Effectiveness of Non-invasive Neuromodulation in Primary Dysmenhorrea: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pain: Numerical Pain Scale (NPRS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 三盲 (受试者、研究者、结局评估者)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- Adult women
- Pain greater than 3 on the NPRS scale
- Women with regular menstrual cycle, considered regular between 25-30 days
排除标准
- 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
研究组 & 干预措施
TENS in the bleeding phase
Participants allocated to this arm will receive active TENS during the bleeding phase.
干预措施: Transcutaneous Electrical Nerve Stimulation (TENS) during bleeding phase (Device)
TENS in the luteal phase
Participants allocated to this arm will receive active TENS during the luteal phase.
干预措施: Transcutaneous Electrical Nerve Stimulation (TENS) during luteal phase (Device)
Sham TENS in the bleeding phase
Participants allocated to this arm will receive sham TENS during the bleeding phase.
干预措施: Sham Transcutaneous Electrical Nerve Stimulation (TENS) during bleeding phase (Device)
结局指标
主要结局
Pain: Numerical Pain Scale (NPRS)
时间窗: Pain intensity on the first day of menstrual bleeding will be assessed, in addition to the three days preceding and following it, across three consecutive cycles.
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.
Pressure pain threshold (PDU): Analog pressure algometer (Wagner FPX, United States)
时间窗: Assessments will be conducted on the first day of menstrual bleeding (within 24h) across three consecutive cycles. In the second cycle, both groups will undergo two assessments instead of one, carried out before and after the first treatment session.
Pressure pain thresholds (PPTs) will be assessed in the abdominal and lumbar regions, corresponding to the usual areas of referred pain in women with dysmenorrhea. Five points will be evaluated in the lower abdominal region: two symmetrically located 4 cm from the umbilicus, two at the midpoint between the umbilicus and the anterior superior iliac spine, and one on the midline above the pubic symphysis (T10-T12). In the posterior region, the PPT will be measured at one point on the midline just below the last lumbar vertebra (L5), another at the central sacral level (S2-S4), and additionally at one point on the lateral wall of the right and left ischiorectal fossa. Bilateral assessments will also be conducted at control sites: the temporal region, the lateral aspect of the arm 10 cm below the lateral border of the acromion (C6-C7), and the anterior aspect of the thigh 15 cm above the superior edge of the patella (L2-L3).
Quality of life related to menstruation: Specific quality of life questionnaire related to menstruation (CVM-22)
时间窗: 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.
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.
Pain: Numerical Pain Scale (NPRS)
时间窗: 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.
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.
Pain: McGill Pain Index (MPQ)
时间窗: 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.
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).
Pressure pain threshold (PDU): Analog pressure algometer (Wagner FPX, United States)
时间窗: 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.
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.
Quality of life: SF12 Health Questionnaire
时间窗: 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.
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.
次要结局
- Anxiety and Depresion: Hospital Anxiety and Depression Scale (HADS)(Assessment using the scale will be conducted on the first day of menstrual bleeding during three consecutive cycles, together with the other scales.)
- Catastrophic thinking: Pain Catastrophizing Scale (PCS):(Assessment using the scale will be conducted on the first day of menstrual bleeding during three consecutive cycles, together with the other scales.)
- Sleep quality: Pittsburgh Sleep Quality Index (PSQI):(Assessment using the scale will be conducted on the first day of menstrual bleeding during three consecutive cycles, together with the other scales.)
- Quality of life: SF12 Health Questionnaire(Assessment using the scale will be conducted on the first day of menstrual bleeding during three consecutive cycles, together with the other scales.)
- Pain: McGill Pain Index (MPQ)(Pain assessment using the scale will be conducted on the first day of menstrual bleeding during three consecutive cycles, together with the other scales.)
- Quality of life related to menstruation: Specific quality of life questionnaire related to menstruation (CVM-22)(Assessment using the scale will be conducted on the first day of menstrual bleeding during three consecutive cycles, together with the other scales.)
- 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.)
- 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.)
- 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.)
研究者
Naiara Benítez Aramburu
Principal investigator
Escoles Universitaries Gimbernat
研究点 (2)
标识符
- NCT 编号
- NCT06233786
- 其他研究编号
- 2023.211
日期
- 首次提交
- (2年前)
- 首次发布
- (2年前)
- 主要完成日期
- (5个月前)
- 研究完成日期
- (7天前)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 是否有结果
- 否