Vibration for Pain Reduction During Trigger Point Injection

February 20, 2019 updated by: Young Eun Moon, The Catholic University of Korea

Vibration Anesthesia for Pain Reduction During Trigger Point Injection to the Gastrocnemius

The aim of this study is to evaluate the effects of vibration anesthesia for reducing pain induced by trigger point injection of gastrocnemius.

Sixty patients were randomized into the vibration or placebo group. In vibration groups, vibrator head was applied (100Hz) on the popliteal fossa, during the trigger point injection. In placebo group, same vibrator head was applied with switch-off sate. Then, a visual analog scale to evaluate the pain of trigger point injection and a five-point Likert scale for patients satisfaction were compared between the two groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Bucheon-si, Gyeonggi-do, Korea, Republic of, 14584
        • Soonchunhyang University Hospital, Bucheon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who have the trigger point in the gastrocnemius and show referred pain.

Exclusion Criteria:

  • Those with prior history of trigger point injection
  • Those with taking anti-platelet agent
  • Those with hemorrhage tendency
  • Pregnancy
  • Acute infection
  • those who were unable to understand a visual analog scale (VAS) or a Likert scale

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Vibration group
Vibrator head was applied (100Hz) on the popliteal fossa, during the trigger point injection
Device: Vibration
Vibration applied with vibrator switch-on state (100Hz)
PLACEBO_COMPARATOR: Placebo group
In placebo group, vibrator head was applied with switch-off sate, during the trigger point injection
Device: Placebo vibration
Vibrator applied with switch-off state

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analog scale
Time Frame: Immediately after trigger point injection (within 5 minute)
100 mm visual analog scale for evaluating the pain of trigger point injection
Immediately after trigger point injection (within 5 minute)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5 point Likert scale for participant satisfaction
Time Frame: Immediately after trigger point injection (within 5 minute)
5 point Likert scale to answer "Are you satisfied with the vibration application for reducing the pain of trigger point injection?"
Immediately after trigger point injection (within 5 minute)
5 point Likert scale for repeated usage
Time Frame: Immediately after trigger point injection (within 5 minute)
5 point Likert scale to answer "Will you use the vibration application again if the trigger point injection is repeated in the future?"
Immediately after trigger point injection (within 5 minute)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Collaborators

Soonchunhyang University Hospital

Investigators

  • Principal Investigator: Sang-Hyun Kim, MD,PhD, Soonchunhyang University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 30, 2017

Primary Completion (ACTUAL)

March 30, 2018

Study Completion (ACTUAL)

April 30, 2018

Study Registration Dates

First Submitted

December 3, 2017

First Submitted That Met QC Criteria

December 3, 2017

First Posted (ACTUAL)

December 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 22, 2019

Last Update Submitted That Met QC Criteria

February 20, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TPI vibrator

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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