Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT07237802
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-11-20
First Post:
2025-10-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Online Pain Neuroscience Education for Women With Primary Dysmenorrhea
Sponsor:
Cardenal Herrera University
Organization:
Study Overview
Official Title:
Efficacy of an Online Pain Neuroscience Education Intervention in Women With Primary Dysmenorrhea: A Randomized Controlled Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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,
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: