Online Pain Neuroscience Education for Women With Primary Dysmenorrhea

April 16, 2026 updated by: Juan F. Lisón Párraga, Dr, Cardenal Herrera University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Valencia-valència
      • Valencia, Valencia-valència, Spain, 46006
        • Universidad CEU Cardenal Herrera

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • History of lower abdominal surgery.
  • Presence of severe mental health disorders.
  • Current use of hormonal contraceptives.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Online Pain Neuroscience Education (PNE)
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.
Other: 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.
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.
Other: Lifestyle recommendations
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
pre-intervention and 6 months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS)
Time Frame: pre-intervention and 6 months post-intervention
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.
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
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.
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
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.
pre-intervention and 6 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardenal Herrera University

Investigators

  • Principal Investigator: Juan Francisco Lisón Párraga, Dr, Universidad Cardenal Herrera CEU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Actual)

February 28, 2026

Study Completion (Actual)

February 28, 2026

Study Registration Dates

First Submitted

October 1, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 20, 2025

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNIVERSITYCARDENALHERRERA-100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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