NCT02647008

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
26 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

4 months

First QC Date

January 3, 2016

Last Update Submit

September 11, 2016

Conditions

Uterus Dysfunction

Keywords

outpatient hysteroscopy, TENS

Outcome Measures

Primary Outcomes (1)

  • Pain, assessed by visual analogue scale (VAS)

    5 minutes after hysteroscopy

Secondary Outcomes (1)

  • Pain assessed by Likert scale.

    5 minutes after hysteroscopy

Other Outcomes (3)

  • Heart Rate

    5 minutes after hysteroscopy

  • Blood Pleasure

    5 minutes after hysteroscopy

  • Total procedure time

    5 minutes after hysteroscopy

Study Arms (3)

ACTIVE TENS

EXPERIMENTAL

ACTIVE TENS

Device: TENS

PLACEBO

PLACEBO COMPARATOR

INACTIVE TENS

Device: TENS

CONTROL

NO INTERVENTION

NO TENS

Interventions

TENSDEVICE

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.

ACTIVE TENSPLACEBO

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad CEU Cardenal Herrera

Moncada, Valencia, 46113, Spain

Location

Related Publications (2)

  • 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.

    PMID: 20538494BACKGROUND

  • 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.

    PMID: 28079781DERIVED

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Juan Fco. Lisón, Dr

    University CEU Cardenal Herrera

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Medicine

Study Record Dates

First Submitted

January 3, 2016

First Posted

January 6, 2016

Study Start

February 1, 2016

Primary Completion

June 1, 2016

Study Completion

September 1, 2016

Last Updated

September 13, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)