Ankle Sprain 1St DegreeBRIGHTNCT06854016
Performance and Safety of LightForce® Therapy Lasers on Lateral Ankle Sprain
A study testing Laser therapy and RICE and physiotherapy/exercise protocol in people with Ankle Sprain 1St Degree and Ankle Sprain 2Nd Degree, run by DJO UK Ltd at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Sprain 1St Degree, Ankle Sprain 2Nd Degree, Acute Pain
- What is being tested?
- Laser therapy and RICE and physiotherapy/exercise protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 11 Apr 2025to 12 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Italy6 sites
Casertafisio
Caserta
Carioni Fisioterapia
Cassano d'Adda, MILANO
Rachis Center
Roma, 00199
Fisiolab3
Roma
Fisioterapia Eur
Roma
Fisioterapia Gardenie
Roma
United Kingdom2 sites
INDERGAARD PHYSIOTERAPY Ltd
Leeds
Freedom Care Clinics
Manchester
About this study
Official title: 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
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.
Read the detailed 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.
- Conditions
- Ankle Sprain 1St Degree, Ankle Sprain 2Nd Degree, Acute Pain
- Being tested
- Sham Laser therapy, Laser therapy, RICE and physiotherapy/exercise protocol
- Keywords
- lateral acute grade I and II ankle sprain, pain, laser
- Medical subject headings
- Acute Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham Laser therapyDevice
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 therapyDevice
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 protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Sham Laser treatment - Arm 1 | Sham comparator | Sham Laser therapy Receives: Device: Sham Laser therapy; Other: RICE and physiotherapy/exercise protocol |
| Laser Treatment - Arm 2 | Active comparator | Laser therapy Receives: Device: Laser therapy; Other: RICE and physiotherapy/exercise protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks after treatment start
Secondary outcomes (1)
Safety - adverse event rate
Proportion of patient experiencing an adverse event associated with device use
Measured: through study completion, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start11 Apr 2025
- Primary completion17 Nov 2025
- Study completion12 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle Sprain 1St DegreeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- DJO UK Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Donawa Lifescience Consulting S.r.l.
- Responsible party
- Sponsor
- Investigators
- Ove Indergaard, Physiotherap, Principal investigator, ove@indergaardphysio.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854016
- Sponsor's protocol ID
- ENOVIS-S-INP-0011
- Acronym
- BRIGHT
- Status last verified
- Aug 2026
- First submitted
- 25 Feb 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06854016
- Acronym / sponsor ID
- BRIGHT / ENOVIS-S-INP-0011
- Conditions
- Ankle Sprain 1St Degree, Ankle Sprain 2Nd Degree, Acute Pain
- Keywords
- lateral acute grade I and II ankle sprain, pain, laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- DJO UK LtdIndustry (pharma, biotech, devices)
- Collaborators
- Donawa Lifescience Consulting S.r.l.
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- 17 Nov 2025 (actual)
- Study completion
- 12 Feb 2026 (actual)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Laser treatment - Arm 1 | Sham comparator | Device: Sham Laser therapy, Other: RICE and physiotherapy/exercise protocolSham Laser therapy |
| Laser Treatment - Arm 2 | Active comparator | Device: Laser therapy, Other: RICE and physiotherapy/exercise protocolLaser therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham Laser therapysham 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. | Device | Sham Laser treatment - Arm 1 |
| Laser therapylaser 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. | Device | Laser Treatment - Arm 2 |
| RICE and physiotherapy/exercise protocolRICE 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. | Other | Laser Treatment - Arm 2, Sham Laser treatment - Arm 1 |
Primary outcome
Pain change
Time frame: 2 weeks after treatment start
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
1 secondary outcome
Safety - adverse event rate
Time frame: through study completion, an average of 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ove Indergaard, Physiotherap principal investigator
ove@indergaardphysio.com
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser therapy and RICE and physiotherapy/exercise protocol in people with Ankle Sprain 1St Degree and Ankle Sprain 2Nd Degree, run by DJO UK Ltd at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain change (time frame: 2 weeks after treatment start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.