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

NCT ID: NCT02665507

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2024-07-03

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.

Conditions

Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

LLLI

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 ).

Group Type: ACTIVE_COMPARATOR

GaAlAs 808nm laser

Intervention Type: DEVICE

Hand held superpulsed GaAlAs 808 nm LLLI

Sham

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

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: DEVICE

Hand held laser that emits no LLLI

Interventions

GaAlAs 808nm laser

Hand held superpulsed GaAlAs 808 nm LLLI

Intervention Type: DEVICE

Sham

Hand held laser that emits no LLLI

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebrew University of Jerusalem

OTHER

Sponsor Role: lead

Responsible Party

Lilach Gavish

Study Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lilach Gavish, PhD

Role: STUDY_DIRECTOR

Hebrew University of Jerusalem

Yair Barzilay, MD

Role: PRINCIPAL_INVESTIGATOR

Shaare Zedek Medical Center

Locations

Aviation Medicine Unit

Ramat Gan, , Israel

Countries

Israel

Other Identifiers

0630-15-HMO

Identifier Type: -

Identifier Source: org_study_id