Light Therapy for the Treatment of Back Pain in Pilots (LLL&Pilots) (LLL&Pilots)
Primary Purpose
Back Pain
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
GaAlAs 808nm laser
Sham
Sponsored by
About this trial
This is an interventional treatment trial for Back Pain focused on measuring Photobiomodulation, Aviation
Eligibility Criteria
Inclusion Criteria:
- Pilot (current)
- Level of pain - moderate to severe low back pain (≥40 on the pain VAS)
Exclusion Criteria:
- Low back pain due to non-traumatic etiological causes (infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, cauda equinal syndrome).
- Pregnant
- Recent (up to 1 year) history of trauma
- Current chronic pain other than low back pain
- Physical disability that prevents the patient to lie down/get up
Sites / Locations
- Aviation Medicine Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
LLLI
Sham
Arm Description
Subjects from this group will receive 6 biweekly physiotherapy treatment and in addition LLLI (low level laser irradiation) treatment performed with Gallium-Aluminium-Arsenide 808 nm laser ( GaAlAs 808nm laser ).
Subjects from this group will receive 6 biweekly physiotherapy treatment and in addition sham LLLI treatment
Outcomes
Primary Outcome Measures
Time to reach minimal important change in pain level by visual analog scale (VAS)
Secondary Outcome Measures
Change in pain level by VAS after 3 weeks compared to baseline (before treatment)
Full Information
NCT ID
NCT02665507
First Posted
January 24, 2016
Last Updated
November 8, 2021
Sponsor
Hebrew University of Jerusalem
1. Study Identification
Unique Protocol Identification Number
NCT02665507
Brief Title
Light Therapy for the Treatment of Back Pain in Pilots (LLL&Pilots)
Acronym
LLL&Pilots
Official Title
Evaluation of the Efficacy of Light Therapy for the Treatment of Back Pain in Pilots
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebrew University of Jerusalem
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Back pain is a common complaint among pilots. Current treatments include physiotherapy and chiropractic manipulations. Low-level laser irradiation (LLLI) in the visible to near-infrared range was shown to reduce neck and low back pain.
The purpose of the study is to evaluate the efficacy of Light Therapy for treatment of back pain in pilots.
Detailed Description
Background: Lumbar spine disorders are common conditions in pilots of various aircraft with etiology related to sub-optimal ergonomics, exposure to G-forces, the weight of the head gear and exposure to extensive vibrations. Current treatments include physiotherapy and chiropractic manipulations. Low-level laser irradiation (LLLI) is a non-ionizing, non-thermal irradiation within the visible to near infrared range of the light spectrum. LLLI has been used widely for alleviation of pain in inflammatory processes and acceleration of wound healing. A variety of clinical studies show that LLLT in the near infrared range may be useful in the treatment of back pain.
Objective: To evaluate the efficacy of Light Therapy for treatment of back pain in pilots.
Study design: Prospective, randomized, controlled double blind. Volunteers will receive biweekly physiotherapy treatment for 3 weeks. In addition to the physiotherapy treatment, half the volunteers will receive light therapy and half sham irradiation. Study evaluations will include physical examination by an orthopedic surgeon, subjective pain level by visual analogue scale, validated low back functional questionnaires, a generic functional questionnaire, and patient satisfaction scores. Volunteers will be invited for evaluations at 1 and 3 months after the final treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
Keywords
Photobiomodulation, Aviation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LLLI
Arm Type
Active Comparator
Arm Description
Subjects from this group will receive 6 biweekly physiotherapy treatment and in addition LLLI (low level laser irradiation) treatment performed with Gallium-Aluminium-Arsenide 808 nm laser ( GaAlAs 808nm laser ).
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Subjects from this group will receive 6 biweekly physiotherapy treatment and in addition sham LLLI treatment
Intervention Type
Device
Intervention Name(s)
GaAlAs 808nm laser
Intervention Description
Hand held superpulsed GaAlAs 808 nm LLLI
Intervention Type
Device
Intervention Name(s)
Sham
Intervention Description
Hand held laser that emits no LLLI
Primary Outcome Measure Information:
Title
Time to reach minimal important change in pain level by visual analog scale (VAS)
Time Frame
within 4 months
Secondary Outcome Measure Information:
Title
Change in pain level by VAS after 3 weeks compared to baseline (before treatment)
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pilot (current)
Level of pain - moderate to severe low back pain (≥40 on the pain VAS)
Exclusion Criteria:
Low back pain due to non-traumatic etiological causes (infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, cauda equinal syndrome).
Pregnant
Recent (up to 1 year) history of trauma
Current chronic pain other than low back pain
Physical disability that prevents the patient to lie down/get up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lilach Gavish, PhD
Organizational Affiliation
Hebrew University of Jerusalem
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yair Barzilay, MD
Organizational Affiliation
Shaare Zedek Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aviation Medicine Unit
City
Ramat Gan
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Light Therapy for the Treatment of Back Pain in Pilots (LLL&Pilots)
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