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

Primary Purpose

Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
PHYSICAL ACTIVITY + VIRTUAL REALITY
PHYSICAL ACTIVITY
Sponsored by
Cardenal Herrera University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Virtual Reality, Physical Activity, Range of movement, Pain, Disability, Kinesophobia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Universidad CEU Cardenal HerreraRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Physical Activity + Virtual Reality

Physical Activity

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 3, 2023
Last Updated
July 28, 2023
Sponsor
Cardenal Herrera University
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1. Study Identification

Unique Protocol Identification Number
NCT05838924
Brief Title
Changing Lower Back Pain Through Virtual Reality
Acronym
CLEVER-BODY
Official Title
Changing Lower Back Pain Through Virtual Reality: a Randomised Clinical Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardenal Herrera University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Virtual Reality, Physical Activity, Range of movement, Pain, Disability, Kinesophobia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical Activity + Virtual Reality
Arm Type
Experimental
Arm 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.
Arm Title
Physical Activity
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
PHYSICAL ACTIVITY + VIRTUAL REALITY
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
PHYSICAL ACTIVITY
Intervention Description
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 Outcome Measure Information:
Title
Low back pain
Description
Measured with a Visual Analogue Scale (0-10 points). Higher scores mean a worse pain.
Time Frame
At six weeks
Title
Range of movement
Description
Measured with an electrogoniometer
Time Frame
At six weeks
Title
Disability
Description
Measured with the Roland Morris Questionnaire (0-24 points). Higher scores mean a worse disability.
Time Frame
At six weeks
Secondary Outcome Measure Information:
Title
Physical activity
Description
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.
Time Frame
At six weeks
Title
The Quality of life
Description
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.
Time Frame
At six weeks
Title
Kinesophobia
Description
Measured with the Fear Avoidance Beliefs Questionnaire
Time Frame
At six weeks
Title
Catastrophizing
Description
Measured with the Pain Catastrophizing Scale (0-52 points). Higher scores indicate higher levels of fear-avoidance beliefs.
Time Frame
At six weeks
Title
Physical capacity
Description
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.
Time Frame
At six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JUAN FRANCISCO L PÁRRAGA, PhD
Phone
961369000
Ext
64540
Email
juanfran@uchceu.es
First Name & Middle Initial & Last Name or Official Title & Degree
JUAN JOSÉ L AMER-CUENCA, PhD
Phone
961369000
Ext
64642
Email
juanjoamer@uchceu.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JUAN JOSÉ AMER-CUENCA, PhD
Organizational Affiliation
Cardenal Herrera University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad CEU Cardenal Herrera
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JF Lisón, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25691362
Citation
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.
Results Reference
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Changing Lower Back Pain Through Virtual Reality

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