HealthyPhase 1NCT00503087
Evaluation of Pain Reduction in the Administration of Saline Injections by the Usage of Pneumatic Skin Flattening
A Phase 1 study testing Saline Injection and Pneumatic Skin Flattening (PSF) in people with Healthy, run by PalJect Ltd. at 1 site in Israel.
Trial summary
Each participant will be administered 2 injections of saline - the first in the right gluteal area and the second in the left gluteal area. Both injections will be administered intra-muscularly by the same clinician. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Saline Injection and Pneumatic Skin Flattening (PSF)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2007to Jul 2008
- Phase
- Phase 1
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients 18 years old or older
- Healthy
- Patient informed consent must be obtained
Who cannot join
- Pregnant or nursing women
- Patients unable to understand or sign the informed consent form
- Anticoagulant or aspirin treatment
- Subjects with a history of vaso-vagal reactions to injections
- Coagulopathies
- Skin disease
- Chronic usage of medication
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Emergency Department- Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239
Tatiana Levit, MD
Pinchas Halpern, MD
About this study
Official title: Evaluation of Pain Reduction in the Administration of Saline Injections by the Usage of Pneumatic Skin Flattening (PSF)
Each participant will be administered 2 injections of saline - the first in the right gluteal area and the second in the left gluteal area. Both injections will be administered intra-muscularly by the same clinician. One injection will be given with vacuum (Pneumatic Skin Flattening or PSF Machine) and the other without vacuum. The order of the injections will be randomly assigned. Each subject will serve as a control for himself. Between injections a 30 min pause will be given to minimize pain sensation bias of the previous injection. Immediately after each injection the pain level will be assessed by the VAS scale. The researcher assessing the pain will be blinded for the type of injection given. The evaluation of the pain reduction will be made by comparison of the pain level with and without the application of the PSF.
Hypothesis: PSF Technique will reduce the pain associated with saline injections.
Read the detailed description
Injections are currently the gold-standard for administrating various medications parenterally. The most significant side-effect related to injections is the accompanying pain. Injection pain is related to the penetration of the skin by the needle and to the mechanical and chemical effects of the drug during and after its injection. This pain remains a major obstacle in medication administration in children as well as in other populations subject to needle-phobia because of the pain experience. The associated pain may thus prevent optimized medical care for these patients.
Current methods to alleviate immediate pain include the utilization of topical anesthesia whereas some patients do not utilize any form of pain relief and simply endure the pain of the injection. Other methods for pain reduction are taking advantage of the applying pressure or vibration to alleviate pain. These methods have resulted in a number of pain relieving devices currently on the market. Such predicate devices primarily involve vibration devices commonly used to alleviate the injection pain. Published data suggests possible use of pressure application mechanism in pain alleviation related to injections.
We suggest here, for the first time, the use of the Pneumatic Skin Flattening (PSF) technology for alleviation of pain associated with injections. The PSF technology is currently used worldwide in the FDA cleared Serenity device (Serenity, Inolase Ltd.) for pain reduction in hair removal. The device generates contact and compression between a transparent sapphire window and the skin. The compression creatures pressure signal which, based on the gate theory, is though to depress the pain associated with the hair removal treatment. We assume the same mechanism would apply for the reduction of pain associated with injections.
Comparison: Intra-Subject pain level change of injection with PSF and without PSF
- Conditions
- Healthy
- Being tested
- Saline Injection, Pneumatic Skin Flattening (PSF)
- Keywords
- Injections, Vacuum, Pain, Pneumatic Skin Flattening, PSF
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline InjectionProcedure or surgery
Pneumatic Skin Flattening (PSF)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS pain scaling differences between saline injection with PSF and without PSF
Measured: Immediately after each injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2007 (estimated)
- Study startAug 2007
- Study completionJul 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PalJect Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pinchas Halpern, MD, Study director, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503087
- Sponsor's protocol ID
- TASMC 07- TL -268 CTIL
- Status last verified
- Aug 2007
- First submitted
- 17 Jul 2007
- Last updated
- 8 Aug 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
MELZACK R, WALL PD. On the nature of cutaneous sensory mechanisms. Brain. 1962 Jun;85:331-56. doi: 10.1093/brain/85.2.331. No abstract available.
PubMed 14472486Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available.
PubMed 5320816Lask G, Friedman D, Elman M, Fournier N, Shavit R, Slatkine M. Pneumatic skin flattening (PSF): a novel technology for marked pain reduction in hair removal with high energy density lasers and IPLs. J Cosmet Laser Ther. 2006 Jun;8(2):76-81. doi: 10.1080/14764170600719775.
PubMed 16766485
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pain Reduction in the Administration of Saline Injections by the Usage of Pneumatic Skin Flattening (PSF)
- ClinicalTrials.gov ID
- NCT00503087
- Acronym / sponsor ID
- TASMC 07- TL -268 CTIL
- Conditions
- Healthy
- Keywords
- Injections, Vacuum, Pain, Pneumatic Skin Flattening, PSF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- PalJect Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2007
- Study completion
- Jul 2008 (estimated)
- First posted
- 18 Jul 2007 (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.
Each participant will be administered 2 injections of saline - the first in the right gluteal area and the second in the left gluteal area. Both injections will be administered intra-muscularly by the same clinician. One injection will be given with vacuum (Pneumatic Skin Flattening or PSF Machine) and the other without vacuum. The order of the injections will be randomly assigned. Each subject will serve as a control for himself. Between injections a 30 min pause will be given to minimize pain sensation bias of the previous injection. Immediately after each injection the pain level will be assessed by the VAS scale. The researcher assessing the pain will be blinded for the type of injection given. The evaluation of the pain reduction will be made by comparison of the pain level with and without the application of the PSF.
Hypothesis: PSF Technique will reduce the pain associated with saline injections.
Detailed description
Injections are currently the gold-standard for administrating various medications parenterally. The most significant side-effect related to injections is the accompanying pain. Injection pain is related to the penetration of the skin by the needle and to the mechanical and chemical effects of the drug during and after its injection. This pain remains a major obstacle in medication administration in children as well as in other populations subject to needle-phobia because of the pain experience. The associated pain may thus prevent optimized medical care for these patients.
Current methods to alleviate immediate pain include the utilization of topical anesthesia whereas some patients do not utilize any form of pain relief and simply endure the pain of the injection. Other methods for pain reduction are taking advantage of the applying pressure or vibration to alleviate pain. These methods have resulted in a number of pain relieving devices currently on the market. Such predicate devices primarily involve vibration devices commonly used to alleviate the injection pain. Published data suggests possible use of pressure application mechanism in pain alleviation related to injections.
We suggest here, for the first time, the use of the Pneumatic Skin Flattening (PSF) technology for alleviation of pain associated with injections. The PSF technology is currently used worldwide in the FDA cleared Serenity device (Serenity, Inolase Ltd.) for pain reduction in hair removal. The device generates contact and compression between a transparent sapphire window and the skin. The compression creatures pressure signal which, based on the gate theory, is though to depress the pain associated with the hair removal treatment. We assume the same mechanism would apply for the reduction of pain associated with injections.
Comparison: Intra-Subject pain level change of injection with PSF and without PSF
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients 18 years old or older
- Healthy
- Patient informed consent must be obtained
Key exclusion criteria (7 listed)
- Pregnant or nursing women
- Patients unable to understand or sign the informed consent form
- Anticoagulant or aspirin treatment
- Subjects with a history of vaso-vagal reactions to injections
- Coagulopathies
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 |
|---|---|---|
| Saline Injection | Procedure or surgery | – |
| Pneumatic Skin Flattening (PSF) | Device | – |
Primary outcome
VAS pain scaling differences between saline injection with PSF and without PSF
Time frame: Immediately after each injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2007.
- Background: PubMed 14472486MELZACK R, WALL PD. On the nature of cutaneous sensory mechanisms. Brain. 1962 Jun;85:331-56. doi: 10.1093/brain/85.2.331. No abstract available.
- Background: PubMed 5320816Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available.
- Background: PubMed 16766485Lask G, Friedman D, Elman M, Fournier N, Shavit R, Slatkine M. Pneumatic skin flattening (PSF): a novel technology for marked pain reduction in hair removal with high energy density lasers and IPLs. J Cosmet Laser Ther. 2006 Jun;8(2):76-81. doi: 10.1080/14764170600719775.
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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.
Pinchas Halpern, MD study director
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Saline Injection and Pneumatic Skin Flattening (PSF) in people with Healthy, run by PalJect Ltd. at 1 site in Israel.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 8 Aug 2007. 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 Israel. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pinchas Halpern, MD (+972-3-697-3829, dr_halperin@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS pain scaling differences between saline injection with PSF and without PSF (time frame: Immediately after each injection). 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 NCT00503087, which also lists 3 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 8 Aug 2007.