Primary Dysmenorrhea (PD)PNM-PDNCT07354451
Pelvic Nerve Mobilization for Primary Dysmenorrhea
A study testing External Pelvic Nerve Mobilization in people with Primary Dysmenorrhea (PD), run by University of Hail at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Primary Dysmenorrhea (PD)
- What is being tested?
- External Pelvic Nerve Mobilization
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Oct 2025to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
farah ahmed, PP-DPT contact
Pakistan1 site, 1 recruiting
- Recruiting
International Institute of Science Arts and Technology
Sialkot
farah ahmed, PP-DPT, 00923039582712, r.sheikh@uoh.edu.sa
farah ahmed, PP-DPT
About this study
Official title: Efficacy of Pelvic Nerve Mobilization in Reducing Symptoms of Primary Dysmenorrhea: A Randomized Controlled 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.
Read the 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.
- Conditions
- Primary Dysmenorrhea (PD)
- Being tested
- External Pelvic Nerve Mobilization, Sham Mobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Pelvic Nerve MobilizationOther
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 MobilizationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sham Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline (Cycle 0; daily for a full 28-day menstrual cycle) and daily across Cycles 1, 2, and 3 (each cycle = 28 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start20 Oct 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Dysmenorrhea (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hail
- Sponsor type
- University, hospital or other
- Collaborators
- Health Education Research Foundation (HERF)
- Responsible party
- Principal investigator, Raheela Kanwal, University of Hail
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354451
- Sponsor's protocol ID
- HERF/Research/REC/No-2020-013
- Acronym
- PNM-PD
- Status last verified
- Apr 2026
- First submitted
- 23 Dec 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the dataset contains sensitive participant information, and there is a risk of re-identification. The study does not include a data-sharing plan or a secure mechanism for providing external access.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pelvic Nerve Mobilization in Reducing Symptoms of Primary Dysmenorrhea: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07354451
- Acronym / sponsor ID
- PNM-PD / HERF/Research/REC/No-2020-013
- Conditions
- Primary Dysmenorrhea (PD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of HailUniversity, hospital or other
- Collaborators
- Health Education Research Foundation (HERF)
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: External Pelvic Nerve Mobilization | Experimental | Other: External Pelvic Nerve MobilizationParticipants 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. |
| Arm 2: Sham Mobilization | Sham comparator | Other: Sham MobilizationParticipants 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External Pelvic Nerve MobilizationParticipants 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 | Other | Arm 1: External Pelvic Nerve Mobilization |
| Sham MobilizationParticipants 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 | Arm 2: Sham Mobilization |
Primary outcome
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.
3 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the dataset contains sensitive participant information, and there is a risk of re-identification. The study does not include a data-sharing plan or a secure mechanism for providing external access.
Related trials for Primary Dysmenorrhea (PD)
Not yet recruiting
Transcutaneous Cervical Vagus Nerve Stimulation for Primary Dysmenorrhea
Primary Dysmenorrhea (PD), Menstrual Pain
Not yet recruiting
Effects of Transcutaneous Tibial and Auricular Vagus Nerve Stimulation in Females With Primary Dysmenorrhea
Primary Dysmenorrhea (PD)
Not yet recruiting
Individualized Acupoint Therapy for Dysmenorrhea: An Exploratory Research Design Based on Meridian Measurement
Primary Dysmenorrhea (PD)
Recruiting
Effectiveness of an Acupressure Band for Primary Dysmenorrhea in College Students
Primary Dysmenorrhea (PD)
Not yet recruiting
Effect of Pilates Exercises Versus Gym Exercises On Primary Dysmenorrhea
Primary Dysmenorrhea (PD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
farah ahmed, PP-DPT contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External Pelvic Nerve Mobilization in people with Primary Dysmenorrhea (PD), run by University of Hail at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact raheela kanwal sheikh, phd (+966564194172, r.sheikh@uoh.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.