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Recruiting NCT07354451

Pelvic Nerve Mobilization for Primary Dysmenorrhea

No phase Interventional Primary Dysmenorrhea (PD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: External Pelvic Nerve Mobilization, Sham Mobilization.
Who it may be relevant to
Registry conditions: Primary Dysmenorrhea (PD). Basic parameters: 18 years — 30 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Other External Pelvic Nerve Mobilization
    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 ba
  • Other Sham Mobilization
    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 outcome measures

  • 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).]
Secondary outcome measures (3)
  • 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).]
  • 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).]
  • 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).]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • International Institute of Science Arts and Technology — Sialkot

Identifiers

NCT: NCT07354451 · HERF/Research/REC/No-2020-013

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗