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

Phase 2

Completed

• Conditions: Back Pain
• Interventions: Device: Sham; Device: GaAlAs 808nm laser

• Registration Number: NCT02665507
• Lead Sponsor: Hebrew University of Jerusalem

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.

Study Timeline

• Study First Submitted: 2016-01-24
• Study First Submitted QC: 2016-01-24
• Study First Posted: 2016-01-27
• Study Start: 2018-03-01
• Primary Completion: 2024-05-03
• Study Completion: 2024-07-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham	Sham	Subjects from this group will receive 6 biweekly physiotherapy treatment and in addition sham LLLI treatment
LLLI	GaAlAs 808nm laser	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 ).

Primary Outcome Measures

Name	Time	Method
Time to reach minimal important change in pain level by visual analog scale (VAS)	within 4 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Aviation Medicine Unit; 🇮🇱 Ramat Gan, Israel