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Completed

NCT Number: NCT05838924

Changing Lower Back Pain Through Virtual Reality

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).

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Key information

Conditions

Low Back Pain Anxiety Disorders Back Pain Behavior Kinesiophobia Mental Disorders Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Phobic Disorders Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad CEU Cardenal Herrera

Valencia, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. Low back pain

    Time frame: At six weeks

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

  2. Range of movement

    Time frame: At six weeks

    Measured with an electrogoniometer

  3. Disability

    Time frame: At six weeks

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

Secondary outcomes

  1. Physical activity

    Time frame: 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.

  2. The Quality of life

    Time frame: 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.

  3. Kinesophobia

    Time frame: At six weeks

    Measured with the Fear Avoidance Beliefs Questionnaire

  4. Catastrophizing

    Time frame: At six weeks

    Measured with the Pain Catastrophizing Scale (0-52 points). Higher scores indicate higher levels of fear-avoidance beliefs.

  5. Physical capacity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cardenal Herrera University

Other

Registry information

Official study title

Changing Lower Back Pain Through Virtual Reality: a Randomised Clinical Controlled Trial

Acronym: CLEVER-BODY

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 3, 2023
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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