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出境医 / 临床实验 / Evaluating Different Low-level Laser Therapies to Treat Neck Pain in Air Force Pilots and Flight Crew

Evaluating Different Low-level Laser Therapies to Treat Neck Pain in Air Force Pilots and Flight Crew

Study Description
Brief Summary:
Determine the most effective and efficient treatment protocols for treating neck pain with LLLT.

Condition or disease Intervention/treatment Phase
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

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 Design
Layout table for study information
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
Arms and Interventions
Arm Intervention/treatment
Experimental: Group 1 (Pinnacle, lower dosimetry parameters)
Utilize the Pinnacle Series Laser by Aspen Laser Systems to apply LLLT
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:

  • Subgroup 1: 10 minutes at 5 mW
  • Subgroup 2: 10 minutes at 15 mW
  • Subgroup 3: 10 minutes at 32 mW
  • Subgroup 4: 15 minutes at 5 mW
  • Subgroup 5: 15 minutes at 15 mW
  • Subgroup 6: 15 minutes at 32 mW

Experimental: Group 2 (Pinnacle, higher dosimetry parameters)
Utilize the Pinnacle Series Laser by Aspen Laser Systems to apply LLLT
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:

  • Subgroup 1: 10 minutes at 5 mW
  • Subgroup 2: 10 minutes at 15 mW
  • Subgroup 3: 10 minutes at 32 mW
  • Subgroup 4: 15 minutes at 5 mW
  • Subgroup 5: 15 minutes at 15 mW
  • Subgroup 6: 15 minutes at 32 mW

Experimental: Group 3 (Phoenix)
Utilizing the Phoenix Thera-Lase by Phoenix Thera-Lase Systems, we will apply LLT.
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:

  • Subgroup 1: 10 minutes at 5 mW
  • Subgroup 2: 10 minutes at 15 mW
  • Subgroup 3: 10 minutes at 32 mW
  • Subgroup 4: 15 minutes at 5 mW
  • Subgroup 5: 15 minutes at 15 mW
  • Subgroup 6: 15 minutes at 32 mW

Outcome Measures
Primary Outcome Measures :
  1. Number of grounding days from flying due to neck pain -- Interval Variable [ Time Frame: Record during screening visit ]
    Number of grounding days from flying due to neck pain -- Interval Variable

  2. Change in Neck Disability Index (NDI) [ Time Frame: visit 0 (screening visit), visit 1 (day 1), visit 10 (day 10) ]

    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:

    • NDI Score 0-4 (0-8%) is total capacity (no disability)
    • NDI Score 5-14 (10-28%) is mild incapacity (mild disability)
    • NDI Score 15-24 (30-48%) is mild incapacity (moderate disability)
    • NDI Score 25-34 (50-64%) is serious capacity (severe disability)
    • NDI Score 35-50 (70-100%) is severe incapacity (complete disability)

  3. Change in Defense and Veterans Pain Rating Scale (DVPRS) [ Time Frame: visit 0 (screening visit), visit 1 (day 1), visit 10 (day 10) ]

    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.



Secondary Outcome Measures :
  1. Change in Interleukin 2 Receptor (CD25) Soluble Biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]

    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


  2. Change in Interleukin 12 biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]

    Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions.

    Interleukin 12

    Standard curve range: 1.56-6400 pg/mL


  3. Change in Interleukin 4 Biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]

    Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions.

    Interleukin 4

    Standard curve range: 9.35-38300 pg/mL


  4. Change in Interleukin 5 biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]

    Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions.

    Interleukin 5

    Standard curve range: 6.52-26700 pg/mL


  5. Change in Interleukin 10 Biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]

    Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions.

    Interleukin 10

    Standard curve range: 2.49-10200 pg/mL


  6. Change in Interleukin 13 Biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]

    Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions.

    Interleukin 13

    Standard curve range: 3.27-13400 pg/mL


  7. Change in Interleukin 1 beta Biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]

    Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions.

    Interleukin 1 beta

    Standard curve range: 2.39-9800 pg/mL


  8. Change in Interleukin 6 Biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]

    Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions.

    Interleukin 6

    Standard curve range: 6.74-27600 pg/mL


  9. Change in Interleukin 8 Biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]

    Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions.

    Interleukin 8

    Standard curve range: 2.38-9750 pg/mL


  10. Change in Tumor Necrosis Factor - alpha Biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]

    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


  11. Change in Interleukin 2 Biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]

    Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions.

    Interleukin 2

    Standard curve range: 4.25-17400 pg/mL


  12. Change in Interleukin 17 Biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]

    Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions.

    Interleukin 17

    Standard curve range: 2.22-9100 pg/mL


  13. Change in cyclooxygenase (COX-2 Biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]

    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


  14. Change in cortisol Biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]

    Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions.

    cortisol

    • Standard curve range: cortisol will be compared to normal reference range for the time the blood is drawn, which is noted on lab report
    • 8AM sample using the new assays is 10 to 50 picograms per milliliter (pg/ml); levels are usually less than 20 pg/ml at 4 PM and less than 5-10 pg/ml at midnight.

  15. Change in substance P Biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]

    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


  16. Change in C-reactive protein Biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]

    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


  17. Change in alpha-1 antitrypsin Biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]

    Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions.

    alpha-1 antitrypsin

    Standard curve range: 100-300 mg/dL



Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 62 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

**Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study**

Inclusion Criteria:

  • Active Duty US Air Force pilots or onboard navigators, aged 18- 62 years of age
  • maintain operational flight status at enrollment or within the last 6 months
  • History of neck pain for a period of more than two months
  • Score on the Neck Disability Index ranging from 15-24
  • No physiotherapy or local injection in 3 months before starting the study

Exclusion Criteria:

  • pregnant
  • major surgery or trauma in the previous 3 months
  • unstable cervical spine
  • cervical radiculopathy
  • rheumatoid arthritis
  • open wound over neck
  • pace-maker or defibrillator implantation
  • overt neuropathic pain or radiation pain
  • inability to express pain or quality of life.
  • history of neurological disorders
  • medical diagnosis of fibromyalgia; systemic disease
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Jill M Clark, MBA 7026533298 Jill.M.Clark15.ctr@mail.mil

Locations
Layout table for location information
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   
Sponsors and Collaborators
Paul Crawford
Investigators
Layout table for investigator information
Principal Investigator: Paul F Crawford, MD US Air Force
Tracking Information
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
 (submitted: July 2, 2019)
  • Number of grounding days from flying due to neck pain -- Interval Variable [ Time Frame: Record during screening visit ]
    Number of grounding days from flying due to neck pain -- Interval Variable
  • Change in Neck Disability Index (NDI) [ Time Frame: visit 0 (screening visit), visit 1 (day 1), visit 10 (day 10) ]
    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:
    • NDI Score 0-4 (0-8%) is total capacity (no disability)
    • NDI Score 5-14 (10-28%) is mild incapacity (mild disability)
    • NDI Score 15-24 (30-48%) is mild incapacity (moderate disability)
    • NDI Score 25-34 (50-64%) is serious capacity (severe disability)
    • NDI Score 35-50 (70-100%) is severe incapacity (complete disability)
  • Change in Defense and Veterans Pain Rating Scale (DVPRS) [ Time Frame: visit 0 (screening visit), visit 1 (day 1), visit 10 (day 10) ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 7, 2019)
  • Number of grounding days from flying due to neck pain -- Interval Variable [ Time Frame: Record during screening visit ]
    Number of grounding days from flying due to neck pain -- Interval Variable
  • Change in Neck Disability Index (NDI) [ Time Frame: visit 0 (screening visit), visit 1 (day 1), visit 10 (day 10) ]
    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:
    • NDI Score 0-4 (0-8%) is total capacity (no disability)
    • NDI Score 5-14 (10-28%) is mild incapacity (mild disability)
    • NDI Score 15-24 (30-48%) is mild incapacity (moderate disability)
    • NDI Score 25-34 (50-64%) is serious capacity (severe disability)
    • NDI Score 35-50 (70-100%) is severe incapacity (complete disability)
  • Change in Defense and Veterans Pain Rating Scale (DVPRS) [ Time Frame: visit 0 (screening visit), visit 1 (day 1), visit 10 (day 10) ]
    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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2019)
  • Change in Interleukin 2 Receptor (CD25) Soluble Biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]
    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
  • Change in Interleukin 12 biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]
    Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. Interleukin 12 Standard curve range: 1.56-6400 pg/mL
  • Change in Interleukin 4 Biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]
    Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. Interleukin 4 Standard curve range: 9.35-38300 pg/mL
  • Change in Interleukin 5 biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]
    Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. Interleukin 5 Standard curve range: 6.52-26700 pg/mL
  • Change in Interleukin 10 Biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]
    Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. Interleukin 10 Standard curve range: 2.49-10200 pg/mL
  • Change in Interleukin 13 Biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]
    Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. Interleukin 13 Standard curve range: 3.27-13400 pg/mL
  • Change in Interleukin 1 beta Biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]
    Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. Interleukin 1 beta Standard curve range: 2.39-9800 pg/mL
  • Change in Interleukin 6 Biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]
    Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. Interleukin 6 Standard curve range: 6.74-27600 pg/mL
  • Change in Interleukin 8 Biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]
    Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. Interleukin 8 Standard curve range: 2.38-9750 pg/mL
  • Change in Tumor Necrosis Factor - alpha Biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]
    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
  • Change in Interleukin 2 Biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]
    Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. Interleukin 2 Standard curve range: 4.25-17400 pg/mL
  • Change in Interleukin 17 Biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]
    Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. Interleukin 17 Standard curve range: 2.22-9100 pg/mL
  • Change in cyclooxygenase (COX-2 Biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]
    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
  • Change in cortisol Biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]
    Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. cortisol
    • Standard curve range: cortisol will be compared to normal reference range for the time the blood is drawn, which is noted on lab report
    • 8AM sample using the new assays is 10 to 50 picograms per milliliter (pg/ml); levels are usually less than 20 pg/ml at 4 PM and less than 5-10 pg/ml at midnight.
  • Change in substance P Biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]
    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
  • Change in C-reactive protein Biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]
    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
  • Change in alpha-1 antitrypsin Biomarker Levels [ Time Frame: day 0 (pre-treatment), day 10 (post-treatment) ]
    Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. alpha-1 antitrypsin Standard curve range: 100-300 mg/dL
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
Condition  ICMJE Neck Pain
Intervention  ICMJE
  • 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:

    • Subgroup 1: 10 minutes at 5 mW
    • Subgroup 2: 10 minutes at 15 mW
    • Subgroup 3: 10 minutes at 32 mW
    • Subgroup 4: 15 minutes at 5 mW
    • Subgroup 5: 15 minutes at 15 mW
    • Subgroup 6: 15 minutes at 32 mW
  • 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:

    • Subgroup 1: 10 minutes at 5 mW
    • Subgroup 2: 10 minutes at 15 mW
    • Subgroup 3: 10 minutes at 32 mW
    • Subgroup 4: 15 minutes at 5 mW
    • Subgroup 5: 15 minutes at 15 mW
    • Subgroup 6: 15 minutes at 32 mW
  • 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:

    • Subgroup 1: 10 minutes at 5 mW
    • Subgroup 2: 10 minutes at 15 mW
    • Subgroup 3: 10 minutes at 32 mW
    • Subgroup 4: 15 minutes at 5 mW
    • Subgroup 5: 15 minutes at 15 mW
    • Subgroup 6: 15 minutes at 32 mW
Study Arms  ICMJE
  • Experimental: Group 1 (Pinnacle, lower dosimetry parameters)
    Utilize the Pinnacle Series Laser by Aspen Laser Systems to apply LLLT
    Intervention: Procedure: Group 1 -- using Pinnacle Series Laser Device
  • Experimental: Group 2 (Pinnacle, higher dosimetry parameters)
    Utilize the Pinnacle Series Laser by Aspen Laser Systems to apply LLLT
    Intervention: Procedure: Group 2 -- using Pinnacle Series Laser Device
  • Experimental: Group 3 (Phoenix)
    Utilizing the Phoenix Thera-Lase by Phoenix Thera-Lase Systems, we will apply LLT.
    Intervention: Procedure: Group 3 -- using Phoenix Thera-Lase Device
Publications *
  • Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, Shibuya K, Salomon JA, Abdalla S, Aboyans V, Abraham J, Ackerman I, Aggarwal R, Ahn SY, Ali MK, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Bahalim AN, Barker-Collo S, Barrero LH, Bartels DH, Basáñez MG, Baxter A, Bell ML, Benjamin EJ, Bennett D, Bernabé E, Bhalla K, Bhandari B, Bikbov B, Bin Abdulhak A, Birbeck G, Black JA, Blencowe H, Blore JD, Blyth F, Bolliger I, Bonaventure A, Boufous S, Bourne R, Boussinesq M, Braithwaite T, Brayne C, Bridgett L, Brooker S, Brooks P, Brugha TS, Bryan-Hancock C, Bucello C, Buchbinder R, Buckle G, Budke CM, Burch M, Burney P, Burstein R, Calabria B, Campbell B, Canter CE, Carabin H, Carapetis J, Carmona L, Cella C, Charlson F, Chen H, Cheng AT, Chou D, Chugh SS, Coffeng LE, Colan SD, Colquhoun S, Colson KE, Condon J, Connor MD, Cooper LT, Corriere M, Cortinovis M, de Vaccaro KC, Couser W, Cowie BC, Criqui MH, Cross M, Dabhadkar KC, Dahiya M, Dahodwala N, Damsere-Derry J, Danaei G, Davis A, De Leo D, Degenhardt L, Dellavalle R, Delossantos A, Denenberg J, Derrett S, Des Jarlais DC, Dharmaratne SD, Dherani M, Diaz-Torne C, Dolk H, Dorsey ER, Driscoll T, Duber H, Ebel B, Edmond K, Elbaz A, Ali SE, Erskine H, Erwin PJ, Espindola P, Ewoigbokhan SE, Farzadfar F, Feigin V, Felson DT, Ferrari A, Ferri CP, Fèvre EM, Finucane MM, Flaxman S, Flood L, Foreman K, Forouzanfar MH, Fowkes FG, Franklin R, Fransen M, Freeman MK, Gabbe BJ, Gabriel SE, Gakidou E, Ganatra HA, Garcia B, Gaspari F, Gillum RF, Gmel G, Gosselin R, Grainger R, Groeger J, Guillemin F, Gunnell D, Gupta R, Haagsma J, Hagan H, Halasa YA, Hall W, Haring D, Haro JM, Harrison JE, Havmoeller R, Hay RJ, Higashi H, Hill C, Hoen B, Hoffman H, Hotez PJ, Hoy D, Huang JJ, Ibeanusi SE, Jacobsen KH, James SL, Jarvis D, Jasrasaria R, Jayaraman S, Johns N, Jonas JB, Karthikeyan G, Kassebaum N, Kawakami N, Keren A, Khoo JP, King CH, Knowlton LM, Kobusingye O, Koranteng A, Krishnamurthi R, Lalloo R, Laslett LL, Lathlean T, Leasher JL, Lee YY, Leigh J, Lim SS, Limb E, Lin JK, Lipnick M, Lipshultz SE, Liu W, Loane M, Ohno SL, Lyons R, Ma J, Mabweijano J, MacIntyre MF, Malekzadeh R, Mallinger L, Manivannan S, Marcenes W, March L, Margolis DJ, Marks GB, Marks R, Matsumori A, Matzopoulos R, Mayosi BM, McAnulty JH, McDermott MM, McGill N, McGrath J, Medina-Mora ME, Meltzer M, Mensah GA, Merriman TR, Meyer AC, Miglioli V, Miller M, Miller TR, Mitchell PB, Mocumbi AO, Moffitt TE, Mokdad AA, Monasta L, Montico M, Moradi-Lakeh M, Moran A, Morawska L, Mori R, Murdoch ME, Mwaniki MK, Naidoo K, Nair MN, Naldi L, Narayan KM, Nelson PK, Nelson RG, Nevitt MC, Newton CR, Nolte S, Norman P, Norman R, O'Donnell M, O'Hanlon S, Olives C, Omer SB, Ortblad K, Osborne R, Ozgediz D, Page A, Pahari B, Pandian JD, Rivero AP, Patten SB, Pearce N, Padilla RP, Perez-Ruiz F, Perico N, Pesudovs K, Phillips D, Phillips MR, Pierce K, Pion S, Polanczyk GV, Polinder S, Pope CA 3rd, Popova S, Porrini E, Pourmalek F, Prince M, Pullan RL, Ramaiah KD, Ranganathan D, Razavi H, Regan M, Rehm JT, Rein DB, Remuzzi G, Richardson K, Rivara FP, Roberts T, Robinson C, De Leòn FR, Ronfani L, Room R, Rosenfeld LC, Rushton L, Sacco RL, Saha S, Sampson U, Sanchez-Riera L, Sanman E, Schwebel DC, Scott JG, Segui-Gomez M, Shahraz S, Shepard DS, Shin H, Shivakoti R, Singh D, Singh GM, Singh JA, Singleton J, Sleet DA, Sliwa K, Smith E, Smith JL, Stapelberg NJ, Steer A, Steiner T, Stolk WA, Stovner LJ, Sudfeld C, Syed S, Tamburlini G, Tavakkoli M, Taylor HR, Taylor JA, Taylor WJ, Thomas B, Thomson WM, Thurston GD, Tleyjeh IM, Tonelli M, Towbin JA, Truelsen T, Tsilimbaris MK, Ubeda C, Undurraga EA, van der Werf MJ, van Os J, Vavilala MS, Venketasubramanian N, Wang M, Wang W, Watt K, Weatherall DJ, Weinstock MA, Weintraub R, Weisskopf MG, Weissman MM, White RA, Whiteford H, Wiersma ST, Wilkinson JD, Williams HC, Williams SR, Witt E, Wolfe F, Woolf AD, Wulf S, Yeh PH, Zaidi AK, Zheng ZJ, Zonies D, Lopez AD, Murray CJ, AlMazroa MA, Memish ZA. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2163-96. doi: 10.1016/S0140-6736(12)61729-2. Erratum in: Lancet. 2013 Feb 23;381(9867):628. AlMazroa, Mohammad A [added]; Memish, Ziad A [added].
  • Hämäläinen O, Heinijoki H, Vanharanta H. Neck training and +Gz-related neck pain: a preliminary study. Mil Med. 1998 Oct;163(10):707-8.
  • Harrison MF, Neary JP, Albert WJ, Kuruganti U, Croll JC, Chancey VC, Bumgardner BA. Measuring neuromuscular fatigue in cervical spinal musculature of military helicopter aircrew. Mil Med. 2009 Nov;174(11):1183-9.
  • Salmon DM, Harrison MF, Neary JP. Neck pain in military helicopter aircrew and the role of exercise therapy. Aviat Space Environ Med. 2011 Oct;82(10):978-87. Review.
  • (2018) International Association for the Study of Pain : Neck pain.
  • Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20. Review.
  • Attal N, Lanteri-Minet M, Laurent B, Fermanian J, Bouhassira D. The specific disease burden of neuropathic pain: results of a French nationwide survey. Pain. 2011 Dec;152(12):2836-2843. doi: 10.1016/j.pain.2011.09.014. Epub 2011 Oct 20.
  • Torrance N, Ferguson JA, Afolabi E, Bennett MI, Serpell MG, Dunn KM, Smith BH. Neuropathic pain in the community: more under-treated than refractory? Pain. 2013 May;154(5):690-699. doi: 10.1016/j.pain.2012.12.022. Epub 2013 Jan 23.
  • Mester E, Ludány G, Sellyei M, Szende B, Gyenes G, Tota GJ. [Studies on the inhibiting and activating effects of laser beams]. Langenbecks Arch Chir. 1968;322:1022-7. German.
  • Avci P, Gupta A, Sadasivam M, Vecchio D, Pam Z, Pam N, Hamblin MR. Low-level laser (light) therapy (LLLT) in skin: stimulating, healing, restoring. Semin Cutan Med Surg. 2013 Mar;32(1):41-52. Review.
  • (2018) North American Association for Photobiomodulation Therapy.
  • Guarini D, Gracia B, Ramírez-Lobos V, Noguera-Pantoja A, Solé-Ventura P. Laser Biophotomodulation in Patients with Neurosensory Disturbance of the Inferior Alveolar Nerve After Sagittal Split Ramus Osteotomy: A 2-Year Follow-Up Study. Photomed Laser Surg. 2018 Jan;36(1):3-9. doi: 10.1089/pho.2017.4312. Epub 2017 Oct 12.
  • Chow RT, Heller GZ, Barnsley L. The effect of 300 mW, 830 nm laser on chronic neck pain: a double-blind, randomized, placebo-controlled study. Pain. 2006 Sep;124(1-2):201-10. Epub 2006 Jun 27.
  • Enwemeka CS, Parker JC, Dowdy DS, Harkness EE, Sanford LE, Woodruff LD. The efficacy of low-power lasers in tissue repair and pain control: a meta-analysis study. Photomed Laser Surg. 2004 Aug;22(4):323-9.
  • Carrasco TG, Guerisoli LD, Guerisoli DM, Mazzetto MO. Evaluation of low intensity laser therapy in myofascial pain syndrome. Cranio. 2009 Oct;27(4):243-7.
  • Olavi A, Pekka R, Pertti K, Pekka P. Effects of the infrared laser therapy at treated and non-treated trigger points. Acupunct Electrother Res. 1989;14(1):9-14.
  • Graham N, Gross AR, Carlesso LC, Santaguida PL, Macdermid JC, Walton D, Ho E; ICON. An ICON Overview on Physical Modalities for Neck Pain and Associated Disorders. Open Orthop J. 2013 Sep 20;7:440-60. doi: 10.2174/1874325001307010440. eCollection 2013.
  • Ceccherelli F, Altafini L, Lo Castro G, Avila A, Ambrosio F, Giron GP. Diode laser in cervical myofascial pain: a double-blind study versus placebo. Clin J Pain. 1989 Dec;5(4):301-4.
  • Ozdemir F, Birtane M, Kokino S. The clinical efficacy of low-power laser therapy on pain and function in cervical osteoarthritis. Clin Rheumatol. 2001;20(3):181-4.
  • Konstantinovic LM, Cutovic MR, Milovanovic AN, Jovic SJ, Dragin AS, Letic MDj, Miler VM. Low-level laser therapy for acute neck pain with radiculopathy: a double-blind placebo-controlled randomized study. Pain Med. 2010 Aug;11(8):1169-78. doi: 10.1111/j.1526-4637.2010.00907.x.
  • Gur A, Sarac AJ, Cevik R, Altindag O, Sarac S. Efficacy of 904 nm gallium arsenide low level laser therapy in the management of chronic myofascial pain in the neck: a double-blind and randomize-controlled trial. Lasers Surg Med. 2004;35(3):229-35.
  • Ilbuldu E, Cakmak A, Disci R, Aydin R. Comparison of laser, dry needling, and placebo laser treatments in myofascial pain syndrome. Photomed Laser Surg. 2004 Aug;22(4):306-11.
  • Hakgüder A, Birtane M, Gürcan S, Kokino S, Turan FN. Efficacy of low level laser therapy in myofascial pain syndrome: an algometric and thermographic evaluation. Lasers Surg Med. 2003;33(5):339-43.
  • Woodruff LD, Bounkeo JM, Brannon WM, Dawes KS, Barham CD, Waddell DL, Enwemeka CS. The efficacy of laser therapy in wound repair: a meta-analysis of the literature. Photomed Laser Surg. 2004 Jun;22(3):241-7.
  • Huang YY, Chen AC, Carroll JD, Hamblin MR. Biphasic dose response in low level light therapy. Dose Response. 2009 Sep 1;7(4):358-83. doi: 10.2203/dose-response.09-027.Hamblin.
  • Huang YY, Sharma SK, Carroll J, Hamblin MR. Biphasic dose response in low level light therapy - an update. Dose Response. 2011;9(4):602-18. doi: 10.2203/dose-response.11-009.Hamblin. Epub 2011 Sep 2.
  • Huang YY, Nagata K, Tedford CE, McCarthy T, Hamblin MR. Low-level laser therapy (LLLT) reduces oxidative stress in primary cortical neurons in vitro. J Biophotonics. 2013 Oct;6(10):829-38. doi: 10.1002/jbio.201200157. Epub 2012 Dec 27.
  • Huang YY, Nagata K, Tedford CE, Hamblin MR. Low-level laser therapy (810 nm) protects primary cortical neurons against excitotoxicity in vitro. J Biophotonics. 2014 Aug;7(8):656-64. doi: 10.1002/jbio.201300125. Epub 2013 Oct 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 7, 2019)
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:

  • Active Duty US Air Force pilots or onboard navigators, aged 18- 62 years of age
  • maintain operational flight status at enrollment or within the last 6 months
  • History of neck pain for a period of more than two months
  • Score on the Neck Disability Index ranging from 15-24
  • No physiotherapy or local injection in 3 months before starting the study

Exclusion Criteria:

  • pregnant
  • major surgery or trauma in the previous 3 months
  • unstable cervical spine
  • cervical radiculopathy
  • rheumatoid arthritis
  • open wound over neck
  • pace-maker or defibrillator implantation
  • overt neuropathic pain or radiation pain
  • inability to express pain or quality of life.
  • history of neurological disorders
  • medical diagnosis of fibromyalgia; systemic disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 62 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jill M Clark, MBA 7026533298 Jill.M.Clark15.ctr@mail.mil
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: We do not plan on sharing data
Responsible Party Paul Crawford, Mike O'Callaghan Military Hospital
Study Sponsor  ICMJE Paul Crawford
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paul F Crawford, MD US Air Force
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