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

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03945240
• Other study ID #: FWH20190105H
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: September 2025

Study information

• Verified date: January 2024
• Source: Mike O'Callaghan Military Hospital
• Contact: Jill M Clark, MBA
• Phone: 7026533298
• Email: Jill.M.Clark15.ctr[@]mail.mil
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Determine the most effective and efficient treatment protocols for treating neck pain with LLLT.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 296
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 62 Years

Eligibility

**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

Related Conditions & MeSH terms

• Neck Pain

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
United States	Mike O'Callaghan Military Medical Center	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Paul Crawford

Country where clinical trial is conducted

United States, 

References & Publications (28)

(2018) International Association for the Study of Pain : Neck pain.

(2018) North American Association for Photobiomodulation Therapy.

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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. — View Citation

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. — View Citation

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. — View Citation

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)