Light Therapy for the Treatment of Back Pain in Pilots (LLL&Pilots)

NCT02665507 | Completed Phase 2

• 1 other identifier: 0630-15-HMO
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Pain

Keywords

Photobiomodulation; Aviation

Outcome Measures

Primary Outcomes (1)

• Time to reach minimal important change in pain level by visual analog scale (VAS)

  within 4 months

Secondary Outcomes (1)

• Change in pain level by VAS after 3 weeks compared to baseline (before treatment)

  3 weeks

Study Arms (2)

LLLI

ACTIVE COMPARATOR

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 ).

Device: GaAlAs 808nm laser

Sham

SHAM COMPARATOR

Subjects from this group will receive 6 biweekly physiotherapy treatment and in addition sham LLLI treatment

Device: Sham

Interventions

GaAlAs 808nm laser DEVICE

Hand held superpulsed GaAlAs 808 nm LLLI

LLLI

Sham DEVICE

Hand held laser that emits no LLLI

Sham

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pilot (current)
• Level of pain - moderate to severe low back pain (≥40 on the pain VAS)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hebrew University of Jerusalem: lead

Study Sites (1)

Aviation Medicine Unit

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Back Pain

Interventions

Lasers

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Lilach Gavish, PhD

  Hebrew University of Jerusalem

  STUDY DIRECTOR

• Yair Barzilay, MD

  Shaare Zedek Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: January 24, 2016
• First Posted: January 27, 2016
• Study Start: March 1, 2018
• Primary Completion: May 3, 2024
• Study Completion: July 3, 2024
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)