Evaluation of the Efficacy and Tolerability of a Transcutaneous Electrical Nerve Stimulation (TENS) Device for the Management of Endometriosis-associated Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Change in the mean value of average pain
研究概览
简要总结
ELECTRE is a single-center, randomized, prospective, longitudinal, controlled, two-arm, single-blind study lasting 4 weeks (P1 investigation phase) after a 4-week run-in period.
The study is followed by a 4-week extension phase (P2) in which all participants will be treated with active TENS.
Randomization will be balanced according to a 1:1 ratio.
详细描述
- Endometriosis is defined by the presence of endometrial tissue outside the uterine cavity. It affects 6% to 10% of women of childbearing age. Depending on its location, a distinction is made between superficial endometriosis, adenomyosis, and deep endometriosis. The potential mechanisms of endometriosis are still under discussion.
- Endometriosis is accompanied by a painful triad combining dysmenorrhea, dyspareunia, and chronic pelvic pain.
- Pain requires treatment due to its multiple impacts in terms of quality of life, anxiety, depression, loss of productivity at work, and absenteeism.
- Approximately one-third of women with endometriosis continue to suffer despite medical treatment.
- The pain of endometriosis is multifactorial, involving inflammatory, nociceptive, neuropathic, neurovascular, myofascial, and hormonal mechanisms. The recurrence of endometriosis-related pain means that it must be considered a chronic pain syndrome leading to peripheral and central neural sensitization. The intensity of the pain is not correlated with the severity of the disease.
- Transcutaneous electrical nerve stimulation (TENS) is a non-invasive, easy-to-use, well-tolerated, self-administered technique widely used for its analgesic effect in acute and chronic pain. Several studies have suggested the effectiveness of TENS in the management of pelvic pain related to endometriosis, but they are of uneven quality.
- Evaluating the effectiveness of TENS in the management of endometriosis-related pain under the best methodological conditions remains essential.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged ≥ 18 years
- •Endometriosis and/or adenomyosis diagnosed by imaging and/or histology
- •Undergoing continuous, stable, and functional hormone treatment (with no menstruation) for at least 2 months
- •No change in hormone treatment planned for the duration of the study
- •Chronic pelvic pain for more than 6 months
- •Pelvic pain at least equal to 2 out of 3 (on the intensity scale: "0 - None," "1 - Mild," "2 - Moderate," "3 - Severe")
- •Agreeing to participate in the study
- •Agrees to limit pain relief treatment during the study to level I painkillers paracetamol and Acupan® (nefopam), and the NSAID Antadys® (flurbiprofen)
- •Has a computer, tablet, or cell phone with an internet connection
- •Is affiliated with a social security system or is a beneficiary of such a system
排除标准
- •Pregnant or breastfeeding women
- •Menopausal women
- •Patients who, in the investigator's opinion, have experienced an acute worsening of endometriosis symptoms in the last 28 days
- •Patients with altered sensitivity in the area where the device is applied (hypoesthesia)
- •Skin allergy to the gel or electrodes
- •Dermatological problem in the stimulation area
- •Patients with an implanted pacemaker or active implanted medical device.
- •Current thrombophlebitis or arterial thrombosis
- •Cancer or malignant disease with an expected survival of < 12 months
- •Alcoholism or drug addiction
- •Fibromyalgia
- •Women who have already tried TENS
- •Patients unable to understand and use the English language to communicate fluently
- •Patients with cognitive impairments
- •Untreated severe psychiatric illness and/or psychological condition that is the primary determinant of the patient's condition
- •Participation in another intervention study that may impact the results of the current study
- •Patient using > 90 morphine equivalents/day (at least once in the last 28 days)
- •Gynecological and/or endometriosis surgery planned within the next 3 months
- •History of endometriosis surgery within the last 6 months
- •Patient who has undergone a hysterectomy or bilateral oophorectomy
- •Patient under legal protection (guardianship or conservatorship) or patient deprived of liberty
研究组 & 干预措施
Conventional TENS Group
Conventional TENS for 4 weeks
干预措施: Conventional TENS (Device)
Microstimulation TENS
Microstimulation TENS for 4 weeks
干预措施: Microstimulation TENS (Device)
结局指标
主要结局
Change in the mean value of average pain
时间窗: 56 days
Change in the mean value of average pain over the previous 24 hours, measured daily during the P1 investigation phase (between D1 and D28±2), compared with the run-in period (between D-35 and D-8). Participants will assess their average pain over the past 24 hours on a 100 mm visual analog scale (VAS) every day. The average of these daily values will be calculated over the run-in period (between D-35 and D-8), during the P1 investigation phase (between D1 and D28±2), and during the P2 extension phase (between D29±2 and D56±2). The visual analog scale will be available on the data collection tool/website provided and accessible throu PC, tablet or smartphone. The VAS is presented as a 100 mm horizontal line with no boundaries, marked at the left end with "no pain" and at the other end with "worst pain imaginable." Repeated pain measurements during the run-in period will provide a reliable baseline value that takes into account daily variations.
次要结局
未报告次要终点