The effect of virtual reality during manual therapy techniques on pain intensity in physiotherapy of patients with total knee arthroplasty: A randomized controlled trial
Determining the effect of virtual reality while applying manual therapy techniques on the intensity of knee joint pain in physiotherapy of patients with total knee arthroplasty
Design
The clinical trial has two groups (intervention and control) with parallel groups, one blind, randomized, on 50 patients. The rand function of Excel software was used for randomization.
Settings and conduct
This study will be conducted in a physiotherapy center located in Tabriz city and the outcome examiner will be blind to the study.
Participants/Inclusion and exclusion criteria
55-75 years old, unilateral TKA for the first time, referral to physiotherapy up to 3 months after surgery, knee pain intensity higher than 3 on the VAS scale at rest, limitation of knee joint range of motion more than 30 degrees
Intervention groups
1. Intervention group:
The participants in this group will be immersed in the virtual environment for 10 minutes while performing manual therapy techniques by the physiotherapist along with conventional physiotherapy treatments.
2. Control group:
Participants in this group will benefit from conventional physiotherapy, including electrotherapy, manual therapy and exercise therapy.
Main outcome variables
The intensity of knee joint pain will be measured with a visual analog scale (VAS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240213060998N1
Registration date:2024-06-25, 1403/04/05
Registration timing:registered_while_recruiting
Last update:2024-06-25, 1403/04/05
Update count:0
Registration date
2024-06-25, 1403/04/05
Registrant information
Name
Zahra Salahzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3327 1531
Email address
zsalahzadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2025-01-19, 1403/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of virtual reality during manual therapy techniques on pain intensity in physiotherapy of patients with total knee arthroplasty: A randomized controlled trial
Public title
Virtual Reality in knee arthroplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 55 to 75 years
Unilateral TKA for the first time
Refer to physiotherapy up to three months after surgery
Knee pain intensity above 3 on the VAS scale at rest
Restriction of the range of motion of the knee joint more than 30 degrees
Exclusion criteria:
Overweight (body mass index above 30 kg/m2)
Severe osteoporosis
Ligament damage or prosthesis fracture during surgery
Previous orthopedic surgeries on the same limb (Total hip Arthroplasty)
Unstable health condition (heart or lung disease), use of psychoactive drugs
Complications after surgery (fever, failure of wound healing, open wound after surgery, deep vein thrombosis)
Visual or hearing impairment
Balance disorder, dizziness, use of antiepileptic drugs
Inability to understand exercise instructions
Age
From 55 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Permuted block randomization
6blocks
How to make a sequence: using Random Allocation Software
Allocation concealment: Sequentially numbered, sealed, opaque envelopes
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the examiner will evaluate once before assigning people to groups and once at the end of the 10th session without knowing the group of people.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Total Knee Arthroplasty (TKA), Osteoarthritis of knee
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Pain intensity in the knee joint will be measured by a Visual Analog Scale (VAS)
Timepoint
1. Evaluation at the beginning of each session 2. Evaluation during the application of manual therapy techniques 3. Evaluation at the end of each session 4. Evaluation at the follow-up session two months after the last session
Method of measurement
Patients will determine the intensity of their pain on a horizontal 100 mm chart, where 0 indicates no pain and 100 indicates the highest level of pain.
Secondary outcomes
1
Description
The range of motion of the knee joint in the open chain will be measured by a goniometer.
Timepoint
1. Initial evaluation before the start of the first session 2. Final evaluation at the end of the tenth session
Method of measurement
The patient is lying in a supine position and the hip joint is bent to 90 degrees without rotation, in order to prevent additional movements, one hand of the therapist is placed on the thigh and one hand is placed on the ankle, and the person brings the ankle as close to the hip as possible. The maximum range of knee flexion in TKA patients will be 120 degrees.
2
Description
Functional disability of the knee will be evaluated by the Persian version of The Western Ontario and McMaster Universities Arthritis Index Questionnaire (WOMAC).
Timepoint
1. Initial evaluation before the start of the first session 2. Evaluation at the end of the 10th session 3. Final evaluation in the follow-up session two months after the last session
Method of measurement
The equivalent Persian version of the WOMAC questionnaire will be used to check the level of functional disability in the knee joint. This questionnaire is a form that is used to evaluate the functional status and general health of the patient in knee arthritis, which includes 33 questions and measures the patient's health and performance from various aspects, including: clinical symptoms, joint stiffness, pain intensity, and daily activities.
3
Description
The level of satisfaction with the treatment will be measured by the treatment satisfaction form with 7 questions and scoring from 1 to 6.
Timepoint
1. Evaluation at the end of the tenth session 2. Evaluation at the follow-up session two months after the last session
Method of measurement
The participants will complete the treatment satisfaction form, which includes 7 questions and scores from 1 to 6, from very dissatisfied to very satisfied.
4
Description
Adherence to exercise will be measured by the Exercise Adherence Rating Scale (EARS).
Timepoint
1. Evaluation at the end of the tenth session 2. Evaluation at the follow-up session two months after the last session
Method of measurement
In order to measure adherence to exercises, the EARS questionnaire has been used, which includes 16 questions, and each question is graded from 0 to 4.
Intervention groups
1
Description
The participants in this group will enjoy immersion in the virtual environment for 10 minutes while performing manual therapy techniques by the physiotherapist in addition to conventional physiotherapy treatments. Treatment sessions will be 3 times a week for 10 sessions.360 degree environments with 3 degrees of freedom of movement in space and based on smartphones will be used for immersion. These environments will be experienced using virtual reality glasses and smartphones. Relaxing environments with free access will be used.
Category
Rehabilitation
2
Description
Control group: Participants in this group will only receive conventional physiotherapy, which includes: 1. Electrotherapy (Transcutaneous Electrical Nerve Stimulation and Functional Electrical Stimulation) for the knee joint for 20 minutes 2. cryotherapy for 10 minutes around the knee joint 3.Application of manual therapy techniques by physiotherapist (massage, release of soft tissue around the joint and mobilization of patello-femoral joint) 4.Therapeutic exercise (stretching, strengthening hip, knee and leg muscles) 5.Teaching the correct walking pattern 6.Stationary bicycle for 10 minutes (according to the condition of the patient)
Faculty of Rehabilitation Sciences, University of Medical Sciences, 29 Bahman Blvd, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3337 2072
Email
rehab.fac@tbzedmed.ac.ir
Web page address
https://rehabilitation.tbzmed.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
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
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Salahzadeh
Position
Associated Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation Sciences, University of Medical Sciences, 29 Bahman Blvd, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3337 2072
Email
salahzadeh@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Salahzadeh
Position
Associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation Sciences, University of Medical Sciences, 29 Bahman Blvd, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3337 2072
Email
salahzadeh@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Yaghoubi
Position
Masters of course student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation Sciences, University of Medical Sciences, 29 Bahman Blvd., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3337 2072
Email
Fateme.yb@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
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
1. The data file of the participants will be designed and collected without mentioning the name and with ID definition.
2. The study protocol will be published in the form of an article after the start of data collection.
3. The statistical analysis map will be prepared in SPSS file format after data collection.
4. The informed consent form of this study was designed and will be available to the participants.
5. The clinical study report will be prepared and published in the form of six-month reports and the final report.
When the data will become available and for how long
Access to data begins six months after publication of study results
To whom data/document is available
The study protocol and final study results will be available to the public after publication.
Access to other data is done upon request.
Under which criteria data/document could be used
In order to design other research projects in this field, data will be sent.
From where data/document is obtainable
To receive the data and documents of this study, the scientific officer of this project can be contacted via e-mail.
email address:
zsalahzadeh@gmail.com
What processes are involved for a request to access data/document
After sending and reviewing the request for access to the data, in accordance with the principle of confidentiality of the personal information of the study participants, the data will be sent within a few days to a few weeks.