Low Back PainNCT05571358
Virtual Reality to Improve Low-back Pain and Pelvic Pain During Pregnancy
A study testing Virtual Reality (Nature Trek) in people with Low Back Pain and Pelvic Pain, run by University of Malaga.
Trial summary
A large percentage of women suffer low back and pelvic pain both during and after pregnancy. There are several factors to which these complaints are attributed, even affecting their daily lives. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Pelvic Pain
- What is being tested?
- Virtual Reality (Nature Trek)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Dec 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult woman over 18 years old
- Pregnant woman with Low Back Pain, Pelvic Pain (PP) or both conditions with symptomatic character.
- Pregnant woman between the 12th and 36th week of gestation, corresponding to the 2nd and 3rd trimester.
- Pain intensity greater than 4/10 on VAS, indicating moderate-severe pain.
- Live in Sevilla or Malaga during the research period.
Who cannot join
- Patients with LBP or PP pain prior to pregnancy.
- Cognitive ability not suitable for the use of technological tools.
- Patients with absolute or relative contraindications.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Virtual Reality to Improve Low-back Pain and Pelvic Pain During Pregnancy for a Multicentre Randomized Controlled Trial
A large percentage of women suffer low back and pelvic pain both during and after pregnancy. There are several factors to which these complaints are attributed, even affecting their daily lives. It is identified that many of these women do not receive adequate health care, however, different physiotherapeutic interventions are recommended to alleviate these conditions, presenting moderate levels of evidence. Virtual reality (VR) is presented as a complementary and promising treatment method to physiotherapy for the improvement of fundamental variables such as perceived pain and pain avoidance. The main objective is to evaluate the efficacy of a combined VR and physiotherapy program of 4 weeks duration compared to a standard physiotherapy intervention in pregnant women with low back pain and pelvic pain for the improvement of pain avoidance, pain intensity, disability and functional level. As a secondary objective the investigators propose to investigate patient satisfaction with the VR intervention. This research will be carried out by means of a multicenter randomized controlled clinical trial in pregnant patients residing in the provinces of Seville and Malaga with a diagnosis of low back pain and pelvic pain during pregnancy. The alternative hypothesis of this research is that the implementation of a Virtual Reality program together with standard physiotherapy in pregnant patients with low back and pelvic pain presents better clinical results obtained with the current standard intervention, which may represent an opportunity to define new policies and interventions for these pathologies and their consequences.
- Conditions
- Low Back Pain, Pelvic Pain
- Being tested
- Virtual Reality (Nature Trek)
- Medical subject headings
- Low Back Pain, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality (Nature Trek)Device
At the end of each session, participants will experience an immersive virtual landscape displayed by Nature Trek VR software (httpp://naturetreksvr.com/). First, participants will be placed in a sit down position and guided for their breathing control during 5 minutes ("meditation Lotus option"). After that, they will be encouraged to freely move around a relaxing virtual environment during 15 minutes taking special attention to soothing sounds of nature. The themes environment will be selected based on the preferences of the participants.
At the beginning of the study, advice is given on general care, in physical activity and issues concerning drug intake. Patients are advised to refrain from any other specific training during the intervention period. Any deviations from the adherence and practice of the VRi are recorded daily, noting any adverse incidents.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Following clinical practice guidelines, subjects in the control group will receive multidisciplinary rehabilitation programmes with coordinated delivery of supervised exercise therapy, cognitive behavioural therapy (education on pain), as well as therapeutic massage to relieve low back pain during pregnancy. |
| Virtual Reality (Nature Trek) | Experimental | * Subjects in the experimental group will receive the same treatment described for the control group.
* Subjects in the experimental group will receive an additional Virtual Reality Intervention (VRi). Receives: Device: Virtual Reality (Nature Trek) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Fear-Avoidance Components Scale (FACS)
FACS. Pain-related fear avoidance (FA), a common problem for patients with painful medical conditions, involves pain-related catastrophizing cognitions, hypervigilance, and avoidance behaviors, which can ultimately lead to decreased functioning, depression, and disability. (FACS) was developed, which incorporates important components of previous FA- related measures, and includes components of the FA model not previously considered in the earlier-developed questionnaires. The FACS has 20 items, each measured on a 6-point Likert scale, for total possible score of 100 and the lowest possible score of 0, requesting the respondent to either: (5) completely agree; (4) mostly agree; (3) slightly agree; (2) slightly disagree; (1) mostly disagree; (0) completely disagree. Higher scores are intended to indicate higher levels of FA.
Measured: Baseline FACS
The Fear-Avoidance Components Scale (FACS)
FACS. Pain-related fear avoidance (FA), a common problem for patients with painful medical conditions, involves pain-related catastrophizing cognitions, hypervigilance, and avoidance behaviors, which can ultimately lead to decreased functioning, depression, and disability. (FACS) was developed, which incorporates important components of previous FA- related measures, and includes components of the FA model not previously considered in the earlier-developed questionnaires. The FACS has 20 items, each measured on a 6-point Likert scale, for total possible score of 100 and the lowest possible score of 0, requesting the respondent to either: (5) completely agree; (4) mostly agree; (3) slightly agree; (2) slightly disagree; (1) mostly disagree; (0) completely disagree. Higher scores are intended to indicate higher levels of FA.
Measured: 4 weeks FACS
Pain Intensity
The Visual Analog Scale (VAS) has been used in previous studies investigating changes in pain and, specifically, in all the randomized trials of interventions for back pain in pregnancy included in or published since the Cochrane and systematic reviews. The VAS was used for assessment of pain before and after the intervention. Measurement will be performed with a 10-cm scale marked with 1-cm increments. Pain felt by participants will be recorded. Pain was rated on a scale of 0 a 10, with 10 representing the most excruciating pain. The value indicated on the scale by the participants was used as the score.
Measured: Baseline
Pain Intensity
The Visual Analog Scale (VAS) has been used in previous studies investigating changes in pain and, specifically, in all the randomized trials of interventions for back pain in pregnancy included in or published since the Cochrane and systematic reviews. The VAS was used for assessment of pain before and after the intervention. Measurement will be performed with a 10-cm scale marked with 1-cm increments. Pain felt by participants will be recorded. Pain was rated on a scale of 0 a 10, with 10 representing the most excruciating pain. The value indicated on the scale by the participants was used as the score.
Measured: 4 weeks
Disability and Physical function
The investigators focus on the 2 back-specific measures of function recommended in the "core-set," the Roland-Morris disability Questionnaire (RMDQ) and the Oswestry Disability Index (ODI). The RMDQ will be used for measurement of the severity of disability in participants who had less severe Low Back Pain (LBP). There are 24 categories comprised of yes or no questions. Each participant can have a maximum score of 24. Scoring closer to 24 indicates greater functional disability.
Measured: Baseline RMDQ
Disability and Physical function
The investigators focus on the 2 back-specific measures of function recommended in the "core-set," the Roland-Morris disability Questionnaire (RMDQ) and the Oswestry Disability Index (ODI). The RMDQ will be used for measurement of the severity of disability in participants who had less severe Low Back Pain (LBP). There are 24 categories comprised of yes or no questions. Each participant can have a maximum score of 24. Scoring closer to 24 indicates greater functional disability.
Measured: 4 weeks RMDQ
Disability and Physical function
The investigators focus on the 2 back-specific measures of function recommended in the "core-set," the Roland-Morris disability Questionnaire (RMDQ) and the Oswestry Disability Index (ODI). The Oswestry low-back pain disability index (ODI) will be completed by the participants and included 10 questions assessing activities of daily living in order to examine the functional level when experiencing LBP. Each category will be scored from zero to five with regard to the severity of disability caused during daily life.
Measured: Baseline ODI
Disability and Physical function
The investigators focus on the 2 back-specific measures of function recommended in the "core-set," the Roland-Morris disability Questionnaire (RMDQ) and the Oswestry Disability Index (ODI). The Oswestry low-back pain disability index (ODI) will be completed by the participants and included 10 questions assessing activities of daily living in order to examine the functional level when experiencing LBP. Each category will be scored from zero to five with regard to the severity of disability caused during daily life.
Measured: 4 weeks ODI
Secondary outcomes (2)
Satisfaction with Virtual Reality intervention
The User Satisfaction Evaluation Questionnaire (USEQ) is a questionnaire that is designed to properly evaluate the satisfaction of the user (which constitutes part of usability) in virtual rehabilitation systems. The USEQ questionnaire is composed of the set of questions in the SEQ that evaluate satisfaction. The USEQ has six questions with a five-point Likert Scale. The total score of the USEQ questionnaire ranges from 6 (poor satisfaction) to 30 (excellent satisfaction). To calculate this total score, we consider all of the questions to be positive, except for Q5, which is considered to be a negative question. The numerical value of the positive questions is used to calculate the score (for instance, if the patient selects 4 in Q1, then 4 is added to the total score). The negative question subtracts the numerical value of the response from 6 and then adds this result to the total score (for instance, if the patient selects 2 in Q5, then 4 is added to the total score).
Measured: Baseline USEQ
Satisfaction with Virtual Reality intervention
To assess the Satisfaction with the Virtual Rehabilitation Systems the investigators will use the User Satisfaction Evaluation Questionnaire (USEQ). The USEQ is a questionnaire that is designed to properly evaluate the satisfaction of the user (which constitutes part of usability) in virtual rehabilitation systems. The USEQ questionnaire is composed of the set of questions in the SEQ that evaluate satisfaction. The USEQ has six questions with a five-point Likert Scale. The total score of the USEQ questionnaire ranges from 6 (poor satisfaction) to 30 (excellent satisfaction).
Measured: 4 weeks USEQ
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study startJan 2024 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Jose García Lopez, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571358
- Sponsor's protocol ID
- VR - LBP
- Status last verified
- Nov 2023
- First submitted
- 23 Jun 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garcia-Lopez FJ, Pastora-Bernal JM, Moreno-Morales N, Estebanez-Perez MJ, Linan-Gonzalez A, Martin-Valero R. Virtual reality to improve low-back pain and pelvic pain during pregnancy: a pilot RCT for a multicenter randomized controlled trial. Front Med (Lausanne). 2023 Sep 4;10:1206799. doi: 10.3389/fmed.2023.1206799. eCollection 2023.
PubMed 37731709
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality to Improve Low-back Pain and Pelvic Pain During Pregnancy for a Multicentre Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05571358
- Acronym / sponsor ID
- VR - LBP
- Conditions
- Low Back Pain, Pelvic Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 7 Oct 2022 (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.
A large percentage of women suffer low back and pelvic pain both during and after pregnancy. There are several factors to which these complaints are attributed, even affecting their daily lives. It is identified that many of these women do not receive adequate health care, however, different physiotherapeutic interventions are recommended to alleviate these conditions, presenting moderate levels of evidence. Virtual reality (VR) is presented as a complementary and promising treatment method to physiotherapy for the improvement of fundamental variables such as perceived pain and pain avoidance. The main objective is to evaluate the efficacy of a combined VR and physiotherapy program of 4 weeks duration compared to a standard physiotherapy intervention in pregnant women with low back pain and pelvic pain for the improvement of pain avoidance, pain intensity, disability and functional level. As a secondary objective the investigators propose to investigate patient satisfaction with the VR intervention. This research will be carried out by means of a multicenter randomized controlled clinical trial in pregnant patients residing in the provinces of Seville and Malaga with a diagnosis of low back pain and pelvic pain during pregnancy. The alternative hypothesis of this research is that the implementation of a Virtual Reality program together with standard physiotherapy in pregnant patients with low back and pelvic pain presents better clinical results obtained with the current standard intervention, which may represent an opportunity to define new policies and interventions for these pathologies and their consequences.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Following clinical practice guidelines, subjects in the control group will receive multidisciplinary rehabilitation programmes with coordinated delivery of supervised exercise therapy, cognitive behavioural therapy (education on pain), as well as therapeutic massage to relieve low back pain during pregnancy. |
| Virtual Reality (Nature Trek) | Experimental | Device: Virtual Reality (Nature Trek)* Subjects in the experimental group will receive the same treatment described for the control group. * Subjects in the experimental group will receive an additional Virtual Reality Intervention (VRi). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult woman over 18 years old
- Pregnant woman with Low Back Pain, Pelvic Pain (PP) or both conditions with symptomatic character.
- Pregnant woman between the 12th and 36th week of gestation, corresponding to the 2nd and 3rd trimester.
- Pain intensity greater than 4/10 on VAS, indicating moderate-severe pain.
- Live in Sevilla or Malaga during the research period.
Key exclusion criteria (3 listed)
- Patients with LBP or PP pain prior to pregnancy.
- Cognitive ability not suitable for the use of technological tools.
- Patients with absolute or relative contraindications.
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 |
|---|---|---|
| Virtual Reality (Nature Trek)At the end of each session, participants will experience an immersive virtual landscape displayed by Nature Trek VR software (httpp://naturetreksvr.com/). First, participants will be placed in a sit down position and guided for their breathing control during 5 minutes ("meditation Lotus option"). After that, they will be encouraged to freely move around a relaxing virtual environment during 15 minutes taking special attention to soothing sounds of nature. The themes environment will be selected based on the preferences of the participants. At the beginning of the study, advice is given on general care, in physical activity and issues concerning drug intake. Patients are advised to refrain from any other specific training during the intervention period. Any deviations from the adherence and practice of the VRi are recorded daily, noting any adverse incidents. | Device | Virtual Reality (Nature Trek) |
Primary outcome
The Fear-Avoidance Components Scale (FACS)
Time frame: Baseline FACS
FACS. Pain-related fear avoidance (FA), a common problem for patients with painful medical conditions, involves pain-related catastrophizing cognitions, hypervigilance, and avoidance behaviors, which can ultimately lead to decreased functioning, depression, and disability. (FACS) was developed, which incorporates important components of previous FA- related measures, and includes components of the FA model not previously considered in the earlier-developed questionnaires. The FACS has 20 items, each measured on a 6-point Likert scale, for total possible score of 100 and the lowest possible score of 0, requesting the respondent to either: (5) completely agree; (4) mostly agree; (3) slightly agree; (2) slightly disagree; (1) mostly disagree; (0) completely disagree. Higher scores are intended to indicate higher levels of FA.
The Fear-Avoidance Components Scale (FACS)
Time frame: 4 weeks FACS
FACS. Pain-related fear avoidance (FA), a common problem for patients with painful medical conditions, involves pain-related catastrophizing cognitions, hypervigilance, and avoidance behaviors, which can ultimately lead to decreased functioning, depression, and disability. (FACS) was developed, which incorporates important components of previous FA- related measures, and includes components of the FA model not previously considered in the earlier-developed questionnaires. The FACS has 20 items, each measured on a 6-point Likert scale, for total possible score of 100 and the lowest possible score of 0, requesting the respondent to either: (5) completely agree; (4) mostly agree; (3) slightly agree; (2) slightly disagree; (1) mostly disagree; (0) completely disagree. Higher scores are intended to indicate higher levels of FA.
Pain Intensity
Time frame: Baseline
The Visual Analog Scale (VAS) has been used in previous studies investigating changes in pain and, specifically, in all the randomized trials of interventions for back pain in pregnancy included in or published since the Cochrane and systematic reviews. The VAS was used for assessment of pain before and after the intervention. Measurement will be performed with a 10-cm scale marked with 1-cm increments. Pain felt by participants will be recorded. Pain was rated on a scale of 0 a 10, with 10 representing the most excruciating pain. The value indicated on the scale by the participants was used as the score.
Pain Intensity
Time frame: 4 weeks
The Visual Analog Scale (VAS) has been used in previous studies investigating changes in pain and, specifically, in all the randomized trials of interventions for back pain in pregnancy included in or published since the Cochrane and systematic reviews. The VAS was used for assessment of pain before and after the intervention. Measurement will be performed with a 10-cm scale marked with 1-cm increments. Pain felt by participants will be recorded. Pain was rated on a scale of 0 a 10, with 10 representing the most excruciating pain. The value indicated on the scale by the participants was used as the score.
Disability and Physical function
Time frame: Baseline RMDQ
The investigators focus on the 2 back-specific measures of function recommended in the "core-set," the Roland-Morris disability Questionnaire (RMDQ) and the Oswestry Disability Index (ODI). The RMDQ will be used for measurement of the severity of disability in participants who had less severe Low Back Pain (LBP). There are 24 categories comprised of yes or no questions. Each participant can have a maximum score of 24. Scoring closer to 24 indicates greater functional disability.
Disability and Physical function
Time frame: 4 weeks RMDQ
The investigators focus on the 2 back-specific measures of function recommended in the "core-set," the Roland-Morris disability Questionnaire (RMDQ) and the Oswestry Disability Index (ODI). The RMDQ will be used for measurement of the severity of disability in participants who had less severe Low Back Pain (LBP). There are 24 categories comprised of yes or no questions. Each participant can have a maximum score of 24. Scoring closer to 24 indicates greater functional disability.
Disability and Physical function
Time frame: Baseline ODI
The investigators focus on the 2 back-specific measures of function recommended in the "core-set," the Roland-Morris disability Questionnaire (RMDQ) and the Oswestry Disability Index (ODI). The Oswestry low-back pain disability index (ODI) will be completed by the participants and included 10 questions assessing activities of daily living in order to examine the functional level when experiencing LBP. Each category will be scored from zero to five with regard to the severity of disability caused during daily life.
Disability and Physical function
Time frame: 4 weeks ODI
The investigators focus on the 2 back-specific measures of function recommended in the "core-set," the Roland-Morris disability Questionnaire (RMDQ) and the Oswestry Disability Index (ODI). The Oswestry low-back pain disability index (ODI) will be completed by the participants and included 10 questions assessing activities of daily living in order to examine the functional level when experiencing LBP. Each category will be scored from zero to five with regard to the severity of disability caused during daily life.
2 secondary outcomes
Satisfaction with Virtual Reality intervention
Time frame: Baseline USEQ
Satisfaction with Virtual Reality intervention
Time frame: 4 weeks USEQ
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Derived from this study: PubMed 37731709Garcia-Lopez FJ, Pastora-Bernal JM, Moreno-Morales N, Estebanez-Perez MJ, Linan-Gonzalez A, Martin-Valero R. Virtual reality to improve low-back pain and pelvic pain during pregnancy: a pilot RCT for a multicenter randomized controlled trial. Front Med (Lausanne). 2023 Sep 4;10:1206799. doi: 10.3389/fmed.2023.1206799. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality (Nature Trek) in people with Low Back Pain and Pelvic Pain, run by University of Malaga.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francisco José García López, Physiotherapy (695332991, fjgarlop@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Fear-Avoidance Components Scale (FACS) (time frame: Baseline FACS). The study lists 8 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 NCT05571358, which also lists 1 linked publication.
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 29 Nov 2023.