Primary Dysmenorrhea (PD)
Conditions
Keywords
Pain, Dysmenorrhea, Kinesiophobia
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
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,
Interventions
OTHERPNE 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.
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.
Sponsors
Cardenal Herrera University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Spain
Outcome results
None listed