Chronic Low-back PainNCT06054074
Virtual Reality-based Induction to Improve Positive Body Image in Low Back Pain Patients.
A study testing Positive Appreciation of Body Functionality Induction and Negative Appreciation of Body Functionality Induction in people with Chronic Low-back Pain and Low Back Pain, run by University of Valencia at 1 site in Spain.
Trial summary
The aim of this study is to examine the effects of a Virtual Reality-based induction to modify positive body image in individuals with low back pain. Participants will receive both a positive and a negative induction of the appreciation of body functionality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low-back Pain, Low Back Pain
- What is being tested?
- Positive Appreciation of Body Functionality Induction and Negative Appreciation of Body Functionality Induction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2022to 24 Jan 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.
About this study
Official title: Efficacy of a Positive Induction Through the Use of a Virtual Reality-based Program to Modify Positive Body Image Related Variables in Patients With Low Back Pain.
The aim of this study is to examine the effects of a Virtual Reality-based induction to modify positive body image in individuals with low back pain.
Participants will receive both a positive and a negative induction of the appreciation of body functionality. This induction consists of an elaborated narrative to increase/decrease the appreciation of functionality. In addition, each induction includes a virtual costume representing their body's strengths or weaknesses to enrich the induction. After both induction procedures, participants will perform activities of daily living involving the use of the lumbar region in virtual reality. Subsequently, the different variables of interest will be assessed before and after each induction.
Researchers will analyze changes in the variables of interest after induction procedures compared to baseline.
Read the detailed description
The aim of this study is to examine the effects of a Virtual Reality-based induction to modify positive body image in individuals with low back pain.
Firstly, improvement in the study variables is expected after the positive induction. Secondly, the opposite results are expected after negative induction. Thirdly, a greater change is expected in the group of patients with low back pain.
The whole study is conducted in one single 1-hour session. First, participants will be screened to check eligibility inclusion/exclusion criteria. Second, eligible participants will complete baseline measures. Third, participants will be exposed to both induction procedures, counterbalancing the order. At the end of each induction, they will have to perform different virtual reality-based tasks of daily life that involve the use of the lumbar region, such as placing books on a bookshelf, throwing objects into a trash can or painting a wall. Fourth, state measures will be applied to assess the change in the study variables.
The study will be conducted following the principles stated in the Declaration of Helsinki.
- Conditions
- Chronic Low-back Pain, Low Back Pain
- Being tested
- Positive Appreciation of Body Functionality Induction, Negative Appreciation of Body Functionality Induction
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Appreciation of Body Functionality InductionBehavioural
The positive induction takes place in a virtual environment of a dressing room and includes the following methods to induce positive appreciation of body functionality: 1) a narrative that aims to take the participants back to a time in the past when they held a higher positive body image. 2) A green virtual costume, representing their body at that time in the past and the positive attitude and feelings towards their body. 3) Five daily life tasks involving the use of the lower back, accompanied by auditory reminders and visual cues (green costume) to preserve the induction effect.
Negative Appreciation of Body Functionality InductionBehavioural
The negative induction takes place in a virtual environment of a dressing room and includes the following methods to induce a lower appreciation of body functionality: 1) a narrative that aims to take the participants back to a time in the past when they held a lower positive body image. 2) A red virtual costume, representing their body at that time in the past and the negative attitude and feelings towards their body. 3) Five daily life tasks involving the use of the lower back, accompanied by auditory reminders and visual cues (red costume) to preserve the induction effect.
| Study group | Role | What they receive |
|---|---|---|
| Low back pain | Experimental | Participants with low back pain. They will perform the two induction procedures. Receives: Behavioral: Positive Appreciation of Body Functionality Induction; Behavioral: Negative Appreciation of Body Functionality Induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appreciation of Body Functionality: Baseline
Baseline measure of Functionality Appreciation Scale (FAS). The scores range from 1 to 5, where higher scores indicates higher levels of appreciation of body functionality.
Measured: The whole study is conducted in a single experimental session: Immediately before induction procedures.
Appreciation of Body Functionality: Post positive induction procedure
Post positive induction measure of FAS. The scores range from 1 to 5, where higher scores indicates higher levels of appreciation of body functionality.
Measured: The whole study is conducted in a single experimental session: Immediately after positive induction procedure.
Appreciation of Body Functionality: Post negative induction procedure
Post negative induction measure of FAS. The scores range from 1 to 5, where higher scores indicates higher levels of appreciation of body functionality.
Measured: The whole study is conducted in a single experimental session: Immediately after negative induction procedure.
Body Awareness: Body Trusting; Baseline
Baseline measure of "Trusting" subscale from Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2). The scores range from 0 to 5, where higher scores indicate a higher level of trust in one's own body.
Measured: The whole study is conducted in a single experimental session: Immediately before induction procedures.
Body Awareness: Body Trusting; Post positive induction procedure
Post positive induction measure of "Trusting" subscale from MAIA-2. The scores range from 0 to 5, where higher scores indicate a higher level of trust in one's own body.
Measured: The whole study is conducted in a single experimental session: Immediately after positive induction procedure.
Body Awareness: Body Trusting; Post negative induction procedure
Post negative induction measure of "Trusting" subscale from MAIA-2. The scores range from 0 to 5, where higher scores indicate a higher level of trust in one's own body.
Measured: The whole study is conducted in a single experimental session: Immediately after negative induction procedure.
Positive Embodiment: Positive Body Connection and Comfort (PBCC); Baseline
Baseline measure of PBCC subscale from Experience of Embodiment Scale (EES). The scores range from 1 to 5, where higher scores indicates a more positive experience of embodiment.
Measured: The whole study is conducted in a single experimental session: Immediately before induction procedures.
Positive Embodiment: Positive Body Connection and Comfort (PBCC); Post positive induction procedure
Post positive induction measure of PBCC subscale from EES. The scores range from 1 to 5, where higher scores indicates a more positive experience of embodiment.
Measured: The whole study is conducted in a single experimental session: Immediately after positive induction procedure.
Positive Embodiment: Positive Body Connection and Comfort (PBCC); Post negative induction procedure
Post negative induction measure of PBCC subscale from EES. The scores range from 1 to 5, where higher scores indicates a more positive experience of embodiment.
Measured: The whole study is conducted in a single experimental session: Immediately after negative induction procedure.
Attitudes or Feelings towards One's Own Body; Baseline
Baseline measure of a semantic differential developed to assess attitudes and feelings towards one's own body. The scores range from 0 to 10, with higher scores representing a more positive evaluation of the one's own body.
Measured: The whole study is conducted in a single experimental session: Immediately before the induction procedures and immediately after the first applied induction procedure.
Attitudes or Feelings towards One's Own Body; Post first induction procedure
Post first induction procedure measure of a semantic differential developed to assess attitudes and feelings towards one's own body. The scores range from 0 to 10, with higher scores representing a more positive evaluation of the one's own body.
Measured: The whole study is conducted in a single experimental session: Immediately before the first induction procedure.
Secondary outcomes (7)
Pain intensity: Baseline
Baseline measure of pain (numerical rating scale). The scores ranges to 0: "no pain" to 10: "maximum pain".
Measured: The whole study is conducted in a single experimental session: Immediately before the induction procedures.
Pain intensity: Post positive induction procedure
Post positive induction measure of pain (numerical rating scale). The scores ranges to 0: "no pain" to 10: "maximum pain".
Measured: The whole study is conducted in a single experimental session: Immediately after positive induction procedure.
Pain intensity: Post negative induction procedure
Post negative induction measure of pain (numerical rating scale). The scores ranges to 0: "no pain" to 10: "maximum pain".
Measured: The whole study is conducted in a single experimental session: Immediately after negative induction procedure.
Fear of movement; Post positive induction procedure
Post positive induction measure of fear of movement with a single item (numerical rating scale); ranging from 0: " No fear" to 10: "maximum fear".
Measured: The whole study is conducted in a single experimental session: Immediately after the positive induction procedure.
Fear of movement; Post negative induction procedure
Post negative induction measure of fear of movement with a single item (numerical rating scale); ranging from 0: " No fear" to 10: "maximum fear".
Measured: The whole study is conducted in a single experimental session: Immediately after the negative induction procedure.
Task difficulty; Post positive induction procedure
Post positive induction measure of task difficulty with a single item (numerical rating scale); ranging from 0: "very easy" to 10: "very hard".
Measured: The whole study is conducted in a single experimental session: Immediately after the positive induction procedure.
Task difficulty; Post negative induction procedure
Post negative induction measure of task difficulty with a single item (numerical rating scale); ranging from 0: "very easy" to 10: "very hard".
Measured: The whole study is conducted in a single experimental session: Immediately after the negative induction procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start1 Nov 2022
- Primary completion24 Jan 2024
- Study completion24 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosa M. Baños Rivera, University of Valencia
- Investigators
- Rosa M Baños, PhD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054074
- Sponsor's protocol ID
- CEIm: 30/2021
- Other IDs
- FPU20/05798
- Status last verified
- Jun 2024
- First submitted
- 20 Jun 2023
- Last updated
- 18 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alleva JM, Tylka TL, Kroon Van Diest AM. The Functionality Appreciation Scale (FAS): Development and psychometric evaluation in U.S. community women and men. Body Image. 2017 Dec;23:28-44. doi: 10.1016/j.bodyim.2017.07.008. Epub 2017 Aug 17.
PubMed 28822275Mehling WE, Acree M, Stewart A, Silas J, Jones A. The Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2). PLoS One. 2018 Dec 4;13(12):e0208034. doi: 10.1371/journal.pone.0208034. eCollection 2018.
PubMed 30513087Piran N, Teall TL, Counsell A. The experience of embodiment scale: Development and psychometric evaluation. Body Image. 2020 Sep;34:117-134. doi: 10.1016/j.bodyim.2020.05.007. Epub 2020 Jun 14.
PubMed 32554242
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Positive Induction Through the Use of a Virtual Reality-based Program to Modify Positive Body Image Related Variables in Patients With Low Back Pain.
- ClinicalTrials.gov ID
- NCT06054074
- Acronym / sponsor ID
- CEIm: 30/2021
- Conditions
- Chronic Low-back Pain, Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 24 Jan 2024 (actual)
- Study completion
- 24 Jan 2024 (actual)
- First posted
- 26 Sep 2023 (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 aim of this study is to examine the effects of a Virtual Reality-based induction to modify positive body image in individuals with low back pain.
Participants will receive both a positive and a negative induction of the appreciation of body functionality. This induction consists of an elaborated narrative to increase/decrease the appreciation of functionality. In addition, each induction includes a virtual costume representing their body's strengths or weaknesses to enrich the induction. After both induction procedures, participants will perform activities of daily living involving the use of the lumbar region in virtual reality. Subsequently, the different variables of interest will be assessed before and after each induction.
Researchers will analyze changes in the variables of interest after induction procedures compared to baseline.
Detailed description
The aim of this study is to examine the effects of a Virtual Reality-based induction to modify positive body image in individuals with low back pain.
Firstly, improvement in the study variables is expected after the positive induction. Secondly, the opposite results are expected after negative induction. Thirdly, a greater change is expected in the group of patients with low back pain.
The whole study is conducted in one single 1-hour session. First, participants will be screened to check eligibility inclusion/exclusion criteria. Second, eligible participants will complete baseline measures. Third, participants will be exposed to both induction procedures, counterbalancing the order. At the end of each induction, they will have to perform different virtual reality-based tasks of daily life that involve the use of the lumbar region, such as placing books on a bookshelf, throwing objects into a trash can or painting a wall. Fourth, state measures will be applied to assess the change in the study variables.
The study will be conducted following the principles stated in the Declaration of Helsinki.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low back pain | Experimental | Behavioral: Positive Appreciation of Body Functionality Induction, Behavioral: Negative Appreciation of Body Functionality InductionParticipants with low back pain. They will perform the two induction procedures. |
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)
- Spinal tumor, infection or fracture
- Systemic disease (autoimmune, infectious, vascular, endocrine, metabolic...)
- Fibromyalgia
- Cauda equina syndrome
- History of 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 |
|---|---|---|
| Positive Appreciation of Body Functionality InductionThe positive induction takes place in a virtual environment of a dressing room and includes the following methods to induce positive appreciation of body functionality: 1) a narrative that aims to take the participants back to a time in the past when they held a higher positive body image. 2) A green virtual costume, representing their body at that time in the past and the positive attitude and feelings towards their body. 3) Five daily life tasks involving the use of the lower back, accompanied by auditory reminders and visual cues (green costume) to preserve the induction effect. | Behavioural | Low back pain |
| Negative Appreciation of Body Functionality InductionThe negative induction takes place in a virtual environment of a dressing room and includes the following methods to induce a lower appreciation of body functionality: 1) a narrative that aims to take the participants back to a time in the past when they held a lower positive body image. 2) A red virtual costume, representing their body at that time in the past and the negative attitude and feelings towards their body. 3) Five daily life tasks involving the use of the lower back, accompanied by auditory reminders and visual cues (red costume) to preserve the induction effect. | Behavioural | Low back pain |
Primary outcome
Appreciation of Body Functionality: Baseline
Time frame: The whole study is conducted in a single experimental session: Immediately before induction procedures.
Baseline measure of Functionality Appreciation Scale (FAS). The scores range from 1 to 5, where higher scores indicates higher levels of appreciation of body functionality.
Appreciation of Body Functionality: Post positive induction procedure
Time frame: The whole study is conducted in a single experimental session: Immediately after positive induction procedure.
Post positive induction measure of FAS. The scores range from 1 to 5, where higher scores indicates higher levels of appreciation of body functionality.
Appreciation of Body Functionality: Post negative induction procedure
Time frame: The whole study is conducted in a single experimental session: Immediately after negative induction procedure.
Post negative induction measure of FAS. The scores range from 1 to 5, where higher scores indicates higher levels of appreciation of body functionality.
Body Awareness: Body Trusting; Baseline
Time frame: The whole study is conducted in a single experimental session: Immediately before induction procedures.
Baseline measure of "Trusting" subscale from Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2). The scores range from 0 to 5, where higher scores indicate a higher level of trust in one's own body.
Body Awareness: Body Trusting; Post positive induction procedure
Time frame: The whole study is conducted in a single experimental session: Immediately after positive induction procedure.
Post positive induction measure of "Trusting" subscale from MAIA-2. The scores range from 0 to 5, where higher scores indicate a higher level of trust in one's own body.
Body Awareness: Body Trusting; Post negative induction procedure
Time frame: The whole study is conducted in a single experimental session: Immediately after negative induction procedure.
Post negative induction measure of "Trusting" subscale from MAIA-2. The scores range from 0 to 5, where higher scores indicate a higher level of trust in one's own body.
Positive Embodiment: Positive Body Connection and Comfort (PBCC); Baseline
Time frame: The whole study is conducted in a single experimental session: Immediately before induction procedures.
Baseline measure of PBCC subscale from Experience of Embodiment Scale (EES). The scores range from 1 to 5, where higher scores indicates a more positive experience of embodiment.
Positive Embodiment: Positive Body Connection and Comfort (PBCC); Post positive induction procedure
Time frame: The whole study is conducted in a single experimental session: Immediately after positive induction procedure.
Post positive induction measure of PBCC subscale from EES. The scores range from 1 to 5, where higher scores indicates a more positive experience of embodiment.
Positive Embodiment: Positive Body Connection and Comfort (PBCC); Post negative induction procedure
Time frame: The whole study is conducted in a single experimental session: Immediately after negative induction procedure.
Post negative induction measure of PBCC subscale from EES. The scores range from 1 to 5, where higher scores indicates a more positive experience of embodiment.
Attitudes or Feelings towards One's Own Body; Baseline
Time frame: The whole study is conducted in a single experimental session: Immediately before the induction procedures and immediately after the first applied induction procedure.
Baseline measure of a semantic differential developed to assess attitudes and feelings towards one's own body. The scores range from 0 to 10, with higher scores representing a more positive evaluation of the one's own body.
Attitudes or Feelings towards One's Own Body; Post first induction procedure
Time frame: The whole study is conducted in a single experimental session: Immediately before the first induction procedure.
Post first induction procedure measure of a semantic differential developed to assess attitudes and feelings towards one's own body. The scores range from 0 to 10, with higher scores representing a more positive evaluation of the one's own body.
7 secondary outcomes
Pain intensity: Baseline
Time frame: The whole study is conducted in a single experimental session: Immediately before the induction procedures.
Pain intensity: Post positive induction procedure
Time frame: The whole study is conducted in a single experimental session: Immediately after positive induction procedure.
Pain intensity: Post negative induction procedure
Time frame: The whole study is conducted in a single experimental session: Immediately after negative induction procedure.
Fear of movement; Post positive induction procedure
Time frame: The whole study is conducted in a single experimental session: Immediately after the positive induction procedure.
Fear of movement; Post negative induction procedure
Time frame: The whole study is conducted in a single experimental session: Immediately after the negative induction procedure.
Task difficulty; Post positive induction procedure
Time frame: The whole study is conducted in a single experimental session: Immediately after the positive induction procedure.
Task difficulty; Post negative induction procedure
Time frame: The whole study is conducted in a single experimental session: Immediately after the negative induction procedure.
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 18 Jun 2024.
- Background: PubMed 28822275Alleva JM, Tylka TL, Kroon Van Diest AM. The Functionality Appreciation Scale (FAS): Development and psychometric evaluation in U.S. community women and men. Body Image. 2017 Dec;23:28-44. doi: 10.1016/j.bodyim.2017.07.008. Epub 2017 Aug 17.
- Background: PubMed 30513087Mehling WE, Acree M, Stewart A, Silas J, Jones A. The Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2). PLoS One. 2018 Dec 4;13(12):e0208034. doi: 10.1371/journal.pone.0208034. eCollection 2018.
- Background: PubMed 32554242Piran N, Teall TL, Counsell A. The experience of embodiment scale: Development and psychometric evaluation. Body Image. 2020 Sep;34:117-134. doi: 10.1016/j.bodyim.2020.05.007. Epub 2020 Jun 14.
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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.
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 Positive Appreciation of Body Functionality Induction and Negative Appreciation of Body Functionality Induction in people with Chronic Low-back Pain and 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 18 Jun 2024. 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?
Appreciation of Body Functionality: Baseline (time frame: The whole study is conducted in a single experimental session: Immediately before induction procedures.). The study lists 11 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 NCT06054074, which also lists 3 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 18 Jun 2024.