Performance and Safety of LightForce® Therapy Lasers on Lateral Ankle Sprain (BRIGHT)

November 14, 2025 updated by: DJO UK Ltd

Randomized, Sham Controlled, Single Blind Study on the Performance and Safety of Photo Biomodulation Therapy (PBMT) With LightForce® Therapy Lasers on Lateral Ankle Sprain Pain Reduction

DJO UK Ltd (ENOVIS) is conducting this study to assess the effectiveness of LightForce® Therapy Lasers on pain reduction in subjects with ankle soft tissue trauma and/or sport injury. In detail this study will assess superiority of LightForce® Therapy Lasers combined with standard of care, represented by RICE and physiotherapy/exercise program, compared to sham laser combined with standard of care (RICE and physiotherapy/exercise program) on pain reduction in subjects with acute grade I - II lateral ankle sprain. In addition, this study allows to collect post market clinical data on the safety and performance of LightForce® Therapy Lasers, when used, following the normal clinical practice, in accordance with its approved and CE marked intended use.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This clinical investigation is a post-market, International, multi center, prospective, randomized, sham controlled, single blind study to assess the effectiveness of LightForce® Therapy Lasers and to collect PMCF data on the safety and performance of LightForce® Therapy Lasers when used in accordance with its approved labeling, to comply with Medical Device Regulation (EU) 2017/745 (MDR) Article 61 and Part B of Annex XI.

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient male or female with age ≥18 years old
  2. Patient with diagnosis of LAS (as confirmed by physical examination) to be treated by LightForce® Therapy Lasers according to its indications.
  3. Patient suffering from LAS pain for no more than 72 hours prior to enrollment
  4. Pain (either persistent or during activities) score reported by the subject at baseline ≥ 40 mm measured on VAS
  5. Patient able to provide written informed consent

Exclusion Criteria:

  1. Patient with musculoskeletal pathological conditions not to be treated with/contraindication to the use of LightForce® Therapy Lasers according to its intended use and indications
  2. Patients who are taking drugs that have heat or light sensitive contraindications, such as but not limited to certain types of steroids
  3. Patients who have been administered with corticosteroids after injury
  4. Pregnant females or females of childbearing potentially planning to become pregnant during the study participation
  5. Patients who had systemic inflammatory conditions (i.e. rheumatoid arthritis, polymyalgia rheumatica)
  6. Patients affected by chronic ankle instability (recurrent sprains, ankle instability, functional ankle instability, mechanical ankle instability fol¬lowing the first-time injury)
  7. Patients with bilateral ankle sprain
  8. Patients who have a disease that would limit their participation in exercises (i.e. severe chronic obstructive pulmonary disease, severe heart failure, cerebrovascular event history)
  9. Patients with fractures (as confirmed by radiological examination)
  10. Patients with a diagnosis of active cancer
  11. Patients with tattoos covering more than 30% of the area to be treated with LightForce® Therapy Lasers
  12. Patients who are mentally or physically incapacitated
  13. Patient participating in other clinical study or has completed a clinical study less than 30 days prior to enrollment
  14. Patients with other clinically significant co-morbidities that make the patient unsuitable for study participation, at the discretion of the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham Laser treatment - Arm 1
Sham Laser therapy
Device: Sham Laser therapy
sham laser therapy for 4 consecutive weeks with a minimum of 3 sessions per week, for the first 2 weeks, and then a minimum of 2 sessions per week for the following 2 weeks.
Other: RICE and physiotherapy/exercise protocol
RICE plus physiotherapy/exercise protocol represents the standard of care (SOC) and the program includes: for the first 2 weeks RICE protocol performed daily at home by the patient, for the following 4 weeks a physiotherapy/exercise protocol will be performed at site with 2 sessions per week.
Active Comparator: Laser Treatment - Arm 2
Laser therapy
Other: RICE and physiotherapy/exercise protocol
RICE plus physiotherapy/exercise protocol represents the standard of care (SOC) and the program includes: for the first 2 weeks RICE protocol performed daily at home by the patient, for the following 4 weeks a physiotherapy/exercise protocol will be performed at site with 2 sessions per week.
Device: Laser therapy
laser therapy for 4 consecutive weeks with a minimum of 3 sessions per week, for the first 2 weeks, and then a minimum of 2 sessions per week for the following 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain change
Time Frame: 2 weeks after treatment start
Pain reduction measured with Visual Analog Scale (VAS) (in a scale 0-100 mm, where 0 is no pain and 100 is the worst possible pain) after 4 weeks of treatment compared to pre-treatment (baseline) VAS
2 weeks after treatment start

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety - adverse event rate
Time Frame: through study completion, an average of 12 weeks
Proportion of patient experiencing an adverse event associated with device use
through study completion, an average of 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient overall status change
Time Frame: 2, 4, 6 ans 12 weeks after treatment start
Patient ratings of overall improvement, assessed by QoL (SF-12): The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. The SF-12 uses 12 items and scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. SF-12 will be assessed at 2, 4, 6 weeks and at 12 weeks and compared to baseline
2, 4, 6 ans 12 weeks after treatment start
Pain change
Time Frame: 1,3,4, 6 and 12 weeks after treatment start
Pain measured with Visual Analog Scale (VAS) (in a scale 0-100 mm, where 0 is no pain and 100 is the worst possible pain) at 1,3,4, 6 and 12 weeks after treatment start to assess short-term and long-term pain management compared to baseline
1,3,4, 6 and 12 weeks after treatment start
Ankle pain and Disability
Time Frame: 1, 2, 3, 4, 6 and at 12 weeks after treatment start
Ankle pain and disability measured with the Foot and Ankle Disability Index (FADI) questionnaire (the score output is given as a percentace) and the highest the percentage the better is the clinical outome, the lowest the percentage the worse is the clinical outcome; performed at 1, 2, 3, 4, 6 and at 12 weeks after treatment start compared to baseline.
1, 2, 3, 4, 6 and at 12 weeks after treatment start
Range of motion (ROM) of the ankle
Time Frame: 1, 2, 3, 4, 6 and 12 weeks after treatment start
Range of motion for the ankle (flex-extension) measured by a universal goniometer at 1,2, 4, 6 and 12 weeks after treatment start compared to baseline
1, 2, 3, 4, 6 and 12 weeks after treatment start
Return to pre-injury activity/sport level
Time Frame: 2, 3, 4, 6 and 12 weeks after treatment start
Return to pre-injury activity/sport level measured on a 1 to 5 Likert scale at 2, 3, 4 ,6 and 12 weeks. This will be assessed as time-to-recovery: time after injury needed for the patient to reach the pre injury/sport level.
2, 3, 4, 6 and 12 weeks after treatment start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DJO UK Ltd

Collaborators

Donawa Lifescience Consulting SRL

Investigators

  • Principal Investigator: Ove Indergaard, Physiotherap, ove@indergaardphysio.com

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

February 25, 2025

First Posted (Actual)

March 3, 2025

Study Record Updates

Last Update Posted (Actual)

November 17, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENOVIS-S-INP-0011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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