Pelvic Nerve Mobilization for Primary Dysmenorrhea

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-30
SponsorUniversity of Hail

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Secondary dysmenorrhea (e.g., endometriosis, fibroids, pelvic inflammatory disease)

History of pelvic or spinal surgery

Neurological disorders

Current pregnancy or lactation

Trial design

Design model

Parallel

Treatments tested in this trial

  • External Pelvic Nerve Mobilization

    Other intervention

    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

  • Sham Mobilization

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Arm 1: External Pelvic Nerve MobilizationExperimental treatment 1 intervention
Group B: Arm 2: Sham MobilizationSham comparator 1 intervention

Trial outcomes

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.

Time frame
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

1

Analgesic consumption

Analgesic consumption will be measured as the total number of analgesic doses consumed for menstrual pain management. Participants will record the type and number of doses taken during menstruation. Higher values indicate greater medication use.

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

Academic absenteeism

Academic absenteeism will be assessed as the total number of hours missed from academic activities due to menstrual pain, as self-reported by participants. Higher values indicate greater absenteeism.

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

DAILY RECORD OF SEVERITY OF PROBLEMS

Menstrual-related symptoms will be assessed using the Daily Record of Severity of Problems (DRSP) questionnaire. The DRSP evaluates physical, emotional, and behavioral symptoms on a 6-point Likert scale (1 = not at all to 6 = extreme), with higher scores indicating greater symptom severity.

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

Other outcomes

Sponsors and contacts

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University of Hail

Lead sponsor

Health Education Research Foundation (HERF)

Collaborator