Primary Dysmenorrhea (PD)NCT07237802
Online Pain Neuroscience Education for Women With Primary Dysmenorrhea
A study testing PNE online + lifestyle recommendations. and Lifestyle recommendations in people with Primary Dysmenorrhea (PD), run by Cardenal Herrera University at 1 site in Spain.
Trial summary
Primary dysmenorrhea is a highly prevalent condition characterized by recurrent menstrual pain in the absence of identifiable pelvic pathology. It affects up to 95% of menstruating women and often interferes with quality of life. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Primary Dysmenorrhea (PD)
- What is being tested?
- PNE online + lifestyle recommendations. and Lifestyle recommendations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSpain
- Study dates
- 10 Oct 2025to 28 May 2026
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Nulliparous women aged 18 to 35 years.
- Clinical diagnosis of primary dysmenorrhea.
- History of moderate to severe menstrual pain for at least six consecutive menstrual cycles.
- Pain intensity score greater than 5 on a numerical rating scale (0-10).
- No prior use of pain neuroscience education (PNE).
- No history of pregnancy.
Who cannot join
- History of lower abdominal surgery.
- Presence of severe mental health disorders.
- Current use of hormonal contraceptives.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of an Online Pain Neuroscience Education Intervention in Women With Primary Dysmenorrhea: A Randomized Controlled Trial
Primary dysmenorrhea is a highly prevalent condition characterized by recurrent menstrual pain in the absence of identifiable pelvic pathology. It affects up to 95% of menstruating women and often interferes with quality of life. Pain neuroscience education (PNE) has shown positive effects in musculoskeletal conditions but has not yet been studied in women with primary dysmenorrhea. This study aims to evaluate the effect of an online PNE intervention combined with lifestyle recommendations, compared to lifestyle recommendations alone
Read the detailed description
This randomized controlled trial will compare an online pain neuroscience education (PNE) program plus lifestyle recommendations with lifestyle recommendations alone in women with primary dysmenorrhea. Participants will be randomized (1:1) to either the intervention group (4-week online PNE modules plus lifestyle recommendations) or the control group (lifestyle recommendations only). The program is based on Butler and Moseley's pain neuroscience principles, adapted to menstrual pain. Outcomes will be assessed at baseline and at 6 months. The primary outcome is pain intensity. Secondary outcomes include anxiety, depression, kinesiophobia and pain catastrophizing,
- Conditions
- Primary Dysmenorrhea (PD)
- Being tested
- PNE online + lifestyle recommendations., Lifestyle recommendations
- Keywords
- Pain, Dysmenorrhea, Kinesiophobia
- Medical subject headings
- Pain, Dysmenorrhea, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNE online + lifestyle recommendations.Other
Four-week online educational program with audiovisual modules on the neurobiology and biopsychosocial aspects of pain, adapted to women with primary dysmenorrhea. In addition, participants receive usual lifestyle recommendations, including general advice on healthy habits and self-management strategies commonly provided in clinical practice.
Lifestyle recommendationsOther
Participants in this arm will receive online lifestyle recommendations for four weeks, including general advice on healthy habits and self-management strategies commonly provided in clinical practice for women with primary dysmenorrhea.
| Study group | Role | What they receive |
|---|---|---|
| Online Pain Neuroscience Education (PNE) | Experimental | Participants in this arm will receive an online pain neuroscience education (PNE) program plus usual lifestyle recommendations. The PNE intervention consists of four weekly audiovisual and written modules adapted to the context of primary dysmenorrhea, focusing on the neurobiology and biopsychosocial aspects of pain, with practical strategies to reduce maladaptive beliefs, kinesiophobia, and catastrophizing. Receives: Other: PNE online + lifestyle recommendations. |
| Active Comparator | Active comparator | Participants in this arm will receive the usual lifestyle recommendations for primary dysmenorrhea. These recommendations include general advice on healthy habits and self-management strategies typically provided in clinical practice. Receives: Other: Lifestyle recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity measured by the 11-point Numeric Rating Scale (NRS)
Pain intensity will be assessed using the 11-point Numeric Rating Scale (NRS). Participants will rate their average menstrual pain intensity over the previous cycle, from 0 ("no pain") to 10 ("worst imaginable pain"). Higher scores indicate greater pain intensity.
Measured: pre-intervention and 6 months post-intervention
Secondary outcomes (3)
Anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) has 14 items, with two subscales: HADS-Anxiety (7 items) and HADS-Depression (7 items). Each subscale ranges 0-21; higher scores indicate greater anxiety/depression.
Measured: pre-intervention and 6 months post-intervention
Kinesiophobia measured by the Tampa Scale for Kinesiophobia-11 (TSK-11)
The Tampa Scale for Kinesiophobia-11 (TSK-11) has 11 items scored 1 ("strongly disagree") to 4 ("strongly agree"). Total score 11-44; higher scores indicate greater fear of movement/re-injury.
Measured: pre-intervention and 6 months post-intervention
Pain catastrophizing measured by the Pain Catastrophizing Scale (PCS)
The Pain Catastrophizing Scale (PCS) includes 13 items scored 0 ("not at all") to 4 ("all the time"). Total score 0-52; higher scores indicate greater pain catastrophizing.
Measured: pre-intervention and 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start10 Oct 2025
- Primary completion28 May 2026
- Study completion28 May 2026
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 Primary Dysmenorrhea (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individually randomized, two-arm parallel trial (1:1) comparing an online pain neuroscience education (PNE) program plus lifestyle recommendations with lifestyle recommendations alone in women with primary dysmenorrhea. Randomization will be computer-generated and allocation concealed by an independent researcher. Outcomes will be assessed at baseline and at 6-month follow-up by blinded assessors/analysts. Intention-to-treat analysis will be applied.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 82 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
- Investigators
- Juan Francisco Lisón Párraga, Dr, Principal investigator, Universidad Cardenal Herrera CEU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237802
- Sponsor's protocol ID
- UNIVERSITYCARDENALHERRERA-100
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Soderman L, Edlund M, Marions L. Prevalence and impact of dysmenorrhea in Swedish adolescents. Acta Obstet Gynecol Scand. 2019 Feb;98(2):215-221. doi: 10.1111/aogs.13480. Epub 2018 Nov 6.
PubMed 30312470Butler DS, Moseley GL. Explain Pain. 2nd ed. Adelaide, South Australia: Noigroup Publications; 2013.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Online Pain Neuroscience Education Intervention in Women With Primary Dysmenorrhea: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07237802
- Acronym / sponsor ID
- UNIVERSITYCARDENALHERRERA-100
- Conditions
- Primary Dysmenorrhea (PD)
- Keywords
- Pain, Dysmenorrhea, Kinesiophobia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 28 May 2026 (actual)
- Study completion
- 28 May 2026 (actual)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary dysmenorrhea is a highly prevalent condition characterized by recurrent menstrual pain in the absence of identifiable pelvic pathology. It affects up to 95% of menstruating women and often interferes with quality of life. Pain neuroscience education (PNE) has shown positive effects in musculoskeletal conditions but has not yet been studied in women with primary dysmenorrhea. This study aims to evaluate the effect of an online PNE intervention combined with lifestyle recommendations, compared to lifestyle recommendations alone
Detailed description
This randomized controlled trial will compare an online pain neuroscience education (PNE) program plus lifestyle recommendations with lifestyle recommendations alone in women with primary dysmenorrhea. Participants will be randomized (1:1) to either the intervention group (4-week online PNE modules plus lifestyle recommendations) or the control group (lifestyle recommendations only). The program is based on Butler and Moseley's pain neuroscience principles, adapted to menstrual pain. Outcomes will be assessed at baseline and at 6 months. The primary outcome is pain intensity. Secondary outcomes include anxiety, depression, kinesiophobia and pain catastrophizing,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Individually randomized, two-arm parallel trial (1:1) comparing an online pain neuroscience education (PNE) program plus lifestyle recommendations with lifestyle recommendations alone in women with primary dysmenorrhea. Randomization will be computer-generated and allocation concealed by an independent researcher. Outcomes will be assessed at baseline and at 6-month follow-up by blinded assessors/analysts. Intention-to-treat analysis will be applied.
| Arm | Type | Receives |
|---|---|---|
| Online Pain Neuroscience Education (PNE) | Experimental | Other: PNE online + lifestyle recommendations.Participants in this arm will receive an online pain neuroscience education (PNE) program plus usual lifestyle recommendations. The PNE intervention consists of four weekly audiovisual and written modules adapted to the context of primary dysmenorrhea, focusing on the neurobiology and biopsychosocial aspects of pain, with practical strategies to reduce maladaptive beliefs, kinesiophobia, and catastrophizing. |
| Active Comparator | Active comparator | Other: Lifestyle recommendationsParticipants in this arm will receive the usual lifestyle recommendations for primary dysmenorrhea. These recommendations include general advice on healthy habits and self-management strategies typically provided in clinical practice. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Nulliparous women aged 18 to 35 years.
- Clinical diagnosis of primary dysmenorrhea.
- History of moderate to severe menstrual pain for at least six consecutive menstrual cycles.
- Pain intensity score greater than 5 on a numerical rating scale (0-10).
- No prior use of pain neuroscience education (PNE).
Key exclusion criteria (3 listed)
- History of lower abdominal surgery.
- Presence of severe mental health disorders.
- Current use of hormonal contraceptives.
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 |
|---|---|---|
| PNE online + lifestyle recommendations.Four-week online educational program with audiovisual modules on the neurobiology and biopsychosocial aspects of pain, adapted to women with primary dysmenorrhea. In addition, participants receive usual lifestyle recommendations, including general advice on healthy habits and self-management strategies commonly provided in clinical practice. | Other | Online Pain Neuroscience Education (PNE) |
| Lifestyle recommendationsParticipants in this arm will receive online lifestyle recommendations for four weeks, including general advice on healthy habits and self-management strategies commonly provided in clinical practice for women with primary dysmenorrhea. | Other | Active Comparator |
Primary outcome
Pain intensity measured by the 11-point Numeric Rating Scale (NRS)
Time frame: pre-intervention and 6 months post-intervention
Pain intensity will be assessed using the 11-point Numeric Rating Scale (NRS). Participants will rate their average menstrual pain intensity over the previous cycle, from 0 ("no pain") to 10 ("worst imaginable pain"). Higher scores indicate greater pain intensity.
3 secondary outcomes
Anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS)
Time frame: pre-intervention and 6 months post-intervention
Kinesiophobia measured by the Tampa Scale for Kinesiophobia-11 (TSK-11)
Time frame: pre-intervention and 6 months post-intervention
Pain catastrophizing measured by the Pain Catastrophizing Scale (PCS)
Time frame: pre-intervention and 6 months post-intervention
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 30 Oct 2026.
- Background: PubMed 30312470Soderman L, Edlund M, Marions L. Prevalence and impact of dysmenorrhea in Swedish adolescents. Acta Obstet Gynecol Scand. 2019 Feb;98(2):215-221. doi: 10.1111/aogs.13480. Epub 2018 Nov 6.
- BackgroundButler DS, Moseley GL. Explain Pain. 2nd ed. Adelaide, South Australia: Noigroup Publications; 2013.
- 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.
Juan Francisco Lisón Párraga, Dr principal investigator
Universidad Cardenal Herrera CEU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNE online + lifestyle recommendations. and Lifestyle recommendations in people with Primary Dysmenorrhea (PD), 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 6 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: finished, as of the sponsor's last update on 30 Oct 2026. 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 measured by the 11-point Numeric Rating Scale (NRS) (time frame: pre-intervention and 6 months post-intervention). 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 NCT07237802, 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 30 Oct 2026.