Effects of Transcutaneous Tibial and Auricular Vagus Nerve Stimulation in Females With Primary Dysmenorrhea

NCT07834658 | Not Yet Recruiting

• 1 other identifier: Maryam Malik
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief 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 (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.

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; Randomized Controlled Trial; Women's Health Physiotherapy; NSAID Consumption

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline, 4th Week, 8th Week , and 12th Week

Secondary Outcomes (2)

• Menstrual Symptoms - Menstrual Distress Questionnaire (MEDI-Q) Score

  Baseline, Week 4, Week 8 and Week 12

• NSAID Consumption

  Baseline, Week 4, Week 8 and Week 12.

Study Arms (4)

TTNS

EXPERIMENTAL

Participants will receive Transcutaneous Tibial Nerve Stimulation (TTNS) using TENS by standard stimulation parameters for the treatment of primary dysmenorrhea.

Device: Transcutaneous Tibial Nerve Stimulation (TTNS)

TaVNS

EXPERIMENTAL

Participants will receive Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) using standardized stimulation parameters.

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

Device: TTNS+TaVNS

Sham Stimulation

SHAM COMPARATOR

Participants will receive sham stimulation that mimics the active interventions without providing therapeutic stimulation.

Device: Sham Stimulation

Interventions

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.

TTNS

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.

TaVNS

TTNS+TaVNS DEVICE

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.

TTNS+TaVNS

Sham Stimulation DEVICE

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.

Sham Stimulation

Eligibility Criteria

• Age: 14 Years - 30 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Related Publications (2)

• 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.

  PMID: 39994446 BACKGROUND

• McKiernan 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.

  PMID: 39324711 BACKGROUND

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Huma Riaz, PhD

  Riphah International University, Faculty of Rehabilitation & Allied Health Sciences

  STUDY CHAIR

Central Study Contacts

Maryam Malik, MSPT*

CONTACT

923355533352; Maryamlik666@gmail.com

Huma Riaz, PhD

CONTACT

+92 321 5242874; Huma.riaz@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is a single-blinded randomized controlled trial. Outcome assessors will be blinded to treatment allocation throughout the study. Randomization and allocation concealment will be performed by an independent researcher. Due to the nature of the interventions, participants and intervention providers cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: September 22, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share