Online Pain Neuroscience Education for Women With Primary Dysmenorrhea

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,

• 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

• Pain intensity measured by the 11-point Numeric Rating Scale (NRS) [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

• Anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS) [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.
• Kinesiophobia measured by the Tampa Scale for Kinesiophobia-11 (TSK-11) [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.
• Pain catastrophizing measured by the Pain Catastrophizing Scale (PCS) [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.

Sex: Female, ages: 18 Years to 35 Years

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.

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

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