Effectiveness of motor imagery technique on pain, range of motion and physical function in patients who underwent total knee replacement; A randomized controlled trial
To compare the effectiveness of motor imagery technique along with conventional therapy and conventional therapy alone on pain intensity, range of motion and physical function in patients who underwent total knee replacement.
Design
Randomised, superiority, parallel group trial with blinded outcome assessment. Randomisation was centralised and computerised with concealed randomisation sequence carried out at an external site
Settings and conduct
Rehman medical institute, Peshawar
Due to nature of study blinding the researcher/therapist and subjects will not be feasible. However, the assessor, who will compare pre and post scores will be blinded.
Participants/Inclusion and exclusion criteria
INCLUSION CRITERIA:
1. Age group 45-75 years
2. Males & females
3. Patients who had undergone unilateral total knee replacement
EXCLUSION CRITERIA:
1. Uncontrolled hypertension and Uncontrolled diabetes mellitus
2. A history of any neurological disorder, multiple sclerosis, Parkinson’s disease
3. Patients with rheumatoid arthritis or active cancer
4. Previous history of deep veinous thrombosis
Intervention groups
Experimental Group (Group A): This group will be same as control group (as having conventional physical therapy) but with addition of the motor imagery techniques session. Each session will be of 30 minutes per day for five days per week.
The treatment will be provided for three days during hospitalization and two weeks after discharge.
Control Group (Group B): This group will comprise of conventional therapy for the participants. Conventional therapies include CPM (continuous passive machine), Icing and physical exercises.
Main outcome variables
Tools to be used are numeric rating scale for pain intensity, western ontario mcmaster universities osteoarthritis index (WOMAC) for physical function and Goniometer for range of motion.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220524054977N1
Registration date:2022-07-03, 1401/04/12
Registration timing:registered_while_recruiting
Last update:2022-07-03, 1401/04/12
Update count:0
Registration date
2022-07-03, 1401/04/12
Registrant information
Name
Wagma Wajid
Name of organization / entity
Rehman Medical Institute, Peshawar
Country
Pakistan
Phone
+92 91 5822632
Email address
wagma.wajid@rmi.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-13, 1401/03/23
Expected recruitment end date
2022-12-13, 1401/09/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of motor imagery technique on pain, range of motion and physical function in patients who underwent total knee replacement; A randomized controlled trial
Public title
Effectiveness of motor imagery technique on pain, range of motion and physical function in patients who underwent total knee replacement; A randomized controlled trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age group 45-75 years
Males & females
Patients who had undergone unilateral TKR
Exclusion criteria:
Uncontrolled hypertension and Uncontrolled diabetes mellitus
A history of any neurological disorder, multiple sclerosis, Parkinson’s disease
Patients with rheumatoid arthritis or active cancer
Previous history of deep veinous thrombosis
Age
From 45 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
After patients are selected and baseline similarities are assessed, they will be randomly allocated to the control group and experimental group using the lottery method.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the nature of the study, it will not be feasible to blind the researcher/therapist and subjects. However, the assessor, who will assess pre and post scores, will be blinded
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Advance Studies & Research Board (AS&RB)
Street address
Physical therapy, Rehman Medical Institute
City
Peshawar
Postal code
25000
Approval date
2022-06-13, 1401/03/23
Ethics committee reference number
AS&RB Khyber medical university
Health conditions studied
1
Description of health condition studied
Total Knee replacement
ICD-10 code
Z96.651
ICD-10 code description
Presence of right artificial knee joint
Primary outcomes
1
Description
Physical Function
Timepoint
Baseline measurement and after 2 weeks
Method of measurement
WOMAC questionnaire
Secondary outcomes
1
Description
Range of motion (ROM)
Timepoint
baseline and 2 weeks
Method of measurement
goniometer
2
Description
Pain
Timepoint
baseline and 2 weeks
Method of measurement
Numeric rating scale
Intervention groups
1
Description
Intervention group:This group will be given conventional physical therapy with addition of the motor imagery techniques session. Each MI session will be of 30 minutes per day for five days per week. The treatment will be provided for three days during hospitalization and for two weeks after discharge.
Category
Rehabilitation
2
Description
Control group: This group will comprise of conventional therapy for the participants. Conventional therapies include CPM (continuous passive machine), Icing and physical exercises. Each physical exercise will be of 10 Repetitions, 1 set and 2 sessions per day.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehman Medical institute, Peshawar
Full name of responsible person
Wagma Wajid
Street address
Physical therapy, Rehman Medical Institute
City
Peshawar
Postal code
25000
Phone
+92 91 5838000
Email
wagma.wajid@rmi.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khbyer Medical University, Peshawar
Full name of responsible person
Wagma Wajid
Street address
Physical therapy, Rehman Medical Institute
City
Peshawar
Postal code
25000
Phone
+92 91 5838000
Email
wagma.wajid@rmi.edu.pk
Grant name
Dr. Zia ul Haq
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
No funding
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
Rehman Medical University, Peshawar
Full name of responsible person
Dr. Bilal Khan
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Physical therapy, Rehman Medical Institute
City
Peshawar
Province
Khyber Pakhtunkhwa
Postal code
25000
Phone
+92 91 5838000
Email
bilal.khan@rmi.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khyber Medical University, Peshawar
Full name of responsible person
Mujeeb Ur Rehman
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Physical therapy, Khyber Medical University, Peshawar
City
Peshawar
Province
Khyber Pakhtunkhwa
Postal code
25000
Phone
+92 91 5892885
Email
mujeeb.rahman@kmu.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Rehman Medical Institute, Peshawar
Full name of responsible person
Muhammmad Zulfiqar
Position
Clinical Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Physical therapy, Rehman Medical Institute
City
Peshawar
Province
Khyber Pakhtunkhwa
Postal code
25000
Phone
+92 91 5838000
Email
muhammad.zulfiqar@rmi.edu.pk
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
Effectiveness of motor imagery technique on pain, range of motion and physical function in patients who underwent total knee replacement; A randomized controlled trial
When the data will become available and for how long
1 year
To whom data/document is available
RMI, Peshawar
Under which criteria data/document could be used
N/A
From where data/document is obtainable
N/A
What processes are involved for a request to access data/document