Pain Relief During Unsedated Office Hysteroscopy by Applying TENS

Uterus Dysfunction Clinical Trial

Official title:

Pain Relief During Unsedated Office Hysteroscopy by Applying Transcutaneous Electrical Nerve Stimulation (TENS): A Randomized Double-blind Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02647008
• Other study ID #: UNIVERSITY CARDENAL HERRERA-2
• Status: Completed
• Phase: N/A
• First received: January 3, 2016
• Last updated: September 11, 2016
• Start date: February 2016
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Cardenal Herrera University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Uterus Dysfunction

Intervention

Device:
• TENS
Transcutaneous electrical nerve stimulation (TENS) is a nonpharmacological intervention that activates a complex neuronal network to reduce pain by activating descending inhibitory systems in the central nervous system to reduce hyperalgesia.These small battery powered devices deliver alternating current via cutaneous electrodes positioned near the painful area.

Locations

Country	Name	City	State
Spain	Universidad CEU Cardenal Herrera	Moncada	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Cardenal Herrera University

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Amer-Cuenca JJ, Goicoechea C, Girona-López A, Andreu-Plaza JL, Palao-Román R, Martínez-Santa G, Lisón 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heart Rate		5 minutes after hysteroscopy	No
Other	Blood Pleasure		5 minutes after hysteroscopy	No
Other	Total procedure time		5 minutes after hysteroscopy	No
Primary	Pain, assessed by visual analogue scale (VAS)		5 minutes after hysteroscopy	No
Secondary	Pain assessed by Likert scale.		5 minutes after hysteroscopy	No