Condition or disease | Intervention/treatment | Phase |
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Neck Pain | Procedure: Group 1 -- using Pinnacle Series Laser Device Procedure: Group 2 -- using Pinnacle Series Laser Device Procedure: Group 3 -- using Phoenix Thera-Lase Device | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 296 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Evaluating Different Low-level Laser Therapies to Treat Neck Pain in Air Force Pilots and Flight Crew |
Actual Study Start Date : | October 1, 2020 |
Estimated Primary Completion Date : | September 2022 |
Estimated Study Completion Date : | September 2022 |
Arm | Intervention/treatment |
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Experimental: Group 1 (Pinnacle, lower dosimetry parameters)
Utilize the Pinnacle Series Laser by Aspen Laser Systems to apply LLLT
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Procedure: Group 1 -- using Pinnacle Series Laser Device
Utilizing the Pinnacle Series Laser by Aspen Laser Systems, investigators will apply 635-780nm, 10 mW cw, ~ 5-105 J/cm2 at the following time and mW intervals. The beam will be applied at 12 application patterns equidistant and parallel to each other. Each application point will be treated for the timeframes referenced below:
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Experimental: Group 2 (Pinnacle, higher dosimetry parameters)
Utilize the Pinnacle Series Laser by Aspen Laser Systems to apply LLLT
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Procedure: Group 2 -- using Pinnacle Series Laser Device
Utilizing the Pinnacle Series Laser by Aspen Laser Systems, we will apply 830nm, 30- 50mW cw, ~ 1-20 J/cm2 at the following time and mW intervals. The beam will be applied at 12 application patterns equidistant and parallel to each other. Each application point will be treated for the timeframes referenced below:
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Experimental: Group 3 (Phoenix)
Utilizing the Phoenix Thera-Lase by Phoenix Thera-Lase Systems, we will apply LLT.
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Procedure: Group 3 -- using Phoenix Thera-Lase Device
Utilizing the Phoenix Thera-Lase by Phoenix Thera-Lase Systems, we will apply 904nm, 40mW (pulsed) @10000Hz, ~ 4-18 J/cm2 at the following time and mW intervals. The beam will be applied at 12 application patterns equidistant and parallel to each other. Each application point will be treated for the timeframes referenced below:
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The NDI assessing functional capacity, has 10 parts, which evaluate pain intensity, personal care, lifting objects, reading, headache, concentration, work, driving, sleeping, and recreation. NDI scores, ranging from 0-50, may be doubled and also expressed as a percentage of function on a scale of 0-100%; thereby allowing the measure to be treated as an interval variable. It has also been categorized into 5 ordinal measurements, which are shown below with corresponding score and percentage measurements:
The Defense and Veterans Pain Rating Scale is an assessment tool that utilizes a numerical rating scale, enhanced by functional word descriptors, color coding, and graphical facial expressions to evaluate a patient's self-reported pain levels.
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used.
Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions.
Interleukin 2 Receptor (CD25) Soluble
Standard curve range: 4.25-17400 pg/mL
Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions.
Interleukin 12
Standard curve range: 1.56-6400 pg/mL
Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions.
Interleukin 4
Standard curve range: 9.35-38300 pg/mL
Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions.
Interleukin 5
Standard curve range: 6.52-26700 pg/mL
Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions.
Interleukin 10
Standard curve range: 2.49-10200 pg/mL
Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions.
Interleukin 13
Standard curve range: 3.27-13400 pg/mL
Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions.
Interleukin 1 beta
Standard curve range: 2.39-9800 pg/mL
Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions.
Interleukin 6
Standard curve range: 6.74-27600 pg/mL
Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions.
Interleukin 8
Standard curve range: 2.38-9750 pg/mL
Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions.
Tumor Necrosis Factor - alpha
Standard curve range: 6.42-26300 pg/mL
Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions.
Interleukin 2
Standard curve range: 4.25-17400 pg/mL
Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions.
Interleukin 17
Standard curve range: 2.22-9100 pg/mL
Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions.
cyclooxygenase (COX-2)
Standard curve range: 7.5 U/ml - 60 U/ml
Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions.
cortisol
Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions.
substance P
Standard curve range: N/A, values from day 0 time will be compared with day 10 values
Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions.
C-reactive protein
Standard curve range: 3 mg/L-10 mg/L
Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions.
alpha-1 antitrypsin
Standard curve range: 100-300 mg/dL
Ages Eligible for Study: | 18 Years to 62 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
**Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study**
Inclusion Criteria:
Exclusion Criteria:
Contact: Jill M Clark, MBA | 7026533298 | Jill.M.Clark15.ctr@mail.mil |
United States, Nevada | |
Mike O'Callaghan Military Medical Center | Recruiting |
Las Vegas, Nevada, United States, 89191 | |
Contact: Jill M Clark, MBA/HCM 702-653-3298 jill.m.clark15.ctr@mail.mil |
Principal Investigator: | Paul F Crawford, MD | US Air Force |
Tracking Information | |||||||
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First Submitted Date ICMJE | May 1, 2019 | ||||||
First Posted Date ICMJE | May 10, 2019 | ||||||
Last Update Posted Date | December 17, 2020 | ||||||
Actual Study Start Date ICMJE | October 1, 2020 | ||||||
Estimated Primary Completion Date | September 2022 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Evaluating Different Low-level Laser Therapies to Treat Neck Pain in Air Force Pilots and Flight Crew | ||||||
Official Title ICMJE | Evaluating Different Low-level Laser Therapies to Treat Neck Pain in Air Force Pilots and Flight Crew | ||||||
Brief Summary | Determine the most effective and efficient treatment protocols for treating neck pain with LLLT. | ||||||
Detailed Description | The purpose of this study is to identify what are the most effective low level laser therapy (LLLT) dosimetry parameters when treating pilots and navigators complaining of flight related neck pain. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Neck Pain | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
296 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | September 2022 | ||||||
Estimated Primary Completion Date | September 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
**Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study** Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 62 Years (Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03945240 | ||||||
Other Study ID Numbers ICMJE | FWH20190105H | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Paul Crawford, Mike O'Callaghan Military Hospital | ||||||
Study Sponsor ICMJE | Paul Crawford | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Mike O'Callaghan Military Hospital | ||||||
Verification Date | December 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |