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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Back Pain

Intervention / Treatment
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* Device: GaAlAs 808nm laser
* Device: Sham


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LLLI<br>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<br>* Hand held superpulsed GaAlAs 808 nm LLLI<br>|
| Sham Comparator: Sham<br>Subjects from this group will receive 6 biweekly physiotherapy treatment and in addition sham LLLI treatment | Device: Sham<br>* Hand held laser that emits no LLLI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to reach minimal important change in pain level by visual analog scale (VAS) |  | within 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain level by VAS after 3 weeks compared to baseline (before treatment) |  | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aviation, Photobiomodulation