"Psychological Intervention Enhanced by Virtual Reality for the Improvement of Appreciation of Body Functionality in Patients With Chronic Low-back-pain".

A study testing CLEVER in people with Chronic Low-back Pain, run by University of Valencia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to test whether a positive body image-based intervention is able to improve pain, disability, interference and emotional distress in people with chronic low back pain. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Low-back Pain
What is being tested?: CLEVER
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteSpain
Study dates: 3 Jun 2024to 15 Jul 2024
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

Individuals with low back pain.

Who cannot join

Meeting any of the following medical conditions:
Spinal tumor, infection or fracture
Systemic disease (autoimmune, infectious, vascular, endocrine, metabolic...)
Fibromyalgia
Cauda equina syndrome
History of spinal surgery
Musculoskeletal injury of lower extremities

Trial locations and contacts

1 site in 1 country.

Spain1 site

Arnau de Vilanova Hospital
Valencia, Valencia, 46015

Other trials in Spain

About this study

The purpose of this study is to test whether a positive body image-based intervention is able to improve pain, disability, interference and emotional distress in people with chronic low back pain.

Patients will receive 4 sessions approaching 5 different clinical modules: Pain Psychoeducation, Body Awareness, Pain Acceptance, Body Appreciation and Functionality and Gratitude. 2 sessions will include virtual reality (VR) environments to enhance the clinical outcomes.

Researchers will analyse changes in the variables of interest after intervention compared to baseline.

Read the detailed description

The purpose of this intervention is to examine the effects of a positive body image-based intervention using virtual reality to improve pain, interference and emotional distress.

The first session will be dedicated to psychoeducation about pain. Investigators will discuss what chronic pain is, what factors influence pain, chronification, body image and a brief presentation of the modules.

In the second session, a brief introduction to body awareness will be given and a VR environment will be used to carry out a body scan.

In the third session, Acceptance of pain will be worked on and a VR environment will be used to work on some variables related to the chronification of pain, such as paradoxical control or avoidance.

In the fourth session, the modules of Appreciation and Gratitude will be addressed.

Each session will last approximately one hour. First, participants will be screened to check eligibility inclusion/exclusion criteria. Second, eligible participants will complete baseline measures.

The study will be conducted following the principles stated in the Declaration of Helsinki.

The design chosen for the intervention will be a Multiple Baseline Single Case Design (SCD-MB). Data will be analysed by visual and statistical analysis. For visual analysis, the mean and/or median will be used to report the level, trend and stability of the 'within phase' data. For "between-phase" data, "Nonoverlap Statistics" such as "Nonoverlap of All Pairs" (NAP) will be used. For statistical analyses a Cohen's Difference of Means (Cohen's d) will be used to estimate the effect size at the individual level and multilevel analyses for across-case effect sizes.

Conditions: Chronic Low-back Pain
Being tested: CLEVER

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CLEVERBehavioural
CLEVER: A positive body image-based intervention for Chronic Low Back Pain.
Patients will receive 4 sessions to approach 5 clinical modules: Pain Psychoeducation, Body Awareness, Pain Acceptance, Body Appreciation and Functionality and Gratitude. virtual reality environments will be used to enhance the clinical outcomes in two sessions. Each session will last 60 minutes.

Study groups in NCT06506604
Study group	Role	What they receive
Participants with low back pain. Multiple Base Line Single Case Design - 7 days wait	Experimental	Positive body image-based intervention. Main Components: Psychoeducation, Body Awareness, Acceptance, Functionality Appreciation and Gratitude toward the body. Receives: Behavioral: CLEVER
Participants with low back pain. Multiple Base Line Single Case Design - 10 days wait	Experimental	Positive body image-based intervention. Main Components: Psychoeducation, Body Awareness, Acceptance, Functionality Appreciation and Gratitude toward the body. Receives: Behavioral: CLEVER
Participants with low back pain. Multiple Base Line Single Case Design - 14 days wait	Experimental	Positive body image-based intervention. Main Components: Psychoeducation, Body Awareness, Acceptance, Functionality Appreciation and Gratitude toward the body. Receives: Behavioral: CLEVER
Participants with low back pain. Multiple Base Line Single Case Design - 11 days wait	Experimental	Positive body image-based intervention. Main Components: Psychoeducation, Body Awareness, Acceptance, Functionality Appreciation and Gratitude toward the body. Receives: Behavioral: CLEVER

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: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
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: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
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: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
Level of Quality of Life
The EuroQol-5D (EQ-5D) scale is a 5-item scale to assess the quality of life of patients with several pathologies, chronic pain included. The individual assesses his or her own state of health, first in levels of severity by dimensions (descriptive system) and then on a more general visual analogue scale (VAS).
Measured: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).

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").
Two items: 'I'M AFRAID OF UNINTENTIONALLY INJURING MYSELF', ´PHYSICAL ACTIVITY AGGRAVATES MY PAIN´ will be administered daily for 43 days via MPATH
Measured: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
Body Awareness
Dimensions of "Not Worrying" (items 9, 10 and 11), "Not distracting" (items 5, 6 and 7) and "Trusting" (items 30, 31 and 32) from the Multidimensional Assessment of Interoceptive Awareness (MAIA) will be used. This scale 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: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43) and one of the items of the scale: 'I NOTICE WHEN I FEEL UNCOMFORTABLE IN MY BODY´ will be administered daily for 43 days via MPATH.
Body Awareness
The following items have been created ad-hoc for this experiment:
1. In general, I am able to pay attention to both pleasant and unpleasant bodily sensations.
2. When I feel pain, I am also able to notice pleasant bodily sensations.
3. Today I have noticed pleasant bodily sensations.
4. Today I have noticed unpleasant bodily sensations.
5. I am able to notice and differentiate the various sensations I experience in my body, regardless of whether they are pleasant or unpleasant (examples).
6. I have the ability to pay attention to body signals, whether positive or negative.
7. I am aware of physical sensations in my body, whether pleasant or uncomfortable.
One of the items of the scale: 'TODAY I HAVE NOTICED PLEASANT BODILY SENSATIONS´ and 'TODAY I HAVE NOTICED UNPLEASANT BODILY SENSATIONS´ will be administered daily for 43 days via MPATH.
Measured: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
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).
Two items: 'WHETHER I FELT PAIN OR NOT, I HAD A SATISFACTORY DAY´ and 'WHETHER I FELT PAIN OR NOT, I HAVE HAD A SATISFYING DAY TODAY´ will be administered daily for 43 days via MPATH.
Measured: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
Body Appreciation
Body Appreciation Scale 2 (BAS-2). Numerical rating scale ranging from 1 "Never" to 5 "Always", 10 items where higher scores indicate a higher Appreciation of the body.
Measured: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43) and one of the items of the scale -'I FEEL LOVE AND RESPECT FOR MY BODY'- will be administered daily for 43 days via MPATH.
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.
Two items of the scale -'I APPRECIATE MY BODY FOR WHAT IT IS ABLE TO DO'- and -'I AM GRATEFUL THAT MY BODY ALLOWS ME TO BE INVOLVED IN ACTIVITIES THAT I ENJOY OR THAT SEEM IMPORTANT TO ME´ will be administered daily for 43 days via MPATH
Measured: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
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").
Two of the items of the scale: -'I'M AFRAID THE PAIN WILL GET WORSE'- and -'I CAN'T STOP THINKING ABOUT HOW MUCH IT HURTS'- will be administered daily for 43 days via MPATH
Measured: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
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: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
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: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jun 202415 Jul 2024

First posted17 Jul 2024
Study start3 Jun 2024
Primary completion3 Jun 2024
Study completion15 Jul 2024

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 PainStudies of the same condition, open and under way.
More trials run by University of ValenciaThe sponsor's other registered studies.
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
Model description: Multiple Baseline Single Case Design
Masking: Single blind
Who is masked: Participant
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06506604
Sponsor's protocol ID: PID2020-115609RB-C21
Status last verified: Jan 2025
First submitted: 27 Jun 2024
Last updated: 22 Jan 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Valenzuela-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 28348526
Bailey 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 26002149
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 30035583
Kratochwill TR, Levin JR. Enhancing the scientific credibility of single-case intervention research: randomization to the rescue. Psychol Methods. 2010 Jun;15(2):124-44. doi: 10.1037/a0017736.
PubMed 20515235

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
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All Chronic Low-back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: "Psychological Intervention Enhanced by Virtual Reality for the Improvement of Appreciation of Body Functionality in Patients With Chronic Low-back-pain".
ClinicalTrials.gov ID: NCT06506604
Acronym / sponsor ID: PID2020-115609RB-C21
Conditions: Chronic Low-back Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: University of ValenciaUniversity, hospital or other
Study start: 3 Jun 2024 (actual)
Primary completion: 3 Jun 2024 (actual)
Study completion: 15 Jul 2024 (actual)
First posted: 17 Jul 2024 (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 purpose of this study is to test whether a positive body image-based intervention is able to improve pain, disability, interference and emotional distress in people with chronic low back pain.

Researchers will analyse changes in the variables of interest after intervention compared to baseline.

Detailed description

The purpose of this intervention is to examine the effects of a positive body image-based intervention using virtual reality to improve pain, interference and emotional distress.

In the second session, a brief introduction to body awareness will be given and a VR environment will be used to carry out a body scan.

In the third session, Acceptance of pain will be worked on and a VR environment will be used to work on some variables related to the chronification of pain, such as paradoxical control or avoidance.

In the fourth session, the modules of Appreciation and Gratitude will be addressed.

Each session will last approximately one hour. First, participants will be screened to check eligibility inclusion/exclusion criteria. Second, eligible participants will complete baseline measures.

The study will be conducted following the principles stated in the Declaration of Helsinki.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4
Model description: Multiple Baseline Single Case Design

Arm	Type	Receives
Participants with low back pain. Multiple Base Line Single Case Design - 7 days wait	Experimental	Behavioral: CLEVERPositive body image-based intervention. Main Components: Psychoeducation, Body Awareness, Acceptance, Functionality Appreciation and Gratitude toward the body.
Participants with low back pain. Multiple Base Line Single Case Design - 10 days wait	Experimental	Behavioral: CLEVERPositive body image-based intervention. Main Components: Psychoeducation, Body Awareness, Acceptance, Functionality Appreciation and Gratitude toward the body.
Participants with low back pain. Multiple Base Line Single Case Design - 14 days wait	Experimental	Behavioral: CLEVERPositive body image-based intervention. Main Components: Psychoeducation, Body Awareness, Acceptance, Functionality Appreciation and Gratitude toward the body.
Participants with low back pain. Multiple Base Line Single Case Design - 11 days wait	Experimental	Behavioral: CLEVERPositive body image-based intervention. Main Components: Psychoeducation, Body Awareness, Acceptance, Functionality Appreciation and Gratitude toward the body.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Individuals with low back pain.

Key exclusion criteria (7 listed)

Meeting any of the following medical conditions:

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
CLEVERCLEVER: A positive body image-based intervention for Chronic Low Back Pain. Patients will receive 4 sessions to approach 5 clinical modules: Pain Psychoeducation, Body Awareness, Pain Acceptance, Body Appreciation and Functionality and Gratitude. virtual reality environments will be used to enhance the clinical outcomes in two sessions. Each session will last 60 minutes.	Behavioural	Participants with low back pain. Multiple Base Line Single Case Design - 10 days wait, Participants with low back pain. Multiple Base Line Single Case Design - 11 days wait, Participants with low back pain. Multiple Base Line Single Case Design - 14 days wait, Participants with low back pain. Multiple Base Line Single Case Design - 7 days wait

Primary outcome

Body Disability
Time frame: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
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: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
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: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
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".
Level of Quality of Life
Time frame: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
The EuroQol-5D (EQ-5D) scale is a 5-item scale to assess the quality of life of patients with several pathologies, chronic pain included. The individual assesses his or her own state of health, first in levels of severity by dimensions (descriptive system) and then on a more general visual analogue scale (VAS).

9 secondary outcomes

Fear of movement
Time frame: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
Body Awareness
Time frame: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43) and one of the items of the scale: 'I NOTICE WHEN I FEEL UNCOMFORTABLE IN MY BODY´ will be administered daily for 43 days via MPATH.
Body Awareness
Time frame: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
Chronic Pain Acceptance
Time frame: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
Body Appreciation
Time frame: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43) and one of the items of the scale -'I FEEL LOVE AND RESPECT FOR MY BODY'- will be administered daily for 43 days via MPATH.
Appreciation of Body Functionality
Time frame: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
Pain Catastrophizing
Time frame: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
Depression
Time frame: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
Anxiety
Time frame: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).

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 22 Jan 2025.
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 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 20515235Kratochwill TR, Levin JR. Enhancing the scientific credibility of single-case intervention research: randomization to the rescue. Psychol Methods. 2010 Jun;15(2):124-44. doi: 10.1037/a0017736.
Individual participant dataSharing planned: No

Related trials for Chronic Low-back Pain

Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain

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.

Rosa M. Baños, PhD principal investigator

University of Valencia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CLEVER in people with Chronic Low-back Pain, run by University of Valencia 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 1 inclusion and 7 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 22 Jan 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: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).). 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 NCT06506604, 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 22 Jan 2025.