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

June 10, 2025 updated by: JORGE VELAZQUEZ SAORNIL, Universidad Católica de Ávila

Effectiveness of Low-intensity Laser on Pain in Patients With Supraspinatus Tendinopathy: Randomized Controlled Clinical 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 was carried out in which a physiotherapy intervention was performed using therapeutic laser for four weeks, to observe the influence on the pain generated by supraspinatus muscle tendinopathy in the shoulder. A sample of 82 patients was recruited and randomly divided into two groups: experimental group and control group. Laser therapy was applied to the first group and to the second group it was applied as a placebo

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

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
        • 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:

  • Age 30-65 years.
  • Present a 3 or higher on the visual analogue scale in the shoulder.
  • Adequate cognitive capacity for comprehension.
  • Tendinopathy of the rotator cuff confirmed by ultrasound at the study center, either by inflammation of the tendon, presence of hypoechoic zones, calcification, fibrillar disorganization and/or neovascularization in the supraspinatus muscle.
  • Pain in the proximal side of the arm that is aggravated by abduction.

Exclusion Criteria:

  • Laser-specific contraindications (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 antiaggregants.
  • Diabetes mellitus.
  • Cardiac dysfunctions.
  • Infiltrative and/or rehabilitative treatment in the two months prior to recruitment.
  • Pre-existing diseases associated with pain in the upper extremities.
  • Difficulties of follow-up.
  • Depression.
  • Treatment with another intervention, during the development of the study will not be able to perform.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laser treatment
Patients diagnosed with laser-treated supraspinatus tendinopathy
Device: Laser
High frequency laser device
Active Comparator: Placebo Group
Patients diagnosed with supraspinatus tendinopathy treated with placebo
Other: Placebo
Same device but without pressing the ON button

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale
Time Frame: 12 weeks
pain scale where 0 is the lowest possible pain score and 10 is the maximum possible pain score
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of movement
Time Frame: 12 weeks
joint mobility of the shoulder measured by digital goniometer
12 weeks
pain threshold
Time Frame: 12 weeks
pressure pain threshold measured by digital algometre
12 weeks

Collaborators and Investigators

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

Sponsor

Universidad Católica de Ávila

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)

June 1, 2024

Primary Completion (Actual)

November 30, 2024

Study Completion (Actual)

May 24, 2025

Study Registration Dates

First Submitted

June 2, 2025

First Submitted That Met QC Criteria

June 9, 2025

First Posted (Actual)

June 10, 2025

Study Record Updates

Last Update Posted (Actual)

June 13, 2025

Last Update Submitted That Met QC Criteria

June 10, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02/06/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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