Clinical trial NCT05838924: Changing Lower Back Pain Through Virtual Reality
Official title: Changing Lower Back Pain Through Virtual Reality: a Randomised Clinical Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Virtual Reality
Physical Activity
Range of movement
Pain
Disability
Kinesophobia
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this randomized controlled trial is to investigate the efficacy of a 6-week therapeutic exercise program, performed with virtual reality (VR) manipulating visual proprioceptive information during all lumbar movements in the different therapeutic exercises (experimental group), on pain and disability, kinesiophobia, range of motion (ROM), catastrophizing, quality of life, and physical fitness in patients with chronic non-specific low back pain compared to the same therapeutic exercise program without VR (control group).

Detailed description: Chronic pain is considered an urgent global public health problem. One of the most prevalent chronic pain pathologies worldwide is low back pain (LBP). Kinesophobia (fear of movement) has been largely associated with pain intensity, disability, worse quality of life and chronification in LBP; while physical reconditioning has been proposed in clinical practice as a key element in the treatment of LBP.(20-22) However, the efficacy of physical reconditioning programs developed so far would require considerable improvement. The induction of illusions in virtual reality (VR) through visual cues could be a valid alternative to evoke motion illusions and be able to modify proprioceptive integration, acting on kinesiophobia, in turn. The main objective of this randomized controlled trial is to investigate the efficacy of a 6-week therapeutic exercise program, performed with VR manipulating visual proprioceptive information during all lumbar movements in the different therapeutic exercises (experimental group), on pain and disability, kinesiophobia, range of motion (ROM), catastrophizing, quality of life, and physical fitness in patients with chronic non-specific low back pain compared to the same therapeutic exercise program without VR (control group).

Eligibility criteria: Inclusion Criteria:

* Diagnosis of chronic non-specific lower back pain according to the European COST B13 guideline.
* Pain score of 3 or higher on the Numeric Rating Scale (NRS) in the last 6 months.

Exclusion Criteria:

* Presence of spinal tumor.
* Presence of infection.
* Presence of fracture.
* Presence of systemic disease.
* Presence of fibromyalgia.
* Presence of cauda equina syndrome.
* Previous spinal surgery.
* Presence of musculoskeletal injuries of the lower extremities.

Primary outcomes:
measure: Low back pain
timeFrame: At six weeks
measure: Range of movement
timeFrame: At six weeks
measure: Disability
timeFrame: At six weeks
Secondary outcomes:
measure: Physical activity
timeFrame: At six weeks
measure: The Quality of life
timeFrame: At six weeks
measure: Kinesophobia
timeFrame: At six weeks
measure: Catastrophizing
timeFrame: At six weeks
measure: Physical capacity
timeFrame: At six weeks
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Universidad CEU Cardenal Herrera
Study officials:
affiliation: Cardenal Herrera University
name: JUAN JOSÉ AMER-CUENCA, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Harvie DS, Broecker M, Smith RT, Meulders A, Madden VJ, Moseley GL. Bogus visual feedback alters onset of movement-evoked pain in people with neck pain. Psychol Sci. 2015 Apr;26(4):385-92. doi: 10.1177/0956797614563339. Epub 2015 Feb 17.