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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
