Effectiveness of Low-intensity Laser on Pain in Patients With Supraspinatus Tendinopathy.

April 28, 2026 updated by: Jorge Velazquez, Universidad Pontificia de Salamanca

Effectiveness of Low-intensity Laser on Pain in Patients With Supraspinatus Tendinopathy. A Triple-Blind Randomized Controlled Trial.

Tendinopathy is an inflammatory process that occurs in and around the tendon when both are affected by a certain injury. In the case of the supraspinatus muscle it is one of the most frequent causes of shoulder pain. To test the efficacy of laser treatment in reducing shoulder pain caused by supraspinatus muscle tendinopathy. A randomized controlled clinical trial (RCT) was carried out in which a physiotherapy intervention was performed using therapeutic laser for three months, to observe the influence on the pain generated by supraspinatus muscle tendinopathy in the shoulder.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Salamanca, Spain, 37002
        • Universidad Pontificia de Salamanca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Score of 3 or higher on the VAS scale for the shoulder.
  • Adequate cognitive ability for comprehension.
  • Rotator cuff tendinopathy confirmed by ultrasound at the study center, either due to tendon inflammation, presence of hypoechoic areas, calcification, fibrillar disorganization, and/or neovascularization in the supraspinatus muscle.
  • Pain in the proximal lateral part of the arm that worsens with abduction.

Exclusion Criteria:

  • Contraindications specific to laser treatment (e.g., tumors, presence of pacemaker or defibrillator, pregnancy, etc.).
  • History of glenohumeral fracture and rheumatoid arthritis.
  • Rheumatic, neurological, or structural polymyalgia affecting the joint.
  • Previous surgeries.
  • Pregnant or breastfeeding women.
  • Taking anticoagulants or antiplatelet agents.
  • Diabetes mellitus.
  • Cardiac dysfunction.
  • Infiltrative and/or rehabilitative treatment in the two months prior to recruitment.
  • Pre-existing conditions associated with pain in the upper extremities. Difficulties with follow-up.
  • Depression.
  • Treatment with another intervention; during the study, they will not be able to undergo it.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laser treatment
Laser treatment on tendinophaty shoulder.
Device: Laser Group
Therapeutic laser treatment is performed on the shoulder.
Placebo Comparator: Placebo Group
Placebo treatment on tendinophaty shoulder.
Device: Placebo Group
A placebo treatment is carried out on the shoulder, simulating the application of the laser.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intensity of pain.
Time Frame: 3 months
measured using the VAS scale, where 0 is the least possible pain and 10 is the greatest possible pain
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion
Time Frame: 3 months
Shoulder mobility in the joint ranges of flexion, extension, abduction, adduction, and external and internal rotation. Measurement in degrees using a goniometer.
3 months
Patient quality of life
Time Frame: 3 months
DASH questionnaire The score ranges from 0, which is equivalent to having no disability, to a maximum of 100, which is equivalent to having a very severe functional limitation.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Pontificia de Salamanca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2023

Primary Completion (Actual)

July 24, 2024

Study Completion (Actual)

June 12, 2025

Study Registration Dates

First Submitted

November 22, 2025

First Submitted That Met QC Criteria

November 22, 2025

First Posted (Actual)

December 3, 2025

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 221123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data, including the data dictionary, will be shared with qualified researchers. The shared IPD will include the data needed to reproduce the study findings, such as the de-identified participant-level data underlying the results reported in the publication.

IPD Sharing Time Frame

Currently and for 12 months.

IPD Sharing Access Criteria

Upon request to the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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