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Completed

NCT Number: NCT03365674

Vibration for Pain Reduction During Trigger Point Injection

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Soonchunhyang University Hospital, Bucheon

Bucheon-si, Gyeonggi-do, 14584, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vibration

Device

Vibration applied with vibrator switch-on state (100Hz)

Placebo vibration

Device

Vibrator applied with switch-off state

Primary outcomes

  1. 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

  1. 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?"

  2. 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?"

Sponsors and collaborators

Lead sponsor

The Catholic University of Korea

Other

Collaborators

  • Soonchunhyang University Hospital

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 7, 2017
Registry last updated
Feb 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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