Online Pain Neuroscience Education for Women With Primary Dysmenorrhea

NCT07237802 | Completed

• 1 other identifier: UNIVERSITYCARDENALHERRERA-100
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Primary Dysmenorrhea (PD)

Keywords

Pain; Dysmenorrhea; Kinesiophobia

Outcome Measures

Primary Outcomes (1)

• 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.

  pre-intervention and 6 months post-intervention

Secondary Outcomes (3)

• Anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS)

  pre-intervention and 6 months post-intervention

• Kinesiophobia measured by the Tampa Scale for Kinesiophobia-11 (TSK-11)

  pre-intervention and 6 months post-intervention

• Pain catastrophizing measured by the Pain Catastrophizing Scale (PCS)

  pre-intervention and 6 months post-intervention

Study Arms (2)

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.

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.

Other: Lifestyle recommendations

Interventions

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.

Online Pain Neuroscience Education (PNE)

Lifestyle recommendations OTHER

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.

Active Comparator

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cardenal Herrera University: lead

Study Sites (1)

Universidad CEU Cardenal Herrera

Valencia, Valencia-valència, 46006, Spain

Location

Related Publications (2)

• 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.

  PMID: 30312470 BACKGROUND

• Butler DS, Moseley GL. Explain Pain. 2nd ed. Adelaide, South Australia: Noigroup Publications; 2013.

  BACKGROUND

MeSH Terms

Conditions

Pain; Dysmenorrhea; Kinesiophobia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances; Pathologic Processes; Pelvic Pain; Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Juan Francisco Lisón Párraga, Dr

  Universidad Cardenal Herrera CEU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and data analysts will be blinded to group allocation. Participants and intervention providers will not be masked due to the nature of the educational program. Allocation will be concealed using a computer-generated randomization sequence managed by an independent researcher.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: 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.

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: November 20, 2025
• Study Start: September 1, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

ES (1)