All studies
RecruitingNAINTERVENTIONAL

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

Researchers are investigating if a new laser treatment, the LightForce® Therapy Laser, can effectively reduce pain for people suffering from common shoulder issues such as shoulder impingement syndrome or rotator cuff tendinitis. The study compares the laser treatment combined with standard exercises to a 'sham' (fake) laser treatment plus the same exercises. The main goal is to see if the real laser provides more pain relief. They're also gathering important information on the safety of the LightForce® Therapy Laser when used in a real-world setting, following its approved guidelines. This is for people aged 18 and over who have had shoulder pain for at least three months.

At a glance

Status
Recruiting
Phase
NA
Sponsor
DJO UK Ltd
Enrolment target
130
Start
21 Feb 2025
Estimated completion
01 Dec 2026

What is this study about?

Imagine you've been struggling with ongoing shoulder pain, maybe from something like a trapped tendon (shoulder impingement) or a strained tendon (rotator cuff tendinitis). These sorts of problems can make everyday tasks difficult and uncomfortable. This study is being done to see if a specific type of laser treatment, called LightForce® Therapy Laser, can help reduce that pain.

The researchers want to compare the laser treatment with what's called a 'sham' treatment. A sham treatment looks and feels like the real thing, but doesn't actually deliver the active treatment. In this study, both groups will also do a standard exercise programme. This helps the researchers understand if any pain relief is truly coming from the laser itself, or if it's due to the exercises or other factors.

Ultimately, they hope to find out if using the LightForce® Therapy Laser alongside your usual exercises can give you better pain relief than just the exercises and a fake laser. They are also checking to make sure the laser is safe and works as expected when used by doctors and therapists.

Key takeaways

  • Investigating LightForce® Therapy Laser for shoulder pain relief.
  • Compares laser with standard exercises to a 'sham' laser and exercises.
  • Aimed at people with shoulder impingement or rotator cuff tendinitis.
  • Checks both effectiveness and safety of the laser treatment.
  • Participants must be 18+ and have had pain for over 3 months.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been experiencing shoulder pain for more than three months due to shoulder impingement syndrome or rotator cuff tendinitis. Your pain level should be at a certain minimum point, and you must be able to understand and sign consent forms.

There are several reasons why someone might not be able to join. For example, if you have other serious health problems that affect your muscles or bones, or if you're taking medications that react badly to heat or light. If you've recently had injections in your shoulder (like steroids or PRP), or if you've had surgery on that shoulder with metal implants, you also can't take part. Pregnant women or those planning to become pregnant during the study, people with certain inflammatory conditions like rheumatoid arthritis, or those with active cancer are also unable to participate. If you have tattoos covering a large part of the area to be treated, or are already in another clinical study, you would also be excluded.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Have you had ongoing shoulder pain (impingement or tendinitis) for at least 3 months?
  3. Do you have a current pain level that is at least moderate?
  4. Are you able to agree to take part and sign a consent form?
  5. Have you *not* had a shoulder injection in the last 3 months?
  6. Have you *not* had shoulder surgery with metal implants in the affected shoulder?
Answer every question to see your result.

What does participation involve?

The specific details of your participation aren't fully outlined, but generally, taking part in a study like this would involve several visits to a clinic. You would likely undergo a physical examination and may have imaging scans of your shoulder. You would be randomly placed into one of two groups: one receiving the real laser treatment along with physiotherapy exercises, and the other receiving a 'sham' (inactive) laser treatment along with the same exercises. You wouldn't know which group you're in. You would attend regular sessions for the laser treatment and exercise guidance. Throughout the study, your pain levels and shoulder function would be assessed repeatedly using questionnaires and possibly physical tests. The total duration of your involvement could range from several weeks to a few months, including follow-up appointments.

Potential risks and benefits

Potential benefits of taking part could include receiving a treatment that might reduce your shoulder pain more effectively, and you'll be closely monitored by medical professionals. You would also be contributing to medical knowledge that could help others with similar conditions in the future. Potential risks might include minor side effects from the laser treatment (though these are usually rare and mild), or that the treatment might not work for you. As with any medical procedure, there's a small chance of unexpected reactions. Importantly, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (10)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Cabinet Attal
    Verified postcode
    Serris, France· Completed
  • Fisioterapia Carioni
    Verified postcode
    Cassano d'Adda, Italy· Recruiting
  • Casertafisio
    Verified postcode
    Caserta, Italy· Recruiting
  • Rachis Center
    Verified postcode
    Roma, Italy· Recruiting
  • Fisiolab3
    Verified postcode
    Roma, Italy· Recruiting
  • Fisioterapia Eur
    Verified postcode
    Roma, Italy· Recruiting
  • Fisioterapia Gardenie
    Verified postcode
    Roma, Italy· Recruiting
  • Freedom Care Clinics
    Verified postcode
    Leeds, United Kingdom· Recruiting
  • Indergaard Physiotherapy Ltd
    Verified postcode
    Leeds, United Kingdom· Completed
  • Freedom Care Clinic
    Verified postcode
    Manchester, United Kingdom· Recruiting

Common questions

What is a 'sham' laser treatment?

A sham laser treatment looks and feels like the real laser treatment but doesn't actually deliver any active laser energy. It's used so researchers can compare the real treatment to a placebo effect.

Will I know if I'm getting the real laser or the sham laser?

No, this is a 'single-blind' study, meaning you won't know if you're receiving the active laser treatment or the sham treatment. This helps ensure the results are unbiased.

What happens if my pain gets worse during the study?

Your pain and condition will be monitored closely throughout the study. If your pain worsens or you have concerns, you should inform the study team immediately, and they can advise on next steps. You can also withdraw at any time.

Do I have to pay to join this study?

No, you do not have to pay to participate in a clinical study. The costs associated with the study treatments and assessments are covered by the study sponsors.

What is rotator cuff tendinitis?

Rotator cuff tendinitis is when the tendons around your shoulder joint become irritated and inflamed, often causing pain and difficulty moving your arm.

How to find out more

Elena Arcangeli

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Performance and Safety of LightForce® Therapy Lasers on Shou…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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