Low Back PainNCT05976854
Online Intervention Based on Pain Neuroscience Education for Women with Pregnancy-related Lumbopelvic Pain
A study testing Pain neuroscience education and Prenatal education in people with Low Back Pain, run by Cardenal Herrera University at 1 site in Spain.
Trial summary
60-70% of pregnant women suffer from pregnancy-related lumbopelvic pain. In the general population, patient education is the first line of treatment. For pregnant women with LBP, the guidelines are the same as for the general population. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Pain neuroscience education and Prenatal education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 10 Aug 2023to 1 Nov 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- pregnant women older than 18 years, who are in the early third trimester of pregnancy;
- minimum score of 3/10 on the numerical pain scale over the past week.
Who cannot join
- multiple pregnancy;
- previous spinal surgery;
- presence of psychiatric disorders;
- women who have participated in similar programs or interventions before enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of an Online Intervention Based on Pain Neuroscience Education for Women with Pregnancy-related Lumbopelvic Pain
60-70% of pregnant women suffer from pregnancy-related lumbopelvic pain. In the general population, patient education is the first line of treatment. For pregnant women with LBP, the guidelines are the same as for the general population. In fact, prenatal education programs specifically collect recommendations and educational strategies for managing this pain. Within educational strategies, education in the neuroscience of pain has gained special relevance in recent years due to its positive results in reducing pain in patients with low back pain. Despite the beneficial effects shown in patients with low back pain, its use has not yet been explored, to our knowledge, in women with pregnancy-related lumbopelvic pain.
Read the detailed description
60-70% of pregnant women suffer from pregnancy-related lumbopelvic pain. Its multifactorial origin makes it difficult to establish an appropriate treatment for pain control. In the general population, patient education is the first line of treatment. For pregnant women with LBP, the guidelines are the same as for the general population. In fact, prenatal education programs specifically collect recommendations and educational strategies for managing this pain. Within educational strategies, education in the neuroscience of pain has gained special relevance in recent years due to its positive results in reducing pain in patients with low back pain. This type of education is based on reconceptualizing pain through teaching the neurobiological mechanisms that underlie the pain experience. Despite the beneficial effects shown in patients with low back pain, its use has not yet been explored, to our knowledge, in pregnant women with pregnancy-related low back and pelvic pain.
- Conditions
- Low Back Pain
- Being tested
- Pain neuroscience education, Prenatal education
- 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.
Pain neuroscience educationOther
The patients in the intervention group will receive, in addition to the prenatal educational content, the 12 Pain neuroscience education lessons in audiovisual format. Each lesson will last between 10-15 minutes. The contents of PNE will be an adaptation, focused on the context of a pregnant woman, of the Butler \& Moseley postulates. These contents have already been previously adapted according to the nature of the patients' pain, both in chronic pain and in acute pain. In summary, the participants will receive a detailed explanation about the biopsychosocial component of pain through the use of diagrams, metaphors and practical examples. In turn, the objectives of this program could be summarized as: (1) Reformulate erroneous beliefs about pain, (2) Inform about the biology and protective nature of pain and (3) Provide techniques to reduce kinesiophobia and, consequently, promote physical activity, with the beneficial effect it entails for patients with pain.
Prenatal educationOther
The standard prenatal education is based on the Pregnancy and Postpartum Clinical Practice Guide, consisting of general information about pregnancy (visits and monitoring of pregnancy, diet, phases of delivery, lactation, etc.), as well as specific recommendations for lumbopelvic pain associated with pregnancy. These contents will be developed by midwives from the participating hospitals. Participants will receive 12 educational sessions, with an estimated duration of 10 minutes each.
| Study group | Role | What they receive |
|---|---|---|
| Pain neuroscience education (PNE) | Experimental | The patients in the intervention group will receive, in addition to the prenatal educational content, the 12 PNE lessons in audiovisual format. Each lesson will last between 10-15 minutes. The contents of PNE will be an adaptation, focused on the context of a pregnant woman, of the Butler \& Moseley postulates. These contents have already been previously adapted according to the nature of the patients' pain, both in chronic pain and in acute pain. In summary, the participants will receive a detailed explanation about the biopsychosocial component of pain through the use of diagrams, metaphors and practical examples. In turn, the objectives of this program could be summarized as: (1) Reformulate erroneous beliefs about pain, (2) Inform about the biology and protective nature of pain and (3) Provide techniques to reduce kinesiophobia and, consequently, promote physical activity, with the beneficial effect it entails for patients with pain. Receives: Other: Pain neuroscience education; Other: Prenatal education |
| Prenatal education (PE) | Other | Patients assigned to the PE group will receive different content on standard PE based on the Pregnancy and Postpartum Clinical Practice Guide, consisting of general information about pregnancy (visits and monitoring of pregnancy, diet, phases of delivery, lactation, etc.), as well as specific recommendations for lumbopelvic pain associated with pregnancy. These contents will be developed by midwives from the participating hospitals. Participants will receive 12 educational sessions, with an estimated duration of 10 minutes each. Receives: Other: Prenatal education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
The primary outcome will be mean pain intensity over the previous week assessed using an 11-point numerical rating scale (range, 0 [no pain] to 10 [worst pain imaginable]).
Measured: 4 weeks
Secondary outcomes (5)
Disability
The Roland Morris questionnaire will be used. This is a validated questionnaire for the Spanish population and has previously been used in women with lumbopelvic pain. The questionnaire assesses the degree of physical disability in patients with non-specific low back pain and is made up of 24 items that describe daily activities that may be difficult to perform due to low back pain. A point is added to each item marked "yes", and a maximum score of 24 points can be obtained. The greater the number of positive responses, the greater the disability.
Measured: 4 weeks
Kinesiophobia
The short version of the Tampa TSK-11 kinesiophobia scale will be used The Spanish version of this scale has been validated in patients with acute and chronic low back pain. The scale consists of 11 items, in which each item receives a score from 1 to 4 on the Likert scale (1=strongly disagree; 4=strongly agree). The score ranges from 11 to 44 points, with higher scores indicating a greater fear of movement.
Measured: 4 weeks
Pain catastrophizing
The pain catastrophizing scale is an instrument made up of 13 items (each item scores between 0 and 4), which measures the degree to which patients develop feelings and thoughts related to their nociceptive experience. This scale, which has a validated version for Spanish, shows adequate internal consistency.
Measured: 4 weeks
Anxiety and depression
The Hospital Anxiety and Depression Scale (HADS) questionnaire will be used. This consists of 14 questions, of which 7 assess symptoms of anxiety (HADS-A) and 7 measure symptoms of depression (HADS-D). Each item scores from 0 to 3, with a score range in each subscale from 0-21. Scores of 0-7 indicate no anxiety or depression; scores between 8-10 indicate medium levels; scores of 11-14 indicate moderate levels and scores of 15-21 indicate severe levels of anxiety or depression. The HADS scale has good internal consistency, reliability, and validity.
Measured: 4 weeks
Level of physical activity
The abbreviated version of the international physical activity questionnaire (International Physical Activity Questionnaire - IPAQ - short) will be used. This is a self-administered questionnaire consisting of 7 items and collecting information on physical activity performed in the last 7 days. This questionnaire has been previously validated in 12 countries and shows adequate psychometric properties. The short version (IPAD-SF) has shown acceptable validity in the Spanish adult population.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start10 Aug 2023
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan F. Lisón Párraga, Dr, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976854
- Sponsor's protocol ID
- UNIVERSITY CARDENAL HERRERA-65
- Status last verified
- Nov 2024
- First submitted
- 28 Jul 2023
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Garcia-Lucas C, Chen E, Serrano-Raya L, Boldo-Roda A, Arguisuelas MD, Suso-Marti L, Pardo J, Amer-Cuenca JJ, Lison JF, Bivia-Roig G. Association between lumbopelvic pain in pregnancy and fear of childbirth: a multicenter cross-sectional case-control study. BMC Pregnancy Childbirth. 2025 Nov 17;25(1):1215. doi: 10.1186/s12884-025-08425-y.
PubMed 41250063Garcia-Lucas C, Serrano-Raya L, Boldo-Roda A, Ibanez-Meca N, Arguisuelas MD, Suso-Marti L, Chen E, Amer-Cuenca JJ, Lison JF, Bivia-Roig G. Efficacy of an online pain neuroscience education intervention for women with pregnancy-related lumbopelvic pain: a randomized controlled trial. Pain Med. 2026 Apr 1;27(4):418-425. doi: 10.1093/pm/pnaf150.
PubMed 41143559
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Online Intervention Based on Pain Neuroscience Education for Women with Pregnancy-related Lumbopelvic Pain
- ClinicalTrials.gov ID
- NCT05976854
- Acronym / sponsor ID
- UNIVERSITY CARDENAL HERRERA-65
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 4 Aug 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.
60-70% of pregnant women suffer from pregnancy-related lumbopelvic pain. In the general population, patient education is the first line of treatment. For pregnant women with LBP, the guidelines are the same as for the general population. In fact, prenatal education programs specifically collect recommendations and educational strategies for managing this pain. Within educational strategies, education in the neuroscience of pain has gained special relevance in recent years due to its positive results in reducing pain in patients with low back pain. Despite the beneficial effects shown in patients with low back pain, its use has not yet been explored, to our knowledge, in women with pregnancy-related lumbopelvic pain.
Detailed description
60-70% of pregnant women suffer from pregnancy-related lumbopelvic pain. Its multifactorial origin makes it difficult to establish an appropriate treatment for pain control. In the general population, patient education is the first line of treatment. For pregnant women with LBP, the guidelines are the same as for the general population. In fact, prenatal education programs specifically collect recommendations and educational strategies for managing this pain. Within educational strategies, education in the neuroscience of pain has gained special relevance in recent years due to its positive results in reducing pain in patients with low back pain. This type of education is based on reconceptualizing pain through teaching the neurobiological mechanisms that underlie the pain experience. Despite the beneficial effects shown in patients with low back pain, its use has not yet been explored, to our knowledge, in pregnant women with pregnancy-related low back and pelvic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain neuroscience education (PNE) | Experimental | Other: Pain neuroscience education, Other: Prenatal educationThe patients in the intervention group will receive, in addition to the prenatal educational content, the 12 PNE lessons in audiovisual format. Each lesson will last between 10-15 minutes. The contents of PNE will be an adaptation, focused on the context of a pregnant woman, of the Butler \& Moseley postulates. These contents have already been previously adapted according to the nature of the patients' pain, both in chronic pain and in acute pain. In summary, the participants will receive a detailed explanation about the biopsychosocial component of pain through the use of diagrams, metaphors and practical examples. In turn, the objectives of this program could be summarized as: (1) Reformulate erroneous beliefs about pain, (2) Inform about the biology and protective nature of pain and (3) Provide techniques to reduce kinesiophobia and, consequently, promote physical activity, with the beneficial effect it entails for patients with pain. |
| Prenatal education (PE) | Other | Other: Prenatal educationPatients assigned to the PE group will receive different content on standard PE based on the Pregnancy and Postpartum Clinical Practice Guide, consisting of general information about pregnancy (visits and monitoring of pregnancy, diet, phases of delivery, lactation, etc.), as well as specific recommendations for lumbopelvic pain associated with pregnancy. These contents will be developed by midwives from the participating hospitals. Participants will receive 12 educational sessions, with an estimated duration of 10 minutes each. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- pregnant women older than 18 years, who are in the early third trimester of pregnancy;
- minimum score of 3/10 on the numerical pain scale over the past week.
Key exclusion criteria (4 listed)
- multiple pregnancy;
- previous spinal surgery;
- presence of psychiatric disorders;
- women who have participated in similar programs or interventions before enrollment.
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 |
|---|---|---|
| Pain neuroscience educationThe patients in the intervention group will receive, in addition to the prenatal educational content, the 12 Pain neuroscience education lessons in audiovisual format. Each lesson will last between 10-15 minutes. The contents of PNE will be an adaptation, focused on the context of a pregnant woman, of the Butler \& Moseley postulates. These contents have already been previously adapted according to the nature of the patients' pain, both in chronic pain and in acute pain. In summary, the participants will receive a detailed explanation about the biopsychosocial component of pain through the use of diagrams, metaphors and practical examples. In turn, the objectives of this program could be summarized as: (1) Reformulate erroneous beliefs about pain, (2) Inform about the biology and protective nature of pain and (3) Provide techniques to reduce kinesiophobia and, consequently, promote physical activity, with the beneficial effect it entails for patients with pain. | Other | Pain neuroscience education (PNE) |
| Prenatal educationThe standard prenatal education is based on the Pregnancy and Postpartum Clinical Practice Guide, consisting of general information about pregnancy (visits and monitoring of pregnancy, diet, phases of delivery, lactation, etc.), as well as specific recommendations for lumbopelvic pain associated with pregnancy. These contents will be developed by midwives from the participating hospitals. Participants will receive 12 educational sessions, with an estimated duration of 10 minutes each. | Other | Pain neuroscience education (PNE), Prenatal education (PE) |
Primary outcome
Pain intensity
Time frame: 4 weeks
The primary outcome will be mean pain intensity over the previous week assessed using an 11-point numerical rating scale (range, 0 [no pain] to 10 [worst pain imaginable]).
5 secondary outcomes
Disability
Time frame: 4 weeks
Kinesiophobia
Time frame: 4 weeks
Pain catastrophizing
Time frame: 4 weeks
Anxiety and depression
Time frame: 4 weeks
Level of physical activity
Time frame: 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 2 Dec 2024.
- Derived from this study: PubMed 41250063Garcia-Lucas C, Chen E, Serrano-Raya L, Boldo-Roda A, Arguisuelas MD, Suso-Marti L, Pardo J, Amer-Cuenca JJ, Lison JF, Bivia-Roig G. Association between lumbopelvic pain in pregnancy and fear of childbirth: a multicenter cross-sectional case-control study. BMC Pregnancy Childbirth. 2025 Nov 17;25(1):1215. doi: 10.1186/s12884-025-08425-y.
- Derived from this study: PubMed 41143559Garcia-Lucas C, Serrano-Raya L, Boldo-Roda A, Ibanez-Meca N, Arguisuelas MD, Suso-Marti L, Chen E, Amer-Cuenca JJ, Lison JF, Bivia-Roig G. Efficacy of an online pain neuroscience education intervention for women with pregnancy-related lumbopelvic pain: a randomized controlled trial. Pain Med. 2026 Apr 1;27(4):418-425. doi: 10.1093/pm/pnaf150.
- Individual participant dataSharing planned: Undecided
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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 Pain neuroscience education and Prenatal education in people with Low Back Pain, 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 2 inclusion and 4 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 2 Dec 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?
Pain intensity (time frame: 4 weeks). 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 NCT05976854, which also lists 2 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 2 Dec 2024.