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Completed

NCT Number: NCT02845869

Evaluating Light Therapy for Treatment of Overuse Anterior Knee Pain

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IDF bases

Jerusalem, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

THOR Laser LX2 System

Device

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

Device

The therapeutic light will be turned off but the system will produce similar noises and mild heat.

Primary outcomes

  1. 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"

Secondary outcomes

  1. Change from baseline to 3 month follow up in subjective pain level using a Visual Analogue Scale (VAS)

    Time frame: 3 month post treatments

    Subject assessment of pain will be evaluated using a Visual Analogue Scale (VAS), were 0 is "no pain" and 100 is "intolerable pain"

Sponsors and collaborators

Lead sponsor

Hebrew University of Jerusalem

Other

Collaborators

  • International Diabetes Federation
  • Shaare Zedek Medical Center

Registry information

Official study title

Evaluation of the Efficacy of Light Therapy for the Treatment of Anterior Knee Pain: A Prospective, Randomized, Double-Blind, Sham-Controlled Clinical Trial

Acronym: LLL&KP02

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jul 27, 2016
Registry last updated
Aug 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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