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

NCT05267756 | Unknown

• 1 other identifier: VR with LBP
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

CLBP - Chronic Low Back Pain

Keywords

CLBP; VR; Fear of movement; Disability; Video Game; Adherence

Outcome Measures

Primary Outcomes (1)

• 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)

  The change after 2 weeks of intervention

Secondary Outcomes (1)

• Numeric Pain Rating Scale (NPRS)

  The change after 2 weeks of intervention

Other Outcomes (4)

• The Oswestry disability index (ODI)

  The change after 2 weeks of intervention

• The Back Belief Questionnaire (BBQ)

  The change after 2 weeks of intervention

• physical performance test .

  The change after 2 weeks of intervention

Study Arms (2)

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

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

Interventions

(kurki-application),VR glasses DEVICE

it is virtual reality immersive based-exercise game

intervention Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

Security Forces Hospital

Riyadh, 3643, Saudi Arabia

Location

Related Publications (6)

• Awaji, M. A. (2016). Epidemiology of low back pain in Saudi Arabia. Journal of Advances in Medical and Pharmaceutical Sciences, 1-9.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 29573871 RESULT

• 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.

  PMID: 30817741 RESULT

• 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.

  PMID: 17180640 RESULT

• 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.

  PMID: 24535053 RESULT

MeSH Terms

Conditions

Kinesiophobia

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• kholoud A Almufaireej, master

  King saud unviersity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Therapist

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 4, 2022
• Study Start: October 10, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 30, 2022
• Last Updated: July 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)