Actively Recruiting
Performance and Safety of LightForce® Therapy Lasers on Shoulder Soft Tissue Inflammation Pain Reduction
Led by DJO UK Ltd · Updated on 2025-11-17
130
Participants Needed
10
Research Sites
92 weeks
Total Duration
On this page
Sponsors
D
DJO UK Ltd
Lead Sponsor
D
Donawa Lifescience Consulting
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 shoulder soft tissue inflammation. In detail this study will assess superiority of LightForce® Therapy Lasers combined with standard of care, represented by physiotherapy/exercise program compared to sham laser combined with standard of care (physiotherapy/exercise program) on pain reduction in subjects with shoulder soft tissue inflammation due to Impingement (Subacromial impingement syndrome (SAIS)) or Rotator Cuff Tendinopathy (RCT),. 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 Shoulder Soft Tissue Inflammation Pain Reduction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient male or female with age 518 years old
- Diagnosis of shoulder soft tissue inflammation due to Subacromial Impingement Syndrome or Rotator Cuff Tendinopathy confirmed by physical exam or imaging
- Shoulder pain from these conditions lasting more than 3 months before enrollment
- Pain score of at least 40 mm on the Visual Analog Scale at baseline
- Ability to provide written informed consent
You will not qualify if you...
- Musculoskeletal conditions not suitable for treatment with LightForce� Therapy Lasers
- Use of drugs causing heat or light sensitivity, including certain steroids
- Corticosteroid treatment within 2 weeks before study start
- Pregnant or planning pregnancy during study
- Systemic inflammatory diseases like rheumatoid arthritis or polymyalgia rheumatica
- Intra-articular shoulder injections within last 3 months
- Diseases limiting exercise participation such as severe COPD, heart failure, or stroke history
- Prior shoulder surgery or metal implant in affected shoulder
- Active cancer diagnosis
- Tattoos covering more than 30% of treatment area
- Mental or physical incapacity
- Participation in another clinical study within 30 days before enrollment
- Recent shoulder acute inflammation due to sports injury or trauma
- Other significant shoulder musculoskeletal problems or recent shoulder surgery/fracture
- Other co-morbidities making study participation unsuitable as judged by investigator
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Cabinet Attal
Serris, France
Completed
2
Fisioterapia Carioni
Cassano d'Adda, Milano, Italy
Actively Recruiting
3
Casertafisio
Caserta, Italy
Actively Recruiting
4
Rachis Center
Roma, Italy, 00199
Actively Recruiting
5
Fisiolab3
Roma, Italy
Actively Recruiting
6
Fisioterapia Eur
Roma, Italy
Actively Recruiting
7
Fisioterapia Gardenie
Roma, Italy
Actively Recruiting
8
Freedom Care Clinics
Leeds, United Kingdom
Actively Recruiting
9
Indergaard Physiotherapy Ltd
Leeds, United Kingdom
Completed
10
Freedom Care Clinic
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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