NCT02845869

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

August 9, 2019

Status Verified

August 1, 2019

Enrollment Period

1.7 years

First QC Date

July 24, 2016

Last Update Submit

August 8, 2019

Conditions

Anterior Knee Pain Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    3 month post treatments

Study Arms (2)

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.

Device: THOR Laser LX2 System

Sham Therapy

SHAM COMPARATOR

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

Device: Sham Therapy

Interventions

THOR Laser LX2 SystemDEVICE

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.

Light Therapy
Sham TherapyDEVICE

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

Sham Therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IDF bases

Jerusalem, Israel

Location

Related Publications (1)

  • 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.

    PMID: 34101208DERIVED

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Yair Barzilay, MD

    Shaare Zedek Hospital

    PRINCIPAL INVESTIGATOR

  • Lilach Gavish, PhD

    HUJI

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Director

Study Record Dates

First Submitted

July 24, 2016

First Posted

July 27, 2016

Study Start

March 1, 2017

Primary Completion

November 18, 2018

Study Completion

February 1, 2019

Last Updated

August 9, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)