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Completed

NCT Number: NCT07013708

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 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

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Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Pontificia de Salamanca

Salamanca, Spain

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

laser

Device

High frequency laser device

Placebo

Other

Same device but without pressing the ON button

Primary outcomes

  1. 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

Secondary outcomes

  1. Range of movement

    Time frame: 12 weeks

    joint mobility of the shoulder measured by digital goniometer

  2. pain threshold

    Time frame: 12 weeks

    pressure pain threshold measured by digital algometre

Sponsors and collaborators

Lead sponsor

Universidad Católica de Ávila

Other

Registry information

Official study title

Effectiveness of Low-intensity Laser on Pain in Patients With Supraspinatus Tendinopathy: Randomized Controlled Clinical Trial.

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jun 10, 2025
Registry last updated
Jun 13, 2025

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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