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Effect Virtual Reality Fully Immersive Based Exercise Game on Reducing Fear of Movement in People With CLBP

Primary Purpose

CLBP - Chronic Low Back Pain

Status
Active
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
(kurki-application),VR glasses
Sponsored by
King Saud University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CLBP - Chronic Low Back Pain focused on measuring CLBP, VR, Fear of movement, Disability, Video Game, Adherence

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Consented adult patients, male and female, aged 18 or older.
  2. patient diagnosed with chronic non-specific low back pain (symptoms duration more than 3 month).
  3. patient reported no health condition that would restrict movement or prevent safe participation
  4. patient able to use smart phone.

Exclusion Criteria:

  1. patients age more than 60 years. (As patient has high risk of morbidity could affect balance and movement)
  2. Patients with spine surgery, hip arthroplasty, or spinal deformity like scoliosis.
  3. Patient with red flags (e.g., active cancer, report recent or unexplained loss weight, infection, inflammation, or fracture)
  4. Clinical neurological features like lumbar radiculopathy.
  5. vestibular system dysfunction like vertigo or imbalance by using Head impulse test(Furman & Barton, 2015).
  6. pregnancy.

Sites / Locations

  • Security Forces Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention Group

Control Group

Arm Description

Patient will be receive . 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. 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

Patient will be receive . 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. The control group will have in addition to usual care that included the education patients, a Brochure for LBP therapeutic exercises

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
February 24, 2022
Last Updated
June 30, 2022
Sponsor
King Saud University
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1. Study Identification

Unique Protocol Identification Number
NCT05267756
Brief Title
Effect Virtual Reality Fully Immersive Based Exercise Game on Reducing Fear of Movement in People With CLBP
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 10, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
July 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Saud University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CLBP - Chronic Low Back Pain
Keywords
CLBP, VR, Fear of movement, Disability, Video Game, Adherence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention Group
Arm Type
Experimental
Arm Description
Patient will be receive . 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. 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
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patient will be receive . 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. The control group will have in addition to usual care that included the education patients, a Brochure for LBP therapeutic exercises
Intervention Type
Device
Intervention Name(s)
(kurki-application),VR glasses
Intervention Description
it is virtual reality immersive based-exercise game
Primary Outcome Measure Information:
Title
Fear-avoidance Belief Questionnaire (FABQ)
Description
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)
Time Frame
The change after 2 weeks of intervention
Secondary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
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
Time Frame
The change after 2 weeks of intervention
Other Pre-specified Outcome Measures:
Title
The Oswestry disability index (ODI)
Description
This scale is self-assess questionnaire, which is designed to assess level of function and (disability) in activities of daily living in individual with LBP.It consists of ten everyday activities .A total score is calculated, percentage of disability (score obtained divided by 50 and multiplied by 100)
Time Frame
The change after 2 weeks of intervention
Title
The Back Belief Questionnaire (BBQ)
Description
This is a specific self-report questionnaire consists of 14 items beliefs score help to Measuring back beliefs are associated with pain chronicity and disability in people with LBP.Score Range from 9 to 45 the higher the patients scores mean, the less he\she displays fear and false beliefs
Time Frame
The change after 2 weeks of intervention
Title
physical performance test .
Description
six-minutes walking test , Repeated times sit to stand ,Repeated trunk flexion
Time Frame
The change after 2 weeks of intervention
Title
Adherence to home exercise program
Description
diary to record every time they exercised
Time Frame
The patient commits to the intervention within 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
kholoud A Almufaireej, master
Organizational Affiliation
King saud unviersity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Security Forces Hospital
City
Riyadh
ZIP/Postal Code
3643
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Awaji, M. A. (2016). Epidemiology of low back pain in Saudi Arabia. Journal of Advances in Medical and Pharmaceutical Sciences, 1-9.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
29573871
Citation
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.
Results Reference
result
PubMed Identifier
30817741
Citation
Alamam 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 Reference
result
PubMed Identifier
17180640
Citation
Leeuw 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 Reference
result
PubMed Identifier
24535053
Citation
Garrett 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.
Results Reference
result

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Effect Virtual Reality Fully Immersive Based Exercise Game on Reducing Fear of Movement in People With CLBP

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