Clinical trial NCT02845869: Evaluating Light Therapy for Treatment of Overuse Anterior Knee Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Knee Pain Syndrome
Lead sponsor: Hebrew University of Jerusalem
Sponsor class: OTHER
Collaborators: name: Shaare Zedek Medical Center
name: International Diabetes Federation
First posted: 2016-07-27
Enrollment: 85
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: 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.

Eligibility criteria: Inclusion Criteria:

1. Age: 18 - 65
2. Knee pain on the background of overuse as determined by the orthopedic surgeon
3. Willing to sign informed consent

Exclusion Criteria:

1. Previous trauma to the knee
2. Previous or planned surgical treatment to the knee
3. Suspected meniscus injury
4. Suffering from significant concurrent illness, such as cardiac disorders, or pertinent neurological disorders.
5. Suffering from condition that does not permit filling questionnaires
6. Use of NSAIDs during the 2 weeks before the development of Knee pain or before receiving treatment.

Primary outcomes:
measure: Change from baseline to end of treatments in subjective pain level using a Visual Analogue Scale (VAS)
timeFrame: 1 month (end of treatments)
Secondary outcomes:
measure: Change from baseline to 3 month follow up in subjective pain level using a Visual Analogue Scale (VAS)
timeFrame: 3 month post treatments
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: IDF bases
Study officials:
affiliation: Shaare Zedek Hospital
name: Yair Barzilay, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HUJI
name: Lilach Gavish, PhD
role: STUDY_DIRECTOR
References:
citation: Gavish 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.