Anterior Knee Pain SyndromeLLL&KP02NCT02845869
Evaluating Light Therapy for Treatment of Overuse Anterior Knee Pain
A study testing THOR Laser LX2 System in people with Anterior Knee Pain Syndrome, run by Hebrew University of Jerusalem at 1 site in Israel.
Trial summary
During basic training, 15% of military recruits develop knee pain, which hinders their chance to complete training. Current therapeutic options have had variable levels of success. Light therapy was shown to reduce pain in chronic inflammatory related knee pathology. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anterior Knee Pain Syndrome
- What is being tested?
- THOR Laser LX2 System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2017to 1 Feb 2019
- Phase
- Interventional
- 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
- Age: 18 - 65
- Knee pain on the background of overuse as determined by the orthopedic surgeon
- Willing to sign informed consent
Who cannot join
- Previous trauma to the knee
- Previous or planned surgical treatment to the knee
- Suspected meniscus injury
- Suffering from significant concurrent illness, such as cardiac disorders, or pertinent neurological disorders.
- Suffering from condition that does not permit filling questionnaires
- Use of NSAIDs during the 2 weeks before the development of Knee pain or before receiving treatment.
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 Anterior Knee Pain: A Prospective, Randomized, Double-Blind, Sham-Controlled Clinical Trial
During basic training, 15% of military recruits develop knee pain, which hinders their chance to complete training. Current therapeutic options have had variable levels of success. Light therapy was shown to reduce pain in chronic inflammatory related knee pathology. The current clinical study is designed to evaluate light therapy, as an adjunct to conservative physiotherapy for treatment of acute overuse KP in combat soldiers.
Read the detailed description
During basic training, 15% of military recruits develop knee pain on the background of overuse, which hinders their chance to complete training, and leads to high dropout rate with the accompanying cost to the system. When KP is due to overuse, the time to complete resolution is typically 2-3 months, but symptoms may last for years. Current therapeutic options have had variable levels of success. Finding an alternative non-drug, non-invasive therapeutic modality that is easily incorporated in a field setting and may shorten the resolution of pain may lead to earlier return to duty thereby reducing the associated cost to the system and to the individual soldier.
Low-level laser irradiation (LLLI) is non-ionizing and non-thermal, and is within the visible to near-infrared range of the electromagnetic spectrum. LLLI has been used widely for alleviation of pain, reduction of inflammation, and acceleration of wound healing. Pre-clinical and clinical studies have shown that LLLI reduces pain in chronic inflammatory related knee pathology. However, little is known about the effect of LLLI on acute knee pathology that account for 25-40% of all knee problems in athletes.
The current study is a prospective, randomized, controlled double blind clinical study designed to evaluate light therapy, as an adjunct to conservative physiotherapy for treatment of acute overuse KP in combat soldiers.
The treatment protocol includes conservative physiotherapy and in addition, biweekly sessions of light therapy or sham irradiation for 4 weeks. Two follow up visits will take place at 1 week and 3 months after the last treatment.
Study evaluations will include physical examination, physical activity tests, subjective pain level by visual analogue scale, improvement and satisfaction scores, and functional questionnaires.
- Conditions
- Anterior Knee Pain Syndrome
- Being tested
- THOR Laser LX2 System, Sham Therapy
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THOR Laser LX2 SystemDevice
Treatment session will take up to 25 minutes and will include stimulation of local lymph nodes and soft tissue, de-activation of trigger points, and eliciting analgesia.
Sham TherapyDevice
The therapeutic light will be turned off but the system will produce similar noises and mild heat.
| Study group | Role | What they receive |
|---|---|---|
| Light Therapy | Experimental | Subjects from this group will receive 8 biweekly physiotherapy treatment and in addition Light Therapy treatment with the THOR laser LX2 system. Receives: Device: THOR Laser LX2 System |
| Sham Therapy | Sham comparator | Subjects from this group will receive 8 biweekly physiotherapy treatment and in addition Sham Therapy. Receives: Device: Sham Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to end of treatments in subjective pain level using a Visual Analogue Scale (VAS)
Subject assessment of pain will be evaluated using a Visual Analogue Scale (VAS), were 0 is "no pain" and 100 is "intolerable pain"
Measured: 1 month (end of treatments)
Secondary outcomes (1)
Change from baseline to 3 month follow up in subjective pain level using a Visual Analogue Scale (VAS)
Subject assessment of pain will be evaluated using a Visual Analogue Scale (VAS), were 0 is "no pain" and 100 is "intolerable pain"
Measured: 3 month post treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study start1 Mar 2017
- Primary completion18 Nov 2018
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anterior Knee Pain SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebrew University of Jerusalem
- Sponsor type
- University, hospital or other
- Collaborators
- Shaare Zedek Medical Center, International Diabetes Federation
- Responsible party
- Principal investigator, Lilach Gavish, Hebrew University of Jerusalem
- Investigators
- Yair Barzilay, MD, Principal investigator, Shaare Zedek HospitalLilach Gavish, PhD, Study director, HUJI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845869
- Sponsor's protocol ID
- 0130-16-SZMC
- Acronym
- LLL&KP02
- Status last verified
- Aug 2019
- First submitted
- 24 Jul 2016
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gavish L, Spitzer E, Friedman I, Lowe J, Gertz SD, Eisenkraft A, Olshinka N, Malkin M, Barzilay Y. Sex-specific differences in functional outcomes from anterior knee pain in military personnel. BMJ Mil Health. 2026 Aug 10:military-2026-003339. doi: 10.1136/military-2026-003339. Online ahead of print.
PubMed 42575565Gavish L, Spitzer E, Friedman I, Lowe J, Folk N, Zarbiv Y, Gelman E, Vishnevski L, Fatale E, Herman M, Gofshtein R, Gam A, Gertz SD, Eisenkraft A, Barzilay Y. Photobiomodulation as an Adjunctive Treatment to Physiotherapy for Reduction of Anterior Knee Pain in Combat Soldiers: A Prospective, Double-Blind, Randomized, Pragmatic, Sham-Controlled Trial. Lasers Surg Med. 2021 Dec;53(10):1376-1385. doi: 10.1002/lsm.23442. Epub 2021 Jun 8.
PubMed 34101208
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. 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 Anterior Knee Pain: A Prospective, Randomized, Double-Blind, Sham-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02845869
- Acronym / sponsor ID
- LLL&KP02 / 0130-16-SZMC
- Conditions
- Anterior Knee Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Hebrew University of JerusalemUniversity, hospital or other
- Collaborators
- Shaare Zedek Medical Center, International Diabetes Federation
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 18 Nov 2018 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 27 Jul 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.
During basic training, 15% of military recruits develop knee pain, which hinders their chance to complete training. Current therapeutic options have had variable levels of success. Light therapy was shown to reduce pain in chronic inflammatory related knee pathology. The current clinical study is designed to evaluate light therapy, as an adjunct to conservative physiotherapy for treatment of acute overuse KP in combat soldiers.
Detailed description
During basic training, 15% of military recruits develop knee pain on the background of overuse, which hinders their chance to complete training, and leads to high dropout rate with the accompanying cost to the system. When KP is due to overuse, the time to complete resolution is typically 2-3 months, but symptoms may last for years. Current therapeutic options have had variable levels of success. Finding an alternative non-drug, non-invasive therapeutic modality that is easily incorporated in a field setting and may shorten the resolution of pain may lead to earlier return to duty thereby reducing the associated cost to the system and to the individual soldier.
Low-level laser irradiation (LLLI) is non-ionizing and non-thermal, and is within the visible to near-infrared range of the electromagnetic spectrum. LLLI has been used widely for alleviation of pain, reduction of inflammation, and acceleration of wound healing. Pre-clinical and clinical studies have shown that LLLI reduces pain in chronic inflammatory related knee pathology. However, little is known about the effect of LLLI on acute knee pathology that account for 25-40% of all knee problems in athletes.
The current study is a prospective, randomized, controlled double blind clinical study designed to evaluate light therapy, as an adjunct to conservative physiotherapy for treatment of acute overuse KP in combat soldiers.
The treatment protocol includes conservative physiotherapy and in addition, biweekly sessions of light therapy or sham irradiation for 4 weeks. Two follow up visits will take place at 1 week and 3 months after the last treatment.
Study evaluations will include physical examination, physical activity tests, subjective pain level by visual analogue scale, improvement and satisfaction scores, and functional questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Light Therapy | Experimental | Device: THOR Laser LX2 SystemSubjects from this group will receive 8 biweekly physiotherapy treatment and in addition Light Therapy treatment with the THOR laser LX2 system. |
| Sham Therapy | Sham comparator | Device: Sham TherapySubjects from this group will receive 8 biweekly physiotherapy treatment and in addition Sham Therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 18 - 65
- Knee pain on the background of overuse as determined by the orthopedic surgeon
- Willing to sign informed consent
Key exclusion criteria (6 listed)
- Previous trauma to the knee
- Previous or planned surgical treatment to the knee
- Suspected meniscus injury
- Suffering from significant concurrent illness, such as cardiac disorders, or pertinent neurological disorders.
- Suffering from condition that does not permit filling questionnaires
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 |
|---|---|---|
| THOR Laser LX2 SystemTreatment session will take up to 25 minutes and will include stimulation of local lymph nodes and soft tissue, de-activation of trigger points, and eliciting analgesia. | Device | Light Therapy |
| Sham TherapyThe therapeutic light will be turned off but the system will produce similar noises and mild heat. | Device | Sham Therapy |
Primary outcome
Change from baseline to end of treatments in subjective pain level using a Visual Analogue Scale (VAS)
Time frame: 1 month (end of treatments)
Subject assessment of pain will be evaluated using a Visual Analogue Scale (VAS), were 0 is "no pain" and 100 is "intolerable pain"
1 secondary outcome
Change from baseline to 3 month follow up in subjective pain level using a Visual Analogue Scale (VAS)
Time frame: 3 month post treatments
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 9 Aug 2019.
- Derived from this study: PubMed 42575565Gavish L, Spitzer E, Friedman I, Lowe J, Gertz SD, Eisenkraft A, Olshinka N, Malkin M, Barzilay Y. Sex-specific differences in functional outcomes from anterior knee pain in military personnel. BMJ Mil Health. 2026 Aug 10:military-2026-003339. doi: 10.1136/military-2026-003339. Online ahead of print.
- Derived from this study: PubMed 34101208Gavish L, Spitzer E, Friedman I, Lowe J, Folk N, Zarbiv Y, Gelman E, Vishnevski L, Fatale E, Herman M, Gofshtein R, Gam A, Gertz SD, Eisenkraft A, Barzilay Y. Photobiomodulation as an Adjunctive Treatment to Physiotherapy for Reduction of Anterior Knee Pain in Combat Soldiers: A Prospective, Double-Blind, Randomized, Pragmatic, Sham-Controlled Trial. Lasers Surg Med. 2021 Dec;53(10):1376-1385. doi: 10.1002/lsm.23442. Epub 2021 Jun 8.
- 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.
Yair Barzilay, MD principal investigator
Shaare Zedek Hospital
Lilach Gavish, PhD study director
HUJI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THOR Laser LX2 System in people with Anterior Knee Pain Syndrome, 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 3 inclusion and 6 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 9 Aug 2019. 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.
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?
Change from baseline to end of treatments in subjective pain level using a Visual Analogue Scale (VAS) (time frame: 1 month (end of treatments)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02845869, which also lists 2 linked publications.
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 9 Aug 2019.