Changing Lower Back Pain Through Virtual Reality

NCT05838924 | Completed

• 1 other identifier: UNIVERSITY CARDENAL HERRERA-63
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Low Back Pain

Keywords

Virtual Reality; Physical Activity; Range of movement; Pain; Disability; Kinesophobia

Outcome Measures

Primary Outcomes (3)

• Low back pain

  Measured with a Visual Analogue Scale (0-10 points). Higher scores mean a worse pain.

  At six weeks

• Range of movement

  Measured with an electrogoniometer

  At six weeks

• Disability

  Measured with the Roland Morris Questionnaire (0-24 points). Higher scores mean a worse disability.

  At six weeks

Secondary Outcomes (5)

• Physical activity

  At six weeks

• The Quality of life

  At six weeks

• Kinesophobia

  At six weeks

• Catastrophizing

  At six weeks

• Physical capacity

  At six weeks

Study Arms (2)

Physical Activity + Virtual Reality

EXPERIMENTAL

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.

Other: PHYSICAL ACTIVITY + VIRTUAL REALITY

Physical Activity

ACTIVE COMPARATOR

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.

Other: PHYSICAL ACTIVITY

Interventions

PHYSICAL ACTIVITY + VIRTUAL REALITY OTHER

The VR therapeutic exercise program will be implemented for 6 weeks at a frequency of 2 sessions per week with the aim of improving pain and disability, kinesiophobia, range of motion (ROM), catastrophizing, quality of life, and physical fitness. This group will perform the 8 VR exercises of "Back School" by manipulating visual proprioceptive information during all lumbar movements. They will be performed in 2 sets whose intensity and repetitions will be configured and individualized by a self-reported rating of perceived exertion (RPE) through the Borg 6-20 scale. The appropriate training intensity is established with an RPE score between 13 and 17; for this reason, the first 2 weeks will work at an RPE of 14, the 3rd and 4th weeks at an RPE of 15; and finally, the last 2 weeks will work at an RPE of 16. The first 3 weeks will work without additional load, and the last 3 weeks will work with weights, increasing their weekly load individually.

Physical Activity + Virtual Reality

PHYSICAL ACTIVITY OTHER

The 8 therapeutic exercise program will be implemented for 6 weeks at a frequency of 2 sessions per week with the aim of improving pain and disability, kinesiophobia, range of motion (ROM), catastrophizing, quality of life, and physical fitness. This group will perform the 8 exercises of "Back School" without VR. They will be performed in 2 sets whose intensity and repetitions will be configured and individualized by a self-reported rating of perceived exertion (RPE) through the Borg 6-20 scale. The appropriate training intensity is established with an RPE score between 13 and 17; for this reason, the first 2 weeks will work at an RPE of 14, the 3rd and 4th weeks at an RPE of 15; and finally, the last 2 weeks will work at an RPE of 16. The first 3 weeks will work without additional load, and the last 3 weeks will work with weights, increasing their weekly load individually.

Physical Activity

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cardenal Herrera University: lead

Study Sites (1)

Universidad CEU Cardenal Herrera

Valencia, Spain

Location

Related Publications (1)

• 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.

  PMID: 25691362 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Motor Activity; Pain; Kinesiophobia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• JUAN JOSÉ AMER-CUENCA, PhD

  Cardenal Herrera University

  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: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: May 3, 2023
• Study Start: April 25, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 15, 2023
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)