Actively Recruiting
Performance and Safety of LightForce® Therapy Lasers on Lateral Ankle Sprain
Led by DJO UK Ltd · Updated on 2025-11-17
108
Participants Needed
8
Research Sites
72 weeks
Total Duration
On this page
Sponsors
D
DJO UK Ltd
Lead Sponsor
D
Donawa Lifescience Consulting SRL
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Performance and Safety of LightForce® Therapy Lasers on Lateral Ankle Sprain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient male or female aged 18 years or older
- Diagnosed with lateral ankle sprain confirmed by physical examination
- Suffering from lateral ankle sprain pain for no more than 72 hours before enrollment
- Pain score at baseline of 40 mm or higher on visual analog scale
- Able to provide written informed consent
You will not qualify if you...
- Musculoskeletal conditions contraindicating use of LightForce4 Therapy Lasers
- Taking drugs with heat or light sensitivity contraindications (e.g., certain steroids)
- Received corticosteroids after injury
- Pregnant females or females planning pregnancy during study
- Systemic inflammatory conditions (e.g., rheumatoid arthritis, polymyalgia rheumatica)
- Chronic ankle instability or recurrent sprains
- Bilateral ankle sprain
- Diseases limiting exercise participation (e.g., severe COPD, heart failure, stroke history)
- Fractures confirmed by radiology
- Active cancer diagnosis
- Tattoos covering more than 30% of treatment area
- Mentally or physically incapacitated
- Participation in another clinical study within 30 days before enrollment
- Other significant medical conditions making participation unsuitable as judged by investigator
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Trial Site Locations
Total: 8 locations
1
Carioni Fisioterapia
Cassano d'Adda, Milano, Italy
Actively Recruiting
2
Casertafisio
Caserta, Italy
Actively Recruiting
3
Rachis Center
Roma, Italy, 00199
Actively Recruiting
4
Fisiolab3
Roma, Italy
Actively Recruiting
5
Fisioterapia Eur
Roma, Italy
Actively Recruiting
6
Fisioterapia Gardenie
Roma, Italy
Actively Recruiting
7
INDERGAARD PHYSIOTERAPY Ltd
Leeds, United Kingdom
Completed
8
Freedom Care Clinics
Manchester, United Kingdom
Actively Recruiting
Research Team
E
Elena Arcangeli
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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