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

Primary Purpose

Neck Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group 1 -- using Pinnacle Series Laser Device
Group 2 -- using Pinnacle Series Laser Device
Group 3 -- using Phoenix Thera-Lase Device
Sponsored by
Paul Crawford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

18 Years - 62 Years (Adult)All SexesDoes not accept healthy volunteers

**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

Sites / Locations

  • Mike O'Callaghan Military Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group 1 (Pinnacle, lower dosimetry parameters)

Group 2 (Pinnacle, higher dosimetry parameters)

Group 3 (Phoenix)

Arm Description

Utilize the Pinnacle Series Laser by Aspen Laser Systems to apply LLLT

Utilize the Pinnacle Series Laser by Aspen Laser Systems to apply LLLT

Utilizing the Phoenix Thera-Lase by Phoenix Thera-Lase Systems, we will apply LLT.

Outcomes

Primary Outcome Measures

Number of grounding days from flying due to neck pain -- Interval Variable
Number of grounding days from flying due to neck pain -- Interval Variable
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)
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.

Secondary Outcome Measures

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
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
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
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
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
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
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
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
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
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
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
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
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
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.
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
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
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

Full Information

First Posted
May 1, 2019
Last Updated
January 26, 2023
Sponsor
Paul Crawford
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1. Study Identification

Unique Protocol Identification Number
NCT03945240
Brief Title
Evaluating Different Low-level Laser Therapies to Treat Neck Pain in Air Force Pilots and Flight Crew
Official Title
Evaluating Different Low-level Laser Therapies to Treat Neck Pain in Air Force Pilots and Flight Crew
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Paul Crawford

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
296 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (Pinnacle, lower dosimetry parameters)
Arm Type
Experimental
Arm Description
Utilize the Pinnacle Series Laser by Aspen Laser Systems to apply LLLT
Arm Title
Group 2 (Pinnacle, higher dosimetry parameters)
Arm Type
Experimental
Arm Description
Utilize the Pinnacle Series Laser by Aspen Laser Systems to apply LLLT
Arm Title
Group 3 (Phoenix)
Arm Type
Experimental
Arm Description
Utilizing the Phoenix Thera-Lase by Phoenix Thera-Lase Systems, we will apply LLT.
Intervention Type
Procedure
Intervention Name(s)
Group 1 -- using Pinnacle Series Laser Device
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Group 2 -- using Pinnacle Series Laser Device
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Group 3 -- using Phoenix Thera-Lase Device
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of grounding days from flying due to neck pain -- Interval Variable
Description
Number of grounding days from flying due to neck pain -- Interval Variable
Time Frame
Record during screening visit
Title
Change in Neck Disability Index (NDI)
Description
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)
Time Frame
visit 0 (screening visit), visit 1 (day 1), visit 10 (day 10)
Title
Change in Defense and Veterans Pain Rating Scale (DVPRS)
Description
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.
Time Frame
visit 0 (screening visit), visit 1 (day 1), visit 10 (day 10)
Secondary Outcome Measure Information:
Title
Change in Interleukin 2 Receptor (CD25) Soluble Biomarker Levels
Description
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
Time Frame
day 0 (pre-treatment), day 10 (post-treatment)
Title
Change in Interleukin 12 biomarker Levels
Description
Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. Interleukin 12 Standard curve range: 1.56-6400 pg/mL
Time Frame
day 0 (pre-treatment), day 10 (post-treatment)
Title
Change in Interleukin 4 Biomarker Levels
Description
Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. Interleukin 4 Standard curve range: 9.35-38300 pg/mL
Time Frame
day 0 (pre-treatment), day 10 (post-treatment)
Title
Change in Interleukin 5 biomarker Levels
Description
Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. Interleukin 5 Standard curve range: 6.52-26700 pg/mL
Time Frame
day 0 (pre-treatment), day 10 (post-treatment)
Title
Change in Interleukin 10 Biomarker Levels
Description
Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. Interleukin 10 Standard curve range: 2.49-10200 pg/mL
Time Frame
day 0 (pre-treatment), day 10 (post-treatment)
Title
Change in Interleukin 13 Biomarker Levels
Description
Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. Interleukin 13 Standard curve range: 3.27-13400 pg/mL
Time Frame
day 0 (pre-treatment), day 10 (post-treatment)
Title
Change in Interleukin 1 beta Biomarker Levels
Description
Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. Interleukin 1 beta Standard curve range: 2.39-9800 pg/mL
Time Frame
day 0 (pre-treatment), day 10 (post-treatment)
Title
Change in Interleukin 6 Biomarker Levels
Description
Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. Interleukin 6 Standard curve range: 6.74-27600 pg/mL
Time Frame
day 0 (pre-treatment), day 10 (post-treatment)
Title
Change in Interleukin 8 Biomarker Levels
Description
Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. Interleukin 8 Standard curve range: 2.38-9750 pg/mL
Time Frame
day 0 (pre-treatment), day 10 (post-treatment)
Title
Change in Tumor Necrosis Factor - alpha Biomarker Levels
Description
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
Time Frame
day 0 (pre-treatment), day 10 (post-treatment)
Title
Change in Interleukin 2 Biomarker Levels
Description
Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. Interleukin 2 Standard curve range: 4.25-17400 pg/mL
Time Frame
day 0 (pre-treatment), day 10 (post-treatment)
Title
Change in Interleukin 17 Biomarker Levels
Description
Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. Interleukin 17 Standard curve range: 2.22-9100 pg/mL
Time Frame
day 0 (pre-treatment), day 10 (post-treatment)
Title
Change in cyclooxygenase (COX-2 Biomarker Levels
Description
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
Time Frame
day 0 (pre-treatment), day 10 (post-treatment)
Title
Change in cortisol Biomarker Levels
Description
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.
Time Frame
day 0 (pre-treatment), day 10 (post-treatment)
Title
Change in substance P Biomarker Levels
Description
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
Time Frame
day 0 (pre-treatment), day 10 (post-treatment)
Title
Change in C-reactive protein Biomarker Levels
Description
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
Time Frame
day 0 (pre-treatment), day 10 (post-treatment)
Title
Change in alpha-1 antitrypsin Biomarker Levels
Description
Phlebotomists will draw 750 uL into 3 separate cryovials on two separate occasions. alpha-1 antitrypsin Standard curve range: 100-300 mg/dL
Time Frame
day 0 (pre-treatment), day 10 (post-treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
62 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jill M Clark, MBA
Phone
7026533298
Email
Jill.M.Clark15.ctr@mail.mil
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul F Crawford, MD
Organizational Affiliation
US Air Force
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mike O'Callaghan Military Medical Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89191
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill M Clark, MBA/HCM
Phone
702-653-3298
Email
jill.m.clark15.ctr@mail.mil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We do not plan on sharing data
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Evaluating Different Low-level Laser Therapies to Treat Neck Pain in Air Force Pilots and Flight Crew

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