Clinical trial NCT02647008: Pain Relief During Unsedated Office Hysteroscopy by Applying TENS
Official title: Pain Relief During Unsedated Office Hysteroscopy by Applying Transcutaneous Electrical Nerve Stimulation (TENS): A Randomized Double-blind Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterus Dysfunction
Keywords: outpatient hysteroscopy, TENS
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2016-01-06
Enrollment: 138
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim: To compare the pain-relieving effect of a specific application of TENS vs. placebo TENS and a control group during unsedated diagnostic office hysteroscopy.

Design: double-blind randomized placebo-controlled trial. Setting: Outpatient setting. Population: Women who attended annual gynecological check up, and were indicated for diagnostic office hysteroscopy.

Detailed description: Nowadays, diagnostic hysteroscopy is an easy and economically acceptable technique, that is being used by the gynecologist to evaluate different pathologies that used to be studied by other blind techniques. Although most women tolerate it well, the most common cause for failure during office hysteroscopy is pain. In order to overcome this adversity several studies have been carried out using different types of pain relievers as local anesthesia, misoprostol, music, and NSAID to prevent the occurrence of a vagal reaction, but the results have been contradictory. Other analgesic alternatives that prioritize these three points should be considered. Transcutaneous electrical nerve stimulation (TENS) has become a very common electrotherapy as a pain-reliever because of its attributes, namely a noninvasive and non-pharmacological method based on the delivery of pulsed electrical currents through the skin, using surface electrodes, effective in many variety of conditions, such as neuropathic pain, musculoskeletal pain, headache, gynecological and obstetric pain, to treat both chronic and acute pain, even from visceral organs.

Aim: to compare the pain-relieving effect of a specific application of TENS vs. placebo TENS and a control group during unsedated diagnostic office hysteroscopy.

Design: double-blind randomized placebo-controlled trial. Setting: Outpatient setting; Hospital Provincial de Castellon (Spain) and Hospital General de Castellon (Spain).

Population: Women who attended annual gynecological check up, and were indicated for diagnostic office hysteroscopy

Eligibility criteria: Inclusion Criteria: women who attended annual gynecological check up, and were indicated for diagnostic office hysteroscopy because of different pathologies such as:

* postmenopausal endometrial thickening \>4mm;
* postmenopausal abnormal uterine bleeding;
* suspicious endometrial polyp or leiomyoma;
* infertility study;
* suspicious endometrial carcinoma;
* hypermenorrhea

Exclusion Criteria:

* age less than 18;
* previous cervical surgery;
* neurological deficit;
* chronic or preprocedural use of opioids or psychoactive drugs;
* previous experience in TENS;
* cutaneous damage on the application sites;
* pacemakers or automatic implanted cardiac defibrillators;
* refusal to sign the informed consent form;
* inability to understand informed consent form.

Primary outcomes:
measure: Pain, assessed by visual analogue scale (VAS)
timeFrame: 5 minutes after hysteroscopy
Secondary outcomes:
measure: Pain assessed by Likert scale.
timeFrame: 5 minutes after hysteroscopy
Other outcomes:
measure: Heart Rate
timeFrame: 5 minutes after hysteroscopy
measure: Blood Pleasure
timeFrame: 5 minutes after hysteroscopy
measure: Total procedure time
timeFrame: 5 minutes after hysteroscopy
Locations:
city: Moncada
country: Spain
facility: Universidad CEU Cardenal Herrera
state: Valencia
Study officials:
affiliation: University CEU Cardenal Herrera
name: Juan Fco. Lisón, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amer-Cuenca JJ, Goicoechea C, Girona-Lopez A, Andreu-Plaza JL, Palao-Roman R, Martinez-Santa G, Lison JF. Pain relief by applying transcutaneous electrical nerve stimulation (TENS) during unsedated colonoscopy: a randomized double-blind placebo-controlled trial. Eur J Pain. 2011 Jan;15(1):29-35. doi: 10.1016/j.ejpain.2010.05.006. Epub 2010 Jun 9.
citation: Lison JF, Amer-Cuenca JJ, Piquer-Marti S, Benavent-Caballer V, Bivia-Roig G, Marin-Buck A. Transcutaneous Nerve Stimulation for Pain Relief During Office Hysteroscopy: A Randomized Controlled Trial. Obstet Gynecol. 2017 Feb;129(2):363-370. doi: 10.1097/AOG.0000000000001842.