Skin ManifestationsNCT03873896
The Skin Wrinkle Test: a Simple Clinical Test of Regional Block Success
A study testing Stimulated skin wrinkling test and Digital Nerve Block in people with Skin Manifestations, run by Memorial University of Newfoundland at 1 site in Canada.
Trial summary
Wrinkling of the hands and feet with exposure to moist environments is a commonly observed phenomenon. This "stimulated skin wrinkling" (SSW) is the result of direct stimulation of digital nerve sympathetic fibers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Manifestations
- What is being tested?
- Stimulated skin wrinkling test and Digital Nerve Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteCanada
- Study dates
- 9 Dec 2019to 14 Dec 2019
- 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 18-65 year old of either gender
Who cannot join
- contraindication to regional block
- preexisting nerve damage
- hand or finger injury
- active skin infection
- allergy to local anesthetic
- disease states known to affect aquagenic skin wrinkling including cystic fibrosis, diabetic neuropathy, leprosy, vascular disease and diseases of autonomic function
Show all 11Show fewer
- Patients with history of bleeding disorders or currently using anticoagulation agents
- contraindications to EMLA cream
- breaks in the skin on the finger EMLA is to be applied
- allergy to its constituents
- history of methemoglobinemia.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Memorial University
St. John's, Newfoundland and Labrador, A1B 3V6
About this study
Wrinkling of the hands and feet with exposure to moist environments is a commonly observed phenomenon. This "stimulated skin wrinkling" (SSW) is the result of direct stimulation of digital nerve sympathetic fibers. The resulting effect is a sympathetically mediated vasoconstriction with loss of finger pulp volume, overlying skin traction and wrinkling. It has been established that multiple disease states of the sympathetic nervous system such as diabetic neuropathy, leprosy and nerve injury can lead to impaired SSW of the affected limb. While this test has been successfully utilized for over 80 years to assess patients with sympathetic pathology, it has never been evaluated as a tool to determine the success of a regional nerve block. A regional nerve block is a method of anesthesia that involves injecting a local anesthetic around a particular nerve or nerve bundle in order to block the sensation of pain from that particular body part.
This is of particular importance in the paediatric or non verbal population. These patients may not be able to reliably confirm the effectiveness of their analgesia. Pediatric anesthesiologists often perform these regional blocks on already anesthetized children whereas the non-verbal or cognitively impaired population may not be able to verbalize block effectiveness.
This test, if proven effective as a means of determining block success, would be a quick, non-invasive and inexpensive method of ensuring adequate intra-operative and post operative analgesia for patients. As this is a pilot project focused on establishing the SSW test as an effective tool for assessing regional block success on awake volunteers, further studies would need to be performed to assess test effectiveness in different clinical situations.
Read the detailed description
We estimated the sample size of four based on the use of a non-parametric analysis, and for the purpose to keep the sample of subjects to a minimum. Further that the effect size is expected to be a large effect (e.g. as it's a binary response yes/no wrinkling, previous experience and literature with the use of the cream for obtaining a pronounced effect of wrinkling (4-5) on the PING scale for an individual with normal peripheral nerve response on an unblocked digit. By using the non-parametric chi square statistical analysis it does not rely on means and standard deviation so it is more sensitive to even small differences beyond chance.
After informed written consent is obtained, volunteers will be subjected to a digital nerve block of ring finger of either the left or right hands. The hand to be blocked will be randomized using a coin toss. The nerve block will be performed by members of the research team with extensive experience in regional blockade. After full sterile preparation, 3 cc's of 2% plain lidocaine will be used to perform the digital nerve block. Five minutes after the performance of the block, the affected digit will be tested by both light touch and temperature to confirm block success. Ring fingers of both hands of the volunteer will then be wrapped in an occlusive dressing after 1mL (millilitre) of EMLA (Eutectic Mixture of Local Anesthetic) cream is applied to the pad of each finger. Photos of the blocked finger as well as the corresponding unblocked finger of the opposite hand will be taken with tangential lighting at 0, 10, 20 and 30 minutes from the time of exposure to EMLA cream. The EMLA cream and occlusive dressings will be removed for each photo then reapplied after the photo is completed. Photos will then be evaluated by two members of the research team blinded as to the finger blocked in each volunteer. Evaluators reviewing the photos of individual fingers will be asked to grade the degree of wrinkling on a scale from 0 to 4 described by Ping Ng et al (a previously established scale to assess stimulated skin wrinkling).
Clinical Care Measures To ensure safety of the study participants, digital nerve blocks will be performed by anesthesiologists or anesthesiology residents with experience in performing these blocks and under strict aseptic conditions. A limited amount of lidocaine is utilized to ensure adequate block but minimize duration of block as well as risks of toxicity. The study participants will be fully monitored with continuous 3 lead ECG, NIBP (non-invasive blood pressure) measurements every 5 minutes and continuous pulse oximetry for 120 minutes period after the analysis. The participants will be attended by at least one physician for this entire period. A follow up telephone call will be performed 24 hours after the performance of the digital nerve block to assess for complications.
- Conditions
- Skin Manifestations
- Being tested
- Stimulated skin wrinkling test, Digital Nerve Block
- Medical subject headings
- Skin Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimulated skin wrinkling testDiagnostic test
Stimulated skin wrinkling induced by the application of EMLA (eutectic mixture of local anesthetic) cream to the finger pads of blocked and unblocked fingers of study volunteers (test applied to both study arms)
Digital Nerve BlockProcedure or surgery
A digital nerve block is performed by injecting a total of 3 millilitres of 2% Lidocaine at the base of the ring finger of randomized hand of the volunteer. The effect of the block is confirmed clinically before proceeding with the study data collection. Please see the description for more details on the procedure
| Study group | Role | What they receive |
|---|---|---|
| Blocked finger | Experimental | The experimental arm will be the ring finger of the volunteer that is blocked (randomized either right or left hand) with a digital nerve block (described elsewhere in the submission). The skin wrinkle test (diagnostic test) will be applied to this arm Receives: Diagnostic Test: Stimulated skin wrinkling test; Procedure: Digital Nerve Block |
| Unblocked finger | Active comparator | The control arm will be the finger of the same volunteer that is not under the influence of digital nerve block. This will be the corresponding digit (the ring finger) on the opposite hand of the side that was blocked (determined by coin toss). The skin wrinkle test (diagnostic test) will be applied to this arm Receives: Diagnostic Test: Stimulated skin wrinkling test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in observed skin wrinkling
Determined by judgements based on the "Wrinkling Assessment Scale" originally described by Ping Ng et. al. 2013: Grade 0: Wrinkling absent Grade 1: slight wrinkling and the fingertip is not smooth Grade 2: two or fewer lines of wrinkling on each side of the fingertip Grade 3: 3 or more lines of wrinkling on each side of the fingertip Grade 4: wrinkling completely distorts the pulp of the fingertip (see images presented in Wilder Smith et. al. 2015). A higher score indicates (3 or 4) full nerve function and the lower likelihood of nerve block. A lower score (0-2) indicate lower levels of nerve function and a higher likelihood of successful nerve blockade
Measured: Assessed at baseline (prior to EMLA cream application) and 10, 20 and 30 minutes after its application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start9 Dec 2019
- Primary completion14 Dec 2019
- Study completion14 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Skin ManifestationsStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Blinded control trial assessing aquagenic skin wrinkling after digital nerve blockade in healthy volunteers. Digital nerve blocks to be performed on the left or right ring fingers of volunteers (to be randomized with coin toss) with the unblocked finger of each volunteer acting as its own control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial University of Newfoundland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Collins, Memorial University of Newfoundland
- Investigators
- Peter A Collins, MD, Principal investigator, Memorial University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873896
- Sponsor's protocol ID
- 20190762
- Status last verified
- Jan 2020
- First submitted
- 6 Sep 2018
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wilder-Smith EP. Stimulated skin wrinkling as an indicator of limb sympathetic function. Clin Neurophysiol. 2015 Jan;126(1):10-6. doi: 10.1016/j.clinph.2014.08.007. Epub 2014 Sep 2.
PubMed 25216595Vasudevan TM, van Rij AM, Nukada H, Taylor PK. Skin wrinkling for the assessment of sympathetic function in the limbs. Aust N Z J Surg. 2000 Jan;70(1):57-9. doi: 10.1046/j.1440-1622.2000.01744.x.
PubMed 10696945
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Skin Wrinkle Test: a Simple Clinical Test of Regional Block Success
- ClinicalTrials.gov ID
- NCT03873896
- Acronym / sponsor ID
- 20190762
- Conditions
- Skin Manifestations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Memorial University of NewfoundlandUniversity, hospital or other
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 14 Dec 2019 (actual)
- Study completion
- 14 Dec 2019 (actual)
- First posted
- 14 Mar 2019 (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.
Wrinkling of the hands and feet with exposure to moist environments is a commonly observed phenomenon. This "stimulated skin wrinkling" (SSW) is the result of direct stimulation of digital nerve sympathetic fibers. The resulting effect is a sympathetically mediated vasoconstriction with loss of finger pulp volume, overlying skin traction and wrinkling. It has been established that multiple disease states of the sympathetic nervous system such as diabetic neuropathy, leprosy and nerve injury can lead to impaired SSW of the affected limb. While this test has been successfully utilized for over 80 years to assess patients with sympathetic pathology, it has never been evaluated as a tool to determine the success of a regional nerve block. A regional nerve block is a method of anesthesia that involves injecting a local anesthetic around a particular nerve or nerve bundle in order to block the sensation of pain from that particular body part.
This is of particular importance in the paediatric or non verbal population. These patients may not be able to reliably confirm the effectiveness of their analgesia. Pediatric anesthesiologists often perform these regional blocks on already anesthetized children whereas the non-verbal or cognitively impaired population may not be able to verbalize block effectiveness.
This test, if proven effective as a means of determining block success, would be a quick, non-invasive and inexpensive method of ensuring adequate intra-operative and post operative analgesia for patients. As this is a pilot project focused on establishing the SSW test as an effective tool for assessing regional block success on awake volunteers, further studies would need to be performed to assess test effectiveness in different clinical situations.
Detailed description
We estimated the sample size of four based on the use of a non-parametric analysis, and for the purpose to keep the sample of subjects to a minimum. Further that the effect size is expected to be a large effect (e.g. as it's a binary response yes/no wrinkling, previous experience and literature with the use of the cream for obtaining a pronounced effect of wrinkling (4-5) on the PING scale for an individual with normal peripheral nerve response on an unblocked digit. By using the non-parametric chi square statistical analysis it does not rely on means and standard deviation so it is more sensitive to even small differences beyond chance.
After informed written consent is obtained, volunteers will be subjected to a digital nerve block of ring finger of either the left or right hands. The hand to be blocked will be randomized using a coin toss. The nerve block will be performed by members of the research team with extensive experience in regional blockade. After full sterile preparation, 3 cc's of 2% plain lidocaine will be used to perform the digital nerve block. Five minutes after the performance of the block, the affected digit will be tested by both light touch and temperature to confirm block success. Ring fingers of both hands of the volunteer will then be wrapped in an occlusive dressing after 1mL (millilitre) of EMLA (Eutectic Mixture of Local Anesthetic) cream is applied to the pad of each finger. Photos of the blocked finger as well as the corresponding unblocked finger of the opposite hand will be taken with tangential lighting at 0, 10, 20 and 30 minutes from the time of exposure to EMLA cream. The EMLA cream and occlusive dressings will be removed for each photo then reapplied after the photo is completed. Photos will then be evaluated by two members of the research team blinded as to the finger blocked in each volunteer. Evaluators reviewing the photos of individual fingers will be asked to grade the degree of wrinkling on a scale from 0 to 4 described by Ping Ng et al (a previously established scale to assess stimulated skin wrinkling).
Clinical Care Measures To ensure safety of the study participants, digital nerve blocks will be performed by anesthesiologists or anesthesiology residents with experience in performing these blocks and under strict aseptic conditions. A limited amount of lidocaine is utilized to ensure adequate block but minimize duration of block as well as risks of toxicity. The study participants will be fully monitored with continuous 3 lead ECG, NIBP (non-invasive blood pressure) measurements every 5 minutes and continuous pulse oximetry for 120 minutes period after the analysis. The participants will be attended by at least one physician for this entire period. A follow up telephone call will be performed 24 hours after the performance of the digital nerve block to assess for complications.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Blinded control trial assessing aquagenic skin wrinkling after digital nerve blockade in healthy volunteers. Digital nerve blocks to be performed on the left or right ring fingers of volunteers (to be randomized with coin toss) with the unblocked finger of each volunteer acting as its own control
| Arm | Type | Receives |
|---|---|---|
| Blocked finger | Experimental | Diagnostic Test: Stimulated skin wrinkling test, Procedure: Digital Nerve BlockThe experimental arm will be the ring finger of the volunteer that is blocked (randomized either right or left hand) with a digital nerve block (described elsewhere in the submission). The skin wrinkle test (diagnostic test) will be applied to this arm |
| Unblocked finger | Active comparator | Diagnostic Test: Stimulated skin wrinkling testThe control arm will be the finger of the same volunteer that is not under the influence of digital nerve block. This will be the corresponding digit (the ring finger) on the opposite hand of the side that was blocked (determined by coin toss). The skin wrinkle test (diagnostic test) will be applied to this arm |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy 18-65 year old of either gender
Key exclusion criteria (11 listed)
- contraindication to regional block
- preexisting nerve damage
- hand or finger injury
- active skin infection
- allergy to local anesthetic
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 |
|---|---|---|
| Stimulated skin wrinkling testStimulated skin wrinkling induced by the application of EMLA (eutectic mixture of local anesthetic) cream to the finger pads of blocked and unblocked fingers of study volunteers (test applied to both study arms) | Diagnostic test | Blocked finger, Unblocked finger |
| Digital Nerve BlockA digital nerve block is performed by injecting a total of 3 millilitres of 2% Lidocaine at the base of the ring finger of randomized hand of the volunteer. The effect of the block is confirmed clinically before proceeding with the study data collection. Please see the description for more details on the procedure | Procedure or surgery | Blocked finger |
Primary outcome
Change in observed skin wrinkling
Time frame: Assessed at baseline (prior to EMLA cream application) and 10, 20 and 30 minutes after its application
Determined by judgements based on the "Wrinkling Assessment Scale" originally described by Ping Ng et. al. 2013: Grade 0: Wrinkling absent Grade 1: slight wrinkling and the fingertip is not smooth Grade 2: two or fewer lines of wrinkling on each side of the fingertip Grade 3: 3 or more lines of wrinkling on each side of the fingertip Grade 4: wrinkling completely distorts the pulp of the fingertip (see images presented in Wilder Smith et. al. 2015). A higher score indicates (3 or 4) full nerve function and the lower likelihood of nerve block. A lower score (0-2) indicate lower levels of nerve function and a higher likelihood of successful nerve blockade
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 13 Jan 2020.
- Background: PubMed 25216595Wilder-Smith EP. Stimulated skin wrinkling as an indicator of limb sympathetic function. Clin Neurophysiol. 2015 Jan;126(1):10-6. doi: 10.1016/j.clinph.2014.08.007. Epub 2014 Sep 2.
- Background: PubMed 10696945Vasudevan TM, van Rij AM, Nukada H, Taylor PK. Skin wrinkling for the assessment of sympathetic function in the limbs. Aust N Z J Surg. 2000 Jan;70(1):57-9. doi: 10.1046/j.1440-1622.2000.01744.x.
- Individual participant dataSharing planned: No
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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.
Peter A Collins, MD principal investigator
Memorial University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stimulated skin wrinkling test and Digital Nerve Block in people with Skin Manifestations, run by Memorial University of Newfoundland at 1 site in Canada.
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 11 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 13 Jan 2020. 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 Canada. 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?
Change in observed skin wrinkling (time frame: Assessed at baseline (prior to EMLA cream application) and 10, 20 and 30 minutes after its application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03873896, which also lists 2 linked publications.
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 13 Jan 2020.