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

Hebrew University of Jerusalem

Status and phase: Completed; Phase 3; Phase 2

Conditions: Back Pain

Treatments: Device: GaAlAs 808nm laser; Device: Sham

Study type: Interventional

Funder types: Other

Identifiers

NCT02665507

0630-15-HMO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups

LLLI

Active Comparator group

Description:

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 ).

Treatment:

Device: GaAlAs 808nm laser

Sham

Sham Comparator group

Description:

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

Treatment:

Device: Sham