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
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Experimental: Vibration group
Vibrator head was applied (100Hz) on the popliteal fossa, during the trigger point injection
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
- 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
- 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?"
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
|Contact: Sang-Hyun Kim, MD, PhDfirstname.lastname@example.org|
|Korea, Republic of|
|Soonchunhyang University Hospital, Bucheon||Recruiting|
|Bucheon-si, Gyeonggi-do, Korea, Republic of, 14584|
|Contact: Sang-Hyun Kim, MD,PhD 821023577324 email@example.com|
|Principal Investigator:||Sang-Hyun Kim, MD,PhD||Soonchunhyang University Hospital|