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NCT Number: NCT07237802

Online Pain Neuroscience Education for Women With Primary Dysmenorrhea

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

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Key information

Conditions

Primary Dysmenorrhea (PD) Anxiety Disorders Dysmenorrhea Kinesiophobia Menstruation Disturbances Mental Disorders Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Phobic Disorders Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universidad CEU Cardenal Herrera

Valencia, Valencia-valència, 46006, Spain

About this study

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,

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Cardenal Herrera University

Other

Registry information

Official study title

Efficacy of an Online Pain Neuroscience Education Intervention in Women With Primary Dysmenorrhea: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 20, 2025
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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