Light Therapy for the Treatment of Back Pain in Pilots (L... | NCT02665507

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

NCT02665507

Sponsor

Hebrew University of Jerusalem

Status

Completed

Last Update Posted

Mar 12, 2025Actual

Enrollment

42Actual

Phase

Phase 2Phase 3

Conditions

Back Pain

Interventions

GaAlAs 808nm laser
Sham

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2018Actual

Primary Completion Date

May 3, 2024Actual

Completion Date

Jul 3, 2024Actual

First Submitted Date

Jan 24, 2016

First Submission Date that Met QC Criteria

Jan 24, 2016

First Posted Date

Jan 27, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2025

Last Update Posted Date

Mar 12, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lilach Gavish, Study Director, Hebrew University of JerusalemPrincipal Investigator

Lead Sponsor

Hebrew University of JerusalemOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LLLI	Active Comparator	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
Sham	Sham Comparator	Subjects from this group will receive 6 biweekly physiotherapy treatment and in addition sham LLLI treatment	Device: Sham

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GaAlAs 808nm laser	Device	Hand held superpulsed GaAlAs 808 nm LLLI	LLLI

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lilach Gavish, PhD	Hebrew University of Jerusalem	Study Director
Yair Barzilay, MD	Shaare Zedek Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aviation Medicine Unit		Ramat Gan			Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001416	Back Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007834	Lasers

Ancestor Terms

ID	Term
D055096	Optical Devices
D004864	Equipment and Supplies
D055618	Radiation Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided