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

Primary Dysmenorrhea Clinical Trial

— Dysmenorrhea  

Official title:

Effectiveness of Non-invasive Neuromodulation in Primary Dysmenhorrea: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06233786
• Other study ID #: 2023.211
• Status: Recruiting
• Phase: Phase 3
• Start date: February 2024
• Est. completion date: June 2024

Study information

• Verified date: January 2024
• Source: Escoles Universitaries Gimbernat
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

Device:
• Transcutaneous Electrical Nerve Stimulation (TENS)
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).

Locations

Country	Name	City	State
Spain	Naiara Benítez Aramburu	Torrelavega	Cantabria

Sponsors (1)

Lead Sponsor	Collaborator
Naiara Benítez Aramburu

Country where clinical trial is conducted

Spain, 

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Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain: Numerical Pain Scale (NPRS)	It evaluates the intensity of menstrual pain in this case. This scale is based on asking the patient about the intensity of their pain between a value of 0, which corresponds to the absence of pain, and a value of 10, which corresponds to the highest possible pain.	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.
Primary	Pressure pain threshold (PDU): Analog pressure algometer (Wagner FPX, United States)	The subject will be instructed to communicate to the evaluator, as quickly as she perceives the minimum perceptible pain. Measurements were taken in the abdominal area, both on the right and on the left and 4cm from the navel (T10-T12) and in a single point in the lumbar region below the last lumbar vertebra (S2-S4), corresponding to the usual areas of the pain area reported in women with dysmenorrhea. Along with these points, assessments will also be performed bilaterally on the lateral aspect of the arm 10 cm below the lateral border of the acromion (C6-C7), and on the anterior aspect of the thigh 15 cm above the superior of the patella (L2-L3), these latter areas being control areas.	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.
Primary	Pain: McGill Pain Index (MPQ)	This questionnaire consists of 20 items with the objective of evaluating the different aspects of the patient's perception of pain (sensory perception of pain, emotional affective perception, evaluative perception and the perception of various pains).	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.
Primary	Quality of life related to menstruation: Specific quality of life questionnaire related to menstruation (CVM-22)	It assess the impact of menstruation on the woman's health status during bleeding days. The CVM-22 is a self-administered Likert-type questionnaire, made up of 22 items, where the questionnaire score ranges between 0 and 66, higher scores indicate worse quality of life.	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.
Primary	Quality of life: SF12 Health Questionnaire	It evaluates multidimensional health and it consists of 12 items (physical function, social function, physical role, emotional role, mental health, vitality, body pain and general health). It is a self-administered questionnaire, where the number of response options ranges between 2 and 6, among which the patient can only choose one. This questionnaire allows to obtain two scores, which correspond to the physical summary and the mental summary. A higher score is related to better health status.	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	Anxiety and Depresion: Hospital Anxiety and Depression Scale (HADS)	It is a self-administered questionnaire of 14 items, which evaluates anxiety and depression, composed of two subscales of 7 items, one for anxiety (odd items) and another of depression (even items). The intensity or frequency of the symptom is evaluated on a 4-point Likert scale (0-3) with different responses. The time frame, even when the questions are posed in the present, must refer to the previous week.	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	Catastrophic thinking: Pain Catastrophizing Scale (PCS):	It is a self-report inventory that assesses pain catastrophizing, composed of 13 items, which are grouped into 3 factors, which are cognitive rumination, magnification, and hopelessness. Using a five-point Likert scale (0, not at all; 1, a little; 2, moderately; 3, a lot; and 4, all the time), the informant rates the intensity with which she has experienced each thought while experiencing pain. The higher the score, the greater the pain catastrophizing, which could be a total of 52 points.	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	Sleep quality: Pittsburgh Sleep Quality Index (PSQI):	It is a self-administered questionnaire that measures sleep quality, in addition to the subject's own perception of their sleep. It consists of 24 questions, of which 19 must be answered by the patient themselves (15 closed questions from 0 to 3, and 4 open), while 5 require feedback from the partner or roommate. The 19 self-assessed items are combined to form 7 scoring components (sleep quality, latency, duration, habitual efficiency, sleep disturbances, taking sleep medications, and daytime disturbances), each with a range of 0 to 3. A score of 0 points indicates that there is no difficulty, while a score of 3 corresponds to severe difficulty. The sum of the 7 components would give the global score, which has a range of 0 to 21 points, indicating severe difficulty in all the areas studied, as the score increase.	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.