Phase
Condition
Tendon Injuries
Inflammation
Sprains
Treatment
Sham Laser therapy
physiotherapy/exercise protocol
Laser therapy
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient male or female with age ≥18 years old
Patient with diagnosis of shoulder soft tissue inflammation due to SAIS/RCT (asconfirmed 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 formore than 3 months prior to enrollment
Pain (either persistent or during activities) score reported by the subject atbaseline ≥ 40 mm measured on VAS
Patient able to provide written informed consent
Exclusion
Exclusion Criteria:
Patient with musculoskeletal pathological conditions not to be treatedwith/contraindication to the use of LightForce® Therapy Lasers according to itsintended 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 treatmentat least 2 weeks prior to study treatment start
Pregnant females or females of childbearing potentially planning to become pregnantduring the study participation
Patients who had systemic inflammatory conditions (i.e.rheumatoid arthritis,polymyalgia rheumatica)
Patients who underwent intra-articular injection (Ialuronic acid, platelet richplasma or corticosteroids) in the shoulder in the last 3 months
Patients who have a disease that would limit their participation in exercises (i.e.severe chronic obstructive pulmonary disease, severe heart failure, cerebrovascularevent history)
Patients with a prior history of surgical intervention and implantation of a metalimplant into the affected shoulder
Patients with a diagnosis of active cancer
Patients with tattoos covering more than 30% of the area to be treated withLightForce® Therapy Lasers
Patients who are mentally or physically incapacitated
Patient participating in other clinical study or has completed a clinical study lessthan 30 days prior to enrollment
Patient affected by shoulder soft tissue acute inflammation due to recent sportinjury or trauma
Patients with other musculoskeletal problems of the shoulder joint such ascalcifying tendinitis, full thickness rotator-cuff tear, adhesive capsulitis,fibromyalgia, recent surgery or fracture of the shoulder joint, and/or undergoing tospecific physiotherapy for these ("recent" is defined as within 30 days prior toenrollment).
Patients with other clinically significant co-morbidities that make the patientunsuitable for study participation, at the discretion of the investigator
Study Design
Study Description
Connect with a study center
Cabinet Attal
Serris,
FranceActive - Recruiting
Fisioterapia Carioni
CASSANO d'ADDA, Milano
ItalyActive - Recruiting
Casertafisio
Caserta,
ItalyActive - Recruiting
Fisioterapia Eur
Roma,
ItalySite Not Available
Fisioterapia Gardenie
Roma,
ItalyActive - Recruiting
Indergaard Physiotherapy Ltd
Leeds,
United KingdomActive - Recruiting
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