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Completed

NCT Number: NCT02665507

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Aviation Medicine Unit

Ramat Gan, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GaAlAs 808nm laser

Device

Hand held superpulsed GaAlAs 808 nm LLLI

SHAM

Device

Hand held laser that emits no LLLI

Primary outcomes

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

    Time frame: within 4 months

Secondary outcomes

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

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

Hebrew University of Jerusalem

Other

Registry information

Official study title

Evaluation of the Efficacy of Light Therapy for the Treatment of Back Pain in Pilots

Acronym: LLL&Pilots

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jan 27, 2016
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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