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

NCT03945240 | Terminated

• 1 other identifier: FWH20190105H
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (17)

• Change in Interleukin 2 Receptor (CD25) Soluble Biomarker Levels

  day 0 (pre-treatment), day 10 (post-treatment)

• Change in Interleukin 12 biomarker Levels

  day 0 (pre-treatment), day 10 (post-treatment)

• Change in Interleukin 4 Biomarker Levels

  day 0 (pre-treatment), day 10 (post-treatment)

• Change in Interleukin 5 biomarker Levels

  day 0 (pre-treatment), day 10 (post-treatment)

• Change in Interleukin 10 Biomarker Levels

  day 0 (pre-treatment), day 10 (post-treatment)

Study Arms (3)

Group 1 (Pinnacle, lower dosimetry parameters)

EXPERIMENTAL

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

Procedure: Group 1 -- using Pinnacle Series Laser Device

Group 2 (Pinnacle, higher dosimetry parameters)

EXPERIMENTAL

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

Procedure: Group 2 -- using Pinnacle Series Laser Device

Group 3 (Phoenix)

EXPERIMENTAL

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

Procedure: Group 3 -- using Phoenix Thera-Lase Device

Interventions

Group 1 -- using Pinnacle Series Laser Device PROCEDURE

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 1 (Pinnacle, lower dosimetry parameters)

Group 2 -- using Pinnacle Series Laser Device PROCEDURE

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 2 (Pinnacle, higher dosimetry parameters)

Group 3 -- using Phoenix Thera-Lase Device PROCEDURE

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

Group 3 (Phoenix)

Eligibility Criteria

• Age: 18 Years - 62 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Paul Crawford: lead

Study Sites (1)

Mike O'Callaghan Military Medical Center

Las Vegas, Nevada, 89191, United States

Location

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MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul F Crawford, MD

  US Air Force

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: May 10, 2019
• Study Start: October 1, 2020
• Primary Completion: December 9, 2025
• Study Completion: December 9, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)