Clinical trial NCT06233786: The Effectivenes of Non-invasive Neuromodulation in Adult Women With Primary Dysmenorrhea, Through the TENS Stimulation at Different Times of Mentrual Cycle in Each Group
Official title: Effectiveness of Non-invasive Neuromodulation in Primary Dysmenhorrea: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Primary Dysmenorrhea
Keywords: Primary Dysmenorrhea
Transcutaneous Electrical Nerve Stimulation
Non-Invasive Neuromodulation
Sacral Surface Stimulation
Lead sponsor: Escoles Universitaries Gimbernat
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 25-28 and 1-3 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 immediately after treatment in GI1 and GC, and at the beginning of the next bleeding phase, being 28 days after the intervention in the case of GI1 and GC, and 7 days after the intervention in the case of GI2, as well as 28 days after in this last.

Detailed description: This RCT evaluates 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 5 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 will also be evaluated immediately after treatment and at the beginning of the next bleeding phase (next menstrual cycle), being 28 days after the intervention in the case of GI1 and GC, and 7 days after the intervention in the case of GI2.

Regarding the intervention, the treatment plan to be done will be as follows:

* GI1: TENS stimulation in the menstrual phase between days 25-28 (days before bleeding and where symptoms may begin) and 1-3 (first days of bleeding).
* GI2: TENS stimulation in the follicular phase between days 17 to 24 of the menstrual cycle after the start of bleeding.
* 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).

Eligibility criteria: 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

Primary outcomes:
measure: Pain: Numerical Pain Scale (NPRS)
timeFrame: Baseline, immediately after treatment and at 28 days in bleeding phase and sham TENS, while in luteal phase will be done at baseline, at 7 days and at 28 days.
measure: Pressure pain threshold (PDU): Analog pressure algometer (Wagner FPX, United States)
timeFrame: Baseline, immediately after treatment and at 28 days in bleeding phase and sham TENS, while in luteal phase will be done at baseline, at 7 days and at 28 days.
measure: Pain: McGill Pain Index (MPQ)
timeFrame: Baseline, immediately after treatment and at 28 days in bleeding phase and sham TENS, while in luteal phase will be done at baseline, at 7 days and at 28 days.
measure: Quality of life related to menstruation: Specific quality of life questionnaire related to menstruation (CVM-22)
timeFrame: Baseline, immediately after treatment and at 28 days in bleeding phase and sham TENS, while in luteal phase will be done at baseline, at 7 days and at 28 days.
measure: Quality of life: SF12 Health Questionnaire
timeFrame: Baseline, immediately after treatment and at 28 days in bleeding phase and sham TENS, while in luteal phase will be done at baseline, at 7 days and at 28 days.
Secondary outcomes:
measure: Anxiety and Depresion: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, immediately after treatment and at 28 days in bleeding phase and sham TENS, while in luteal phase will be done at baseline, at 7 days and at 28 days.
measure: Catastrophic thinking: Pain Catastrophizing Scale (PCS):
timeFrame: Baseline, immediately after treatment and at 28 days in bleeding phase and sham TENS, while in luteal phase will be done at baseline, at 7 days and at 28 days.
measure: Sleep quality: Pittsburgh Sleep Quality Index (PSQI):
timeFrame: Baseline, immediately after treatment and at 28 days in bleeding phase and sham TENS, while in luteal phase will be done at baseline, at 7 days and at 28 days.
Other outcomes:
Locations:
city: Torrelavega
country: Spain
facility: Naiara Benítez Aramburu
state: Cantabria
Study officials:
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