Vibration for Pain Reduction During Trigger Point Injection

NCT03365674 | Completed DMC

• 1 other identifier: TPI vibrator
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Myofascial Pain Syndromes

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 5 point Likert scale for participant satisfaction

  Immediately after trigger point injection (within 5 minute)

• 5 point Likert scale for repeated usage

  Immediately after trigger point injection (within 5 minute)

Study Arms (2)

Vibration group

EXPERIMENTAL

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

Device: Vibration

Placebo group

PLACEBO COMPARATOR

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

Device: Placebo vibration

Interventions

Vibration DEVICE

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

Vibration group

Placebo vibration DEVICE

Vibrator applied with switch-off state

Placebo group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Catholic University of Korea: lead
• Soonchunhyang University Hospital: collaborator

Study Sites (1)

Soonchunhyang University Hospital, Bucheon

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

Location

Related Publications (4)

• 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.

  PMID: 19651267 BACKGROUND

• 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.

  PMID: 24464122 BACKGROUND

• 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.

  PMID: 28244902 BACKGROUND

• 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.

  PMID: 30926293 DERIVED

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Sang-Hyun Kim, MD,PhD

  Soonchunhyang University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: December 3, 2017
• First Posted: December 7, 2017
• Study Start: September 30, 2017
• Primary Completion: March 30, 2018
• Study Completion: April 30, 2018
• Last Updated: February 22, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)