Changing Lower Back Pain Through Virtual Reality

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Other: PHYSICAL ACTIVITY + VIRTUAL REALITY; Other: PHYSICAL ACTIVITY

• Registration Number: NCT05838924
• Lead Sponsor: Cardenal Herrera University

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).

Study Timeline

• Study First Submitted: 2023-04-03
• Study Start: 2023-04-25
• Study First Submitted QC: 2023-04-28
• Study First Posted: 2023-05-03
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical Activity + Virtual Reality	PHYSICAL ACTIVITY + VIRTUAL REALITY	A program of 8 VR exercises will be applied, of a therapeutic nature, based on the applied exercises of the "Back School", aimed at gaining strength, stability, mobility and flexibility of the abdomino-lumbo-pelvic region and the lower extremities. For each exercise, the VR goggles will manipulate the visual proprioceptive information by modifying the perceived degree of lumbar flexion and extension, i.e., in the VR goggles they will perceive that your movements are different from what you are actually doing.
Physical Activity	PHYSICAL ACTIVITY	The same therapeutic exercise program will be applied as the experimental group, but without VR. The training methodology and progression of loads, evaluations and supervision by the physiotherapist will also be the same.

Primary Outcome Measures

Name	Time	Method
Disability	At six weeks	Measured with the Roland Morris Questionnaire (0-24 points). Higher scores mean a worse disability.
Low back pain	At six weeks	Measured with a Visual Analogue Scale (0-10 points). Higher scores mean a worse pain.
Range of movement	At six weeks	Measured with an electrogoniometer

Secondary Outcome Measures

Name	Time	Method
The Quality of life	At six weeks	Measured with the Euro Quality of life five dimensions with five levels questionnaire (-0.59 to 1.0). Higher scores mean a better quality of life.
Physical activity	At six weeks	Measured with the International Physical Activity Questionnaire (short-form). This is a 7-item scale used to assess physical activity. Results are divided into different activity levels (low or inactive, moderate, and high activity), and scores are obtained by multiplying the duration of physical activity by the intensity of a task that is metabolically equivalent for each activity level in the last 7 days.
Catastrophizing	At six weeks	Measured with the Pain Catastrophizing Scale (0-52 points). Higher scores indicate higher levels of fear-avoidance beliefs.
Kinesophobia	At six weeks	Measured with the Fear Avoidance Beliefs Questionnaire
Physical capacity	At six weeks	Measured with the Sit-to-Stand 60 test. The STS-60 measures the number of times an individual can sit and stand up from a chair in 60 seconds. Higher number of repetitions indicate higher physical capacity.

Trial Locations

Locations (1)

Universidad CEU Cardenal Herrera; 🇪🇸 Valencia, Spain