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Transcutaneous Electrical Nerve Stimulation Treatment of Renal Colic

Primary Purpose

Renal Colic

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
TENS
placebo group
Sponsored by
Adiyaman University Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Colic focused on measuring Transcutaneous electrical nerve stimulation, emergency medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult patients with renal colic admitted to emergency department.
  2. Adult patients who were definitively diagnosed with acute renal colic due to urinary system stones using unenhanced computed abdominopelvic tomography

Exclusion Criteria:

  1. Patients below 18 years of age
  2. Patients with haemodynamic instability, with fever (temperature=38°C [100.4°F]), with evidence of peritoneal inflammation,
  3. Patients using any analgesic within the previous 48 hours of emergency department presentation
  4. Patients who declined to participate

Sites / Locations

  • Adiyaman University Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

TENS

placebo group

Arm Description

Patients receiving the real transcutaneous electrical nerve stimulation (TENS) with 100 hertz, pulse width 200 microseconds, voltage 2 milliampere

Patients receiving the application of transcutaneous electrical nerve stimulation, but transcutaneous electrical nerve stimulation will not be activated.

Outcomes

Primary Outcome Measures

Reduction of the intensity of pain
Subjects will complete 100 mm visual analog scales at time zero, 15 and 30 minutes after taking Transcutaneous Electrical Nerve Stimulation application

Secondary Outcome Measures

Adverse events
30 minutes after taking Transcutaneous Electrical Nerve Stimulation application

Full Information

First Posted
July 27, 2017
Last Updated
September 8, 2017
Sponsor
Adiyaman University Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03237208
Brief Title
Transcutaneous Electrical Nerve Stimulation Treatment of Renal Colic
Official Title
Patients Undergoing Routine Transcutaneous Electrical Nerve Stimulation Treatment in Patients With Renal Colic Who Admitted to the Emergency Department: A Randomized Double Blind Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
June 12, 2017 (Actual)
Primary Completion Date
August 12, 2017 (Actual)
Study Completion Date
August 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Adiyaman University Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of the present trial was to investigate the analgesic efficacy and safety of Transcutaneous electrical nerve stimulation treatment in patients with renal colic within the emergency department.
Detailed Description
Renal colic, an intensely painful condition, is a common presenting complaint to the emergency department. Parenteral opioids, nonsteroidal anti-inflammatory drugs and acetaminophen are commonly used to provide relief from renal colic. The aim of the present trial was to investigate the analgesic efficacy and safety of Transcutaneous electrical nerve stimulation treatment in patients with renal colic within the emergency department. Study Design and Setting: A prospective, randomized, double-blind, placebo controlled, single-center, clinical trial will be conducted in emergency department of a tertiary care university hospital.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Colic
Keywords
Transcutaneous electrical nerve stimulation, emergency medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TENS
Arm Type
Active Comparator
Arm Description
Patients receiving the real transcutaneous electrical nerve stimulation (TENS) with 100 hertz, pulse width 200 microseconds, voltage 2 milliampere
Arm Title
placebo group
Arm Type
Sham Comparator
Arm Description
Patients receiving the application of transcutaneous electrical nerve stimulation, but transcutaneous electrical nerve stimulation will not be activated.
Intervention Type
Device
Intervention Name(s)
TENS
Intervention Description
Transcutaneous electrical nerve stimulation (TENS) treatment will be activated.
Intervention Type
Device
Intervention Name(s)
placebo group
Intervention Description
Transcutaneous electrical nerve stimulation treatment will not be activated.
Primary Outcome Measure Information:
Title
Reduction of the intensity of pain
Description
Subjects will complete 100 mm visual analog scales at time zero, 15 and 30 minutes after taking Transcutaneous Electrical Nerve Stimulation application
Time Frame
0 minutes, 15 minutes and 30 minutes after taking Transcutaneous Electrical Nerve Stimulation application
Secondary Outcome Measure Information:
Title
Adverse events
Description
30 minutes after taking Transcutaneous Electrical Nerve Stimulation application
Time Frame
30 minutes after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients with renal colic admitted to emergency department. Adult patients who were definitively diagnosed with acute renal colic due to urinary system stones using unenhanced computed abdominopelvic tomography Exclusion Criteria: Patients below 18 years of age Patients with haemodynamic instability, with fever (temperature=38°C [100.4°F]), with evidence of peritoneal inflammation, Patients using any analgesic within the previous 48 hours of emergency department presentation Patients who declined to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Umut Gulacti, M.D.
Organizational Affiliation
Adiyaman University of Medical Faculty
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adiyaman University Research Hospital
City
Adıyaman
State/Province
Central
ZIP/Postal Code
02000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23839103
Citation
Simpson PM, Fouche PF, Thomas RE, Bendall JC. Transcutaneous electrical nerve stimulation for relieving acute pain in the prehospital setting: a systematic review and meta-analysis of randomized-controlled trials. Eur J Emerg Med. 2014 Feb;21(1):10-7. doi: 10.1097/MEJ.0b013e328363c9c1.
Results Reference
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Transcutaneous Electrical Nerve Stimulation Treatment of Renal Colic

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