Name of organization / entity
King Edward Medical University, Mayo Hospital Lahore, Pakistan
Country
Pakistan
Phone
+92 334 4177821
Email address
maheen.shad_25@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-30, 1402/03/09
Expected recruitment end date
2023-12-30, 1402/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effectiveness between pulsed and continuous mode of Ultrasound in knee osteoarthritis.
Public title
Ultrasound effectiveness in knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 50 and 65
Grade I & II osteoarthritis of knee (Kellgen & Lawrence)
Osteoarthritic diagnosed patients with complaints of pain and functional disability for at least three months
Exclusion criteria:
Lower extremity cement or plastic implants
Local dermatological problem e.g. psoriasis and eczema
Thrombophlebitis or any vascular condition in which ultrasound can cause breakage of emboli
Cancer
Pregnancy
Patients using anti-inflammatory medications
Age
From 50 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 60 patients are included in this study. They have been randomized through a system generated software into two groups A and B. Randomization process in concealed from the patients and the practitioner. Computer software generated two lists dividing all the patients into two treatment groups randomly.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants were allocated in two treatment groups named as A and B. None of the participant know which of the two modes of ultrasound has been used on him/her as both modes require the ultrasound machinery and nothing else.
Care provider has been giving treatment according to the protocols decided and he/she has no role in measuring the results.
Outcome assessor or the investigator is involved in the outcome measurements of both groups and has no role in applying treatment protocols of the patients or the randomization.
Data analyser is involved in the analysis of data only and has no role in randomization, treatment appliaction or outcome measurement.
None of the members of DSMB are involved in the appliaction of randomization, treatment application, outcome measurement or the data analysis.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of King Edward Medical University, Lahore Pakistan
Street address
Nila Gumbad Chowk, Neela Gumbad Lahore, Punjab, Pakistan
City
Lahore
Postal code
54000
Approval date
2022-04-27, 1401/02/07
Ethics committee reference number
5641/RE/KEMU/2022
Health conditions studied
1
Description of health condition studied
Osteoarthritis of knee joint diagnosed wit grade I and grade II of Kellgen and Lawrence classification of knee joint osteoarthritis.
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Pain
Timepoint
Before intervention and 2 ,4 weeks after intervention
Method of measurement
Visual Analogue Scale
2
Description
Range of motion of knee joint
Timepoint
Before intervention and 2 ,4 weeks after intervention
Method of measurement
Goniometer
3
Description
Activity level
Timepoint
Before intervention and 2 ,4 weeks after intervention
Method of measurement
Western Ontario and McMaster Universities Arthritis Index.WOMAC
4
Description
Functionality
Timepoint
Before intervention and 2 ,4 weeks after intervention
Method of measurement
Lequesne Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Continuous mode of ultrasound
Category
Rehabilitation
2
Description
Intervention group: Pulsed mode of ultrasound
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
King Edward Medical University, Mayo Hospital, Lahore Pakistan
Full name of responsible person
Maheen Shad
Street address
Nila Gumbad Chowk, Neela Gumbad Lahore, Punjab 54000
City
Lahore
Postal code
54000
Phone
+92 334 4177821
Email
maheenshad25@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
King Edward Medical University, Mayo Hospital Lahore
Full name of responsible person
Maheen Shad
Street address
Nila Gumbad Chowk, Neela Gumbad Lahore, Punjab 54000
City
Lahore
Postal code
54000
Phone
+92 334 4177821
Email
maheenshad25@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
King Edward Medical University, Mayo Hospital 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
King Edward Medical University, Mayo Hospital Lahore
Full name of responsible person
Maheen Shad
Position
Post Graduate Resident
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Nila Gumbad Chowk, Neela Gumbad Lahore, Punjab 54000
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 334 4177821
Email
maheenshad25@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
King Edward Medical University, Mayo Hospital Lahore
Full name of responsible person
Maheen Shad
Position
Post Graduate Resident
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Nila Gumbad Chowk, Neela Gumbad Lahore, Punjab 54000
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 334 4177821
Email
maheenshad25@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
King Edward Medical University, Mayo Hospital Lahore
Full name of responsible person
Maheen Shad
Position
Post Graduate Resident
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Nila Gumbad Chowk, Neela Gumbad Lahore, Punjab 54000
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 334 4177821
Email
maheenshad25@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
Data will be shared in the form of excel and Microsoft word files.
When the data will become available and for how long
6 months after publication
To whom data/document is available
Only available for people working in academic institutions
Under which criteria data/document could be used
Person responsible for data update will be reviewing requests for data. Data will be shared through email.
From where data/document is obtainable
maheenshad25@gmail.com
What processes are involved for a request to access data/document
Provide full detail of the reason you want to pursue data from my study. Then wait for a max of one month to receive it if the request for data is approved.