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Vibration for Pain Reduction During Trigger Point Injection

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ClinicalTrials.gov Identifier: NCT03365674
Recruitment Status : Recruiting
First Posted : December 7, 2017
Last Update Posted : December 7, 2017
Sponsor:
Collaborator:
Soonchunhyang University Hospital
Information provided by (Responsible Party):
Young Eun Moon, The Catholic University of Korea

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.


Condition or disease Intervention/treatment Phase
Myofascial Pain Syndromes Device: Vibration Device: Placebo vibration Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vibration Anesthesia for Pain Reduction During Trigger Point Injection to the Gastrocnemius
Actual Study Start Date : September 30, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vibration group
Vibrator head was applied (100Hz) on the popliteal fossa, during the trigger point injection
Device: Vibration
Vibration applied with vibrator switch-on state (100Hz)

Placebo Comparator: Placebo group
In placebo group, vibrator head was applied with switch-off sate, during the trigger point injection
Device: Placebo vibration
Vibrator applied with switch-off state




Primary Outcome Measures :
  1. Visual analog scale [ Time Frame: Immediately after trigger point injection (within 5 minute) ]
    100 mm visual analog scale for evaluating the pain of trigger point injection


Secondary Outcome Measures :
  1. 5 point Likert scale for participant satisfaction [ Time Frame: Immediately after trigger point injection (within 5 minute) ]
    5 point Likert scale to answer "Are you satisfied with the vibration application for reducing the pain of trigger point injection?"

  2. 5 point Likert scale for repeated usage [ Time Frame: Immediately after trigger point injection (within 5 minute) ]
    5 point Likert scale to answer "Will you use the vibration application again if the trigger point injection is repeated in the future?"



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365674


Contacts
Contact: Sang-Hyun Kim, MD, PhD 821023577324 sanghyunkim71@gmail.com

Locations
Korea, Republic of
Soonchunhyang University Hospital, Bucheon Recruiting
Bucheon-si, Gyeonggi-do, Korea, Republic of, 14584
Contact: Sang-Hyun Kim, MD,PhD    821023577324    sanghyunkim71@gmail.com   
Sponsors and Collaborators
The Catholic University of Korea
Soonchunhyang University Hospital
Investigators
Principal Investigator: Sang-Hyun Kim, MD,PhD Soonchunhyang University Hospital

Publications:
Responsible Party: Young Eun Moon, Medical Doctor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT03365674     History of Changes
Other Study ID Numbers: TPI vibrator
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Young Eun Moon, The Catholic University of Korea:
Myofascial Pain Syndromes, Gastrocnemius, Trigger points, Injections, Vibration

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Fibromyalgia
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases