Injection Site InflammationNCT05651139
Vibration Device Effect on Post-Injection Pain in the Upper Extremity
A study testing Electrical Vibration Device in people with Injection Site Inflammation and Upper Extremity Problem, run by Hatan Mortada at 1 site in Saudi Arabia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Injection Site Inflammation, Upper Extremity Problem
- What is being tested?
- Electrical Vibration Device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 20 Jan 2023to 20 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Those on analgesic medications
- Alcoholics, drug abusers
- Pregnant patients
- Menstruating women
- Patients with reported allergies
- Patients with acute infections
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Saud University Medical City
Riyadh, Central Region
About this study
Official title: The Effectiveness of Using Vibration Device to Ease Pain During Injections Into the Upper Extremity: a Randomized Controlled Trial
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.
Read the 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
- Being tested
- Electrical Vibration Device
- Keywords
- Vibration simulation, Vibration Therapy, Post-Injection Pain, Upper extremity injection pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Vibration DeviceDevice
An electrical Vibration Massage device will be used to induce deep tissue vibration stimulation
| Study group | Role | What they receive |
|---|---|---|
| Receiving vibration stimulation post-injection | Experimental | Using a vibration device post-injection on the affected area. Receives: Device: Electrical Vibration Device |
| control group | No intervention | No intervention will be conducted |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: The satisfaction will be measured immediately post-injection and intervention (with in 5 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start20 Jan 2023
- Primary completion20 Apr 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injection Site InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hatan Mortada
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Hatan Mortada, King Saud Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651139
- Sponsor's protocol ID
- A3261446
- Status last verified
- Dec 2022
- First submitted
- 14 Nov 2022
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Using Vibration Device to Ease Pain During Injections Into the Upper Extremity: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05651139
- Acronym / sponsor ID
- A3261446
- Keywords
- Vibration simulation, Vibration Therapy, Post-Injection Pain, Upper extremity injection pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hatan MortadaOther government
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Receiving vibration stimulation post-injection | Experimental | Device: Electrical Vibration DeviceUsing a vibration device post-injection on the affected area. |
| control group | No intervention | –No intervention will be conducted |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Those on analgesic medications
- Alcoholics, drug abusers
- Pregnant patients
- Menstruating women
- Patients with reported allergies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical Vibration DeviceAn electrical Vibration Massage device will be used to induce deep tissue vibration stimulation | Device | Receiving vibration stimulation post-injection |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Vibration Device in people with Injection Site Inflammation and Upper Extremity Problem, run by Hatan Mortada at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.