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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
Hebrew University of Jerusalem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain focused on measuring Photobiomodulation, Aviation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 24, 2016
Last Updated
November 8, 2021
Sponsor
Hebrew University of Jerusalem
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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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