Pain Relief During Unsedated Office Hysteroscopy by Applying TENS

NCT ID: NCT02647008

Last Updated: 2016-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2016-09-30

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

Conditions

Uterus Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ACTIVE TENS

ACTIVE TENS

Group Type: EXPERIMENTAL

TENS

Intervention Type: DEVICE

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.

PLACEBO

INACTIVE TENS

Group Type: PLACEBO_COMPARATOR

TENS

Intervention Type: DEVICE

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.

CONTROL

NO TENS

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cardenal Herrera University

OTHER

Sponsor Role: lead

Responsible Party

Juan F. Lisón Párraga, Dr

Head of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juan Fco. Lisón, Dr

Role: PRINCIPAL_INVESTIGATOR

University CEU Cardenal Herrera

Locations

Universidad CEU Cardenal Herrera

Moncada, Valencia, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 20538494 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28079781 (View on PubMed)

Other Identifiers

UNIVERSITY CARDENAL HERRERA-2

Identifier Type: -

Identifier Source: org_study_id