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

Back Pain Clinical Trial

— LLL&Pilots  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02665507
• Other study ID #: 0630-15-HMO
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: December 1, 2023

Study information

• Verified date: November 2021
• Source: Hebrew University of Jerusalem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain

Intervention

Device:
• GaAlAs 808nm laser
Hand held superpulsed GaAlAs 808 nm LLLI
• Sham
Hand held laser that emits no LLLI

Locations

Country	Name	City	State
Israel	Aviation Medicine Unit	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Hebrew University of Jerusalem

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to reach minimal important change in pain level by visual analog scale (VAS)		within 4 months
Secondary	Change in pain level by VAS after 3 weeks compared to baseline (before treatment)		3 weeks