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

NCT06854016 | Recruiting

• 1 other identifier: ENOVIS-S-INP-0011
• Study Type: interventional
• Target: 108
• Locations: 2 countries
• Sites: 8

Brief 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.

Conditions

Ankle Sprain 1St Degree; Ankle Sprain 2Nd Degree; Acute Pain

Keywords

lateral acute grade I and II ankle sprain, pain, laser

Outcome Measures

Primary Outcomes (1)

• Pain change

  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 Outcomes (1)

• Safety - adverse event rate

  through study completion, an average of 12 weeks

Other Outcomes (5)

• Pain change

  1,3,4, 6 and 12 weeks after treatment start

• Ankle pain and Disability

  1, 2, 3, 4, 6 and at 12 weeks after treatment start

• Patient overall status change

  2, 4, 6 ans 12 weeks after treatment start

Study Arms (2)

Sham Laser treatment - Arm 1

SHAM COMPARATOR

Sham Laser therapy

Device: Sham Laser therapy; Other: RICE and physiotherapy/exercise protocol

Laser Treatment - Arm 2

ACTIVE COMPARATOR

Laser therapy

Device: Laser therapy; Other: RICE and physiotherapy/exercise protocol

Interventions

Sham Laser therapy DEVICE

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.

Sham Laser treatment - Arm 1

Laser therapy DEVICE

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.

Laser Treatment - Arm 2

RICE and physiotherapy/exercise protocol OTHER

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.

Laser Treatment - Arm 2; Sham Laser treatment - Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Patients who are taking drugs that have heat or light sensitive contraindications, such as but not limited to certain types of steroids
• Patients who have been administered with corticosteroids after injury
• Pregnant females or females of childbearing potentially planning to become pregnant during the study participation
• Patients who had systemic inflammatory conditions (i.e. rheumatoid arthritis, polymyalgia rheumatica)
• Patients affected by chronic ankle instability (recurrent sprains, ankle instability, functional ankle instability, mechanical ankle instability fol¬lowing the first-time injury)
• Patients with bilateral ankle sprain
• 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)
• Patients with fractures (as confirmed by radiological examination)
• Patients with a diagnosis of active cancer
• Patients with tattoos covering more than 30% of the area to be treated with LightForce® Therapy Lasers
• Patients who are mentally or physically incapacitated
• Patient participating in other clinical study or has completed a clinical study less than 30 days prior to enrollment
• Patients with other clinically significant co-morbidities that make the patient unsuitable for study participation, at the discretion of the investigator

Sponsors & Collaborators

• DJO UK Ltd: lead
• Donawa Lifescience Consulting SRL: collaborator

Study Sites (8)

Carioni Fisioterapia

Cassano d'Adda, Milano, Italy

RECRUITING

Casertafisio

Caserta, Italy

RECRUITING

Rachis Center

Roma, 00199, Italy

RECRUITING

Fisiolab3

Roma, Italy

RECRUITING

Fisioterapia Eur

Roma, Italy

RECRUITING

Fisioterapia Gardenie

Roma, Italy

RECRUITING

INDERGAARD PHYSIOTERAPY Ltd

Leeds, United Kingdom

COMPLETED

Freedom Care Clinics

Manchester, United Kingdom

RECRUITING

MeSH Terms

Conditions

Acute Pain; Pain

Interventions

Laser Therapy; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Rehabilitation

Study Officials

• Ove Indergaard, Physiotherap

  ove@indergaardphysio.com

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Arcangeli

CONTACT

3498772528; elena.arcangeli@enovis.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 3, 2025
• Study Start: April 11, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

IT (6); GB (2)