Transcutaneous electrical nerve stimulation for women with primary dysmenorrhea: Study protocol for a randomized controlled clinical trial with economic evaluation.

Primary dysmenorrhea (PD) is a common gynecological disorder characterized by cramping pain in the lower abdomen during menstruation, in the absence of identifiable pathology. While Transcutaneous Electrical Nerve Stimulation (TENS) is used to promote PD pain relief, there is still a need to understand the parameters and cost-effectiveness of this intervention. As such, this study aims to disclose a study that will evaluate the effectiveness and cost-effectiveness of TENS on pain intensity in women with PD. This is a protocol for an assessor-blinded randomized controlled trial that includes 174 women with PD, >18 years old, with menstrual pain greater than or equal to four points in the Numerical Rating Scale. Participants will be randomized into three groups (active TENS, placebo TENS, and educational booklet). Participants allocated to the active TENS group will receive electrical stimulation (F = 100 Hz, pulse duration = 200 µs, for 30 min). In contrast, the placebo TENS group will receive placebo stimulation (same parameters, but for only 30 s, and then the current will be ramped off over a 15-s time frame) for three consecutive months during menstruation. Participants allocated to the educational booklet group will receive instructions about health promotion and education actions related to PD. A blinded assessor will evaluate the pain intensity (Numerical Rating Scale), presenteeism (Stanford Presenteeism Scale), Health-Related Quality of Life (Short-Form 6 dimensions and SF-36), and health costs of menstrual pain. This is the first study to propose a health economic evaluation while assessing the benefits of using TENS to treat PD symptoms. It is hypothesized that active TENS will be more effective than placebo TENS or the educational booklet in improving clinical outcomes in the short-, medium- and long-term. The study will also provide information about the cost-effectiveness of TENS, which can be used by policy makers to improve PD care in public and private health systems.

[Use of transcutaneous electrical nerve stimulation in the Unit of Pain Management of the Alcorcón Foundation University Hospital]. / Características del uso de estimulación nerviosa eléctrica transcutánea en la Unidad del Dolor del Hospital Universitario Fundación Alcorcón.

Transcutaneous electrical nerve stimulation (TENS) is a non-pharmacological therapy used to alleviate pain and is among the current available treatments offered by the Units of Pain Management (Unidades del Dolor) in Spanish Hospitals. The goal of this study was to identify the characteristics of portable electro-stimulator use, and its costs in the Unit of Pain Management of the Alcorcón Foundation University Hospital (Hospital Universitario Fundación Alcorcón). A retrospective descriptive study was carried out between January, 1999, and October, 2010, in the Unit of Pain Management of the Alcorcón Foundation University Hospital. The information on TENS delivery forms and its supplies was collected, and the characteristics of use and the associated costs were calculated. It was observed that the longest period of time used was less than a year. The cost of delivery for the portable equipment was 148 050 euros and the average annual cost for the use of TENS by a patient was 854 euros. From the information gathered, it can be concluded that the use of electro-analgesia is a valid option in terms of expenses for long periods of use, thereby allowing a reduction in costs and decreasing the use of other healthcare treatments.