Pelvic Nerve Mobilization for Primary Dysmenorrhea

NCT07354451 | Recruiting

• 1 other identifier: HERF/Research/REC/No-2020-013
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Primary dysmenorrhea is a highly prevalent condition among young women and is associated with significant pain, reduced quality of life, and academic absenteeism. Although non-steroidal anti-inflammatory drugs are commonly used, many women seek non-pharmacological alternatives due to limited effectiveness or adverse effects. Emerging evidence suggests that altered pelvic neurodynamics may contribute to dysmenorrheic pain. This randomized controlled trial aims to evaluate the effectiveness of external pelvic nerve mobilization in reducing menstrual pain and associated symptoms among university women with primary dysmenorrhea. Participants aged 18-30 years will be randomly allocated to receive either external pelvic nerve mobilization or a sham manual therapy intervention across three consecutive menstrual cycles. Outcomes will include pain intensity, menstrual distress, quality of life, pelvic tenderness, analgesic consumption, and academic absenteeism.

Conditions

Primary Dysmenorrhea (PD)

Outcome Measures

Primary Outcomes (1)

• Menstrual pain intensity

  Menstrual pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS). Participants will rate their average menstrual pain on a scale ranging from 0 to 10, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate greater pain intensity.

  During the first three days of menstruation at baseline and during the first three days of each menstrual cycle for three consecutive cycles (each cycle = 28 days).

Secondary Outcomes (3)

• Analgesic consumption

  Baseline (Cycle 0; prior menstrual cycle, defined as 28 days) and during menstruation for Cycles 1, 2, and 3 (each cycle = 28 days).

• Academic absenteeism

  Baseline (Cycle 0; prior menstrual cycle, defined as 28 days) and during menstruation for Cycles 1, 2, and 3 (each cycle = 28 days).

• DAILY RECORD OF SEVERITY OF PROBLEMS

  Baseline (Cycle 0; daily for a full 28-day menstrual cycle) and daily across Cycles 1, 2, and 3 (each cycle = 28 days).

Study Arms (2)

Arm 1: External Pelvic Nerve Mobilization

EXPERIMENTAL

Participants will receive standardized external neurodynamic mobilization techniques targeting the lumbosacral plexus and pudendal nerve pathways. Sessions will be delivered by trained women's health physiotherapists. Each session will last approximately 30 minutes and will be administered three times per menstrual cycle across three consecutive cycles.

Other: External Pelvic Nerve Mobilization

Arm 2: Sham Mobilization

SHAM COMPARATOR

Participants will receive non-therapeutic light manual contact over the lumbosacral and pelvic regions without neural gliding, joint movement, or tissue mobilization. Session duration and therapist interaction will match the intervention group.

Other: Sham Mobilization

Interventions

Sham Mobilization OTHER

Participants will receive non-therapeutic light manual contact over the lumbosacral and pelvic regions without neural gliding, joint movement, or tissue mobilization. Session duration and therapist interaction will match the intervention group.

Arm 2: Sham Mobilization

External Pelvic Nerve Mobilization OTHER

Participants will receive a standardized, protocol-driven external neurodynamic mobilization intervention specifically designed to target the lumbosacral plexus and pudendal nerve pathways. Unlike general pelvic manual therapy or routine neural mobilization techniques typically used in musculoskeletal physiotherapy, this intervention incorporates: A predefined sequence of graded neurodynamic maneuvers developed exclusively for this study, combining individually titrated sliders and tensioners based on the participant's symptom irritability and neurodynamic response. Non-internal, purely external application, ensuring a consistent, reproducible method across participants while avoiding variability associated with internal pelvic techniques used in other women's health studies

Arm 1: External Pelvic Nerve Mobilization

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female university students aged 18-30 years
• Regular menstrual cycles (24-35 days)
• Clinically diagnosed primary dysmenorrhea
• Average menstrual pain intensity ≥ 5 on Visual Analog Scale
• Willingness to participate and provide informed consent

You may not qualify if:

• Secondary dysmenorrhea (e.g., endometriosis, fibroids, pelvic inflammatory disease)
• History of pelvic or spinal surgery
• Neurological disorders
• Current pregnancy or lactation
• Current physiotherapy or manual therapy treatment
• Contraindications to manual therapy

Sponsors & Collaborators

• University of Hail: lead
• Health Education Research Foundation (HERF): collaborator

Study Sites (1)

International Institute of Science Arts and Technology

Sialkot, Pakistan

RECRUITING

Central Study Contacts

raheela kanwal sheikh, phd

CONTACT

+966564194172; r.sheikh@uoh.edu.sa

farah ahmed, PP-DPT

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 21, 2026
• Study Start: October 20, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)