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临床试验/NCT02845869
NCT02845869已完成不适用

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

Hebrew University of Jerusalem1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2017年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
85
试验地点
1
主要终点
Change from baseline to end of treatments in subjective pain level using a Visual Analogue Scale (VAS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: THOR Laser LX2 System (Device)

Sham Therapy

Sham Comparator

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

干预措施: Sham Therapy (Device)

结局指标

主要结局

Change from baseline to end of treatments in subjective pain level using a Visual Analogue Scale (VAS)

时间窗: 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"

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lilach Gavish

Study Director

Hebrew University of Jerusalem

研究点 (1)

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