Using LightForce® Therapy Lasers to treat lateral ankle sprains

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

This study is testing if using LightForce® Therapy Lasers can help reduce pain in people with recent lateral ankle sprains when combined with regular care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 108 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: DJO UK Ltd (Industry-sponsored)
• Locations: 8 sites (Cassano d'Adda, Milano and 7 other locations)
• Trial ID: NCT06854016 on ClinicalTrials.gov

What this trial studies

This clinical investigation evaluates the effectiveness of LightForce® Therapy Lasers in reducing pain for patients with acute grade I and II lateral ankle sprains. The study compares the laser treatment combined with standard care, including RICE and physiotherapy, against a sham laser treatment with the same standard care. It is a multi-center, randomized, sham-controlled, single-blind study designed to collect post-market clinical data on the safety and performance of the lasers. Participants must have experienced ankle sprain pain for no more than 72 hours prior to enrollment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have been diagnosed with a lateral ankle sprain and are experiencing pain for no more than 72 hours.

Not a fit: Patients with contraindications to laser therapy or those who have received corticosteroids after their injury may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce pain and improve recovery times for patients with lateral ankle sprains.

How similar studies have performed: Other studies have shown promising results with laser therapy for pain management, suggesting potential success for this approach.

Eligibility criteria

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

Where this trial is running

Cassano d'Adda, Milano and 7 other locations

• Carioni Fisioterapia — Cassano d'Adda, Milano, Italy (Recruiting)
• Casertafisio — Caserta, Italy (Recruiting)
• Rachis Center — Roma, 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)

Study contacts

• Principal investigator: Ove Indergaard, Physiotherap — [e-mail]
• Study coordinator: Elena Arcangeli

Conditions Ankle Sprain 1St Degree; Ankle Sprain 2Nd Degree; Acute Pain; lateral acute grade I and II ankle sprain, pain, laser