Evaluating Light Therapy for Treatment of Overuse Anterior Knee Pain

NCT ID: NCT02845869

Last Updated: 2019-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2019-02-01

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.

Conditions

Anterior Knee Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Light Therapy

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

Group Type: EXPERIMENTAL

THOR Laser LX2 System

Intervention Type: 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

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

Group Type: SHAM_COMPARATOR

Sham Therapy

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Sham Therapy

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shaare Zedek Medical Center

OTHER

Sponsor Role: collaborator

International Diabetes Federation

OTHER

Sponsor Role: collaborator

Hebrew University of Jerusalem

OTHER

Sponsor Role: lead

Responsible Party

Lilach Gavish

Study Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yair Barzilay, MD

Role: PRINCIPAL_INVESTIGATOR

Shaare Zedek Hospital

Lilach Gavish, PhD

Role: STUDY_DIRECTOR

HUJI

Locations

IDF bases

Jerusalem, , Israel

Countries

Israel

References

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.

Reference Type: DERIVED

PMID: 34101208 (View on PubMed)

Other Identifiers

0130-16-SZMC

Identifier Type: -

Identifier Source: org_study_id