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Study finishedNA

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

Sponsor: DJO UK Ltd

NCT ID: NCT06854016

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Sham Laser therapy (device), Laser therapy (device), RICE and physiotherapy/exercise protocol (other)
How long the study runs
Study runs about 10 months (dates as stated)
About the drug or intervention
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. · 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. · 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.
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at how well LightForce® therapy lasers work and how safe they are for people with a lateral ankle sprain (a sprain on the outer side of the ankle), including grade 1 and grade 2 sprains and acute (sudden) pain. It is sponsored by DJO UK Ltd. It aims to gather information on this laser treatment for recent ankle sprain pain.

Who can take part

  • Adults aged 18 or over, male or female
  • Have a lateral ankle sprain confirmed by a physical examination, to be treated with LightForce® therapy lasers
  • Ankle sprain pain started no more than 72 hours before joining the study
  • Pain score of at least 40 mm on a visual analogue scale (a pain rating line) at the start
  • Able to give written informed consent

Who may not be able to

  • Musculoskeletal conditions that mean LightForce® therapy lasers cannot be used, or are contraindicated (unsafe) for the person
  • Taking drugs with heat- or light-sensitive contraindications, for example certain steroids
  • Given corticosteroid medicines after the injury
  • Pregnant, or able to become pregnant and planning to during the study
  • Systemic inflammatory conditions, such as rheumatoid arthritis or polymyalgia rheumatica
  • Chronic ankle instability, such as repeated sprains or ongoing ankle instability after a first injury
  • Sprain in both ankles
  • A disease that would limit taking part in exercise, for example severe chronic obstructive pulmonary disease (lung disease), severe heart failure, or a past stroke
  • A fracture (broken bone) confirmed by an X-ray or other scan
  • Active cancer
  • Tattoos covering more than 30% of the area to be treated
  • Mentally or physically incapacitated
  • Currently in another clinical study, or finished one less than 30 days before joining
  • Other significant health conditions that, in the investigator's view, make the person unsuitable

What taking part involves

  • • Treatment with LightForce® therapy lasers, a laser therapy device, for the ankle sprain — further details of the treatment schedule are Not stated — ask the trial team

Time commitment: Not stated — ask the trial team (the data does not say how many visits, how long the study lasts, or what tests are involved).

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
108
Started
2025-04-11
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for ankle sprain 1st degree
  • • NA - 108 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with ankle sprain 1st degree

Where?

  • • Leeds - INDERGAARD PHYSIOTERAPY Ltd
  • • Manchester - Freedom Care Clinics

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Ankle Sprain 1St DegreeAnkle Sprain 2Nd DegreeAcute Pain

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓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...
  • ✓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 agreement to take part

Who cannot take part

  • ✗Patient with musculoskeletal pathological conditions not to be treated with/safety concern to the use of...
  • ✗Patients who are taking drugs that have heat or light sensitive contraindications, such as but not limited to...
  • ✗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)
See the full 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 Is This Study? (2 UK sites)

INDERGAARD PHYSIOTERAPY Ltd

Leeds, United Kingdom

Freedom Care Clinics

Manchester, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-08