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Clinical Trials/NCT05651139
NCT05651139CompletedNot Applicable

The Effectiveness of Using Vibration Device to Ease Pain During Injections Into the Upper Extremity: a Randomized Controlled Trial

Hatan Mortada1 site in 1 country60 target enrollmentStarted: January 20, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
The effects of vibration on upper extremity injection-induced pain

Study Overview

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:

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

The effects of vibration on upper extremity injection-induced pain

Time Frame: Pain will be measured immediately after receiving the intervention (with in 2 minutes)

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

Time Frame: The satisfaction will be measured immediately post-injection and intervention (with in 5 minutes)

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 Outcomes

No secondary outcomes reported

Investigators

Sponsor
Hatan Mortada
Sponsor Class
Other Gov
Responsible Party
Sponsor Investigator
Principal Investigator

Hatan Mortada

Co-investigator

King Saud Medical City

Study Sites (1)

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