Changing Lower Back Pain Through Virtual Reality (CLEVER-BODY)

Cardenal Herrera University

Status: Completed

Conditions: Low Back Pain

Treatments: Other: PHYSICAL ACTIVITY; Other: PHYSICAL ACTIVITY + VIRTUAL REALITY

Study type: Interventional

Funder types: Other

Identifiers

NCT05838924

UNIVERSITY CARDENAL HERRERA-63

Details and patient eligibility

About

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).

Full 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).

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Physical Activity + Virtual Reality

Experimental group

Description:

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.

Treatment:

Other: PHYSICAL ACTIVITY + VIRTUAL REALITY

Physical Activity

Active Comparator group

Description:

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.

Treatment:

Other: PHYSICAL ACTIVITY