Neck PainNCT03945240
Evaluating Different Low-level Laser Therapies to Treat Neck Pain in Air Force Pilots and Flight Crew
A study testing Group 1 -- using Pinnacle Series Laser Device, Group 2 -- using Pinnacle Series Laser Device and Group 3 -- using Phoenix Thera-Lase Device in people with Neck Pain, run by Paul Crawford at 1 site in United States.
Trial summary
Determine the most effective and efficient treatment protocols for treating neck pain with LLLT. Read more about this study
- Who is it for?
- Ages 18 to 62 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Group 1 -- using Pinnacle Series Laser Device, Group 2 -- using Pinnacle Series Laser Device and Group 3 -- using Phoenix Thera-Lase Device
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 9 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 62 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- pregnant
- major surgery or trauma in the previous 3 months
- unstable cervical spine
- cervical radiculopathy
- rheumatoid arthritis
- open wound over neck
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mike O'Callaghan Military Medical Center
Las Vegas, Nevada, 89191
About this study
Determine the most effective and efficient treatment protocols for treating neck pain with LLLT.
Read the 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.
- Conditions
- Neck Pain
- Being tested
- Group 1 -- using Pinnacle Series Laser Device, Group 2 -- using Pinnacle Series Laser Device, Group 3 -- using Phoenix Thera-Lase Device
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 -- using Pinnacle Series Laser DeviceProcedure or surgery
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 DeviceProcedure or surgery
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 DeviceProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Pinnacle, lower dosimetry parameters) | Experimental | Utilize the Pinnacle Series Laser by Aspen Laser Systems to apply LLLT Receives: 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 Receives: 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. Receives: Procedure: Group 3 -- using Phoenix Thera-Lase Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of grounding days from flying due to neck pain -- Interval Variable
Number of grounding days from flying due to neck pain -- Interval Variable
Measured: 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)
Measured: 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.
Measured: visit 0 (screening visit), visit 1 (day 1), visit 10 (day 10)
Secondary outcomes (17)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: day 0 (pre-treatment), day 10 (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start1 Oct 2020
- Primary completion9 Dec 2025
- Study completion9 Dec 2025
Why it stopped: Unable to find qualified subjects and lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paul Crawford
- Sponsor type
- US federal agency
- Responsible party
- Sponsor-investigator, Paul Crawford, Mike O'Callaghan Military Hospital
- Investigators
- Paul F Crawford, MD, Principal investigator, US Air Force
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945240
- Sponsor's protocol ID
- FWH20190105H
- Status last verified
- Dec 2025
- First submitted
- 1 May 2019
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan on sharing data
Publications
Hamalainen O, Heinijoki H, Vanharanta H. Neck training and +Gz-related neck pain: a preliminary study. Mil Med. 1998 Oct;163(10):707-8.
PubMed 9795549Harrison MF, Neary JP, Albert WJ, Kuruganti U, Croll JC, Chancey VC, Bumgardner BA. Measuring neuromuscular fatigue in cervical spinal musculature of military helicopter aircrew. Mil Med. 2009 Nov;174(11):1183-9. doi: 10.7205/milmed-d-00-7409.
PubMed 19960827Salmon DM, Harrison MF, Neary JP. Neck pain in military helicopter aircrew and the role of exercise therapy. Aviat Space Environ Med. 2011 Oct;82(10):978-87. doi: 10.3357/asem.2841.2011.
PubMed 21961403(2018) International Association for the Study of Pain : Neck pain.
Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20.
PubMed 18443635Attal N, Lanteri-Minet M, Laurent B, Fermanian J, Bouhassira D. The specific disease burden of neuropathic pain: results of a French nationwide survey. Pain. 2011 Dec;152(12):2836-2843. doi: 10.1016/j.pain.2011.09.014. Epub 2011 Oct 20.
PubMed 22019149Torrance N, Ferguson JA, Afolabi E, Bennett MI, Serpell MG, Dunn KM, Smith BH. Neuropathic pain in the community: more under-treated than refractory? Pain. 2013 May;154(5):690-699. doi: 10.1016/j.pain.2012.12.022. Epub 2013 Jan 23.
PubMed 23485369Mester E, Ludany G, Sellyei M, Szende B, Gyenes G, Tota GJ. [Studies on the inhibiting and activating effects of laser beams]. Langenbecks Arch Chir. 1968;322:1022-7. doi: 10.1007/BF02453990. No abstract available. German.
PubMed 5758676Avci P, Gupta A, Sadasivam M, Vecchio D, Pam Z, Pam N, Hamblin MR. Low-level laser (light) therapy (LLLT) in skin: stimulating, healing, restoring. Semin Cutan Med Surg. 2013 Mar;32(1):41-52.
PubMed 24049929(2018) North American Association for Photobiomodulation Therapy.
Guarini D, Gracia B, Ramirez-Lobos V, Noguera-Pantoja A, Sole-Ventura P. Laser Biophotomodulation in Patients with Neurosensory Disturbance of the Inferior Alveolar Nerve After Sagittal Split Ramus Osteotomy: A 2-Year Follow-Up Study. Photomed Laser Surg. 2018 Jan;36(1):3-9. doi: 10.1089/pho.2017.4312. Epub 2017 Oct 12.
PubMed 29022844Chow RT, Heller GZ, Barnsley L. The effect of 300 mW, 830 nm laser on chronic neck pain: a double-blind, randomized, placebo-controlled study. Pain. 2006 Sep;124(1-2):201-10. doi: 10.1016/j.pain.2006.05.018. Epub 2006 Jun 27.
PubMed 16806710Enwemeka CS, Parker JC, Dowdy DS, Harkness EE, Sanford LE, Woodruff LD. The efficacy of low-power lasers in tissue repair and pain control: a meta-analysis study. Photomed Laser Surg. 2004 Aug;22(4):323-9. doi: 10.1089/pho.2004.22.323.
PubMed 15345176Carrasco TG, Guerisoli LD, Guerisoli DM, Mazzetto MO. Evaluation of low intensity laser therapy in myofascial pain syndrome. Cranio. 2009 Oct;27(4):243-7. doi: 10.1179/crn.2009.035.
PubMed 19891258Olavi A, Pekka R, Pertti K, Pekka P. Effects of the infrared laser therapy at treated and non-treated trigger points. Acupunct Electrother Res. 1989;14(1):9-14. doi: 10.3727/036012989816358560.
PubMed 2568075
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Different Low-level Laser Therapies to Treat Neck Pain in Air Force Pilots and Flight Crew
- ClinicalTrials.gov ID
- NCT03945240
- Acronym / sponsor ID
- FWH20190105H
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to find qualified subjects and lack of funding
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Paul CrawfordUS federal agency
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 9 Dec 2025 (actual)
- Study completion
- 9 Dec 2025 (actual)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Pinnacle, lower dosimetry parameters) | Experimental | Procedure: Group 1 -- using Pinnacle Series Laser DeviceUtilize the Pinnacle Series Laser by Aspen Laser Systems to apply LLLT |
| Group 2 (Pinnacle, higher dosimetry parameters) | Experimental | Procedure: Group 2 -- using Pinnacle Series Laser DeviceUtilize the Pinnacle Series Laser by Aspen Laser Systems to apply LLLT |
| Group 3 (Phoenix) | Experimental | Procedure: Group 3 -- using Phoenix Thera-Lase DeviceUtilizing the Phoenix Thera-Lase by Phoenix Thera-Lase Systems, we will apply LLT. |
Who may qualify
- Ages
- 18 to 62 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- pregnant
- major surgery or trauma in the previous 3 months
- unstable cervical spine
- cervical radiculopathy
- rheumatoid arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1 -- using Pinnacle Series Laser DeviceUtilizing 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 | Procedure or surgery | Group 1 (Pinnacle, lower dosimetry parameters) |
| Group 2 -- using Pinnacle Series Laser DeviceUtilizing 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 | Procedure or surgery | Group 2 (Pinnacle, higher dosimetry parameters) |
| Group 3 -- using Phoenix Thera-Lase DeviceUtilizing 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 | Procedure or surgery | Group 3 (Phoenix) |
Primary outcome
Number of grounding days from flying due to neck pain -- Interval Variable
Time frame: Record during screening visit
Number of grounding days from flying due to neck pain -- Interval Variable
Change in Neck Disability Index (NDI)
Time frame: visit 0 (screening visit), visit 1 (day 1), visit 10 (day 10)
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)
Time frame: visit 0 (screening visit), visit 1 (day 1), visit 10 (day 10)
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.
17 secondary outcomes
Change in Interleukin 2 Receptor (CD25) Soluble Biomarker Levels
Time frame: day 0 (pre-treatment), day 10 (post-treatment)
Change in Interleukin 12 biomarker Levels
Time frame: day 0 (pre-treatment), day 10 (post-treatment)
Change in Interleukin 4 Biomarker Levels
Time frame: day 0 (pre-treatment), day 10 (post-treatment)
Change in Interleukin 5 biomarker Levels
Time frame: day 0 (pre-treatment), day 10 (post-treatment)
Change in Interleukin 10 Biomarker Levels
Time frame: day 0 (pre-treatment), day 10 (post-treatment)
Change in Interleukin 13 Biomarker Levels
Time frame: day 0 (pre-treatment), day 10 (post-treatment)
Change in Interleukin 1 beta Biomarker Levels
Time frame: day 0 (pre-treatment), day 10 (post-treatment)
Change in Interleukin 6 Biomarker Levels
Time frame: day 0 (pre-treatment), day 10 (post-treatment)
Change in Interleukin 8 Biomarker Levels
Time frame: day 0 (pre-treatment), day 10 (post-treatment)
Change in Tumor Necrosis Factor - alpha Biomarker Levels
Time frame: day 0 (pre-treatment), day 10 (post-treatment)
Change in Interleukin 2 Biomarker Levels
Time frame: day 0 (pre-treatment), day 10 (post-treatment)
Change in Interleukin 17 Biomarker Levels
Time frame: day 0 (pre-treatment), day 10 (post-treatment)
Change in cyclooxygenase (COX-2 Biomarker Levels
Time frame: day 0 (pre-treatment), day 10 (post-treatment)
Change in cortisol Biomarker Levels
Time frame: day 0 (pre-treatment), day 10 (post-treatment)
Change in substance P Biomarker Levels
Time frame: day 0 (pre-treatment), day 10 (post-treatment)
Change in C-reactive protein Biomarker Levels
Time frame: day 0 (pre-treatment), day 10 (post-treatment)
Change in alpha-1 antitrypsin Biomarker Levels
Time frame: day 0 (pre-treatment), day 10 (post-treatment)
Results and safety
The study was stopped early (reason given: Unable to find qualified subjects and lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Background: PubMed 9795549Hamalainen O, Heinijoki H, Vanharanta H. Neck training and +Gz-related neck pain: a preliminary study. Mil Med. 1998 Oct;163(10):707-8.
- Background: PubMed 19960827Harrison MF, Neary JP, Albert WJ, Kuruganti U, Croll JC, Chancey VC, Bumgardner BA. Measuring neuromuscular fatigue in cervical spinal musculature of military helicopter aircrew. Mil Med. 2009 Nov;174(11):1183-9. doi: 10.7205/milmed-d-00-7409.
- Background: PubMed 21961403Salmon DM, Harrison MF, Neary JP. Neck pain in military helicopter aircrew and the role of exercise therapy. Aviat Space Environ Med. 2011 Oct;82(10):978-87. doi: 10.3357/asem.2841.2011.
- Background(2018) International Association for the Study of Pain : Neck pain.
- Background: PubMed 18443635Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20.
- Background: PubMed 22019149Attal N, Lanteri-Minet M, Laurent B, Fermanian J, Bouhassira D. The specific disease burden of neuropathic pain: results of a French nationwide survey. Pain. 2011 Dec;152(12):2836-2843. doi: 10.1016/j.pain.2011.09.014. Epub 2011 Oct 20.
- Background: PubMed 23485369Torrance N, Ferguson JA, Afolabi E, Bennett MI, Serpell MG, Dunn KM, Smith BH. Neuropathic pain in the community: more under-treated than refractory? Pain. 2013 May;154(5):690-699. doi: 10.1016/j.pain.2012.12.022. Epub 2013 Jan 23.
- Background: PubMed 5758676Mester E, Ludany G, Sellyei M, Szende B, Gyenes G, Tota GJ. [Studies on the inhibiting and activating effects of laser beams]. Langenbecks Arch Chir. 1968;322:1022-7. doi: 10.1007/BF02453990. No abstract available. German.
- Background: PubMed 24049929Avci P, Gupta A, Sadasivam M, Vecchio D, Pam Z, Pam N, Hamblin MR. Low-level laser (light) therapy (LLLT) in skin: stimulating, healing, restoring. Semin Cutan Med Surg. 2013 Mar;32(1):41-52.
- Background(2018) North American Association for Photobiomodulation Therapy.
- Background: PubMed 29022844Guarini D, Gracia B, Ramirez-Lobos V, Noguera-Pantoja A, Sole-Ventura P. Laser Biophotomodulation in Patients with Neurosensory Disturbance of the Inferior Alveolar Nerve After Sagittal Split Ramus Osteotomy: A 2-Year Follow-Up Study. Photomed Laser Surg. 2018 Jan;36(1):3-9. doi: 10.1089/pho.2017.4312. Epub 2017 Oct 12.
- Background: PubMed 16806710Chow RT, Heller GZ, Barnsley L. The effect of 300 mW, 830 nm laser on chronic neck pain: a double-blind, randomized, placebo-controlled study. Pain. 2006 Sep;124(1-2):201-10. doi: 10.1016/j.pain.2006.05.018. Epub 2006 Jun 27.
- Individual participant dataSharing planned: No. We do not plan on sharing data
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Nonspecific Low Back Pain
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Strain Counter Strain and Conventional Stretching in School-aged Children With Mechanical Neck Pain Due to Prolong Screen Use
Mechanical Neck Pain
Recruiting
Effects of Alexander Technique Versus Feldenkrais Somatic Training in Patients With Text Neck Syndrome
Text Neck Syndrome
Recruiting
Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
Chronic Neck Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul F Crawford, MD principal investigator
US Air Force
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1 -- using Pinnacle Series Laser Device, Group 2 -- using Pinnacle Series Laser Device and Group 3 -- using Phoenix Thera-Lase Device in people with Neck Pain, run by Paul Crawford at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to find qualified subjects and lack of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of grounding days from flying due to neck pain -- Interval Variable (time frame: Record during screening visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03945240, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.