Primary Dysmenorrhea (PD)NCT07834658
Effects of Transcutaneous Tibial and Auricular Vagus Nerve Stimulation in Females With Primary Dysmenorrhea
A study testing Transcutaneous Tibial Nerve Stimulation (TTNS), Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS) and TTNS+TaVNS in people with Primary Dysmenorrhea (PD), run by Riphah International University.
Trial summary
Primary dysmenorrhea is a common gynecological condition characterized by painful menstrual cramps that can negatively affect daily activities and quality of life. Non-invasive neuromodulation techniques, including Transcutaneous Tibial Nerve Stimulation (TTNS) and Transcutaneous Auricular Vagus Nerve Stimulation… Read more about this study
- Who is it for?
- Ages 14 to 30 years, women only
- Conditions the study is for
- Primary Dysmenorrhea (PD)
- What is being tested?
- Transcutaneous Tibial Nerve Stimulation (TTNS), Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS) and TTNS+TaVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to 31 Jul 2027
- 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 14 to 30 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Nulliparous females aged 14-30 years.
- Regular menstrual cycles.
- Diagnosed with primary dysmenorrhea.
- Pain located in the suprapubic area, abdomen, lower lumbar region, perineum, and/or medial aspect of the thighs during at least half of the annual menstrual cycles or the last three menstrual cycles.
- Pain intensity greater than 4 on the Numeric Pain Rating Scale (NPRS).
Who cannot join
- Females diagnosed with secondary dysmenorrhea (e.g., endometriosis, ovarian cysts).
- Intrauterine device (IUD) users.
- Presence of skin lesions, scars, or erosions on the inner aspect of the ankle.
- Severe mental disorders (e.g., schizophrenia, bipolar disorder).
- Pacemaker or other implanted electrical devices, if applicable to the stimulation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Transcutaneous Tibial and Auricular Vagus Nerve Stimulation on Pain and Autonomic Function in Females With Primary Dysmenorrhea
Primary dysmenorrhea is a common gynecological condition characterized by painful menstrual cramps that can negatively affect daily activities and quality of life. Non-invasive neuromodulation techniques, including Transcutaneous Tibial Nerve Stimulation (TTNS) and Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), have shown potential for pain management and modulation of autonomic nervous system function. However, limited evidence exists regarding the comparative and combined effects of these interventions.
This randomized controlled trial aims to evaluate the comparative and combined effects of TTNS and taVNS on pain, autonomic function, menstrual symptoms, and NSAID consumption in females with primary dysmenorrhea. Eligible participants will be randomly assigned to one of four groups: TTNS, taVNS, combined TTNS + taVNS, or sham stimulation. Outcome measures will be assessed before and after the intervention period by a blinded assessor.
Read the detailed description
Primary dysmenorrhea is one of the most prevalent menstrual disorders among young females and is associated with significant pain, functional limitations, absenteeism, and increased use of analgesic medications. Current management primarily relies on non-steroidal anti-inflammatory drugs (NSAIDs), which may not provide adequate relief for all individuals and can produce adverse effects with repeated use. Therefore, effective non-pharmacological interventions are needed.
Transcutaneous Tibial Nerve Stimulation (TTNS) and Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) are non-invasive neuromodulation techniques that have demonstrated promising effects in reducing pain and regulating autonomic nervous system activity. While each intervention has been investigated separately for various pain conditions, evidence regarding their comparative effectiveness and the potential benefit of combining both interventions in females with primary dysmenorrhea remains limited.
This study is a randomized, parallel-group, assessor-blinded controlled trial. Approximately 66 participants with primary dysmenorrhea will be recruited using consecutive sampling and randomly allocated using computer-generated block randomization into one of four groups:
TTNS group, taVNS group, Combined TTNS + taVNS group Sham stimulation group
Participants will receive their allocated intervention according to standardized treatment protocols. The assessor responsible for outcome measurements will remain blinded to group allocation.
The primary outcomes are pain intensity and autonomic function. Secondary outcomes include menstrual symptoms and NSAID consumption. Outcome assessments will be conducted at baseline and after completion of the intervention period.
The findings of this study are expected to provide evidence regarding the effectiveness of TTNS, taVNS, and their combined application as safe, non-invasive treatment options for the management of primary dysmenorrhea and may contribute to improving conservative physiotherapy management of this condition.
- Conditions
- Primary Dysmenorrhea (PD)
- Being tested
- Transcutaneous Tibial Nerve Stimulation (TTNS), Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS), TTNS+TaVNS, Sham Stimulation
- Keywords
- Primary Dysmenorrhea, Transcutaneous Tibial Nerve Stimulation, TTNS, Transcutaneous Auricular Vagus Nerve Stimulation, TaVNS, Menstrual Pain, Autonomic Function, Heart Rate Variability, Randomized Controlled Trial, Women's Health Physiotherapy, NSAID Consumption
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Tibial Nerve Stimulation (TTNS)Device
Electrical stimulation will be delivered through a TENS device using surface electrodes placed over the posterior tibial nerve for 30 mins according to the study protocol for the management of primary dysmenorrhea. The intervention will be applied for 5 consecutive days, including 2 days before and 3 days during the mensturation period.
Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS)Device
Electrical stimulation delivered through a TENS device using surface electrodes placed on the auricular branch of the vagus nerve for 30 mins according to the study protocol for the management of primary dysmenorrhea. The intervention will be applied for 5 consecutive days, including 2 days before and 3 days during the mensturation period.
TTNS+TaVNSDevice
Electrical stimulation delivered through a TENS device to both the posterior tibial nerve and the auricular branch of the vagus nerve sequentially according to the study protocol. The intervention will be applied for 5 consecutive days, including 2 days before and 3 days during the mensturation period.
Sham StimulationDevice
Sham stimulation delivered using the same TENS device and electrode placement as the active intervention but without therapeutic electrical stimulation. The intervention will be applied for 5 consecutive days, including 2 days before and 3 days during the mensturation period.
| Study group | Role | What they receive |
|---|---|---|
| TTNS | Experimental | Participants will receive Transcutaneous Tibial Nerve Stimulation (TTNS) using TENS by standard stimulation parameters for the treatment of primary dysmenorrhea. Receives: Device: Transcutaneous Tibial Nerve Stimulation (TTNS) |
| TaVNS | Experimental | Participants will receive Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) using standardized stimulation parameters. Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS) |
| TTNS+TaVNS | Experimental | Participants will receive both TTNS and taVNS during the same treatment session according to the study protocol Receives: Device: TTNS+TaVNS |
| Sham Stimulation | Sham comparator | Participants will receive sham stimulation that mimics the active interventions without providing therapeutic stimulation. Receives: Device: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysmenorrhea Severity - WaLIDD Score
Dysmenorrhea severity will be assessed using the WaLIDD score. The WaLIDD score is a multidimensional assessment of dysmenorrhea severity based on the number of pain days, pain intensity, work/activities affected, and history of dysmenorrhea. The total score ranges from 0 to 12, with higher scores indicating greater dysmenorrhea severity.
Measured: Baseline, 4th Week, 8th Week , and 12th Week
Pain Intensity - Numeric Pain Rating Scale (NPRS)
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), ranging from 0 (no pain) to 10 (worst possible pain). NPRS will be recorded immediately before and immediately after each treatment session during the 5-day intervention period of each menstrual cycle.
Measured: Baseline, 4th Week, 8th Week , and 12th Week
Autonomic Function - Heart Rate Variability (RMSSD)
Autonomic function will be assessed using the root mean square of successive differences (RMSSD) derived from heart rate variability. RMSSD will be reported in milliseconds (ms), with changes from pre-treatment to post-treatment used to evaluate autonomic response.
Measured: Baseline, 4th Week, 8th Week , and 12th Week
Autonomic Function - Heart Rate Variability (LF/HF Ratio)
Autonomic function will be assessed using the low-frequency to high-frequency (LF/HF) ratio derived from heart rate variability. The LF/HF ratio will be used to evaluate changes in cardiac autonomic activity in response to the intervention.
Measured: Baseline, 4th Week, 8th Week , and 12th Week
Secondary outcomes (2)
Menstrual Symptoms - Menstrual Distress Questionnaire (MEDI-Q) Score
Menstrual-related symptoms will be assessed using the Menstrual Distress Questionnaire (MDQ). The questionnaire evaluates the severity of menstrual symptoms across multiple symptom categories. Higher scores indicate greater menstrual symptom severity.
Measured: Baseline, Week 4, Week 8 and Week 12
NSAID Consumption
NSAID consumption will be assessed using a participant diary/log to record the frequency and quantity of NSAID use during each menstrual cycle.
Measured: Baseline, Week 4, Week 8 and Week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study startSep 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary Dysmenorrhea (PD)Studies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Model description
- Participants will be randomly assigned to one of four parallel groups: TTNS, taVNS, combined TTNS + taVNS, or sham stimulation. Outcomes will be compared between groups following the intervention period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huma Riaz, PhD, Study chair, Riphah International University, Faculty of Rehabilitation & Allied Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834658
- Sponsor's protocol ID
- Maryam Malik
- Status last verified
- Sep 2026
- First submitted
- 10 Aug 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bashir L, Budhlakoti N, Pradhan AK, Sharma D, Jain A, Rehman SS, Kondal V, Jacob SR, Bhardwaj R, Gaikwad K, Mishra DC, Pandey A, Kaur S, Bhati PK, Singh R, Singh GP, Kumar S. Identification of quantitative trait nucleotides for grain quality in bread wheat under heat stress. Sci Rep. 2025 Feb 24;15(1):6641. doi: 10.1038/s41598-025-91199-2.
PubMed 39994446McKiernan P, Baker E, Baker M. Bloodless Medicine in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation. Clin J Oncol Nurs. 2024 Sep 17;28(5):463-468. doi: 10.1188/24.CJON.463-468.
PubMed 39324711
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Tibial and Auricular Vagus Nerve Stimulation on Pain and Autonomic Function in Females With Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT07834658
- Acronym / sponsor ID
- Maryam Malik
- Conditions
- Primary Dysmenorrhea (PD)
- Keywords
- Primary Dysmenorrhea, Transcutaneous Tibial Nerve Stimulation, TTNS, Transcutaneous Auricular Vagus Nerve Stimulation, TaVNS, Menstrual Pain, Autonomic Function, Heart Rate Variability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 22 Sep 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 common gynecological condition characterized by painful menstrual cramps that can negatively affect daily activities and quality of life. Non-invasive neuromodulation techniques, including Transcutaneous Tibial Nerve Stimulation (TTNS) and Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), have shown potential for pain management and modulation of autonomic nervous system function. However, limited evidence exists regarding the comparative and combined effects of these interventions.
This randomized controlled trial aims to evaluate the comparative and combined effects of TTNS and taVNS on pain, autonomic function, menstrual symptoms, and NSAID consumption in females with primary dysmenorrhea. Eligible participants will be randomly assigned to one of four groups: TTNS, taVNS, combined TTNS + taVNS, or sham stimulation. Outcome measures will be assessed before and after the intervention period by a blinded assessor.
Detailed description
Primary dysmenorrhea is one of the most prevalent menstrual disorders among young females and is associated with significant pain, functional limitations, absenteeism, and increased use of analgesic medications. Current management primarily relies on non-steroidal anti-inflammatory drugs (NSAIDs), which may not provide adequate relief for all individuals and can produce adverse effects with repeated use. Therefore, effective non-pharmacological interventions are needed.
Transcutaneous Tibial Nerve Stimulation (TTNS) and Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) are non-invasive neuromodulation techniques that have demonstrated promising effects in reducing pain and regulating autonomic nervous system activity. While each intervention has been investigated separately for various pain conditions, evidence regarding their comparative effectiveness and the potential benefit of combining both interventions in females with primary dysmenorrhea remains limited.
This study is a randomized, parallel-group, assessor-blinded controlled trial. Approximately 66 participants with primary dysmenorrhea will be recruited using consecutive sampling and randomly allocated using computer-generated block randomization into one of four groups:
TTNS group, taVNS group, Combined TTNS + taVNS group Sham stimulation group
Participants will receive their allocated intervention according to standardized treatment protocols. The assessor responsible for outcome measurements will remain blinded to group allocation.
The primary outcomes are pain intensity and autonomic function. Secondary outcomes include menstrual symptoms and NSAID consumption. Outcome assessments will be conducted at baseline and after completion of the intervention period.
The findings of this study are expected to provide evidence regarding the effectiveness of TTNS, taVNS, and their combined application as safe, non-invasive treatment options for the management of primary dysmenorrhea and may contribute to improving conservative physiotherapy management of this condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Participants will be randomly assigned to one of four parallel groups: TTNS, taVNS, combined TTNS + taVNS, or sham stimulation. Outcomes will be compared between groups following the intervention period.
| Arm | Type | Receives |
|---|---|---|
| TTNS | Experimental | Device: Transcutaneous Tibial Nerve Stimulation (TTNS)Participants will receive Transcutaneous Tibial Nerve Stimulation (TTNS) using TENS by standard stimulation parameters for the treatment of primary dysmenorrhea. |
| TaVNS | Experimental | Device: Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS)Participants will receive Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) using standardized stimulation parameters. |
| TTNS+TaVNS | Experimental | Device: TTNS+TaVNSParticipants will receive both TTNS and taVNS during the same treatment session according to the study protocol |
| Sham Stimulation | Sham comparator | Device: Sham StimulationParticipants will receive sham stimulation that mimics the active interventions without providing therapeutic stimulation. |
Who may qualify
- Ages
- 14 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Nulliparous females aged 14-30 years.
- Regular menstrual cycles.
- Diagnosed with primary dysmenorrhea.
- Pain located in the suprapubic area, abdomen, lower lumbar region, perineum, and/or medial aspect of the thighs during at least half of the annual menstrual cycles or the last three menstrual cycles.
- Pain intensity greater than 4 on the Numeric Pain Rating Scale (NPRS).
Key exclusion criteria (5 listed)
- Females diagnosed with secondary dysmenorrhea (e.g., endometriosis, ovarian cysts).
- Intrauterine device (IUD) users.
- Presence of skin lesions, scars, or erosions on the inner aspect of the ankle.
- Severe mental disorders (e.g., schizophrenia, bipolar disorder).
- Pacemaker or other implanted electrical devices, if applicable to the stimulation
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 |
|---|---|---|
| Transcutaneous Tibial Nerve Stimulation (TTNS)Electrical stimulation will be delivered through a TENS device using surface electrodes placed over the posterior tibial nerve for 30 mins according to the study protocol for the management of primary dysmenorrhea. The intervention will be applied for 5 consecutive days, including 2 days before and 3 days during the mensturation period. | Device | TTNS |
| Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS)Electrical stimulation delivered through a TENS device using surface electrodes placed on the auricular branch of the vagus nerve for 30 mins according to the study protocol for the management of primary dysmenorrhea. The intervention will be applied for 5 consecutive days, including 2 days before and 3 days during the mensturation period. | Device | TaVNS |
| TTNS+TaVNSElectrical stimulation delivered through a TENS device to both the posterior tibial nerve and the auricular branch of the vagus nerve sequentially according to the study protocol. The intervention will be applied for 5 consecutive days, including 2 days before and 3 days during the mensturation period. | Device | TTNS+TaVNS |
| Sham StimulationSham stimulation delivered using the same TENS device and electrode placement as the active intervention but without therapeutic electrical stimulation. The intervention will be applied for 5 consecutive days, including 2 days before and 3 days during the mensturation period. | Device | Sham Stimulation |
Primary outcome
Dysmenorrhea Severity - WaLIDD Score
Time frame: Baseline, 4th Week, 8th Week , and 12th Week
Dysmenorrhea severity will be assessed using the WaLIDD score. The WaLIDD score is a multidimensional assessment of dysmenorrhea severity based on the number of pain days, pain intensity, work/activities affected, and history of dysmenorrhea. The total score ranges from 0 to 12, with higher scores indicating greater dysmenorrhea severity.
Pain Intensity - Numeric Pain Rating Scale (NPRS)
Time frame: Baseline, 4th Week, 8th Week , and 12th Week
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), ranging from 0 (no pain) to 10 (worst possible pain). NPRS will be recorded immediately before and immediately after each treatment session during the 5-day intervention period of each menstrual cycle.
Autonomic Function - Heart Rate Variability (RMSSD)
Time frame: Baseline, 4th Week, 8th Week , and 12th Week
Autonomic function will be assessed using the root mean square of successive differences (RMSSD) derived from heart rate variability. RMSSD will be reported in milliseconds (ms), with changes from pre-treatment to post-treatment used to evaluate autonomic response.
Autonomic Function - Heart Rate Variability (LF/HF Ratio)
Time frame: Baseline, 4th Week, 8th Week , and 12th Week
Autonomic function will be assessed using the low-frequency to high-frequency (LF/HF) ratio derived from heart rate variability. The LF/HF ratio will be used to evaluate changes in cardiac autonomic activity in response to the intervention.
2 secondary outcomes
Menstrual Symptoms - Menstrual Distress Questionnaire (MEDI-Q) Score
Time frame: Baseline, Week 4, Week 8 and Week 12
NSAID Consumption
Time frame: Baseline, Week 4, Week 8 and Week 12.
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 22 Sep 2026.
- Background: PubMed 39994446Bashir L, Budhlakoti N, Pradhan AK, Sharma D, Jain A, Rehman SS, Kondal V, Jacob SR, Bhardwaj R, Gaikwad K, Mishra DC, Pandey A, Kaur S, Bhati PK, Singh R, Singh GP, Kumar S. Identification of quantitative trait nucleotides for grain quality in bread wheat under heat stress. Sci Rep. 2025 Feb 24;15(1):6641. doi: 10.1038/s41598-025-91199-2.
- Background: PubMed 39324711McKiernan P, Baker E, Baker M. Bloodless Medicine in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation. Clin J Oncol Nurs. 2024 Sep 17;28(5):463-468. doi: 10.1188/24.CJON.463-468.
- Individual participant dataSharing planned: No
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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.
Huma Riaz, PhD study chair
Riphah International University, Faculty of Rehabilitation & Allied Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Tibial Nerve Stimulation (TTNS), Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS) and TTNS+TaVNS in people with Primary Dysmenorrhea (PD), run by Riphah International University.
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 5 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: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Maryam Malik, MSPT* (923355533352, Maryamlik666@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysmenorrhea Severity - WaLIDD Score (time frame: Baseline, 4th Week, 8th Week , and 12th Week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07834658, which also lists 2 linked publications.
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 22 Sep 2026.