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NCT Number: NCT07354451

Pelvic Nerve Mobilization for Primary Dysmenorrhea

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.

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Key information

Conditions

Primary Dysmenorrhea (PD)

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

International Institute of Science Arts and Technology

Sialkot, Pakistan

Location status: Recruiting

Location contact

farah ahmed, PP-DPT

CONTACT

[email protected]

00923039582712

farah ahmed, PP-DPT

SUB_INVESTIGATOR

About this study

Primary dysmenorrhea is characterized by painful menstruation in the absence of identifiable pelvic pathology and affects a large proportion of young women. Pain is largely mediated by excessive prostaglandin release, uterine ischemia, and sensitization of pelvic neural pathways. Recurrent nociceptive input may lead to peripheral and central sensitization, exacerbating pain severity.

External pelvic nerve mobilization is a physiotherapy-based neurodynamic intervention designed to restore physiological mobility of pelvic and lumbosacral nerves, reduce neural mechanosensitivity, and modulate nociceptive signaling. Unlike internal pelvic techniques, this approach is entirely external, non-invasive, and suitable for young and student populations.

This single-blind, parallel-group randomized controlled trial will assess whether external pelvic nerve mobilization provides superior pain reduction and functional improvement compared with a sham intervention over three menstrual cycles.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

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.

Primary outcomes

  1. Menstrual 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).

    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.

Secondary outcomes

  1. Analgesic consumption

    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).

    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.

  2. Academic 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).

    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.

  3. DAILY RECORD OF SEVERITY OF PROBLEMS

    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).

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

farah ahmed, PP-DPT

CONTACT

raheela kanwal sheikh, phd

CONTACT

[email protected]

+966564194172

Sponsors and collaborators

Lead sponsor

University of Hail

Other

Collaborators

  • Health Education Research Foundation (HERF)

Registry information

Official study title

Efficacy of Pelvic Nerve Mobilization in Reducing Symptoms of Primary Dysmenorrhea: A Randomized Controlled Trial

Acronym: PNM-PD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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