CLBP - Chronic Low Back PainNCT05267756
Effect Virtual Reality Fully Immersive Based Exercise Game on Reducing Fear of Movement in People With CLBP
A study testing (kurki-application),VR glasses in people with CLBP - Chronic Low Back Pain, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
Low back pain is one of the most common problems among adults and a leading cause of disability worldwide including in Saudi Arabia (Buchbinder et al., 2018) (Awaji, 2016) . Studies have shown that 80% of adults would experience low back pain at least once in their lifetime (Awaji, 2016). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- CLBP - Chronic Low Back Pain
- What is being tested?
- (kurki-application),VR glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 Oct 2021to 30 Jul 2022
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Consented adult patients, male and female, aged 18 or older.
- patient diagnosed with chronic non-specific low back pain (symptoms duration more than 3 month).
- patient reported no health condition that would restrict movement or prevent safe participation
- patient able to use smart phone.
Who cannot join
- patients age more than 60 years. (As patient has high risk of morbidity could affect balance and movement)
- Patients with spine surgery, hip arthroplasty, or spinal deformity like scoliosis.
- Patient with red flags (e.g., active cancer, report recent or unexplained loss weight, infection, inflammation, or fracture)
- Clinical neurological features like lumbar radiculopathy.
- vestibular system dysfunction like vertigo or imbalance by using Head impulse test(Furman \& Barton, 2015).
- pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Difference in Using Virtual Reality Fully Immersive Based Exercise Game or Usual Care on Physical and Psychosocial Factors in People With Chronic Non-specific Low Back Pain
Low back pain is one of the most common problems among adults and a leading cause of disability worldwide including in Saudi Arabia (Buchbinder et al., 2018) (Awaji, 2016) . Studies have shown that 80% of adults would experience low back pain at least once in their lifetime (Awaji, 2016). Research has shown that physical exercises are the most effective rehabilitation method. However, some CLBP patients have fear of movement and fear of increasing the pain (Alamam et al., 2019b), which will lead to inactivity and more disability. Moreover, low adherence to the prescribed exercise program is very common, which could be due to complexity of the program, boredom or lack of supervision and follow up(Elbur, 2015). VR fully-immersive -based exercise game can be used to enhance CLBP rehabilitation by keeping the patients engaged in the virtual environment distracting them from pain and stopping the cycle of fear of movement. Based on the previous problem our research questions are:
- Will the VR fully immersive based exercise game improve patient outcomes (fear, pain, reduce disability and improves physical function and adherence)? Aims of the Study.
- To assess the effectiveness of the VR fully immersive-based exercise game in the rehabilitation program for patients with CNSLBP with kinesiophobia, in reducing fear of movement, pain-related to disability, and improving physical function.
To assess the adherence of the VR-based exercise, which has entertainment aspect is better than adherence to the conventional paper-based exercise.
Read the detailed description
Significance of the Study. Based on the Fear-Avoidance model, the fear comes from the pain perception which increases level of disability (Leeuw et al., 2007). Thus, to break the fear cycle, we need first to reduce the pain intensity. This can be done by a virtual environment into a Head Mounted Displays (HMDs) that provides a fully immersive experience to engage the patients in a virtual environment and distract them from the pain while performing their exercises. Moreover, based on recent clinical guidelines for LBP rehabilitation, exercises are one of the most effective treatments for LBP. Therefore, we believe that a fully immersive based exercise game integrated with physical exercises that include a series of trunk movements such as moving forward, backward, sideways, and rotation. This solution will enhance the rehabilitation outcome since the patients who are suffering from CLBP with fear of movement and high level of disability can use the system at their home and train more for long period of time using a low-cost virtual reality device.
- Conditions
- CLBP - Chronic Low Back Pain
- Being tested
- (kurki-application),VR glasses
- Keywords
- CLBP, VR, Fear of movement, Disability, Video Game, Adherence
- Medical subject headings
- Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(kurki-application),VR glassesDevice
it is virtual reality immersive based-exercise game
| Study group | Role | What they receive |
|---|---|---|
| intervention Group | Experimental | Patient will be receive .
1. usual care that included the education patients(e.g., information, and behavior modification advice techniques) based on the latest clinical practice guidelines (Qaseem et al., 2017 ; Delitto et al., 2012). Also, Patients understood their back problem by reassurance that the condition is not a serious disease and information about the nature of the disorder and prognosis and course of recovery. And what should be done to reduce worry (e.g., stay active and returning to normal activities as soon as possible, avoid worry, coping with having a sore back, and positive attitudes towards back pain are important). The given pamphlets produced by the Saudi Spine Society.
2. The intervention group will have in addition to the usual care, virtual reality immersive based-exercise game, the participants will download (kurki-application), and will given VR glasses Receives: Device: (kurki-application),VR glasses |
| Control Group | No intervention | Patient will be receive . 1. usual care that included the education patients(e.g., information, and behavior modification advice techniques) based on the latest clinical practice guidelines (Qaseem et al., 2017 ; Delitto et al., 2012). Also, Patients understood their back problem by reassurance that the condition is not a serious disease and information about the nature of the disorder and prognosis and course of recovery. And what should be done to reduce worry (e.g., stay active and returning to normal activities as soon as possible, avoid worry, coping with having a sore back, and positive attitudes towards back pain are important). The given pamphlets produced by the Saudi Spine Society. 2. The control group will have in addition to usual care that included the education patients, a Brochure for LBP therapeutic exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear-avoidance Belief Questionnaire (FABQ)
Consists of 16 items a self-report questionnaire based on evaluation on the Fear-avoidance model.The maximum score is 96, that representing higher levels of fear-avoidance beliefs. The FABQ has two subscales: the work subscale (FABQw),and the physical activity subscale (FABQpa)
Measured: The change after 2 weeks of intervention
Secondary outcomes (1)
Numeric Pain Rating Scale (NPRS)
To measure pain intensity, The patients rated their pain level on an 11-point scale ranging from 0 to 10, which 0 indicates no pain and the highest score 10 indicates the worst possible pain
Measured: The change after 2 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start10 Oct 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for CLBP - 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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, kholoud abdullah Almufaireej, King Saud University
- Investigators
- kholoud A Almufaireej, master, Principal investigator, King saud unviersity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267756
- Sponsor's protocol ID
- VR with LBP
- Status last verified
- Jun 2022
- First submitted
- 24 Feb 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Awaji, M. A. (2016). Epidemiology of low back pain in Saudi Arabia. Journal of Advances in Medical and Pharmaceutical Sciences, 1-9.
Elbur, A. I. (2015). Level of adherence to lifestyle changes and medications among male hypertensive patients in two hospitals in Taif; Kingdom of Saudi Arabia. Int J Pharm Pharm Sci, 7(4), 168-172.
Buchbinder R, van Tulder M, Oberg B, Costa LM, Woolf A, Schoene M, Croft P; Lancet Low Back Pain Series Working Group. Low back pain: a call for action. Lancet. 2018 Jun 9;391(10137):2384-2388. doi: 10.1016/S0140-6736(18)30488-4. Epub 2018 Mar 21.
PubMed 29573871Alamam DM, Moloney N, Leaver A, Alsobayel HI, Mackey MG. Pain Intensity and Fear Avoidance Explain Disability Related to Chronic Low Back Pain in a Saudi Arabian Population. Spine (Phila Pa 1976). 2019 Aug 1;44(15):E889-E898. doi: 10.1097/BRS.0000000000003002.
PubMed 30817741Leeuw M, Goossens ME, Linton SJ, Crombez G, Boersma K, Vlaeyen JW. The fear-avoidance model of musculoskeletal pain: current state of scientific evidence. J Behav Med. 2007 Feb;30(1):77-94. doi: 10.1007/s10865-006-9085-0. Epub 2006 Dec 20.
PubMed 17180640Garrett B, Taverner T, Masinde W, Gromala D, Shaw C, Negraeff M. A rapid evidence assessment of immersive virtual reality as an adjunct therapy in acute pain management in clinical practice. Clin J Pain. 2014 Dec;30(12):1089-98. doi: 10.1097/AJP.0000000000000064.
PubMed 24535053
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Difference in Using Virtual Reality Fully Immersive Based Exercise Game or Usual Care on Physical and Psychosocial Factors in People With Chronic Non-specific Low Back Pain
- ClinicalTrials.gov ID
- NCT05267756
- Acronym / sponsor ID
- VR with LBP
- Conditions
- CLBP - Chronic Low Back Pain
- Keywords
- CLBP, VR, Fear of movement, Disability, Video Game, Adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 4 Mar 2022 (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.
Low back pain is one of the most common problems among adults and a leading cause of disability worldwide including in Saudi Arabia (Buchbinder et al., 2018) (Awaji, 2016) . Studies have shown that 80% of adults would experience low back pain at least once in their lifetime (Awaji, 2016). Research has shown that physical exercises are the most effective rehabilitation method. However, some CLBP patients have fear of movement and fear of increasing the pain (Alamam et al., 2019b), which will lead to inactivity and more disability. Moreover, low adherence to the prescribed exercise program is very common, which could be due to complexity of the program, boredom or lack of supervision and follow up(Elbur, 2015). VR fully-immersive -based exercise game can be used to enhance CLBP rehabilitation by keeping the patients engaged in the virtual environment distracting them from pain and stopping the cycle of fear of movement. Based on the previous problem our research questions are:
- Will the VR fully immersive based exercise game improve patient outcomes (fear, pain, reduce disability and improves physical function and adherence)? Aims of the Study.
- To assess the effectiveness of the VR fully immersive-based exercise game in the rehabilitation program for patients with CNSLBP with kinesiophobia, in reducing fear of movement, pain-related to disability, and improving physical function.
To assess the adherence of the VR-based exercise, which has entertainment aspect is better than adherence to the conventional paper-based exercise.
Detailed description
Significance of the Study. Based on the Fear-Avoidance model, the fear comes from the pain perception which increases level of disability (Leeuw et al., 2007). Thus, to break the fear cycle, we need first to reduce the pain intensity. This can be done by a virtual environment into a Head Mounted Displays (HMDs) that provides a fully immersive experience to engage the patients in a virtual environment and distract them from the pain while performing their exercises. Moreover, based on recent clinical guidelines for LBP rehabilitation, exercises are one of the most effective treatments for LBP. Therefore, we believe that a fully immersive based exercise game integrated with physical exercises that include a series of trunk movements such as moving forward, backward, sideways, and rotation. This solution will enhance the rehabilitation outcome since the patients who are suffering from CLBP with fear of movement and high level of disability can use the system at their home and train more for long period of time using a low-cost virtual reality device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention Group | Experimental | Device: (kurki-application),VR glassesPatient will be receive . 1. usual care that included the education patients(e.g., information, and behavior modification advice techniques) based on the latest clinical practice guidelines (Qaseem et al., 2017 ; Delitto et al., 2012). Also, Patients understood their back problem by reassurance that the condition is not a serious disease and information about the nature of the disorder and prognosis and course of recovery. And what should be done to reduce worry (e.g., stay active and returning to normal activities as soon as possible, avoid worry, coping with having a sore back, and positive attitudes towards back pain are important). The given pamphlets produced by the Saudi Spine Society. 2. The intervention group will have in addition to the usual care, virtual reality immersive based-exercise game, the participants will download (kurki-application), and will given VR glasses |
| Control Group | No intervention | –Patient will be receive . 1. usual care that included the education patients(e.g., information, and behavior modification advice techniques) based on the latest clinical practice guidelines (Qaseem et al., 2017 ; Delitto et al., 2012). Also, Patients understood their back problem by reassurance that the condition is not a serious disease and information about the nature of the disorder and prognosis and course of recovery. And what should be done to reduce worry (e.g., stay active and returning to normal activities as soon as possible, avoid worry, coping with having a sore back, and positive attitudes towards back pain are important). The given pamphlets produced by the Saudi Spine Society. 2. The control group will have in addition to usual care that included the education patients, a Brochure for LBP therapeutic exercises |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Consented adult patients, male and female, aged 18 or older.
- patient diagnosed with chronic non-specific low back pain (symptoms duration more than 3 month).
- patient reported no health condition that would restrict movement or prevent safe participation
- patient able to use smart phone.
Key exclusion criteria (6 listed)
- patients age more than 60 years. (As patient has high risk of morbidity could affect balance and movement)
- Patients with spine surgery, hip arthroplasty, or spinal deformity like scoliosis.
- Patient with red flags (e.g., active cancer, report recent or unexplained loss weight, infection, inflammation, or fracture)
- Clinical neurological features like lumbar radiculopathy.
- vestibular system dysfunction like vertigo or imbalance by using Head impulse test(Furman \& Barton, 2015).
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 |
|---|---|---|
| (kurki-application),VR glassesit is virtual reality immersive based-exercise game | Device | intervention Group |
Primary outcome
Fear-avoidance Belief Questionnaire (FABQ)
Time frame: The change after 2 weeks of intervention
Consists of 16 items a self-report questionnaire based on evaluation on the Fear-avoidance model.The maximum score is 96, that representing higher levels of fear-avoidance beliefs. The FABQ has two subscales: the work subscale (FABQw),and the physical activity subscale (FABQpa)
1 secondary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: The change after 2 weeks of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- BackgroundAwaji, M. A. (2016). Epidemiology of low back pain in Saudi Arabia. Journal of Advances in Medical and Pharmaceutical Sciences, 1-9.
- BackgroundElbur, A. I. (2015). Level of adherence to lifestyle changes and medications among male hypertensive patients in two hospitals in Taif; Kingdom of Saudi Arabia. Int J Pharm Pharm Sci, 7(4), 168-172.
- Results publication: PubMed 29573871Buchbinder R, van Tulder M, Oberg B, Costa LM, Woolf A, Schoene M, Croft P; Lancet Low Back Pain Series Working Group. Low back pain: a call for action. Lancet. 2018 Jun 9;391(10137):2384-2388. doi: 10.1016/S0140-6736(18)30488-4. Epub 2018 Mar 21.
- Results publication: PubMed 30817741Alamam DM, Moloney N, Leaver A, Alsobayel HI, Mackey MG. Pain Intensity and Fear Avoidance Explain Disability Related to Chronic Low Back Pain in a Saudi Arabian Population. Spine (Phila Pa 1976). 2019 Aug 1;44(15):E889-E898. doi: 10.1097/BRS.0000000000003002.
- Results publication: PubMed 17180640Leeuw M, Goossens ME, Linton SJ, Crombez G, Boersma K, Vlaeyen JW. The fear-avoidance model of musculoskeletal pain: current state of scientific evidence. J Behav Med. 2007 Feb;30(1):77-94. doi: 10.1007/s10865-006-9085-0. Epub 2006 Dec 20.
- Results publication: PubMed 24535053Garrett B, Taverner T, Masinde W, Gromala D, Shaw C, Negraeff M. A rapid evidence assessment of immersive virtual reality as an adjunct therapy in acute pain management in clinical practice. Clin J Pain. 2014 Dec;30(12):1089-98. doi: 10.1097/AJP.0000000000000064.
- Individual participant dataSharing planned: No
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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.
kholoud A Almufaireej, master principal investigator
King saud unviersity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (kurki-application),VR glasses in people with CLBP - Chronic Low Back Pain, run by King Saud University at 1 site in Saudi Arabia.
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 6 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 6 Jul 2022. 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 Saudi Arabia. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear-avoidance Belief Questionnaire (FABQ) (time frame: The change after 2 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05267756, which also lists 6 linked publications.
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 6 Jul 2022.