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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

December 3, 2017
December 7, 2017
December 7, 2017
September 30, 2017
June 30, 2018   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
  • 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?"
  • 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?"
Same as current
Not Provided
Not Provided
 
Vibration for Pain Reduction During Trigger Point Injection
Vibration Anesthesia for Pain Reduction During Trigger Point Injection to the Gastrocnemius

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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Myofascial Pain Syndromes
  • Device: Vibration
    Vibration applied with vibrator switch-on state (100Hz)
  • Device: Placebo vibration
    Vibrator applied with switch-off state
  • Experimental: Vibration group
    Vibrator head was applied (100Hz) on the popliteal fossa, during the trigger point injection
    Intervention: Device: Vibration
  • Placebo Comparator: Placebo group
    In placebo group, vibrator head was applied with switch-off sate, during the trigger point injection
    Intervention: Device: Placebo vibration

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Same as current
September 30, 2018
June 30, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Older Adult)
No
Contact: Sang-Hyun Kim, MD, PhD 821023577324 sanghyunkim71@gmail.com
Korea, Republic of
 
 
NCT03365674
TPI vibrator
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.
Young Eun Moon, The Catholic University of Korea
The Catholic University of Korea
Soonchunhyang University Hospital
Principal Investigator: Sang-Hyun Kim, MD,PhD Soonchunhyang University Hospital
The Catholic University of Korea
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP