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

November 14, 2025 updated by: DJO UK Ltd

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Serris, France
        • Completed
        • Cabinet Attal
  • Italy
      • Caserta, Italy
        • Recruiting
        • Casertafisio
        • Contact:
        • Principal Investigator:
          • Gianpaolo Papiro
      • Roma, Italy
      • Roma, Italy
        • Recruiting
        • Fisioterapia EUR
        • Contact:
        • Principal Investigator:
          • GUGLIELMO TORRE
      • Roma, Italy, 00199
        • Recruiting
        • Rachis Center
        • Contact:
        • Principal Investigator:
          • Stamatios Liaskos
      • Roma, Italy
        • Recruiting
        • Fisiolab3
        • Contact:
        • Principal Investigator:
          • Fabrizio Bergonzoli
    • Milano
      • Cassano d'Adda, Milano, Italy
        • Recruiting
        • Fisioterapia Carioni
        • Contact:
        • Principal Investigator:
          • CRISTIANO IVAN CARIONI
  • United Kingdom
      • Leeds, United Kingdom
      • Leeds, United Kingdom
        • Completed
        • Indergaard Physiotherapy Ltd
      • Manchester, United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 (as confirmed 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 for more than 3 months prior to enrollment
  4. Pain (either persistent or during activities) score reported by the subject at baseline ≥ 40 mm measured on VAS
  5. Patient able to provide written informed consent

Exclusion Criteria:

  1. 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
  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 treatment at least 2 weeks prior to study treatment start
  4. Pregnant females or females of childbearing potentially planning to become pregnant during 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 rich plasma 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, cerebrovascular event history)
  8. Patients with a prior history of surgical intervention and implantation of a metal implant 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 with LightForce® Therapy Lasers
  11. Patients who are mentally or physically incapacitated
  12. Patient participating in other clinical study or has completed a clinical study less than 30 days prior to enrollment
  13. Patient affected by shoulder soft tissue acute inflammation due to recent sport injury or trauma
  14. Patients with other musculoskeletal problems of the shoulder joint such as calcifying tendinitis, full thickness rotator-cuff tear, adhesive capsulitis, fibromyalgia, recent surgery or fracture of the shoulder joint, and/or undergoing to specific physiotherapy for these ("recent" is defined as within 30 days prior to enrollment).
  15. Patients with other clinically significant co-morbidities that make the patient unsuitable for study participation, at the discretion of the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham Laser treatment - Arm 1
Sham Laser therapy
Device: Sham Laser therapy
sham 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.
Active Comparator: Laser Treatment - Arm 2
Laser therapy
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.
Device: Laser therapy
laser therapy for 4 consecutive weeks with a minimum of 3 sessions per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain change
Time Frame: 4 weeks after treatment start
Pain reduction measured with Visual Analog Scale (VAS) (in a scale 0-100 mm, where 0 is no pain and 100 is the worst possible pain) after 4 weeks of treatment compared to pre-treatment (baseline) VAS
4 weeks after treatment start

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety - adverse event rate
Time Frame: through study completion, an average of 21 weeks
Proportion of patient experiencing an adverse event associated with device use
through study completion, an average of 21 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient overall status change
Time Frame: 2, 4, 6 ans 12 weeks after treatment start
Patient ratings of overall improvement, assessed by QoL (SF-12): The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. The SF-12 uses 12 items and scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. SF-12 will be assessed at 2, 4, 6 weeks and at 12 weeks and compared to baseline
2, 4, 6 ans 12 weeks after treatment start
Pain change
Time Frame: 1,2,3,6, 9 and 12 weeks
Pain measured with Visual Analog Scale (VAS) (in a scale 0-100 mm, where 0 is no pain and 100 is the worst possible pain) at 1,2,3,6, 9 and 12 weeks after treatment start to assess short-term and long-term pain management compared to baseline
1,2,3,6, 9 and 12 weeks
Shoulder pain and disability
Time Frame: 2, 4, 6 and at 12 weeks
Shoulder pain and disability measured with the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire (the score output is given as a percentace -from 0% to 100%- and the lower the percentage the better is the clinical outome, the higher the percentage the worse is the clinical outcome) performed at 2, 4, 6 and at 12 weeks after treatment start compared to baseline.
2, 4, 6 and at 12 weeks
Range of motion (ROM) for shoulder
Time Frame: 2, 4, 6 ans 12 weeks after treatment start
Range of motion for shoulder both passive and active, pain free and at maximum ROM, in all the planes of motion, measured by a universal goniometer at2, 4, 6 ans 12 weeks after treatment start compared to baseline
2, 4, 6 ans 12 weeks after treatment start
Neer test
Time Frame: 2, 4, 6 ans 12 weeks after treatment start
Functional test to assess shoulder pain onset at a certain degree of movement during flexion and pressure application (often used as a diagnositc tool of subacromial impingement) performed at 2,4, 6 and at 12 weeks after treatment start and compared to baseline
2, 4, 6 ans 12 weeks after treatment start
Palm up test
Time Frame: 2, 4, 6 ans 12 weeks after treatment start
Functional test where the patient elevates the extended arm with the palm facing upwards and against examiner's resistance, presence of pain can denote tendonitis (often used as diagnostic tool) and performed at 2,4, 6 and at 12 weeks after treatment start and compared to baseline
2, 4, 6 ans 12 weeks after treatment start
Jobe test
Time Frame: 2, 4, 6 ans 12 weeks after treatment start
Functional testing of the arm with the thumb in 'thumbs up' and resistance provided by the examiner, weakness or pain would represent a positive test indicating a tear of the supraspinatus muscle or tendon, it will be performed at 2,4, 6 and at 12 weeks after treatment start and compared to baseline
2, 4, 6 ans 12 weeks after treatment start
Pain change
Time Frame: 18 weeks after treatment start
pain measured with Visual Analog Scale (VAS) (in a scale 0-100 mm, where 0 is no pain and 100 is the worst possible pain) to assess post study pain
18 weeks after treatment start
Rate of patients needed new treatment
Time Frame: 18 weeks after treatment start
Patients will be asked through a questionnaire whether any new treatment and in case which one (pharmacological, physiotherapic etc) was needed to manage shoulder pain after 12 weeks from treatment start
18 weeks after treatment start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DJO UK Ltd

Collaborators

Donawa Lifescience Consulting

Investigators

  • Principal Investigator: ANDREA TURIACO, Physiotherapist, Fisioterapia Gardenie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 23, 2024

First Submitted That Met QC Criteria

January 3, 2025

First Posted (Actual)

January 6, 2025

Study Record Updates

Last Update Posted (Actual)

November 17, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENOVIS-S-INP-0010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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