NCT06759935

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

Randomized, Sham Controlled, Single Blind Study on the Performance and Safety of Photo Biomodulation Therapy (PBMT) With LightForce® Therapy Lasers on Shoulder Soft Tissue Inflammation Pain Reduction

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: DJO UK Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Shoulder Pain
• Shoulder Impingement Syndrome
• Rotator Cuff Tendinitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-02-21
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2025-01-06
• Last updated: 2025-11-17

Locations

10 sites across 3 countries: France, Italy, United Kingdom