Vibration for Pain Reduction During Trigger Point Injection

NCT ID: NCT03365674

Last Updated: 2019-02-22

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-30

Study Completion Date

2018-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Myofascial Pain Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vibration group

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

Group Type EXPERIMENTAL

Vibration

Intervention Type DEVICE

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

Placebo group

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

Group Type PLACEBO_COMPARATOR

Placebo vibration

Intervention Type DEVICE

Vibrator applied with switch-off state

Interventions

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Vibration

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

Intervention Type DEVICE

Placebo vibration

Vibrator applied with switch-off state

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Soonchunhyang University Hospital

OTHER

Sponsor Role collaborator

The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Young Eun Moon

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sang-Hyun Kim, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Soonchunhyang University Hospital

Locations

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Soonchunhyang University Hospital, Bucheon

Bucheon-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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Yoon SH, Rah UW, Sheen SS, Cho KH. Comparison of 3 needle sizes for trigger point injection in myofascial pain syndrome of upper- and middle-trapezius muscle: a randomized controlled trial. Arch Phys Med Rehabil. 2009 Aug;90(8):1332-9. doi: 10.1016/j.apmr.2009.01.028.

Reference Type BACKGROUND
PMID: 19651267 (View on PubMed)

Mally P, Czyz CN, Chan NJ, Wulc AE. Vibration anesthesia for the reduction of pain with facial dermal filler injections. Aesthetic Plast Surg. 2014 Apr;38(2):413-8. doi: 10.1007/s00266-013-0264-4. Epub 2014 Jan 24.

Reference Type BACKGROUND
PMID: 24464122 (View on PubMed)

Park KY, Lee Y, Hong JY, Chung WS, Kim MN, Kim BJ. Vibration Anesthesia for Pain Reduction During Intralesional Steroid Injection for Keloid Treatment. Dermatol Surg. 2017 May;43(5):724-727. doi: 10.1097/DSS.0000000000001040.

Reference Type BACKGROUND
PMID: 28244902 (View on PubMed)

Moon YE, Kim SH, Seok H, Lee SY. Efficacy of Topical Vibratory Stimulation for Reducing Pain During Trigger Point Injection to the Gastrocnemius: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2019 Sep;100(9):1607-1613. doi: 10.1016/j.apmr.2019.02.010. Epub 2019 Mar 27.

Reference Type DERIVED
PMID: 30926293 (View on PubMed)

Other Identifiers

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TPI vibrator

Identifier Type: -

Identifier Source: org_study_id

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