Shoulder PainSHINENCT06759935
Performance and Safety of LightForce® Therapy Lasers on Shoulder Soft Tissue Inflammation Pain Reduction
A study testing Laser therapy and physiotherapy/exercise protocol in people with Shoulder Pain and Shoulder Impingement Syndrome, run by DJO UK Ltd at 10 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Pain, Shoulder Impingement Syndrome, Rotator Cuff Tendinitis
- What is being tested?
- Laser therapy and physiotherapy/exercise protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 21 Feb 2025to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient male or female with age ≥18 years old
- 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.
- 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 informed consent
Who cannot join
- 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
- Patients who are taking drugs that have heat or light sensitive contraindications, such as but not limited to certain types of steroids
- Patients who are administered with corticosteroids, should discontinue the treatment at least 2 weeks prior to study treatment start
- 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)
- Patients who underwent intra-articular injection (Ialuronic acid, platelet rich plasma or corticosteroids) in the shoulder in the last 3 months
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- 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)
- Patients with a prior history of surgical intervention and implantation of a metal implant into the affected shoulder
- Patients with a diagnosis of active cancer
- Patients with tattoos covering more than 30% of the area to be treated with LightForce® Therapy Lasers
- Patients who are mentally or physically incapacitated
- Patient participating in other clinical study or has completed a clinical study less than 30 days prior to enrollment
- Patient affected by shoulder soft tissue acute inflammation due to recent sport injury or trauma
- 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).
- Patients with other clinically significant co-morbidities that make the patient unsuitable for study participation, at the discretion of the investigator
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Italy6 sites
Casertafisio
Caserta
Fisioterapia Carioni
Cassano d'Adda, MILANO
Fisiolab3
Roma, Italy
Rachis Center
Roma, 00199
Fisioterapia Eur
Roma
Fisioterapia Gardenie
Roma
United Kingdom3 sites
Freedom Care Clinics
Leeds
Indergaard Physiotherapy Ltd
Leeds
Freedom Care Clinic
Manchester
About this study
Official title: 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.
Read the 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.
- Being tested
- Sham Laser therapy, Laser therapy, physiotherapy/exercise protocol
- Medical subject headings
- Shoulder Pain, Shoulder Impingement Syndrome, Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham Laser therapyDevice
sham laser therapy for 4 consecutive weeks with a minimum of 3 sessions per week.
Laser therapyDevice
laser therapy for 4 consecutive weeks with a minimum of 3 sessions per week.
physiotherapy/exercise protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Sham Laser treatment - Arm 1 | Sham comparator | Sham Laser therapy Receives: Device: Sham Laser therapy; Other: physiotherapy/exercise protocol |
| Laser Treatment - Arm 2 | Active comparator | Laser therapy Receives: Device: Laser therapy; Other: physiotherapy/exercise protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain change
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
Measured: 4 weeks after treatment start
Secondary outcomes (1)
Safety - adverse event rate
Proportion of patient experiencing an adverse event associated with device use
Measured: through study completion, an average of 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start21 Feb 2025
- Primary completion30 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- DJO UK Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Donawa Lifescience Consulting S.r.l.
- Responsible party
- Sponsor
- Investigators
- ANDREA TURIACO, Physiotherapist, Principal investigator, Fisioterapia Gardenie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759935
- Sponsor's protocol ID
- ENOVIS-S-INP-0010
- Acronym
- SHINE
- Status last verified
- Aug 2026
- First submitted
- 23 Dec 2024
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06759935
- Acronym / sponsor ID
- SHINE / ENOVIS-S-INP-0010
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- DJO UK LtdIndustry (pharma, biotech, devices)
- Collaborators
- Donawa Lifescience Consulting S.r.l.
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Laser treatment - Arm 1 | Sham comparator | Device: Sham Laser therapy, Other: physiotherapy/exercise protocolSham Laser therapy |
| Laser Treatment - Arm 2 | Active comparator | Device: Laser therapy, Other: physiotherapy/exercise protocolLaser therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient male or female with age ≥18 years old
- 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.
- 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 informed consent
Key exclusion criteria (15 listed)
- 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
- Patients who are taking drugs that have heat or light sensitive contraindications, such as but not limited to certain types of steroids
- Patients who are administered with corticosteroids, should discontinue the treatment at least 2 weeks prior to study treatment start
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham Laser therapysham laser therapy for 4 consecutive weeks with a minimum of 3 sessions per week. | Device | Sham Laser treatment - Arm 1 |
| Laser therapylaser therapy for 4 consecutive weeks with a minimum of 3 sessions per week. | Device | Laser Treatment - Arm 2 |
| physiotherapy/exercise protocolphysiotherapy/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. | Other | Laser Treatment - Arm 2, Sham Laser treatment - Arm 1 |
Primary outcome
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
1 secondary outcome
Safety - adverse event rate
Time frame: through study completion, an average of 21 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ANDREA TURIACO, Physiotherapist principal investigator
Fisioterapia Gardenie
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser therapy and physiotherapy/exercise protocol in people with Shoulder Pain and Shoulder Impingement Syndrome, run by DJO UK Ltd at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy, United Kingdom, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain change (time frame: 4 weeks after treatment start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.