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

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

Detailed Description
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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.

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

Conditions
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Neck Pain

Intervention / Treatment
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* Procedure: Group 1 -- using Pinnacle Series Laser Device
* Procedure: Group 2 -- using Pinnacle Series Laser Device
* Procedure: Group 3 -- using Phoenix Thera-Lase Device


Participation Criteria
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Eligibility Criteria
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**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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 62 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 (Pinnacle, lower dosimetry parameters)<br>Utilize the Pinnacle Series Laser by Aspen Laser Systems to apply LLLT | Procedure: Group 1 -- using Pinnacle Series Laser Device<br>* 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<br>|
| Experimental: Group 2 (Pinnacle, higher dosimetry parameters)<br>Utilize the Pinnacle Series Laser by Aspen Laser Systems to apply LLLT | Procedure: Group 2 -- using Pinnacle Series Laser Device<br>* 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<br>|
| Experimental: Group 3 (Phoenix)<br>Utilizing the Phoenix Thera-Lase by Phoenix Thera-Lase Systems, we will apply LLT. | Procedure: Group 3 -- using Phoenix Thera-Lase Device<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of grounding days from flying due to neck pain -- Interval Variable | Number of grounding days from flying due to neck pain -- Interval Variable | Record during screening visit | 
| Change in Neck Disability Index (NDI) | 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) | visit 0 (screening visit), visit 1 (day 1), visit 10 (day 10) | 
| Change in Defense and Veterans Pain Rating Scale (DVPRS) | 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. | visit 0 (screening visit), visit 1 (day 1), visit 10 (day 10) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Interleukin 2 Receptor (CD25) Soluble Biomarker Levels | 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 | day 0 (pre-treatment), day 10 (post-treatment) | 
| Change in Interleukin 12 biomarker Levels | Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. Interleukin 12 Standard curve range: 1.56-6400 pg/mL | day 0 (pre-treatment), day 10 (post-treatment) | 
| Change in Interleukin 4 Biomarker Levels | Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. Interleukin 4 Standard curve range: 9.35-38300 pg/mL | day 0 (pre-treatment), day 10 (post-treatment) | 
| Change in Interleukin 5 biomarker Levels | Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. Interleukin 5 Standard curve range: 6.52-26700 pg/mL | day 0 (pre-treatment), day 10 (post-treatment) | 
| Change in Interleukin 10 Biomarker Levels | Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. Interleukin 10 Standard curve range: 2.49-10200 pg/mL | day 0 (pre-treatment), day 10 (post-treatment) | 
| Change in Interleukin 13 Biomarker Levels | Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. Interleukin 13 Standard curve range: 3.27-13400 pg/mL | day 0 (pre-treatment), day 10 (post-treatment) | 
| Change in Interleukin 1 beta Biomarker Levels | Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. Interleukin 1 beta Standard curve range: 2.39-9800 pg/mL | day 0 (pre-treatment), day 10 (post-treatment) | 
| Change in Interleukin 6 Biomarker Levels | Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. Interleukin 6 Standard curve range: 6.74-27600 pg/mL | day 0 (pre-treatment), day 10 (post-treatment) | 
| Change in Interleukin 8 Biomarker Levels | Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. Interleukin 8 Standard curve range: 2.38-9750 pg/mL | day 0 (pre-treatment), day 10 (post-treatment) | 
| Change in Tumor Necrosis Factor - alpha Biomarker Levels | 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 | day 0 (pre-treatment), day 10 (post-treatment) | 
| Change in Interleukin 2 Biomarker Levels | Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. Interleukin 2 Standard curve range: 4.25-17400 pg/mL | day 0 (pre-treatment), day 10 (post-treatment) | 
| Change in Interleukin 17 Biomarker Levels | Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. Interleukin 17 Standard curve range: 2.22-9100 pg/mL | day 0 (pre-treatment), day 10 (post-treatment) | 
| Change in cyclooxygenase (COX-2 Biomarker Levels | 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 | day 0 (pre-treatment), day 10 (post-treatment) | 
| Change in cortisol Biomarker Levels | 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. | day 0 (pre-treatment), day 10 (post-treatment) | 
| Change in substance P Biomarker Levels | 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 | day 0 (pre-treatment), day 10 (post-treatment) | 
| Change in C-reactive protein Biomarker Levels | 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 | day 0 (pre-treatment), day 10 (post-treatment) | 
| Change in alpha-1 antitrypsin Biomarker Levels | Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. alpha-1 antitrypsin Standard curve range: 100-300 mg/dL | day 0 (pre-treatment), day 10 (post-treatment) |