Vibration for Pain Reduction During Trigger Point Injection

Myofascial Pain Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03365674
• Other study ID #: TPI vibrator
• Status: Completed
• Phase: N/A
• Start date: September 30, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: February 2019
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 30, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Device:
• Vibration
Vibration applied with vibrator switch-on state (100Hz)
• Placebo vibration
Vibrator applied with switch-off state

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Hospital, Bucheon	Bucheon-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
The Catholic University of Korea	Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog scale	100 mm visual analog scale for evaluating the pain of trigger point injection	Immediately after trigger point injection (within 5 minute)
Secondary	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?"	Immediately after trigger point injection (within 5 minute)
Secondary	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?"	Immediately after trigger point injection (within 5 minute)