NCT05651139

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 14, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

January 20, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2023

Completed
Last Updated

March 6, 2025

Status Verified

December 1, 2022

Enrollment Period

3 months

First QC Date

November 14, 2022

Last Update Submit

March 3, 2025

Conditions

Injection Site InflammationUpper Extremity Problem

Keywords

Vibration simulationVibration TherapyPost-Injection PainUpper extremity injection pain

Outcome Measures

Primary Outcomes (2)

  • 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)

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

  • 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)

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

Study Arms (2)

Receiving vibration stimulation post-injection

EXPERIMENTAL

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

Device: Electrical Vibration Device

control group

NO INTERVENTION

No intervention will be conducted

Interventions

Electrical Vibration DeviceDEVICE

An electrical Vibration Massage device will be used to induce deep tissue vibration stimulation

Receiving vibration stimulation post-injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Those on analgesic medications
  • Alcoholics, drug abusers
  • Pregnant patients
  • Menstruating women
  • Patients with reported allergies
  • Patients with acute infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Saud University Medical City

Riyadh, Central Region, Saudi Arabia

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Co-investigator

Study Record Dates

First Submitted

November 14, 2022

First Posted

December 14, 2022

Study Start

January 20, 2023

Primary Completion

April 20, 2023

Study Completion

June 20, 2023

Last Updated

March 6, 2025

Record last verified: 2022-12

Locations

SA(1)