Vibration for Pain Reduction During Trigger Point Injection

Study Overview
=================
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.

Official Title
-----------------
Vibration Anesthesia for Pain Reduction During Trigger Point Injection to the Gastrocnemius

Conditions
-----------------
Myofascial Pain Syndromes

Intervention / Treatment
-----------------
* Device: Vibration
* Device: Placebo vibration


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vibration group<br>Vibrator head was applied (100Hz) on the popliteal fossa, during the trigger point injection | Device: Vibration<br>* Vibration applied with vibrator switch-on state (100Hz)<br>|
| Placebo Comparator: Placebo group<br>In placebo group, vibrator head was applied with switch-off sate, during the trigger point injection | Device: Placebo vibration<br>* Vibrator applied with switch-off state<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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? | Immediately after trigger point injection (within 5 minute) | 
| 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? | Immediately after trigger point injection (within 5 minute) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myofascial Pain Syndromes, Gastrocnemius, Trigger points, Injections, Vibration