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Vibration for Pain Reduction During Trigger Point Injection

Primary Purpose

Myofascial Pain Syndromes

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Vibration

Placebo vibration

About this trial

This is an interventional treatment trial for Myofascial Pain Syndromes focused on measuring Myofascial Pain Syndromes, Gastrocnemius, Trigger points, Injections, Vibration

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Soonchunhyang University Hospital, Bucheon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vibration group

Placebo group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Visual analog scale

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

Secondary Outcome Measures

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?"

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?"

Full Information

NCT ID

NCT03365674

First Posted

December 3, 2017

Last Updated

February 20, 2019

Sponsor

The Catholic University of Korea

Collaborators

Soonchunhyang University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03365674

Brief Title

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

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

September 30, 2017 (Actual)

Primary Completion Date

March 30, 2018 (Actual)

Study Completion Date

April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Catholic University of Korea

Collaborators

Soonchunhyang University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myofascial Pain Syndromes

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vibration group

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Vibration

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Placebo vibration

Intervention Description

Vibrator applied with switch-off state

Primary Outcome Measure Information:

Title

Visual analog scale

Description

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

Time Frame

Immediately after trigger point injection (within 5 minute)

Secondary Outcome Measure Information:

Title

5 point Likert scale for participant satisfaction

Description

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)

Title

5 point Likert scale for repeated usage

Description

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sang-Hyun Kim, MD,PhD

Organizational Affiliation

Soonchunhyang University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Soonchunhyang University Hospital, Bucheon

City

Bucheon-si

State/Province

Gyeonggi-do

ZIP/Postal Code

14584

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is not a plan to make IPD available.

Citations:

PubMed Identifier

19651267

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.

Results Reference

background

PubMed Identifier

24464122

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.

Results Reference

background

PubMed Identifier

28244902

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.

Results Reference

background

PubMed Identifier

30926293

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.

Results Reference

derived

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Vibration for Pain Reduction During Trigger Point Injection

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