Chronic Low Back Pain (CLBP)CLEVER-BODYNCT06757413
Virtual Reality Programme Incorporating Psychology and Physiotherapy for Chronic Low Back Pain
A study testing Enhanced Virtual reality and Active Comparator: Treatment as usual in people with Chronic Low Back Pain (CLBP), run by Cardenal Herrera University at 1 site in Spain.
Trial summary
The main objective of this randomized controlled pilot trial is to investigate the efficacy of a 4-week multidisciplinary intervention for patients with chronic non-specific low back pain, combining a therapeutic exercise program in physiotherapy and a psychological intervention focused on positive body image in pain… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain (CLBP)
- What is being tested?
- Enhanced Virtual reality and Active Comparator: Treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSpain
- Study dates
- 10 Nov 2024to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with non-specific cLBP according to the COST B13 European guideline
- age older than 18
- an average pain score of 3 or higher on the 11-point Pain Numerical Rating Scale (PNRS-11; with 0 indicating no pain and 10 indicating the worst pain imaginable) in the 6 months prior.
Who cannot join
- spinal tumour, infection, or fracture
- systemic disease
- fibromyalgia
- cauda equina syndrome
- previous spinal surgery
- musculoskeletal injuries in the lower extremities (e.g., sciatica or radiating lower extremity pain, numbness, or weakness symptoms).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality Programme Incorporating Psychology and Physiotherapy for Chronic Low Back Pain: a Randomised Controlled Pilot Trial
The main objective of this randomized controlled pilot trial is to investigate the efficacy of a 4-week multidisciplinary intervention for patients with chronic non-specific low back pain, combining a therapeutic exercise program in physiotherapy and a psychological intervention focused on positive body image in pain intensity, pain interference, emotional distress, kinesophobia and pain catastrophization. Both components are designed to operate in parallel over a 4-week period. The physiotherapy component consists of a therapeutic exercise program of 8 sessions, performed with virtual reality (VR) manipulating visual proprioceptive information during all lumbar movements in the different therapeutic exercises. The psychological positive body image-based intervention consists of 4 sessions approaching 5 different clinical modules: Pain Psychoeducation, Body Awareness, Pain Acceptance, Body Appreciation and Functionality and Gratitude. 2 sessions (Body Awareness and Pain Acceptancce) will include virtual reality environments to enhance the clinical outcomes.
Read the detailed description
This study evaluates a 4-week multidisciplinary intervention for patients with chronic non-specific low back pain, combining physiotherapy and psychological approaches. Both components leverage virtual reality (VR) technology to address physical and psychological aspects of pain management, operating in parallel to maximize patient outcomes.
Physiotherapy Component The physiotherapy intervention consists of a therapeutic exercise program based on the principles of the "Back School," designed to improve strength, stability, mobility, and flexibility in the abdomino-lumbo-pelvic region and lower extremities. Over 8 sessions (2 per week), patients perform VR-guided exercises where visual-proprioceptive information is manipulated. The VR goggles alter the perceived degree of lumbar flexion and extension, creating a mismatch between actual and perceived movements to promote motor learning and reduce maladaptive movement patterns.
Exercises are performed in two sets, with intensity and repetitions individualized using the Borg 6-20 scale for Rating of Perceived Exertion (RPE). During the first two weeks, exercises are performed at an RPE of 14 without additional load, while in weeks three and four, intensity increases to an RPE of 15 with progressively added weights. This program aims to improve outcomes such as pain, disability, kinesiophobia, catastrophizing, quality of life, and physical fitness.
Psychological Component
The psychological intervention aims to enhance positive body image and emotional resilience while addressing pain interference and emotional distress. It consists of four weekly sessions, each lasting approximately one hour, structured as follows:
- Session 1: Pain Psychoeducation. Participants learn about chronic pain, its influencing factors, and the role of body image, with an overview of the intervention modules.
- Session 2: Body Awareness. A virtual reality body scan is introduced to increase awareness of body sensations and perceptions.
- Session 3: Pain Acceptance. Participants explore strategies to accept pain and address variables contributing to chronic pain, such as paradoxical control and avoidance, using a VR environment.
- Session 4: Body Appreciation and Gratitude. Exercises focus on fostering appreciation for body functionality and gratitude for its abilities.
Participants will first undergo eligibility screening and baseline assessments before starting the intervention. The study complies with the ethical principles outlined in the Declaration of Helsinki.
- Conditions
- Chronic Low Back Pain (CLBP)
- Being tested
- Enhanced Virtual reality, Active Comparator: Treatment as usual
- Keywords
- VIRTUAL REALITY, PHYSICAL ACTIVITY, Pain, Disability, Kinesophobia, Psychology
- Medical subject headings
- Motor Activity, Pain, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Virtual realityOther
Also called Virtual Reality Group, Experimental Group
This study evaluates a 4-week multidisciplinary intervention for patients with chronic non-specific low back pain, combining physiotherapy and psychological approaches. Both components leverage virtual reality (VR) technology to address physical and psychological aspects of pain management, operating in parallel to maximize patient outcomes. The physiotherapy intervention consists of a therapeutic exercise program based on the principles of the "Back School". Over 8 sessions (2 per week), patients perform VR-guided exercises where visual-proprioceptive information is manipulated.
The psychological positive body image-based intervention consists of 4 sessions approaching 5 different clinical modules: Pain Psychoeducation, Body Awareness, Pain Acceptance, Body Appreciation and Functionality and Gratitude. 2 sessions (Body Awareness and Pain Acceptancce) will include virtual reality environments to enhance the clinical outcomes.
Active Comparator: Treatment as usualOther
Participants will receive the usual treatment applied at the hospital
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Virtual reality | Experimental | This study evaluates a 4-week multidisciplinary intervention for patients with chronic non-specific low back pain, combining physiotherapy and psychological approaches. Both components leverage virtual reality (VR) technology to address physical and psychological aspects of pain management, operating in parallel to maximize patient outcomes.
Physiotherapy Component. The physiotherapy intervention consists of a therapeutic exercise program based on the principles of the "Back School," designed to improve strength, stability, mobility, and flexibility in the abdomino-lumbo-pelvic region and lower extremities. Over 8 sessions (2 per week), patients perform VR-guided exercises where visual-proprioceptive information is manipulated. The VR goggles alter the perceived degree of lumbar flexion and extension, creating a mismatch between actual and perceived movements to promote motor learning and reduce maladaptive movement patterns. Receives: Other: Enhanced Virtual reality |
| Control Group (treatment as usual) | Active comparator | Participants will receive the usual treatment applied at the hospital. Receives: Other: Active Comparator: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Disability
Roland-Morris Questionnaire (RMQ) is a 24-item patient-reported outcome measure those inquiries about pain-related disability. Items are scored 0 if left blank or 1 if endorsed, for a total RMQ score ranging from 0 to 24.
Measured: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
Emotional Distress
The 4-item Brief Assessment of Distress about Pain (BADP) scale was developed to assess anxiety, fear, and depression related to pain, as well as an overall evaluation of distress about pain. Items are scored from 0 ("Not at all") to 4 ("Extreme"), for a total BADP score ranging from 0 to 16.
Measured: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
Pain Interference and Pain Intensity
The Brief Pain Inventory (BPI) scale was developed to assess the severity of pain and its impact on functioning. The scale consists of 9 items with qualitative and quantitative data on the following dimensions: "Worst pain in last 24 hours", "Least pain in last 24 hours", "Pain on average" and "Pain right now".
Measured: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
Health related Quality of life
The SF-12 Health Survey is a short, standardised questionnaire designed to assess people's health status and quality of life. It consists of 12 questions that evaluate 8 dimensions: physical functioning, limitations due to physical problems, bodily pain, general health, vitality, social functioning, limitations due to emotional problems, and mental health (anxiety and depression). Scores are reported on two scales: the Physical Component Summary (PCS) and the Mental Component Summary (MCS), each ranging from 0 to 100, with higher scores indicating better perceived physical and mental health.
Measured: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
Secondary outcomes (9)
Fear of movement
The Tampa Scale for Kinesophobia (TSK-11SV) is an 11-item scale that measures kinesophobia with statements asking the subject to answer from 1 ("Strongly disagree"), to 4 ("Strongly agree").
Measured: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
Body Awareness
The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a state-trait self-report questionnaire to measure multiple dimensions of interoception (awareness of bodily sensations). These dimensions have been chosen for their relationship to the intervention components and for their good psychometric quality. The scores range from 0 to 5, where higher scores indicate a higher level in that dimension.
Measured: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
Chronic Pain Acceptance
Chronic Pain Acceptance Questionnaire 8 (CPAQ-8). Numerical rating scale ranging from 0 "Never true" to 6 "Always true" where higher scores indicate a higher Chronic Pain Acceptance (Pain Willingness and Activity Engagement).
Measured: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
Body Appreciation
Body Appreciation Scale 2 (BAS-2) is a 10-item measure of one's acceptance, favorable opinions and respect of their own body with a numerical rating scale ranging from 1 "Never" to 5 "Always" where higher scores indicate a higher Appreciation of the body.
Measured: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
Appreciation of Body Functionality
Functionality Appreciation Scale (FAS). The scores range from 1 to 5, where higher scores indicate higher levels of appreciation of body functionality.
Measured: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
Pain Catastrophizing
The Pain Catastrophizing Scale (PCS) consists of 13 statements containing a number of thoughts and feelings typically present in the experience of pain. The items are divided into 3 categories: rumination, magnification and helplessness, with each item scored on a 5-point scale. The patient is asked to indicate the frequency with which these feelings or thoughts appear from 0 ("Not at all") to 4 ("All the time").
Measured: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
Depression
The Patient Health Questionnaire (PHQ-9). The scale is composed of 9 items to assess depressive symptoms and the patient is asked to indicate the frequency with which these feelings, thoughts or states appear from 0 ("Not at all) to 3 ("Nearly every day").
Measured: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
Anxiety
The Generalised Anxiety Disorder-7 (GAD-7) scale is composed of 7 items to assess the different dimensions of the Generalised Anxiety Disorder and the patient is asked to mark the frequency from 'Never' to 'almost every day' in the last two weeks.
Measured: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
Life satisfaction
The Satisfaction with Life Scale (SWLS) is a 5-item self-report tool measuring global life satisfaction-a cognitive component of subjective well-being
Measured: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start10 Nov 2024
- Primary completion30 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back Pain (CLBP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Collaborators
- Clinica Universidad de Navarra, Universidad de Navarra, University of Valencia
- Responsible party
- Principal investigator, Juan F. Lisón Párraga, Dr, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757413
- Sponsor's protocol ID
- Cardenal Herrera University 69
- Other IDs
- PID2020-115609RB-C22
- Acronym
- CLEVER-BODY
- Status last verified
- Apr 2025
- First submitted
- 20 Dec 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators have to decide it between all the researchers
Publications
Alleva JM, Diedrichs PC, Halliwell E, Peters ML, Dures E, Stuijfzand BG, Rumsey N. More than my RA: A randomized trial investigating body image improvement among women with rheumatoid arthritis using a functionality-focused intervention program. J Consult Clin Psychol. 2018 Aug;86(8):666-676. doi: 10.1037/ccp0000317.
PubMed 30035583Valenzuela-Moguillansky C, Reyes-Reyes A, Gaete MI. Exteroceptive and Interoceptive Body-Self Awareness in Fibromyalgia Patients. Front Hum Neurosci. 2017 Mar 13;11:117. doi: 10.3389/fnhum.2017.00117. eCollection 2017.
PubMed 28348526Bailey KA, Gammage KL, van Ingen C, Ditor DS. "It's all about acceptance": A qualitative study exploring a model of positive body image for people with spinal cord injury. Body Image. 2015 Sep;15:24-34. doi: 10.1016/j.bodyim.2015.04.010. Epub 2015 May 21.
PubMed 26002149Harvie 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.
PubMed 25691362
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Programme Incorporating Psychology and Physiotherapy for Chronic Low Back Pain: a Randomised Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT06757413
- Acronym / sponsor ID
- CLEVER-BODY / Cardenal Herrera University 69
- Conditions
- Chronic Low Back Pain (CLBP)
- Keywords
- VIRTUAL REALITY, PHYSICAL ACTIVITY, Pain, Disability, Kinesophobia, Psychology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Collaborators
- Clinica Universidad de Navarra, Universidad de Navarra, University of Valencia
- Study start
- 10 Nov 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this randomized controlled pilot trial is to investigate the efficacy of a 4-week multidisciplinary intervention for patients with chronic non-specific low back pain, combining a therapeutic exercise program in physiotherapy and a psychological intervention focused on positive body image in pain intensity, pain interference, emotional distress, kinesophobia and pain catastrophization. Both components are designed to operate in parallel over a 4-week period. The physiotherapy component consists of a therapeutic exercise program of 8 sessions, performed with virtual reality (VR) manipulating visual proprioceptive information during all lumbar movements in the different therapeutic exercises. The psychological positive body image-based intervention consists of 4 sessions approaching 5 different clinical modules: Pain Psychoeducation, Body Awareness, Pain Acceptance, Body Appreciation and Functionality and Gratitude. 2 sessions (Body Awareness and Pain Acceptancce) will include virtual reality environments to enhance the clinical outcomes.
Detailed description
This study evaluates a 4-week multidisciplinary intervention for patients with chronic non-specific low back pain, combining physiotherapy and psychological approaches. Both components leverage virtual reality (VR) technology to address physical and psychological aspects of pain management, operating in parallel to maximize patient outcomes.
Physiotherapy Component The physiotherapy intervention consists of a therapeutic exercise program based on the principles of the "Back School," designed to improve strength, stability, mobility, and flexibility in the abdomino-lumbo-pelvic region and lower extremities. Over 8 sessions (2 per week), patients perform VR-guided exercises where visual-proprioceptive information is manipulated. The VR goggles alter the perceived degree of lumbar flexion and extension, creating a mismatch between actual and perceived movements to promote motor learning and reduce maladaptive movement patterns.
Exercises are performed in two sets, with intensity and repetitions individualized using the Borg 6-20 scale for Rating of Perceived Exertion (RPE). During the first two weeks, exercises are performed at an RPE of 14 without additional load, while in weeks three and four, intensity increases to an RPE of 15 with progressively added weights. This program aims to improve outcomes such as pain, disability, kinesiophobia, catastrophizing, quality of life, and physical fitness.
Psychological Component
The psychological intervention aims to enhance positive body image and emotional resilience while addressing pain interference and emotional distress. It consists of four weekly sessions, each lasting approximately one hour, structured as follows:
- Session 1: Pain Psychoeducation. Participants learn about chronic pain, its influencing factors, and the role of body image, with an overview of the intervention modules.
- Session 2: Body Awareness. A virtual reality body scan is introduced to increase awareness of body sensations and perceptions.
- Session 3: Pain Acceptance. Participants explore strategies to accept pain and address variables contributing to chronic pain, such as paradoxical control and avoidance, using a VR environment.
- Session 4: Body Appreciation and Gratitude. Exercises focus on fostering appreciation for body functionality and gratitude for its abilities.
Participants will first undergo eligibility screening and baseline assessments before starting the intervention. The study complies with the ethical principles outlined in the Declaration of Helsinki.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Virtual reality | Experimental | Other: Enhanced Virtual realityThis study evaluates a 4-week multidisciplinary intervention for patients with chronic non-specific low back pain, combining physiotherapy and psychological approaches. Both components leverage virtual reality (VR) technology to address physical and psychological aspects of pain management, operating in parallel to maximize patient outcomes. Physiotherapy Component. The physiotherapy intervention consists of a therapeutic exercise program based on the principles of the "Back School," designed to improve strength, stability, mobility, and flexibility in the abdomino-lumbo-pelvic region and lower extremities. Over 8 sessions (2 per week), patients perform VR-guided exercises where visual-proprioceptive information is manipulated. The VR goggles alter the perceived degree of lumbar flexion and extension, creating a mismatch between actual and perceived movements to promote motor learning and reduce maladaptive movement patterns. |
| Control Group (treatment as usual) | Active comparator | Other: Active Comparator: Treatment as usualParticipants will receive the usual treatment applied at the hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosed with non-specific cLBP according to the COST B13 European guideline
- age older than 18
- an average pain score of 3 or higher on the 11-point Pain Numerical Rating Scale (PNRS-11; with 0 indicating no pain and 10 indicating the worst pain imaginable) in the 6 months prior.
Key exclusion criteria (6 listed)
- spinal tumour, infection, or fracture
- systemic disease
- fibromyalgia
- cauda equina syndrome
- previous spinal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Virtual realityAlso: Virtual Reality Group, Experimental GroupThis study evaluates a 4-week multidisciplinary intervention for patients with chronic non-specific low back pain, combining physiotherapy and psychological approaches. Both components leverage virtual reality (VR) technology to address physical and psychological aspects of pain management, operating in parallel to maximize patient outcomes. The physiotherapy intervention consists of a therapeutic exercise program based on the principles of the "Back School". Over 8 sessions (2 per week), patients perform VR-guided exercises where visual-proprioceptive information is manipulated. The psychological positive body image-based intervention consists of 4 sessions approaching 5 different clinical modules: Pain Psychoeducation, Body Awareness, Pain Acceptance, Body Appreciation and Functionality and Gratitude. 2 sessions (Body Awareness and Pain Acceptancce) will include virtual reality environments to enhance the clinical outcomes. | Other | Enhanced Virtual reality |
| Active Comparator: Treatment as usualParticipants will receive the usual treatment applied at the hospital | Other | Control Group (treatment as usual) |
Primary outcome
Body Disability
Time frame: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
Roland-Morris Questionnaire (RMQ) is a 24-item patient-reported outcome measure those inquiries about pain-related disability. Items are scored 0 if left blank or 1 if endorsed, for a total RMQ score ranging from 0 to 24.
Emotional Distress
Time frame: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
The 4-item Brief Assessment of Distress about Pain (BADP) scale was developed to assess anxiety, fear, and depression related to pain, as well as an overall evaluation of distress about pain. Items are scored from 0 ("Not at all") to 4 ("Extreme"), for a total BADP score ranging from 0 to 16.
Pain Interference and Pain Intensity
Time frame: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
The Brief Pain Inventory (BPI) scale was developed to assess the severity of pain and its impact on functioning. The scale consists of 9 items with qualitative and quantitative data on the following dimensions: "Worst pain in last 24 hours", "Least pain in last 24 hours", "Pain on average" and "Pain right now".
Health related Quality of life
Time frame: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
The SF-12 Health Survey is a short, standardised questionnaire designed to assess people's health status and quality of life. It consists of 12 questions that evaluate 8 dimensions: physical functioning, limitations due to physical problems, bodily pain, general health, vitality, social functioning, limitations due to emotional problems, and mental health (anxiety and depression). Scores are reported on two scales: the Physical Component Summary (PCS) and the Mental Component Summary (MCS), each ranging from 0 to 100, with higher scores indicating better perceived physical and mental health.
9 secondary outcomes
Fear of movement
Time frame: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
Body Awareness
Time frame: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
Chronic Pain Acceptance
Time frame: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
Body Appreciation
Time frame: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
Appreciation of Body Functionality
Time frame: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
Pain Catastrophizing
Time frame: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
Depression
Time frame: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
Anxiety
Time frame: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
Life satisfaction
Time frame: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Background: PubMed 30035583Alleva JM, Diedrichs PC, Halliwell E, Peters ML, Dures E, Stuijfzand BG, Rumsey N. More than my RA: A randomized trial investigating body image improvement among women with rheumatoid arthritis using a functionality-focused intervention program. J Consult Clin Psychol. 2018 Aug;86(8):666-676. doi: 10.1037/ccp0000317.
- Background: PubMed 28348526Valenzuela-Moguillansky C, Reyes-Reyes A, Gaete MI. Exteroceptive and Interoceptive Body-Self Awareness in Fibromyalgia Patients. Front Hum Neurosci. 2017 Mar 13;11:117. doi: 10.3389/fnhum.2017.00117. eCollection 2017.
- Background: PubMed 26002149Bailey KA, Gammage KL, van Ingen C, Ditor DS. "It's all about acceptance": A qualitative study exploring a model of positive body image for people with spinal cord injury. Body Image. 2015 Sep;15:24-34. doi: 10.1016/j.bodyim.2015.04.010. Epub 2015 May 21.
- Background: PubMed 25691362Harvie 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.
- Individual participant dataSharing planned: Undecided. The investigators have to decide it between all the researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Virtual reality and Active Comparator: Treatment as usual in people with Chronic Low Back Pain (CLBP), run by Cardenal Herrera University at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Disability (time frame: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06757413, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.