To compare different Virtual reality based exercises with routine physiotherapy in patients with chronic low back pain
Design
A concealed, single blinded randomised controlled trial will be conducted on 100 patients,single centered study
Settings and conduct
University of lahore teaching hospital,Pain Center, single blinded study (patient will be blinded to the recruited group)
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Both male and female patients, age between 25-80 years, Clinically diagnosed with Chronic Low back pain and willing to participate in the study. Exclusion Criteria: Any fracture or dislocation of lumber spine, Any history of surgery on lumber spine, hip or pelvis, Spinal tumors or infections in the intervertebral disc, Inflammatory diseases such as rheumatism, Spinal deformity such as scoliosis, spondylolysthesis.Patients taking medications e.g Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) for pain,Pregnant females,Virtual reality Phobia
Intervention groups
Patients will be randomly divided into control and experimental groups. The control group will receive routine physical therapy while the experimental groups will receive Virtual reality based exercises alongwith the routine physical therapy
Main outcome variables
Pain, Functional Disability , fear avoidance belief and Range of Motion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230426057995N1
Registration date:2023-05-01, 1402/02/11
Registration timing:prospective
Last update:2023-05-01, 1402/02/11
Update count:0
Registration date
2023-05-01, 1402/02/11
Registrant information
Name
Muhammad Waqar
Name of organization / entity
The University of Lahore
Country
Pakistan
Phone
+92 42 111 865 865
Email address
waqarafzalpt@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-13, 1402/02/23
Expected recruitment end date
2023-07-20, 1402/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Different Virtual Reality Based Exercises in addition to Routine Physiotherapy on Chronic Low back Pain
Public title
Effects of Virtual Reality Based Exercises on Chronic Low back Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both male and female patients, age between 25-80 years.Clinically diagnosed as Chronic Low Back Pain and willing to participate in the study
Exclusion criteria:
Any fracture or dislocation of lumber vertebra, history of any surgery of lumber spine, hip or pelvis Spinal tumors or infections, any disc Inflammatory diseases such as rheumatism, Spinal deformity such as scoliosis, spondylolysthesis Patients taking medications e.g NSAIDS for pain, Pregnant females, Virtual reality phobia
Age
From 25 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
By using computer generated random number table, patients will be randomly assigned into two groups. All those random numbers will be enclosed in sealed envelopes. A third person (who will further not be the part of research) will open envelops and the patients will be allocated to the mentioned group accordingly.
Blinding (investigator's opinion)
Single blinded
Blinding description
An independent assessor, who will be a senior and experienced physiotherapist and further will not be the part of study will perform the assessment of patients
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Instititional Review Board
Street address
1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab
City
Lahore
Postal code
54000
Approval date
2020-01-23, 1398/11/03
Ethics committee reference number
IRB-UOL-FAHS/696-IV/2020
Health conditions studied
1
Description of health condition studied
Chronic low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Pain
Timepoint
Before Intervention then after 3rd and 6th Week after Intervention
Method of measurement
Numeric pain rating scale
2
Description
Functional status
Timepoint
Before Intervention then after 3rd and 6th Week after Intervention
Method of measurement
Back Pain Functional Scale
3
Description
Fear Avoidance
Timepoint
Before Intervention then after 3rd and 6th Week after Intervention
Method of measurement
Fear avoidance belief questionnaire
Secondary outcomes
1
Description
Range of Motion
Timepoint
Before Intervention and 6th week after Intervention
Method of measurement
Inclinometer
Intervention groups
1
Description
Intervention group: Virtual Reality Exercises with Body ball game
Category
Rehabilitation
2
Description
Intervention group: Virtual Reality Exercises with Rally Ball game
Category
Rehabilitation
3
Description
Intervention group: Virtual Reality Exercises with Fruit Ninja game
Category
Rehabilitation
4
Description
Control group: Routine Physiotherapy
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Lahore teaching hospital
Full name of responsible person
Umair Ahmad
Street address
1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab
City
Lahore
Postal code
54000
Phone
+92 42 111 865 865
Email
umair.ahmed@uipt.uol.edu.pk
Web page address
https://uol.edu.pk/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Lahore
Full name of responsible person
Umair Ahamd
Street address
1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab
City
Lahore
Postal code
54000
Phone
+92 321 4668377
Email
umair.ahmed@uipt.uol.edu.pk
Web page address
https://uol.edu.pk/
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
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Umair Ahmad
Position
Head of the department
Latest degree
Ph.D.
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 42 111 865 865
Email
umair.ahmed@uipt.uol.edu.pk
Web page address
https://uol.edu.pk/
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Umair Ahmed
Position
Head of department
Latest degree
Ph.D.
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 42 111 865 865
Email
umair.ahmed@uipt.uol.edu.pk
Web page address
https://uol.edu.pk/
Person responsible for updating data
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Muhammad Waqar
Position
Research Coordinator
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 42 111 865 865
Email
waqar.afzal@uipt.uol.edu.pk
Web page address
https://uol.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Primary outcome measure wil be available ( Effects of VR on Chronic low back)
through email at waqarafzalpt@gmail.com
When the data will become available and for how long
After 4 weeks of publications
To whom data/document is available
people working in academic, clinician dealling with low back pain
Under which criteria data/document could be used
By providing the educational background as academic institutions or registered clinician through registerted by the registering body of the Country
From where data/document is obtainable
Through email at waqarafzalpt@gmail.com
What processes are involved for a request to access data/document
Requesting through email at waqarafzalpt@gmail.com with all relevant details