Chronic Low-back PainNCT05859321
Virtual Reality Based Physical Therapy for Patients With Lower Back Pain
A study testing Virtual reality Exercises and Routine Physiotherapy in people with Chronic Low-back Pain, run by University of Lahore at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to compare chronic low back patients. The main question[s] it aims to answer are: pain and disability fear avoidance belief Participants will perform virtual reality exercises virtual reality based exercises Routine Physical Therapy To Compare routine physical therapy treatment in… Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Virtual reality Exercises and Routine Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 sitePakistan
- Study dates
- 15 May 2023to 5 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Low back pain that persists for more than 12 weeks
- Non-radiating low back pain
- Mechanical low back pain
- Both Gender
Who cannot join
- trauma or fracture of the spine
- any cardiac disease
- any systematic disease
- history of any neurological diseases such as Parkinson's disease, stroke and epilepsy
- patient on corticosteroid or anticoagulants
- history of any Drug abuse
Show all 9Show fewer
- any Congenital deformity
- Virtual reality games phobia
- Pregnant female
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
University of Lahore
Lahore, Punjab Province, 54000
Muhammad Waqar, MPhil Physiotherapy, 03214668377, waqarafzalpt@gmail.com
Asim Arif, MS Physiotherapy, 03216597727, asim.pt@gmail.com
About this study
Official title: Effects of Virtual Reality on Pain, Functional Disability and Fear Avoidance Belief in Patients With Chronic Low Back Pain
The goal of this clinical trial is to compare chronic low back patients. The main question[s] it aims to answer are:
- pain and disability
- fear avoidance belief Participants will perform virtual reality exercises
- virtual reality based exercises
- Routine Physical Therapy To Compare routine physical therapy treatment in addition to virtual reality to see effects on pain, functional disability and fear avoidance belief
- Conditions
- Chronic Low-back Pain
- Being tested
- Virtual reality Exercises, Routine Physiotherapy
- Keywords
- low back pain, chronic low back pain, virtual reality
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality ExercisesOther
Virtual reality exercises along with transcutaneous electrical nerve stimulation, Heat Therapy and Stretching and strengthening exercises
Routine PhysiotherapyOther
Also called treatment as usual
transcutaneous electrical nerve stimulation, Heat Therapy and Stretching and strengthening exercises
| Study group | Role | What they receive |
|---|---|---|
| virtual reality | Experimental | virtual reality exercises will be administered along with routine physiotherapy Receives: Other: Virtual reality Exercises |
| Routine Physiotherapy (treatment as usual) | Active comparator | transcutaneous electrical nerve stimulation,Heat Therapy, Stretching and strengthening exercises with Cycling will be administered Receives: Other: Routine Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in individuals,including those with chronic pain. Minimum socre is 0 out of 10 and Maximum 10, out of 10. Zero Indicates no pain and 10 indicates severe maximum pain.
Measured: at baseline
Functional disability
Back pain functional scale (BPFS) is a standardized subjective assessment questionnaire that is used as Outcome tool to assess functional disability in acute and sub-acute low back pain.Minimum score is 0 out of 60 and 60 is maximum score. Zero score indicates unable to perform any functional activities and 60 indicates able to perfrom all functional activities.
Measured: at baseline
Pain Intensity
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in individuals,including those with chronic pain. Minimum socre is 0 out of 10 and Maximum 10, out of 10. Zero Indicates no pain and 10 indicates severe maximum pain.
Measured: at 4th week
Pain intensity
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in individuals,including those with chronic pain. Minimum socre is 0 out of 10 and Maximum 10, out of 10. Zero Indicates no pain and 10 indicates severe maximum pain.
Measured: at 8th week
Functional Disability
Back pain functional scale (BPFS) is a standardized subjective assessment questionnaire that is used as Outcome tool to assess functional disability in acute and sub-acute low back pain.Minimum score is 0 out of 60 and 60 is maximum score. Zero score indicates unable to perform any functional activities and 60 indicates able to perfrom all functional activities.
Measured: 4th week
Functional Disability
Back pain functional scale (BPFS) is a standardized subjective assessment questionnaire that is used as Outcome tool to assess functional disability in acute and sub-acute low back pain.Minimum score is 0 out of 60 and 60 is maximum score. Zero score indicates unable to perform any functional activities and 60 indicates able to perfrom all functional activities.
Measured: 8th week
Secondary outcomes (4)
Fear avoidance belief
Fear avoidance belief questionnaire FABQ) is a questionnaire based on the fear-avoidance model of exaggerated pain perception. The FABQ measures patient's fear of pain and consequent avoidance of physical activity (PA) because of their fear.There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs. There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24)
Measured: at baseline
Range of motion
Inclinometer (minimum range of motion zero and maximum 50).
Measured: Change in range of motion score will be measured at baseline, at 8th week
Fear avoidance belief
Fear avoidance belief questionnaire FABQ) is a questionnaire based on the fear-avoidance model of exaggerated pain perception. The FABQ measures patient's fear of pain and consequent avoidance of physical activity (PA) because of their fear.There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs. There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24)
Measured: 4th week
Fear avoidance belief
Fear avoidance belief questionnaire FABQ) is a questionnaire based on the fear-avoidance model of exaggerated pain perception. The FABQ measures patient's fear of pain and consequent avoidance of physical activity (PA) because of their fear.There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs. There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24)
Measured: 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start15 May 2023
- Primary completion30 Jul 2023
- Study completion5 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mwaqarafzal, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859321
- Sponsor's protocol ID
- IRB-UOL-FAHS/696-IV/2020
- Status last verified
- Aug 2023
- First submitted
- 18 Apr 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality on Pain, Functional Disability and Fear Avoidance Belief in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05859321
- Acronym / sponsor ID
- IRB-UOL-FAHS/696-IV/2020
- Conditions
- Chronic Low-back Pain
- Keywords
- low back pain, chronic low back pain, virtual reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 5 Aug 2023 (estimated)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare chronic low back patients. The main question[s] it aims to answer are:
- pain and disability
- fear avoidance belief Participants will perform virtual reality exercises
- virtual reality based exercises
- Routine Physical Therapy To Compare routine physical therapy treatment in addition to virtual reality to see effects on pain, functional disability and fear avoidance belief
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| virtual reality | Experimental | Other: Virtual reality Exercisesvirtual reality exercises will be administered along with routine physiotherapy |
| Routine Physiotherapy (treatment as usual) | Active comparator | Other: Routine Physiotherapytranscutaneous electrical nerve stimulation,Heat Therapy, Stretching and strengthening exercises with Cycling will be administered |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Low back pain that persists for more than 12 weeks
- Non-radiating low back pain
- Mechanical low back pain
- Both Gender
Key exclusion criteria (9 listed)
- trauma or fracture of the spine
- any cardiac disease
- any systematic disease
- history of any neurological diseases such as Parkinson's disease, stroke and epilepsy
- patient on corticosteroid or anticoagulants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality ExercisesVirtual reality exercises along with transcutaneous electrical nerve stimulation, Heat Therapy and Stretching and strengthening exercises | Other | virtual reality |
| Routine PhysiotherapyAlso: treatment as usualtranscutaneous electrical nerve stimulation, Heat Therapy and Stretching and strengthening exercises | Other | Routine Physiotherapy (treatment as usual) |
Primary outcome
Pain Intensity
Time frame: at baseline
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in individuals,including those with chronic pain. Minimum socre is 0 out of 10 and Maximum 10, out of 10. Zero Indicates no pain and 10 indicates severe maximum pain.
Functional disability
Time frame: at baseline
Back pain functional scale (BPFS) is a standardized subjective assessment questionnaire that is used as Outcome tool to assess functional disability in acute and sub-acute low back pain.Minimum score is 0 out of 60 and 60 is maximum score. Zero score indicates unable to perform any functional activities and 60 indicates able to perfrom all functional activities.
Pain Intensity
Time frame: at 4th week
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in individuals,including those with chronic pain. Minimum socre is 0 out of 10 and Maximum 10, out of 10. Zero Indicates no pain and 10 indicates severe maximum pain.
Pain intensity
Time frame: at 8th week
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in individuals,including those with chronic pain. Minimum socre is 0 out of 10 and Maximum 10, out of 10. Zero Indicates no pain and 10 indicates severe maximum pain.
Functional Disability
Time frame: 4th week
Back pain functional scale (BPFS) is a standardized subjective assessment questionnaire that is used as Outcome tool to assess functional disability in acute and sub-acute low back pain.Minimum score is 0 out of 60 and 60 is maximum score. Zero score indicates unable to perform any functional activities and 60 indicates able to perfrom all functional activities.
Functional Disability
Time frame: 8th week
Back pain functional scale (BPFS) is a standardized subjective assessment questionnaire that is used as Outcome tool to assess functional disability in acute and sub-acute low back pain.Minimum score is 0 out of 60 and 60 is maximum score. Zero score indicates unable to perform any functional activities and 60 indicates able to perfrom all functional activities.
4 secondary outcomes
Fear avoidance belief
Time frame: at baseline
Range of motion
Time frame: Change in range of motion score will be measured at baseline, at 8th week
Fear avoidance belief
Time frame: 4th week
Fear avoidance belief
Time frame: 8th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Individual participant dataSharing planned: Yes
Related trials for Chronic Low-back Pain
Recruiting
The Intervention Effect of Exercise on Lumbar Multifidus Muscle Injuries
Chronic Non-specific Low Back Pain, Lumbar Multifidus Muscle Injury
Not yet recruiting
Acceptance and Commitment Therapy Plus Physiotherapy for Chronic Low Back Pain
Low Back Pain
Not yet recruiting
Erector Spinae Plane Block With or Without Thoracolumbar Fascia Injection for Chronic Low Back Pain
Chronic Low Back Pain
Not yet recruiting
Dual-Task Core Stabilization Training in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low Back Pain
Not yet recruitingPhase 2/3
PRP Versus NP Injections for Chronic Discogenic Low Back Pain
Discogenic Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality Exercises and Routine Physiotherapy in people with Chronic Low-back Pain, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Umair Ahmed, PhD (00924235467358 ext. 5966, umair.ahmed@uipt.uol.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: at baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.