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Laser therapy could ease pain after shoulder surgery

NCT ID NCT07568288

Symptom relief Sponsor: Istituto Ortopedico Rizzoli Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding high-intensity laser therapy to standard physical therapy helps people recover better after arthroscopic rotator cuff repair. 46 adults aged 30-70 with shoulder pain will be randomly assigned to receive either real laser therapy or a sham treatment alongside their rehab. The main goal is to see if the laser reduces pain and improves shoulder movement and function over 4 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
high-intensity laser therapy (device)
What this could lead to
If it works, this could provide a non-invasive way to reduce pain and speed up recovery after rotator cuff surgery.
What could go wrong
This is a small, early-stage trial with only 46 participants. The laser therapy may not provide significant benefits over standard rehab alone, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 46 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Arthroscopic rotator cuff repair of one shoulder for partial or full-thickness tear * Willingness to provide written informed consent * Age between 30 and 70 years * Pain intensity greater than 40/100 on the Visual Analog Scale Exclusion Criteria: * Psychiatric disorders * Cognitive impairment * Rheumatic diseases or Fibromyalgia * Vascular diseases * Neoplastic diseases * Infectious diseases * Neurological disorders * Hemophilia or bleeding diathesis * Use of anticoagulant therapy * Presence of a pacemaker * History of epileptic seizures * Pregnancy or breastfeeding * Skin lesions or abrasions at the laser application site * Known hypersensitivity to laser therapy or photosensitization * Use of photosensitizing medications * Tattoo in the treatment area * Steroid injections in the target area within the previous 2-3 weeks * Recent trauma or injury * Suspected conditions in which deep tissue heating is contraindicated * Use of analgesic or anti-inflammatory medications during the study period * Positive status for human immunodeficiency virus infection

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Conditions

The condition(s) this trial relates to.

Rotator Cuff Injuries rotator cuff syndrome Shoulder Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rotator cuff tears

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Istituto Ortopedico Rizzoli

    Bologna, 40136, Italy

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