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Clinical Trials/NCT03365674
NCT03365674CompletedNot Applicable

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

The Catholic University of Korea2 sites in 1 country60 target enrollmentStarted: September 30, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
2
Primary Endpoint
Visual analog scale

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Vibration group

Experimental

Vibrator head was applied (100Hz) on the popliteal fossa, during the trigger point injection

Intervention: Vibration (Device)

Placebo group

Placebo Comparator

In placebo group, vibrator head was applied with switch-off sate, during the trigger point injection

Intervention: Placebo vibration (Device)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 5 point Likert scale for participant satisfaction(Immediately after trigger point injection (within 5 minute))
  • 5 point Likert scale for repeated usage(Immediately after trigger point injection (within 5 minute))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Young Eun Moon

Medical Doctor

The Catholic University of Korea

Study Sites (2)

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