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Completed

NCT Number: NCT07261449

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

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.

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Key information

Conditions

Tendinopathy Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Tendon Injuries Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Pontificia de Salamanca

Salamanca, 37002, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo Group

Device

A placebo treatment is carried out on the shoulder, simulating the application of the laser.

Laser group

Device

Therapeutic laser treatment is performed on the shoulder.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Universidad Pontificia de Salamanca

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Dec 3, 2025
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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