Transcutaneous Electrical Nerve Stimulation Treatment of Renal Colic

NCT ID: NCT03237208

Last Updated: 2017-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-12

Study Completion Date

2017-08-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Renal Colic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TENS

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

Group Type ACTIVE_COMPARATOR

TENS

Intervention Type DEVICE

Transcutaneous electrical nerve stimulation (TENS) treatment will be activated.

placebo group

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

Group Type SHAM_COMPARATOR

placebo group

Intervention Type DEVICE

Transcutaneous electrical nerve stimulation treatment will not be activated.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TENS

Transcutaneous electrical nerve stimulation (TENS) treatment will be activated.

Intervention Type DEVICE

placebo group

Transcutaneous electrical nerve stimulation treatment will not be activated.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Adiyaman University Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Umut Gulacti

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Umut Gulacti, M.D.

Role: PRINCIPAL_INVESTIGATOR

Adiyaman University of Medical Faculty

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Adiyaman University Research Hospital

Adıyaman, Central, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 23839103 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

08.06.2017/02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.