Evaluating Light Therapy for Treatment of Overuse Anterior Knee Pain

Anterior Knee Pain Syndrome Clinical Trial

— LLL&KP02  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02845869
• Other study ID #: 0130-16-SZMC
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: February 1, 2019

Study information

• Verified date: August 2019
• Source: Hebrew University of Jerusalem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: February 1, 2019
• Est. primary completion date: November 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Knee Pain Syndrome
• Patellofemoral Pain Syndrome

Intervention

Device:
• THOR Laser LX2 System
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 Therapy
The therapeutic light will be turned off but the system will produce similar noises and mild heat.

Locations

Country	Name	City	State
Israel	IDF bases	Jerusalem

Sponsors (3)

Lead Sponsor	Collaborator
Hebrew University of Jerusalem	International Diabetes Federation, Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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"	1 month (end of treatments)
Secondary	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"	3 month post treatments