Clinical trial NCT02665507: Light Therapy for the Treatment of Back Pain in Pilots (LLL&Pilots)
Official title: Evaluation of the Efficacy of Light Therapy for the Treatment of Back Pain in Pilots
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Back Pain
Keywords: Photobiomodulation
Aviation
Lead sponsor: Hebrew University of Jerusalem
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to reach minimal important change in pain level by visual analog scale (VAS)
timeFrame: within 4 months
Secondary outcomes:
measure: Change in pain level by VAS after 3 weeks compared to baseline (before treatment)
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Aviation Medicine Unit
Study officials:
affiliation: Hebrew University of Jerusalem
name: Lilach Gavish, PhD
role: STUDY_DIRECTOR
affiliation: Shaare Zedek Medical Center
name: Yair Barzilay, MD
role: PRINCIPAL_INVESTIGATOR
References: