PainEarly Phase 1NCT03246282
Feasibility of Polychromatic Light Emitting Diode System to Reduce Pain
A Early Phase 1 study testing UVL1000 Treatment Station, Normal Saline 0.9% Infusion Solution Bag and Peripheral Catheterization in people with Pain, run by John W. Reeves, MD at 1 site in United States.
Trial summary
This study uses a prospective non-randomized, non-controlled design. One Hundred Fifty (150) subjects presenting with pain will be enrolled into a single treatment group The purpose of the study is to evaluate the feasibility of PLEDS for PIV catheter light delivery for pain reduction, through change between baseline… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- UVL1000 Treatment Station, Normal Saline 0.9% Infusion Solution Bag and Peripheral Catheterization
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2017to 31 Dec 2018
- Phase
- Early 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntarily signed informed consent form (see Informed Consent Forms)
- Ages 18-70
- Non-Pregnant Female Participants
- Self-reported perceived pain score via "Brief Pain Inventory - Short Form" score of 2 or more.
- No breastfeeding for 1 week prior to enrollment
- Birth control measures to be used throughout the duration of the study for women of child bearing potential
- Powerful antioxidants (e.g. oral antioxidants, Vitamin C and E, glutathione or Myer's cocktail IV infusion therapy) will not be used on treatment days
Who cannot join
- Active infection along potential intravenous catheter sites
- Use of anti-inflammatory medications on day of treatment and no more than 400mg per day for over 30 days
- Suffering from blood clotting disorders (hypercoagulable condition, thrombocytosis, etc.)
- Participated in a clinical study in the last 14 days
- Breastfeeding
- Currently taking photosensitizing agents
Trial locations and contacts
1 site in 1 country.
United States1 site
White Clover Wellness and Research Center
Shreveport, Louisiana, 71106
About this study
Official title: A Polychromatic Light Emitting Diode System to Deliver Low Dose Light Directly Into a Peripheral Intravascular Catheter: A Pain Reduction Study
This study uses a prospective non-randomized, non-controlled design. One Hundred Fifty (150) subjects presenting with pain will be enrolled into a single treatment group The purpose of the study is to evaluate the feasibility of PLEDS for PIV catheter light delivery for pain reduction, through change between baseline average pain and final average VAS score. The absence of a control group is based on the following reason: The purpose of this investigation is to further the understanding of the feasibility of PLEDS for PIV catheter light delivery for pain management. Further, the results of this investigation will be used (internally only) to determine if subject-perceived reductions in pain warrant proceeding with more controlled, targeted and possibly randomized studies.
Read the detailed description
This study uses a prospective non-randomized, non-controlled design. One Hundred Fifty (150) subjects presenting with pain will be enrolled into a single treatment group The purpose of the study is to evaluate the feasibility of Polychromatic Light Emitting Diode System (PLEDS) for Peripheral Intravenous (PIV) catheter light delivery for pain reduction, through change between baseline average pain and final average VAS score. The absence of a control group is based on the following reason: The purpose of this investigation is to further the understanding of the feasibility of PLEDS for PIV catheter light delivery for pain management. Further, the results of this investigation will be used (internally only) to determine if subject-perceived reductions in pain warrant proceeding with more controlled, targeted and possibly randomized studies.
PIV therapy has been used for decades as an effective therapy to maintain proper hydration and electrolyte levels. Additionally, PIV therapy can be infused with various agents, including supplements and pharmacological agents. Low-energy light therapy has been established as an alternative treatment for a myriad of medical conditions including reduction of pain. The concurrent administration of low-light therapy and PIV therapy may serve as a viable therapy for the treatment of pain associated with various medical conditions. Accordingly, this study is designed to assess the feasibility of low light therapy via PLEDS integrated into a standard PIV catheter for the purposes of reduction of pain.
- Conditions
- Pain
- Being tested
- UVL1000 Treatment Station, Normal Saline 0.9% Infusion Solution Bag, Peripheral Catheterization
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UVL1000 Treatment StationDevice
Non-coherent light source administered 365 nm, 630 nm, and 530 nm at an output intensity of 0.1 mW directly into an existing intravascular 20 gauge 1.0" catheter
Normal Saline 0.9% Infusion Solution BagDrug
Also called Normal Saline
250 ml of 0.9% Sodium Chloride Solution
Peripheral CatheterizationDevice
20-gauge 1.0" catheter
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Polychromatic light emitting diode system is a non-significant risk device that administers low-dose light generated by light emitting diode(s). A small adapter attaches directly to a standard 20-guage catheter that threads a small fiber optic through the distal end of the catheter. The optic terminates at the proximal end of the catheter. Polychromatic light is emitted to illuminate the catheter near the site of catheter entrance. Concurrently, normal saline flows through the optic adapter, into and through the 20-gauge catheter.
Device: UVL1000 Treatment Station Drug: Normal Saline 0.9% Infusion Solution Bag Device: Peripheral Catheterization Receives: Device: UVL1000 Treatment Station; Drug: Normal Saline 0.9% Infusion Solution Bag; Device: Peripheral Catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
The use of polychromatic light therapy delivered through an intravascular catheter to assess the change in self-reported VAS pain score.
To evaluate the feasibility of PLEDS for PIV catheter light delivery for the purposes of pain reduction, through assessing the change between baseline average pain (via "Brief Pain Inventory - Short Form") and final average VAS score (via the "Per Treatment VAS Score Form") following treatment administration.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start8 Feb 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Why it stopped: Lack of Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (67)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John W. Reeves, MD
- Sponsor type
- University, hospital or other
- Collaborators
- White Clover Research Foundation, White Clover Wellness and Research Center
- Responsible party
- Sponsor-investigator, John W. Reeves, MD, White Clover Research Foundation
- Investigators
- John W Reeves, MD, Principal investigator, White Clover Wellness and Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246282
- Sponsor's protocol ID
- UVL_P001
- Status last verified
- Nov 2017
- First submitted
- 6 Aug 2017
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Giuliani A, Fernandez M, Farinelli M, Baratto L, Capra R, Rovetta G, Monteforte P, Giardino L, Calza L. Very low level laser therapy attenuates edema and pain in experimental models. Int J Tissue React. 2004;26(1-2):29-37.
PubMed 15573690Xu Y, Lin Y, Gao S. Study on the selection of laser wavelengths in the intravascular low-level laser irradiation therapy. Lasers Med Sci. 2015 May;30(4):1373-6. doi: 10.1007/s10103-015-1732-7. Epub 2015 Mar 24.
PubMed 25800533Martin W. Robert F. Furchgott, Nobel laureate (1916-2009)--a personal reflection. Br J Pharmacol. 2009 Oct;158(3):633-7. doi: 10.1111/j.1476-5381.2009.00418.x. Epub 2009 Aug 13.
PubMed 19681890Ehrreich SJ, Furchgott RF. Relaxation of mammalian smooth muscles by visible and ultraviolet radiation. Nature. 1968 May 18;218(5142):682-4. doi: 10.1038/218682a0. No abstract available.
PubMed 5655961Hegedus B, Viharos L, Gervain M, Galfi M. The effect of low-level laser in knee osteoarthritis: a double-blind, randomized, placebo-controlled trial. Photomed Laser Surg. 2009 Aug;27(4):577-84. doi: 10.1089/pho.2008.2297.
PubMed 19530911Mi XQ, Chen JY, Cen Y, Liang ZJ, Zhou LW. A comparative study of 632.8 and 532 nm laser irradiation on some rheological factors in human blood in vitro. J Photochem Photobiol B. 2004 Mar 19;74(1):7-12. doi: 10.1016/j.jphotobiol.2004.01.003.
PubMed 15043841Fukuzaki Y, Sugawara H, Yamanoha B, Kogure S. 532 nm low-power laser irradiation recovers gamma-secretase inhibitor-mediated cell growth suppression and promotes cell proliferation via Akt signaling. PLoS One. 2013 Aug 7;8(8):e70737. doi: 10.1371/journal.pone.0070737. eCollection 2013.
PubMed 23950991Pereira AN, Eduardo Cde P, Matson E, Marques MM. Effect of low-power laser irradiation on cell growth and procollagen synthesis of cultured fibroblasts. Lasers Surg Med. 2002;31(4):263-7. doi: 10.1002/lsm.10107.
PubMed 12355572Rodrigo SM, Cunha A, Pozza DH, Blaya DS, Moraes JF, Weber JB, de Oliveira MG. Analysis of the systemic effect of red and infrared laser therapy on wound repair. Photomed Laser Surg. 2009 Dec;27(6):929-35. doi: 10.1089/pho.2008.2306.
PubMed 19708798Lopes NN, Plapler H, Lalla RV, Chavantes MC, Yoshimura EM, da Silva MA, Alves MT. Effects of low-level laser therapy on collagen expression and neutrophil infiltrate in 5-fluorouracil-induced oral mucositis in hamsters. Lasers Surg Med. 2010 Aug;42(6):546-52. doi: 10.1002/lsm.20920.
PubMed 20662031Yu W, Naim JO, Lanzafame RJ. Effects of photostimulation on wound healing in diabetic mice. Lasers Surg Med. 1997;20(1):56-63. doi: 10.1002/(sici)1096-9101(1997)20:13.0.co;2-y.
PubMed 9041509Whelan HT, Smits RL Jr, Buchman EV, Whelan NT, Turner SG, Margolis DA, Cevenini V, Stinson H, Ignatius R, Martin T, Cwiklinski J, Philippi AF, Graf WR, Hodgson B, Gould L, Kane M, Chen G, Caviness J. Effect of NASA light-emitting diode irradiation on wound healing. J Clin Laser Med Surg. 2001 Dec;19(6):305-14. doi: 10.1089/104454701753342758.
PubMed 11776448Medrado AR, Pugliese LS, Reis SR, Andrade ZA. Influence of low level laser therapy on wound healing and its biological action upon myofibroblasts. Lasers Surg Med. 2003;32(3):239-44. doi: 10.1002/lsm.10126.
PubMed 12605432Hwang MH, Shin JH, Kim KS, Yoo CM, Jo GE, Kim JH, Choi H. Low level light therapy modulates inflammatory mediators secreted by human annulus fibrosus cells during intervertebral disc degeneration in vitro. Photochem Photobiol. 2015 Mar-Apr;91(2):403-10. doi: 10.1111/php.12415. Epub 2015 Jan 26.
PubMed 25557915Lim W, Choi H, Kim J, Kim S, Jeon S, Zheng H, Kim D, Ko Y, Kim D, Sohn H, Kim O. Anti-inflammatory effect of 635 nm irradiations on in vitro direct/indirect irradiation model. J Oral Pathol Med. 2015 Feb;44(2):94-102. doi: 10.1111/jop.12204. Epub 2014 Jul 28.
PubMed 25066944
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Polychromatic Light Emitting Diode System to Deliver Low Dose Light Directly Into a Peripheral Intravascular Catheter: A Pain Reduction Study
- ClinicalTrials.gov ID
- NCT03246282
- Acronym / sponsor ID
- UVL_P001
- Conditions
- Pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Lack of Funding
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- John W. Reeves, MDUniversity, hospital or other
- Collaborators
- White Clover Research Foundation, White Clover Wellness and Research Center
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 11 Aug 2017 (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.
This study uses a prospective non-randomized, non-controlled design. One Hundred Fifty (150) subjects presenting with pain will be enrolled into a single treatment group The purpose of the study is to evaluate the feasibility of PLEDS for PIV catheter light delivery for pain reduction, through change between baseline average pain and final average VAS score. The absence of a control group is based on the following reason: The purpose of this investigation is to further the understanding of the feasibility of PLEDS for PIV catheter light delivery for pain management. Further, the results of this investigation will be used (internally only) to determine if subject-perceived reductions in pain warrant proceeding with more controlled, targeted and possibly randomized studies.
Detailed description
This study uses a prospective non-randomized, non-controlled design. One Hundred Fifty (150) subjects presenting with pain will be enrolled into a single treatment group The purpose of the study is to evaluate the feasibility of Polychromatic Light Emitting Diode System (PLEDS) for Peripheral Intravenous (PIV) catheter light delivery for pain reduction, through change between baseline average pain and final average VAS score. The absence of a control group is based on the following reason: The purpose of this investigation is to further the understanding of the feasibility of PLEDS for PIV catheter light delivery for pain management. Further, the results of this investigation will be used (internally only) to determine if subject-perceived reductions in pain warrant proceeding with more controlled, targeted and possibly randomized studies.
PIV therapy has been used for decades as an effective therapy to maintain proper hydration and electrolyte levels. Additionally, PIV therapy can be infused with various agents, including supplements and pharmacological agents. Low-energy light therapy has been established as an alternative treatment for a myriad of medical conditions including reduction of pain. The concurrent administration of low-light therapy and PIV therapy may serve as a viable therapy for the treatment of pain associated with various medical conditions. Accordingly, this study is designed to assess the feasibility of low light therapy via PLEDS integrated into a standard PIV catheter for the purposes of reduction of pain.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: UVL1000 Treatment Station, Drug: Normal Saline 0.9% Infusion Solution Bag, Device: Peripheral CatheterizationPolychromatic light emitting diode system is a non-significant risk device that administers low-dose light generated by light emitting diode(s). A small adapter attaches directly to a standard 20-guage catheter that threads a small fiber optic through the distal end of the catheter. The optic terminates at the proximal end of the catheter. Polychromatic light is emitted to illuminate the catheter near the site of catheter entrance. Concurrently, normal saline flows through the optic adapter, into and through the 20-gauge catheter. Device: UVL1000 Treatment Station Drug: Normal Saline 0.9% Infusion Solution Bag Device: Peripheral Catheterization |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntarily signed informed consent form (see Informed Consent Forms)
- Ages 18-70
- Non-Pregnant Female Participants
- Self-reported perceived pain score via "Brief Pain Inventory - Short Form" score of 2 or more.
- No breastfeeding for 1 week prior to enrollment
Key exclusion criteria (6 listed)
- Active infection along potential intravenous catheter sites
- Use of anti-inflammatory medications on day of treatment and no more than 400mg per day for over 30 days
- Suffering from blood clotting disorders (hypercoagulable condition, thrombocytosis, etc.)
- Participated in a clinical study in the last 14 days
- Breastfeeding
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 |
|---|---|---|
| UVL1000 Treatment StationNon-coherent light source administered 365 nm, 630 nm, and 530 nm at an output intensity of 0.1 mW directly into an existing intravascular 20 gauge 1.0" catheter | Device | Treatment Group |
| Normal Saline 0.9% Infusion Solution BagAlso: Normal Saline250 ml of 0.9% Sodium Chloride Solution | Drug | Treatment Group |
| Peripheral Catheterization20-gauge 1.0" catheter | Device | Treatment Group |
Primary outcome
The use of polychromatic light therapy delivered through an intravascular catheter to assess the change in self-reported VAS pain score.
Time frame: 2 weeks
To evaluate the feasibility of PLEDS for PIV catheter light delivery for the purposes of pain reduction, through assessing the change between baseline average pain (via "Brief Pain Inventory - Short Form") and final average VAS score (via the "Per Treatment VAS Score Form") following treatment administration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- Background: PubMed 15573690Giuliani A, Fernandez M, Farinelli M, Baratto L, Capra R, Rovetta G, Monteforte P, Giardino L, Calza L. Very low level laser therapy attenuates edema and pain in experimental models. Int J Tissue React. 2004;26(1-2):29-37.
- Background: PubMed 25800533Xu Y, Lin Y, Gao S. Study on the selection of laser wavelengths in the intravascular low-level laser irradiation therapy. Lasers Med Sci. 2015 May;30(4):1373-6. doi: 10.1007/s10103-015-1732-7. Epub 2015 Mar 24.
- Background: PubMed 19681890Martin W. Robert F. Furchgott, Nobel laureate (1916-2009)--a personal reflection. Br J Pharmacol. 2009 Oct;158(3):633-7. doi: 10.1111/j.1476-5381.2009.00418.x. Epub 2009 Aug 13.
- Background: PubMed 5655961Ehrreich SJ, Furchgott RF. Relaxation of mammalian smooth muscles by visible and ultraviolet radiation. Nature. 1968 May 18;218(5142):682-4. doi: 10.1038/218682a0. No abstract available.
- Background: PubMed 19530911Hegedus B, Viharos L, Gervain M, Galfi M. The effect of low-level laser in knee osteoarthritis: a double-blind, randomized, placebo-controlled trial. Photomed Laser Surg. 2009 Aug;27(4):577-84. doi: 10.1089/pho.2008.2297.
- Background: PubMed 15043841Mi XQ, Chen JY, Cen Y, Liang ZJ, Zhou LW. A comparative study of 632.8 and 532 nm laser irradiation on some rheological factors in human blood in vitro. J Photochem Photobiol B. 2004 Mar 19;74(1):7-12. doi: 10.1016/j.jphotobiol.2004.01.003.
- Background: PubMed 23950991Fukuzaki Y, Sugawara H, Yamanoha B, Kogure S. 532 nm low-power laser irradiation recovers gamma-secretase inhibitor-mediated cell growth suppression and promotes cell proliferation via Akt signaling. PLoS One. 2013 Aug 7;8(8):e70737. doi: 10.1371/journal.pone.0070737. eCollection 2013.
- Background: PubMed 12355572Pereira AN, Eduardo Cde P, Matson E, Marques MM. Effect of low-power laser irradiation on cell growth and procollagen synthesis of cultured fibroblasts. Lasers Surg Med. 2002;31(4):263-7. doi: 10.1002/lsm.10107.
- Background: PubMed 19708798Rodrigo SM, Cunha A, Pozza DH, Blaya DS, Moraes JF, Weber JB, de Oliveira MG. Analysis of the systemic effect of red and infrared laser therapy on wound repair. Photomed Laser Surg. 2009 Dec;27(6):929-35. doi: 10.1089/pho.2008.2306.
- Background: PubMed 20662031Lopes NN, Plapler H, Lalla RV, Chavantes MC, Yoshimura EM, da Silva MA, Alves MT. Effects of low-level laser therapy on collagen expression and neutrophil infiltrate in 5-fluorouracil-induced oral mucositis in hamsters. Lasers Surg Med. 2010 Aug;42(6):546-52. doi: 10.1002/lsm.20920.
- Background: PubMed 9041509Yu W, Naim JO, Lanzafame RJ. Effects of photostimulation on wound healing in diabetic mice. Lasers Surg Med. 1997;20(1):56-63. doi: 10.1002/(sici)1096-9101(1997)20:13.0.co;2-y.
- Background: PubMed 11776448Whelan HT, Smits RL Jr, Buchman EV, Whelan NT, Turner SG, Margolis DA, Cevenini V, Stinson H, Ignatius R, Martin T, Cwiklinski J, Philippi AF, Graf WR, Hodgson B, Gould L, Kane M, Chen G, Caviness J. Effect of NASA light-emitting diode irradiation on wound healing. J Clin Laser Med Surg. 2001 Dec;19(6):305-14. doi: 10.1089/104454701753342758.
- 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.
John W Reeves, MD principal investigator
White Clover Wellness and Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing UVL1000 Treatment Station, Normal Saline 0.9% Infusion Solution Bag and Peripheral Catheterization in people with Pain, run by John W. Reeves, MD at 1 site in United States.
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 7 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: paused, as of the sponsor's last update on 14 Nov 2017. 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 United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
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 use of polychromatic light therapy delivered through an intravascular catheter to assess the change in self-reported VAS pain score. (time frame: 2 weeks). 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 NCT03246282, which also lists 67 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 14 Nov 2017.