Performance and Safety of LightForce® Therapy Lasers on Shoulder Soft Tissue Inflammation Pain Reduction

Last updated: March 18, 2025
Sponsor: DJO UK Ltd
Overall Status: Active - Recruiting

Phase

N/A

Condition

Tendon Injuries

Inflammation

Sprains

Treatment

Sham Laser therapy

physiotherapy/exercise protocol

Laser therapy

Clinical Study ID

NCT06759935
ENOVIS-S-INP-0010
  • Ages > 18
  • All Genders

Study Summary

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

Inclusion

Inclusion Criteria:

  1. Patient male or female with age ≥18 years old

  2. 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.

  3. Patient suffering from shoulder soft tissue inflammation due to SAIS/RCT pain formore than 3 months prior to enrollment

  4. Pain (either persistent or during activities) score reported by the subject atbaseline ≥ 40 mm measured on VAS

  5. Patient able to provide written informed consent

Exclusion

Exclusion Criteria:

  1. Patient with musculoskeletal pathological conditions not to be treatedwith/contraindication to the use of LightForce® Therapy Lasers according to itsintended use and indications

  2. Patients who are taking drugs that have heat or light sensitive contraindications,such as but not limited to certain types of steroids

  3. Patients who are administered with corticosteroids, should discontinue the treatmentat least 2 weeks prior to study treatment start

  4. Pregnant females or females of childbearing potentially planning to become pregnantduring the study participation

  5. Patients who had systemic inflammatory conditions (i.e.rheumatoid arthritis,polymyalgia rheumatica)

  6. Patients who underwent intra-articular injection (Ialuronic acid, platelet richplasma or corticosteroids) in the shoulder in the last 3 months

  7. Patients who have a disease that would limit their participation in exercises (i.e.severe chronic obstructive pulmonary disease, severe heart failure, cerebrovascularevent history)

  8. Patients with a prior history of surgical intervention and implantation of a metalimplant into the affected shoulder

  9. Patients with a diagnosis of active cancer

  10. Patients with tattoos covering more than 30% of the area to be treated withLightForce® Therapy Lasers

  11. Patients who are mentally or physically incapacitated

  12. Patient participating in other clinical study or has completed a clinical study lessthan 30 days prior to enrollment

  13. Patient affected by shoulder soft tissue acute inflammation due to recent sportinjury or trauma

  14. 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).

  15. Patients with other clinically significant co-morbidities that make the patientunsuitable for study participation, at the discretion of the investigator

Study Design

Total Participants: 130
Treatment Group(s): 3
Primary Treatment: Sham Laser therapy
Phase:
Study Start date:
February 21, 2025
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Cabinet Attal

    Serris,
    France

    Active - Recruiting

  • Fisioterapia Carioni

    CASSANO d'ADDA, Milano
    Italy

    Active - Recruiting

  • Casertafisio

    Caserta,
    Italy

    Active - Recruiting

  • Fisioterapia Eur

    Roma,
    Italy

    Site Not Available

  • Fisioterapia Gardenie

    Roma,
    Italy

    Active - Recruiting

  • Indergaard Physiotherapy Ltd

    Leeds,
    United Kingdom

    Active - Recruiting

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