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Laser light could take the ouch out of ankle sprains
NCT ID NCT06854016
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 2 times
Summary
This study tests whether a device called LightForce® Therapy Laser can reduce pain from mild to moderate ankle sprains. About 108 adults with acute ankle sprain pain will receive either real laser therapy or a sham (fake) laser, plus standard care like rest and ice. The main goal is to see if the real laser leads to greater pain reduction after 4 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LightForce® Therapy Laser (photobiomodulation therapy device)
- What this could lead to
- If it works, this could offer a non-drug option to ease pain from ankle sprains and speed recovery.
- What could go wrong
- This is a small, early-stage trial with 108 people, and the sham group also gets standard care, so the added benefit of the laser may be small or none. Results may not apply to severe sprains.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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108 people
The number who actually took part.
- Started
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Apr 2025
- Finished
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Feb 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Carioni Fisioterapia
Cassano d'Adda, MILANO, Italy
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Casertafisio
Caserta, Italy
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Fisiolab3
Roma, Italy
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Fisioterapia Eur
Roma, Italy
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Fisioterapia Gardenie
Roma, Italy
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Freedom Care Clinics
Manchester, United Kingdom
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INDERGAARD PHYSIOTERAPY Ltd
Leeds, United Kingdom
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Rachis Center
Roma, 00199, Italy
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