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Low-level Laser Therapy
Low-level Laser Therapy for Neck Pain
N/A
Recruiting
Led By Paul F Crawford, MD
Research Sponsored by Paul Crawford
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Active Duty US Air Force pilots or onboard navigators, aged 18- 62 years of age
History of neck pain for a period of more than two months
Must not have
Cervical radiculopathy
Open wound over neck
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 (pre-treatment), day 10 (post-treatment)
Awards & highlights
No Placebo-Only Group
Summary
This trial will find the best way to treat neck pain using low-level laser therapy.
Who is the study for?
This trial is for active US Air Force pilots or navigators, aged 18-62, who can get care at Nellis Air Force Base. They should have had neck pain for over two months and a moderate disability score on the Neck Disability Index. Exclusions include those with open neck wounds, pacemakers, certain chronic diseases like fibromyalgia or rheumatoid arthritis, recent major surgery or trauma, pregnancy, and unstable cervical conditions.
What is being tested?
The study aims to find out which low-level laser therapy (LLLT) device is best for treating neck pain in air force personnel. Participants will be divided into three groups; each group will receive treatment using different LLLT devices: Phoenix Thera-Lase Device or Pinnacle Series Laser Device.
What are the potential side effects?
Low-level laser therapies are generally considered safe but may cause minor side effects such as slight discomfort at the site of application, mild redness or swelling. Serious side effects are rare.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an active US Air Force pilot or navigator, aged 18-62.
Select...
I have had neck pain for over two months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have nerve pain or weakness from my neck.
Select...
I have an open wound on my neck.
Select...
I have rheumatoid arthritis.
Select...
I have a history of neurological disorders.
Select...
I have been diagnosed with fibromyalgia.
Select...
I experience severe nerve or radiation-related pain.
Select...
I have not had major surgery or serious injury in the last 3 months.
Select...
My neck bones are unstable.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ visit 0 (screening visit), visit 1 (day 1), visit 10 (day 10)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 0 (screening visit), visit 1 (day 1), visit 10 (day 10)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Defense and Veterans Pain Rating Scale (DVPRS)
Change in Neck Disability Index (NDI)
Number of grounding days from flying due to neck pain -- Interval Variable
Secondary study objectives
Change in C-reactive protein Biomarker Levels
Change in Interleukin 1 beta Biomarker Levels
Change in Interleukin 10 Biomarker Levels
+14 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Group 3 (Phoenix)Experimental Treatment1 Intervention
Utilizing the Phoenix Thera-Lase by Phoenix Thera-Lase Systems, we will apply LLT.
Group II: Group 2 (Pinnacle, higher dosimetry parameters)Experimental Treatment1 Intervention
Utilize the Pinnacle Series Laser by Aspen Laser Systems to apply LLLT
Group III: Group 1 (Pinnacle, lower dosimetry parameters)Experimental Treatment1 Intervention
Utilize the Pinnacle Series Laser by Aspen Laser Systems to apply LLLT
Find a Location
Who is running the clinical trial?
Paul CrawfordLead Sponsor
5 Previous Clinical Trials
671 Total Patients Enrolled
Paul F Crawford, MDPrincipal InvestigatorUS Air Force
7 Previous Clinical Trials
310 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have nerve pain or weakness from my neck.I have an open wound on my neck.I am an active US Air Force pilot or navigator, aged 18-62.I have rheumatoid arthritis.I have a history of neurological disorders.I experience severe nerve or radiation-related pain.You are unable to communicate about your pain or how you feel.I haven't had physiotherapy or local injections in the last 3 months.I have been diagnosed with fibromyalgia.Your neck disability score is between 15 and 24.I have had neck pain for over two months.You have a pacemaker or defibrillator implanted in your body.I have not had major surgery or serious injury in the last 3 months.My neck bones are unstable.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1 (Pinnacle, lower dosimetry parameters)
- Group 2: Group 2 (Pinnacle, higher dosimetry parameters)
- Group 3: Group 3 (Phoenix)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.