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Study finishedNA

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

Sponsor: DJO UK Ltd

NCT ID: NCT06759935

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Sham Laser therapy (device), Laser therapy (device), physiotherapy/exercise protocol (other)
How long the study runs
Study runs about 13 months (dates as stated)
About the drug or intervention
Sham Laser therapy — device: sham laser therapy for 4 consecutive weeks with a minimum of 3 sessions per week. · Laser therapy — device: laser therapy for 4 consecutive weeks with a minimum of 3 sessions per week. · physiotherapy/exercise protocol — other: 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.
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at how well LightForce® therapy lasers work and how safe they are for reducing shoulder pain caused by soft tissue inflammation, such as shoulder impingement or rotator cuff tendinitis. It is sponsored by DJO UK Ltd.

Who can take part

  • Adults aged 18 or over, male or female
  • Have shoulder soft tissue inflammation from shoulder impingement (SAIS) or rotator cuff tendinitis, confirmed by examination or imaging
  • Have had this shoulder pain for more than 3 months before joining
  • Have a pain score of at least 40 mm on a pain scale (VAS) at the start
  • Able to give written informed consent

Who may not be able to

  • Have a muscle or joint condition for which the laser should not be used
  • Take medicines that react badly to heat or light, such as some steroids
  • Have had corticosteroid treatment within the last 2 weeks
  • Are pregnant or planning to become pregnant during the study
  • Have a body-wide inflammatory condition such as rheumatoid arthritis or polymyalgia rheumatica
  • Had a shoulder injection (hyaluronic acid, platelet-rich plasma, or corticosteroids) in the last 3 months
  • Have an illness that limits exercise, such as severe lung disease, severe heart failure, or past stroke
  • Have had shoulder surgery or a metal implant in the affected shoulder
  • Have active cancer
  • Have tattoos covering more than 30% of the treatment area
  • Are mentally or physically incapacitated
  • Are in another clinical study, or finished one within the last 30 days
  • Have shoulder inflammation from a recent sports injury or trauma
  • Have other shoulder problems, such as calcifying tendinitis, a full rotator cuff tear, frozen shoulder, fibromyalgia, recent shoulder surgery or fracture (within 30 days), or are having physiotherapy for these
  • Have other health problems that, in the researcher's view, make them unsuitable

What taking part involves

  • • Treatment with LightForce® therapy lasers on the affected shoulder

Time commitment: Not stated — ask the trial team about number of visits, how long the study lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
104
Started
2025-02-21
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for shoulder pain
  • • NA - 104 participants
  • • DJO UK Ltd (ENOVIS) is conducting this study to assess the effectiveness of LightForce® Therapy Lasers on pain reduction in shoulder soft tissue inflammation

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with shoulder pain

Where?

  • • Leeds - Freedom Care Clinics
  • • Leeds - Indergaard Physiotherapy Ltd
  • • Manchester - Freedom Care Clinic

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Shoulder PainShoulder Impingement SyndromeRotator Cuff Tendinitis

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
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Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Patient male or female with age ≥18 years old
  • ✓Patient suffering from shoulder soft tissue inflammation due to SAIS/RCT pain for more than 3 months prior to enrollment
  • ✓Pain (either persistent or during activities) score reported by the subject at baseline ≥ 40 mm measured on VAS
  • ✓Patient able to provide written agreement to take part

Who cannot take part

  • ✗Patient with musculoskeletal pathological conditions not to be treated with/safety concern to the use of...
  • ✗Patients who are taking drugs that have heat or light sensitive contraindications, such as but not limited to...
  • ✗Patients who are administered with corticosteroids, should discontinue the treatment at least 2 weeks prior to study...
  • ✗Pregnant females or females of childbearing potentially planning to become pregnant during the study participation
  • ✗Patients who had systemic inflammatory conditions (i.e.rheumatoid arthritis, polymyalgia rheumatica)
See the full criteria
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

Where Is This Study? (3 UK sites)

Freedom Care Clinics

Leeds, United Kingdom

Indergaard Physiotherapy Ltd

Leeds, United Kingdom

Freedom Care Clinic

Manchester, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-08