Changing Lower Back Pain Through Virtual Reality

Low Back Pain Clinical Trial

— CLEVER-BODY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05838924
• Other study ID #: UNIVERSITY CARDENAL HERRERA-63
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2023
• Est. completion date: December 15, 2023

Study information

• Verified date: July 2023
• Source: Cardenal Herrera University
• Contact: JUAN FRANCISCO L PÁRRAGA, PhD
• Phone: 961369000
• Email: juanfran[@]uchceu.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 15, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• PHYSICAL ACTIVITY + VIRTUAL REALITY
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
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.

Locations

Country	Name	City	State
Spain	Universidad CEU Cardenal Herrera	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Cardenal Herrera University

Country where clinical trial is conducted

Spain, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low back pain	Measured with a Visual Analogue Scale (0-10 points). Higher scores mean a worse pain.	At six weeks
Primary	Range of movement	Measured with an electrogoniometer	At six weeks
Primary	Disability	Measured with the Roland Morris Questionnaire (0-24 points). Higher scores mean a worse disability.	At six weeks
Secondary	Physical activity	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.	At six weeks
Secondary	The Quality of life	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.	At six weeks
Secondary	Kinesophobia	Measured with the Fear Avoidance Beliefs Questionnaire	At six weeks
Secondary	Catastrophizing	Measured with the Pain Catastrophizing Scale (0-52 points). Higher scores indicate higher levels of fear-avoidance beliefs.	At six weeks
Secondary	Physical capacity	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.	At six weeks