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

NCT07261449 | Completed

• 1 other identifier: 221123
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tendinopathy

Keywords

pain; range of motion; quality of life

Outcome Measures

Primary Outcomes (1)

• intensity of pain.

  measured using the VAS scale, where 0 is the least possible pain and 10 is the greatest possible pain

  3 months

Secondary Outcomes (2)

• Range of motion

  3 months

• Patient quality of life

  3 months

Study Arms (2)

Laser treatment

EXPERIMENTAL

Laser treatment on tendinophaty shoulder.

Device: Laser Group

Placebo Group

PLACEBO COMPARATOR

Placebo treatment on tendinophaty shoulder.

Device: Placebo Group

Interventions

Laser Group DEVICE

Therapeutic laser treatment is performed on the shoulder.

Laser treatment

Placebo Group DEVICE

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

Placebo Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Pontificia de Salamanca: lead

Study Sites (1)

Universidad Pontificia de Salamanca

Salamanca, 37002, Spain

Location

Related Publications (5)

• Redondo-Alonso L, Chamorro-Moriana G, Jimenez-Rejano JJ, Lopez-Tarrida P, Ridao-Fernandez C. Relationship between chronic pathologies of the supraspinatus tendon and the long head of the biceps tendon: systematic review. BMC Musculoskelet Disord. 2014 Nov 18;15:377. doi: 10.1186/1471-2474-15-377.

  PMID: 25408141 RESULT

• Haik MN, Alburquerque-Sendin F, Moreira RF, Pires ED, Camargo PR. Effectiveness of physical therapy treatment of clearly defined subacromial pain: a systematic review of randomised controlled trials. Br J Sports Med. 2016 Sep;50(18):1124-34. doi: 10.1136/bjsports-2015-095771. Epub 2016 Jun 10.

  PMID: 27288517 RESULT

• Romero-Morales C, Bravo-Aguilar M, Abuin-Porras V, Almazan-Polo J, Calvo-Lobo C, Martinez-Jimenez EM, Lopez-Lopez D, Navarro-Flores E. Current advances and novel research on minimal invasive techniques for musculoskeletal disorders. Dis Mon. 2021 Oct;67(10):101210. doi: 10.1016/j.disamonth.2021.101210. Epub 2021 Jun 4.

  PMID: 34099238 RESULT

• Asensio-Olea L, Leiros-Rodriguez R, Marques-Sanchez MP, de Carvalho FO, Maciel LYS. Efficacy of percutaneous electrolysis for the treatment of tendinopathies: A systematic review and meta-analysis. Clin Rehabil. 2023 Jun;37(6):747-759. doi: 10.1177/02692155221144272. Epub 2022 Dec 30.

  PMID: 36583575 RESULT

• Sanchez-Sanchez JL, Calderon-Diez L, Herrero-Turrion J, Mendez-Sanchez R, Arias-Buria JL, Fernandez-de-Las-Penas C. Changes in Gene Expression Associated with Collagen Regeneration and Remodeling of Extracellular Matrix after Percutaneous Electrolysis on Collagenase-Induced Achilles Tendinopathy in an Experimental Animal Model: A Pilot Study. J Clin Med. 2020 Oct 15;9(10):3316. doi: 10.3390/jcm9103316.

  PMID: 33076550 RESULT

MeSH Terms

Conditions

Tendinopathy; Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: triple blinding
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: December 3, 2025
• Study Start: September 12, 2023
• Primary Completion: July 24, 2024
• Study Completion: June 12, 2025
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Currently and for 12 months.
• Access Criteria: Upon request to the corresponding author.

Locations

ES (1)