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Vibration Device Effect on Post-Injection Pain in The Upper Extremity

Primary Purpose

Injection Site Inflammation, Upper Extremity Problem

Status
Not yet recruiting
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Electrical Vibration Device
Sponsored by
Hatan Mortada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Injection Site Inflammation focused on measuring Vibration simulation, Vibration Therapy, Post-Injection Pain, Upper extremity injection pain

Eligibility Criteria

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

Inclusion Criteria: At least 18 years of age American Society of Anesthesiologists (ASA) physical status class I Pain free Adult patients scheduled to receive local anesthesia or corticosteroid injections in their upper extremities Exclusion Criteria: Those on analgesic medications Alcoholics, drug abusers Pregnant patients Menstruating women Patients with reported allergies Patients with acute infections

Sites / Locations

  • King Saud University Medical City

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Receiving vibration stimulation post-injection

control group

Arm Description

Using a vibration device post-injection on the affected area.

No intervention will be conducted

Outcomes

Primary Outcome Measures

The effects of vibration on upper extremity injection-induced pain
Measuring the pain using the Visual Analog Scale (VAS) for pain, which is a validated tool. the scale measures pain from 0 (no pain) to 10 (pain as bad as it could possibly be)
The effects of vibration on injection satisfaction for upper extremity injections
The satisfaction will be measured using Satisfaction visual analog scale, which is a validated tool. the scale measures the satisfaction from 0 (not satisfied) to 10 (very satisfied)

Secondary Outcome Measures

Full Information

First Posted
November 14, 2022
Last Updated
December 6, 2022
Sponsor
Hatan Mortada
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1. Study Identification

Unique Protocol Identification Number
NCT05651139
Brief Title
Vibration Device Effect on Post-Injection Pain in The Upper Extremity
Official Title
The Effectiveness of Using Vibration Device to Ease Pain During Injections Into the Upper Extremity: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 20, 2023 (Anticipated)
Primary Completion Date
April 20, 2023 (Anticipated)
Study Completion Date
June 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hatan Mortada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Background: Vibratory stimulation is one of several non-pharmacological techniques used to reduce pain. Local vibration therapy generates vibrations that can penetrate up to 6 centimeters into the tissue and is utilized to manage muscle tone, alleviate localized pain, and induce an increase in blood and lymphatic circulation. This therapy is most commonly used to treat chronic pathologies of the muscles, tendons, and joints. A few studies investigating the effects of local vibration therapy on skeletal muscles and joints have found it to be beneficial in improving joint mobility and decreasing pain. Previous reports have indicated that whole-body vibration can suppress chronic low back pain, knee osteoarthritis, and peripheral neuropathy. The aim of this study is to evaluate the effects of the application of vibration stimulation on upper extremity injection-induced pain and satisfaction. Objectives: The purpose of this study is to assess the effect of vibration stimulation application on upper extremity injection pain and satisfaction. Methods: An electrical massage kit that induces vibration will be used on adult patients who are scheduled to receive local anesthesia or corticosteroid injections in their upper extremities. Two validated scales will be used to first assess the pain after the injection and the patient's satisfaction following the use of the vibration device.
Detailed Description
Study design: randomized controlled trial Study duration: 12 months, beginning in November 2022 and ending in May 2023. Study settings: Data will be collected from patients coming to the plastic surgery department. Study population: adult patients scheduled to receive local anesthesia or corticosteroid injections in their upper extremities. Eligibility criteria: Adult patients with (ASA) physical status class 1 who are scheduled to receive local anesthesia or corticosteroid injections Sample size: 60 adult patients who are attending plastic surgery clinic for upper extremity injections. Ethical consideration: The authors have no ethical or financial considerations to disclose. Rationale for using the device: Vibrational stimulation is a relevant treatment option for pain. It has shown promise in reducing pain in a number of musculoskeletal conditions where it has been used successfully. There aren't any randomized controlled trials that explore the effect vibration stimulation has on post-injection pain in the upper extremity. Data collection method: Data will be collected through a data sheet. The co-investigators will collect the data directly from the patients after the injections and measure the pain using a visual analogue scale for pain. A satisfaction visual scale is also provided to assess satisfaction with the vibration device. There will also be a control group that will receive the injections without using the vibration device. Randomization will be carried out using a coin flip. Statistical analysis: Data will be analyzed using SPSS 24.0 version statistical software. Descriptive statistics (mean, standard deviation, frequencies, and percentages) will be used to describe the quantitative and categorical variables. Bivariate statistical analysis will be carried out using appropriate (chi-square, student's t test, one-way analysis of variance, and Pearson's correlation) statistical test, based on the type of study and outcome variables. A p-value of <0.05 and 95% CI will be used to report the statistical significance and precision of results

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injection Site Inflammation, Upper Extremity Problem
Keywords
Vibration simulation, Vibration Therapy, Post-Injection Pain, Upper extremity injection pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Receiving vibration stimulation post-injection
Arm Type
Experimental
Arm Description
Using a vibration device post-injection on the affected area.
Arm Title
control group
Arm Type
No Intervention
Arm Description
No intervention will be conducted
Intervention Type
Device
Intervention Name(s)
Electrical Vibration Device
Intervention Description
An electrical Vibration Massage device will be used to induce deep tissue vibration stimulation
Primary Outcome Measure Information:
Title
The effects of vibration on upper extremity injection-induced pain
Description
Measuring the pain using the Visual Analog Scale (VAS) for pain, which is a validated tool. the scale measures pain from 0 (no pain) to 10 (pain as bad as it could possibly be)
Time Frame
Pain will be measured immediately after receiving the intervention (with in 2 minutes)
Title
The effects of vibration on injection satisfaction for upper extremity injections
Description
The satisfaction will be measured using Satisfaction visual analog scale, which is a validated tool. the scale measures the satisfaction from 0 (not satisfied) to 10 (very satisfied)
Time Frame
The satisfaction will be measured immediately post-injection and intervention (with in 5 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years of age American Society of Anesthesiologists (ASA) physical status class I Pain free Adult patients scheduled to receive local anesthesia or corticosteroid injections in their upper extremities Exclusion Criteria: Those on analgesic medications Alcoholics, drug abusers Pregnant patients Menstruating women Patients with reported allergies Patients with acute infections
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hatan Mortada, MBBS
Phone
+966546680755
Email
hatanmortada@gmail.com
Facility Information:
Facility Name
King Saud University Medical City
City
Riyadh
State/Province
Central Region
Country
Saudi Arabia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hatan Mortada, MBBS
Phone
+966546680755
Email
hatanmortada@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Vibration Device Effect on Post-Injection Pain in The Upper Extremity

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