Evaluating Light Therapy for Treatment of Overuse Anterior Knee Pain (LLL&KP02)

Hebrew University of Jerusalem

Status: Completed

Conditions: Anterior Knee Pain Syndrome

Treatments: Device: THOR Laser LX2 System; Device: Sham Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02845869

0130-16-SZMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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85 participants in 2 patient groups

Light Therapy

Experimental group

Description:

Subjects from this group will receive 8 biweekly physiotherapy treatment and in addition Light Therapy treatment with the THOR laser LX2 system.

Treatment:

Device: THOR Laser LX2 System

Sham Therapy

Sham Comparator group

Description:

Subjects from this group will receive 8 biweekly physiotherapy treatment and in addition Sham Therapy.

Treatment:

Device: Sham Therapy