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CompletedNCT03365674Updated Feb 22, 2019

Vibration for Pain Reduction During Trigger Point Injection

An interventional study of Vibration and Placebo vibration in Myofascial Pain Syndromes, sponsored by The Catholic University of Korea. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-02-22.

Sponsored by The Catholic University of Korea · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Myofascial Pain Syndromes

Keywords

  • Myofascial Pain Syndromes, Gastrocnemius, Trigger points, Injections, Vibration
03

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Vibration group

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

    Device: Vibration

  • Placebo comparator
    Placebo group

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

    Device: Placebo vibration

Interventions

  • DeviceVibration

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

  • DevicePlacebo vibration

    Vibrator applied with switch-off state

05

What researchers measure

Primary outcomes

  1. Visual analog scale

    100 mm visual analog scale for evaluating the pain of trigger point injection

    Time frame: Immediately after trigger point injection (within 5 minute)

Secondary outcomes

  1. 5 point Likert scale for participant satisfaction

    5 point Likert scale to answer "Are you satisfied with the vibration application for reducing the pain of trigger point injection?"

    Time frame: Immediately after trigger point injection (within 5 minute)

  2. 5 point Likert scale for repeated usage

    5 point Likert scale to answer "Will you use the vibration application again if the trigger point injection is repeated in the future?"

    Time frame: Immediately after trigger point injection (within 5 minute)

06

Study locations

1 site
  • Soonchunhyang University Hospital, Bucheon
    Bucheon-si, Gyeonggi-do 14584, Korea, Republic of
07

References and documents

Publications

  • 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. PubMed 19651267 ↗
  • 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. PubMed 24464122 ↗
  • 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. PubMed 28244902 ↗
  • 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. PubMed 30926293 ↗

Individual participant data

Plan to share: No — There is not a plan to make IPD available.

08

Registry details

Key details

Study ID
NCT03365674
Lead sponsor
The Catholic University of Korea
Collaborators
Soonchunhyang University Hospital
Responsible party
Young Eun Moon (Medical Doctor, The Catholic University of Korea) — Principal investigator
First posted
Dec 7, 2017
Start date
Sep 30, 2017
Primary completion
Mar 30, 2018
Completion
Apr 30, 2018
Last update
Feb 22, 2019

Study contacts

Sang-Hyun Kim, MD,PhD
principal investigator · Soonchunhyang University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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