Clinical trial NCT03365674: Vibration for Pain Reduction During Trigger Point Injection
Official title: Vibration Anesthesia for Pain Reduction During Trigger Point Injection to the Gastrocnemius
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain Syndromes
Keywords: Myofascial Pain Syndromes, Gastrocnemius, Trigger points, Injections, Vibration
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
Collaborators: name: Soonchunhyang University Hospital
First posted: 2017-12-07
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Visual analog scale
timeFrame: Immediately after trigger point injection (within 5 minute)
Secondary outcomes:
measure: 5 point Likert scale for participant satisfaction
timeFrame: Immediately after trigger point injection (within 5 minute)
measure: 5 point Likert scale for repeated usage
timeFrame: Immediately after trigger point injection (within 5 minute)
Other outcomes:
Locations:
city: Bucheon-si
country: Korea, Republic of
facility: Soonchunhyang University Hospital, Bucheon
state: Gyeonggi-do
Study officials:
affiliation: Soonchunhyang University Hospital
name: Sang-Hyun Kim, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
citation: 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.