Pain, AnalgesiaNCT02870595
The Use of Micro Vibratory Stimulation Technique to Control the Pain of Digit Block Anesthesia
A study testing Microvibratory Stimulator and Microvibratory Stimulator' in people with Pain, Analgesia, run by Christus Spohn Memorial Medical Center.
Trial summary
The investigators hypothesize that patients who receive 1% lidocaine injections for digit blocks of the finger will experience less pain when the injection is accompanied by the use of a micro-vibratory stimulator (MVS) compared with patients who receive injections without the MVS. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Analgesia
- What is being tested?
- Microvibratory Stimulator and Microvibratory Stimulator'
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Sep 2015
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals between the ages of 18 and 65 who are willing and able to consent and who require the use of local anesthetic digit block to both sides of a finger for the treatment of wounds, injuries, infections, or laceration of the fingers.
Who cannot join
- Allergy to any type of local anesthetic.
- Inability to Consent.
- Inability to complete a numeric pain scale.
- Clinical appearance or clinical evidence of intoxication.
- Significant compromising conditions such as major trauma and severe respiratory distress.
About this study
The investigators hypothesize that patients who receive 1% lidocaine injections for digit blocks of the finger will experience less pain when the injection is accompanied by the use of a micro-vibratory stimulator (MVS) compared with patients who receive injections without the MVS.
Read the detailed description
Research Question/Hypothesis
The investigators hypothesize that patients who receive 1% lidocaine injections for digit blocks of the finger will experience less pain when the injection is accompanied by the use of a micro-vibratory stimulator (MVS) compared with patients who receive injections without the MVS.
Objectives
The primary objective of this study is to compare the pain rating scale from an exposure group (digit block injection with the aid MVS) and the control group (traditional injection).
- Conditions
- Pain, Analgesia
- Being tested
- Microvibratory Stimulator, Microvibratory Stimulator'
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microvibratory StimulatorDevice
Informed consent will be obtained from patients undergoing finger local anesthesia digit blocks. Subjects will be randomly assigned (using GraphPAD Randomization Software Tool) to receive the first of their two digit block injections with either the traditional technique (control) or while using the DVICS/ Microvibratory Stimulator. All injections will utilize a 27-gauge needle. The subjects will be given a standard dose of 2mls of 1% lidocaine without epinephrine delivered over 30 seconds. Injections will be timed and performed by a single clinician to avoid large variations in technique and expertise.
Microvibratory Stimulator'Device
As above, Microvibratory Stimulator will be used as a sham device in parallel group.
| Study group | Role | What they receive |
|---|---|---|
| Parallel lidocaine injection | Active comparator | Informed consent will be obtained from patients undergoing finger local anesthesia digit blocks. Subjects will be randomly assigned (using GraphPAD Randomization Software Tool) to receive the first of their two digit block injections with either the traditional technique (control) or while using the DVICS/ Microvibratory Stimulator. All injections will utilize a 27-gauge needle. The subjects will be given a standard dose of 2mls of 1% lidocaine without epinephrine delivered over 30 seconds. Injections will be timed and performed by a single clinician to avoid large variations in technique and expertise. Receives: Device: Microvibratory Stimulator; Device: Microvibratory Stimulator' |
| Parallel | Sham comparator | In the sham comparator, the device will be placed on the skin, but not turned on. Digit block anesthesia will progress in usual fashion as with active comparator, except without the vibratory device engaged. Receives: Device: Microvibratory Stimulator; Device: Microvibratory Stimulator' |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain associated with injection of lidocaine
Subjects will rate pain of injection using a 0-10 VAS
Measured: 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startJun 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AnalgesiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christus Spohn Memorial Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02870595
- Sponsor's protocol ID
- 14-007
- Status last verified
- Aug 2016
- First submitted
- 11 Aug 2016
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data to be published
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Micro Vibratory Stimulation Technique to Control the Pain of Digit Block Anesthesia
- ClinicalTrials.gov ID
- NCT02870595
- Acronym / sponsor ID
- 14-007
- Conditions
- Pain, Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Christus Spohn Memorial Medical CenterUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 17 Aug 2016 (estimated)
- 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.
The investigators hypothesize that patients who receive 1% lidocaine injections for digit blocks of the finger will experience less pain when the injection is accompanied by the use of a micro-vibratory stimulator (MVS) compared with patients who receive injections without the MVS.
Detailed description
Research Question/Hypothesis
The investigators hypothesize that patients who receive 1% lidocaine injections for digit blocks of the finger will experience less pain when the injection is accompanied by the use of a micro-vibratory stimulator (MVS) compared with patients who receive injections without the MVS.
Objectives
The primary objective of this study is to compare the pain rating scale from an exposure group (digit block injection with the aid MVS) and the control group (traditional injection).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parallel lidocaine injection | Active comparator | Device: Microvibratory Stimulator, Device: Microvibratory Stimulator'Informed consent will be obtained from patients undergoing finger local anesthesia digit blocks. Subjects will be randomly assigned (using GraphPAD Randomization Software Tool) to receive the first of their two digit block injections with either the traditional technique (control) or while using the DVICS/ Microvibratory Stimulator. All injections will utilize a 27-gauge needle. The subjects will be given a standard dose of 2mls of 1% lidocaine without epinephrine delivered over 30 seconds. Injections will be timed and performed by a single clinician to avoid large variations in technique and expertise. |
| Parallel | Sham comparator | Device: Microvibratory Stimulator, Device: Microvibratory Stimulator'In the sham comparator, the device will be placed on the skin, but not turned on. Digit block anesthesia will progress in usual fashion as with active comparator, except without the vibratory device engaged. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy individuals between the ages of 18 and 65 who are willing and able to consent and who require the use of local anesthetic digit block to both sides of a finger for the treatment of wounds, injuries, infections, or laceration of the fingers.
Key exclusion criteria (5 listed)
- Allergy to any type of local anesthetic.
- Inability to Consent.
- Inability to complete a numeric pain scale.
- Clinical appearance or clinical evidence of intoxication.
- Significant compromising conditions such as major trauma and severe respiratory distress.
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 |
|---|---|---|
| Microvibratory StimulatorInformed consent will be obtained from patients undergoing finger local anesthesia digit blocks. Subjects will be randomly assigned (using GraphPAD Randomization Software Tool) to receive the first of their two digit block injections with either the traditional technique (control) or while using the DVICS/ Microvibratory Stimulator. All injections will utilize a 27-gauge needle. The subjects will be given a standard dose of 2mls of 1% lidocaine without epinephrine delivered over 30 seconds. Injections will be timed and performed by a single clinician to avoid large variations in technique and expertise. | Device | Parallel, Parallel lidocaine injection |
| Microvibratory Stimulator'As above, Microvibratory Stimulator will be used as a sham device in parallel group. | Device | Parallel, Parallel lidocaine injection |
Primary outcome
Pain associated with injection of lidocaine
Time frame: 30 seconds
Subjects will rate pain of injection using a 0-10 VAS
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 17 Aug 2016.
- Individual participant dataSharing planned: Yes. Data to be published
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Microvibratory Stimulator and Microvibratory Stimulator' in people with Pain, Analgesia, run by Christus Spohn Memorial Medical Center.
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 1 inclusion and 5 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 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Pain associated with injection of lidocaine (time frame: 30 seconds). 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 17 Aug 2016.