Performance and Safety of LightForce® Therapy Lasers on Shoulder Soft Tissue Inflammation Pain Reduction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDJO UK Ltd
About this trial
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.
Eligibility criteria
Qualifiers
Patient male or female with age ≥18 years old
Patient with diagnosis of shoulder soft tissue inflammation due to SAIS/RCT (as confirmed by physical examination and/or imaging) to be treated by LightForce® Therapy Lasers according to its indications.
Patient suffering from shoulder soft tissue inflammation due to SAIS/RCT pain for more than 3 months prior to enrollment
Pain (either persistent or during activities) score reported by the subject at baseline ≥ 40 mm measured on VAS
Disqualifiers
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 are administered with corticosteroids, should discontinue the treatment at least 2 weeks prior to study treatment start
Pregnant females or females of childbearing potentially planning to become pregnant during the study participation
Trial design
Treatments tested in this trial
- Sham Laser therapy
- Laser therapy
- physiotherapy/exercise protocol
Treatment groups
130 Participants
are divided into 2 treatment groupsSponsors and collaborators
DJO UK Ltd
Lead sponsor
Donawa Lifescience Consulting
Collaborator
Source ClinicalTrials.gov