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

NCT06759935 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2025-11-17

No results posted yet for this 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.

Conditions

  • Shoulder Pain
  • Shoulder Impingement Syndrome
  • Rotator Cuff Tendinitis

Interventions

DEVICE

Sham Laser therapy

sham laser therapy for 4 consecutive weeks with a minimum of 3 sessions per week.

DEVICE

Laser therapy

laser therapy for 4 consecutive weeks with a minimum of 3 sessions per week.

OTHER

physiotherapy/exercise protocol

physiotherapy/exercise protocol represents the standard of care (SOC) and the program includes Codman's pendulum exercise, range of motion (ROM) exercises, stretching and isometric strengthening exercises, for 4 consecutive weeks with a minimum of 3 sessions per week.

Sponsors & Collaborators

  • Donawa Lifescience Consulting

    collaborator UNKNOWN

  • DJO UK Ltd

    lead INDUSTRY

Principal Investigators

  • ANDREA TURIACO, Physiotherapist · Fisioterapia Gardenie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-21
Primary Completion
2026-08-31
Completion
2026-12-31

Countries

  • France
  • Italy
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06759935 on ClinicalTrials.gov