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

Last updated: November 14, 2025
Sponsor: DJO UK Ltd
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain

Sprains

Acute Pain

Treatment

Laser therapy

RICE and physiotherapy/exercise protocol

Sham Laser therapy

Clinical Study ID

NCT06854016
ENOVIS-S-INP-0011
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 treatedby 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 atbaseline ≥ 40 mm measured on VAS

  5. Patient able to provide written informed consent

Exclusion

Exclusion Criteria:

  1. Patient with musculoskeletal pathological conditions not to be treatedwith/contraindication to the use of LightForce® Therapy Lasers according to itsintended 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 pregnantduring 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, ankleinstability, functional ankle instability, mechanical ankle instability fol¬lowingthe 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, cerebrovascularevent 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 withLightForce® Therapy Lasers

  12. Patients who are mentally or physically incapacitated

  13. Patient participating in other clinical study or has completed a clinical study lessthan 30 days prior to enrollment

  14. Patients with other clinically significant co-morbidities that make the patientunsuitable for study participation, at the discretion of the investigator

Study Design

Total Participants: 108
Treatment Group(s): 3
Primary Treatment: Laser therapy
Phase:
Study Start date:
April 11, 2025
Estimated Completion Date:
September 30, 2026

Study 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.

Connect with a study center

  • Carioni Fisioterapia

    Cassano D'adda, Milano
    Italy

    Site Not Available

  • Carioni Fisioterapia

    Cassano d'Adda 3179795, Milano
    Italy

    Active - Recruiting

  • Casertafisio

    Caserta,
    Italy

    Site Not Available

  • Casertafisio

    Caserta 3179866,
    Italy

    Active - Recruiting

  • Fisioterapia Eur

    Roma,
    Italy

    Active - Recruiting

  • Fisioterapia Gardenie

    Roma,
    Italy

    Active - Recruiting

  • Rachis Center

    Roma, 00199
    Italy

    Site Not Available

  • Fisiolab3

    Roma 8957247,
    Italy

    Active - Recruiting

  • Fisioterapia Eur

    Roma 8957247,
    Italy

    Active - Recruiting

  • Fisioterapia Gardenie

    Roma 8957247,
    Italy

    Active - Recruiting

  • Rachis Center

    Roma 8957247, 00199
    Italy

    Active - Recruiting

  • INDERGAARD PHYSIOTERAPY Ltd

    Leeds,
    United Kingdom

    Site Not Available

  • INDERGAARD PHYSIOTERAPY Ltd

    Leeds 2644688,
    United Kingdom

    Completed

  • Freedom Care Clinics

    Manchester 2643123,
    United Kingdom

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.