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

NCT06233786 | Unknown Phase 3 DMC

• 1 other identifier: 2023.211
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Dysmenorrhea

Keywords

Primary Dysmenorrhea; Transcutaneous Electrical Nerve Stimulation; Non-Invasive Neuromodulation; Sacral Surface Stimulation

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (3)

• Anxiety and Depresion: Hospital Anxiety and Depression Scale (HADS)

  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.

• Catastrophic thinking: Pain Catastrophizing Scale (PCS):

  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.

• Sleep quality: Pittsburgh Sleep Quality Index (PSQI):

  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.

Study Arms (3)

TENS in the bleeding phase

EXPERIMENTAL

After completing the screening questionnaire and being evaluated, they receive 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). They are evaluated again immediately after treatment and at the beginning of the next bleeding phase, being 28 days after the intervention.

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

TENS in the luteal phase

EXPERIMENTAL

After completing the screening questionnaire and being evaluated, they receive TENS stimulation TENS stimulation in the luteal phase between days 17 to 24 of the menstrual cycle after the start of bleeding. They are evaluated again at the beginning of the next bleeding phase, being 7 days after the intervention, as well as 28 days after, being the next cycle.

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Sham TENS in the bleeding phase

SHAM COMPARATOR

Same procedure as TENS in the bleeding phase, but without TENS stimulation.

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS) DEVICE

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).

Sham TENS in the bleeding phase; TENS in the bleeding phase; TENS in the luteal phase

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Naiara Benítez Aramburu: lead

Study Sites (1)

Naiara Benítez Aramburu

Torrelavega, Cantabria, 39300, Spain

RECRUITING

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MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 31, 2024
• Study Start: February 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

ES (1)