The Effectivenes of Non-invasive Neuromodulation in Adult Women With Primary Dysmenorrhea, Through the TENS Stimulation at Different Times of Menstrual Cycle in Each Group

Naiara Benítez Aramburu

Status: Completed

Conditions: Primary Dysmenorrhea

Treatments: Device: Transcutaneous Electrical Nerve Stimulation (TENS) during luteal phase; Device: Transcutaneous Electrical Nerve Stimulation (TENS) during bleeding phase; Device: Sham Transcutaneous Electrical Nerve Stimulation (TENS) during bleeding phase

Study type: Interventional

Funder types: Other

Identifiers

NCT06233786

2023.211

Details and patient eligibility

About

The effectiveness of non-invasive neuromodulation in adult women with primary dysmenorrhea, through the TENS stimulation at different times in each group: during the bleeding phase (G1), between days 1 and 3 of menstrual cycle, and in the luteal phase (GI2), between days 17 to 24 of menstrual cycle.

The control group (CG) will be treated just like GI1, during the bleeding phase, but without the TENS transmitting the current. Participants will be evaluated by the NPRS, MPQ, SF12, CVM-22, HADS, PCS, PSQI and UDP in the first day of menstruation. Aditionally, GI1 and GC women, will be evaluated inmediatelly after the first sesion of treatment.

Full description

This RCT will evaluate women of legal age, with pain greater than 3 on the NPRS scale, and whose menstrual cycle is regular, considered regular between 25-30 days. The sample will be divided into a cases group, which in turn will be divided into 2 subgroups: stimulation intervention in women with dysmenorrhea during the bleeding phase (GI1), and in the luteal phase (GI2). On the other hand, the control group (CG) will be treated just like GI1, during the bleeding phase, but without the transcutaneous electrical nerve stimulation (TENS) transmitting the current.

Initially, a screening questionnaire will be completed. Subsequently, a first assessment will be done to all included participants, which will be conducted by completing the Numerical Pain Scale (NPRS) in relation to their pain for 7 days, McGill Pain Questionnaire (MPQ), SF12 Health Survey, Specific Quality of life Questionnaire Related to Menstruation (CVM-22), Hospital Anxiety and Depression Scale (HADS) and Pain Catastrophizing Scale (PCS) and Pittsburgh Sleep Quality Index (PSQI), as well as pressure pain threshold measure (PPT).

Participants of G1 and GC group, will contact the researcher again to comunicate again the first day of bleeding of this second cycle to being evaluated that same day (without 24 hours passing). In this case, the scales, questionnaires and PPT are done before the intervention in order to observe possible changes from one cycle to another, so that it can be seen if the improvement achieved after treatment has been due to the treatment or other factors. Once the intervention in the bleeding phase is completed, only pain and PTT will be assessed. A second session will be done after 48 hour, but without any data being collected this time, and repeating the assessment on the first day of bleeding of the third cycle.

Regarding GI2, the two interventions sessions will be executed in the middle of the luteal phase, considering 21 days after the cycle start. They will be evaluated again on the first day of the bleeding of the second cycle, within 24 hours, which is estimated to be 7 days after the intervention.

• GI1: TENS stimulation in the bleeding phase (days 1 and 3)
• GI2: TENS stimulation in the follicular phase (days between 17 and 24)
• GC: Same procedure as GI1, but without TENS stimulation.

This intervention is performed using a TENS with an asymmetric biphasic wave of 200 µs width, frequency of 100Hz and maximum intensity tolerated by the participant, adapting to avoid accommodation. The intervention will be carried out for 30 minutes, once a day, and 2 days a week, with 48-72 hours between both interventions. Regarding the electrodes, 4 adhesive electrodes (5.0x5.0) will be placed, 2 in the lower lumbar region and two in the parasacral region (S2-S4).

Enrollment: 60 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult women
• Pain greater than 3 on the NPRS scale
• Women with regular menstrual cycle, considered regular between 25-30 days

Exclusion criteria

• Pregnancy or breastfeeding
• Used of intrauterine device
• Diagnosed gynaecological pathology: endometriosis, polycystic ovaries, uterine fibroid, adenomyosis, fibrosis, uterine malformation, pelvic inflammation, scars, SDT...
• Skin lesions that prevent the placement of the electrodes
• Other diagnosed pathologies that contraindicate the application of TENS, neurological pathologies, or cardiovascular diseases
• Absence or doubling of bleeding in one month
• Taking analgesic medications and/or NSAIDs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups

TENS in the bleeding phase

Experimental group

Description:

Participants allocated to this arm will receive active TENS during the bleeding phase.

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation (TENS) during bleeding phase

TENS in the luteal phase

Experimental group

Description:

Participants allocated to this arm will receive active TENS during the luteal phase.

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation (TENS) during luteal phase

Sham TENS in the bleeding phase

Sham Comparator group

Description:

Participants allocated to this arm will receive sham TENS during the bleeding phase.

Treatment:

Device: Sham Transcutaneous Electrical Nerve Stimulation (TENS) during bleeding phase