Clinical trial NCT03945240: 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
Overall status: RECRUITING
Phase: NA
Conditions: Neck Pain
Lead sponsor: Mike O'Callaghan Military Hospital
Sponsor class: FED
First posted: 2019-05-10
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of grounding days from flying due to neck pain -- Interval Variable
timeFrame: Record during screening visit
measure: Change in Neck Disability Index (NDI)
timeFrame: visit 0 (screening visit), visit 1 (day 1), visit 10 (day 10)
measure: Change in Defense and Veterans Pain Rating Scale (DVPRS)
timeFrame: visit 0 (screening visit), visit 1 (day 1), visit 10 (day 10)
Secondary outcomes:
measure: Change in Interleukin 2 Receptor (CD25) Soluble Biomarker Levels
timeFrame: day 0 (pre-treatment), day 10 (post-treatment)
measure: Change in Interleukin 12 biomarker Levels
timeFrame: day 0 (pre-treatment), day 10 (post-treatment)
measure: Change in Interleukin 4 Biomarker Levels
timeFrame: day 0 (pre-treatment), day 10 (post-treatment)
measure: Change in Interleukin 5 biomarker Levels
timeFrame: day 0 (pre-treatment), day 10 (post-treatment)
measure: Change in Interleukin 10 Biomarker Levels
timeFrame: day 0 (pre-treatment), day 10 (post-treatment)
measure: Change in Interleukin 13 Biomarker Levels
timeFrame: day 0 (pre-treatment), day 10 (post-treatment)
measure: Change in Interleukin 1 beta Biomarker Levels
timeFrame: day 0 (pre-treatment), day 10 (post-treatment)
measure: Change in Interleukin 6 Biomarker Levels
timeFrame: day 0 (pre-treatment), day 10 (post-treatment)
measure: Change in Interleukin 8 Biomarker Levels
timeFrame: day 0 (pre-treatment), day 10 (post-treatment)
measure: Change in Tumor Necrosis Factor - alpha Biomarker Levels
timeFrame: day 0 (pre-treatment), day 10 (post-treatment)
measure: Change in Interleukin 2 Biomarker Levels
timeFrame: day 0 (pre-treatment), day 10 (post-treatment)
measure: Change in Interleukin 17 Biomarker Levels
timeFrame: day 0 (pre-treatment), day 10 (post-treatment)
measure: Change in cyclooxygenase (COX-2 Biomarker Levels
timeFrame: day 0 (pre-treatment), day 10 (post-treatment)
measure: Change in cortisol Biomarker Levels
timeFrame: day 0 (pre-treatment), day 10 (post-treatment)
measure: Change in substance P Biomarker Levels
timeFrame: day 0 (pre-treatment), day 10 (post-treatment)
measure: Change in C-reactive protein Biomarker Levels
timeFrame: day 0 (pre-treatment), day 10 (post-treatment)
measure: Change in alpha-1 antitrypsin Biomarker Levels
timeFrame: day 0 (pre-treatment), day 10 (post-treatment)
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Mike O'Callaghan Military Medical Center
state: Nevada
Study officials:
affiliation: US Air Force
name: Paul F Crawford, MD
role: PRINCIPAL_INVESTIGATOR
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