Back PainPhase 2/3LLL&PilotsNCT02665507
Light Therapy for the Treatment of Back Pain in Pilots (LLL&Pilots)
A Phase 2/3 study testing GaAlAs 808nm laser in people with Back Pain, run by Hebrew University of Jerusalem at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Back Pain
- What is being tested?
- GaAlAs 808nm laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2018to 3 Jul 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pilot (current)
- Level of pain - moderate to severe low back pain (≥40 on the pain VAS)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Light Therapy for the Treatment of Back Pain in Pilots
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.
Read the 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.
- Conditions
- Back Pain
- Being tested
- GaAlAs 808nm laser, Sham
- Keywords
- Photobiomodulation, Aviation
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GaAlAs 808nm laserDevice
Hand held superpulsed GaAlAs 808 nm LLLI
ShamDevice
Hand held laser that emits no LLLI
| Study group | Role | What they receive |
|---|---|---|
| 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 ). Receives: Device: GaAlAs 808nm laser |
| Sham | Sham comparator | Subjects from this group will receive 6 biweekly physiotherapy treatment and in addition sham LLLI treatment Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to reach minimal important change in pain level by visual analog scale (VAS)
Measured: within 4 months
Secondary outcomes (1)
Change in pain level by VAS after 3 weeks compared to baseline (before treatment)
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study start1 Mar 2018
- Primary completion3 May 2024
- Study completion3 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebrew University of Jerusalem
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lilach Gavish, Hebrew University of Jerusalem
- Investigators
- Lilach Gavish, PhD, Study director, Hebrew University of JerusalemYair Barzilay, MD, Principal investigator, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665507
- Sponsor's protocol ID
- 0630-15-HMO
- Acronym
- LLL&Pilots
- Status last verified
- Mar 2025
- First submitted
- 24 Jan 2016
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Light Therapy for the Treatment of Back Pain in Pilots
- ClinicalTrials.gov ID
- NCT02665507
- Acronym / sponsor ID
- LLL&Pilots / 0630-15-HMO
- Conditions
- Back Pain
- Keywords
- Photobiomodulation, Aviation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hebrew University of JerusalemUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 3 May 2024 (actual)
- Study completion
- 3 Jul 2024 (actual)
- First posted
- 27 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LLLI | Active comparator | Device: GaAlAs 808nm laserSubjects 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 ). |
| Sham | Sham comparator | Device: ShamSubjects from this group will receive 6 biweekly physiotherapy treatment and in addition sham LLLI treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pilot (current)
- Level of pain - moderate to severe low back pain (≥40 on the pain VAS)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GaAlAs 808nm laserHand held superpulsed GaAlAs 808 nm LLLI | Device | LLLI |
| ShamHand held laser that emits no LLLI | Device | Sham |
Primary outcome
Time to reach minimal important change in pain level by visual analog scale (VAS)
Time frame: within 4 months
1 secondary outcome
Change in pain level by VAS after 3 weeks compared to baseline (before treatment)
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lilach Gavish, PhD study director
Hebrew University of Jerusalem
Yair Barzilay, MD principal investigator
Shaare Zedek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing GaAlAs 808nm laser in people with Back Pain, run by Hebrew University of Jerusalem at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to reach minimal important change in pain level by visual analog scale (VAS) (time frame: within 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.