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

NCT ID: NCT07261449

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-12

Study Completion Date

2025-06-12

Brief Summary

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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.

Detailed Description

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Conditions

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Tendinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
triple blinding

Study Groups

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Laser treatment

Laser treatment on tendinophaty shoulder.

Group Type EXPERIMENTAL

Laser Group

Intervention Type DEVICE

Therapeutic laser treatment is performed on the shoulder.

Placebo Group

Placebo treatment on tendinophaty shoulder.

Group Type PLACEBO_COMPARATOR

Placebo Group

Intervention Type DEVICE

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

Interventions

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Placebo Group

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

Intervention Type DEVICE

Laser Group

Therapeutic laser treatment is performed on the shoulder.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Pontificia de Salamanca

OTHER

Sponsor Role lead

Responsible Party

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Jorge Velazquez

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidad Pontificia de Salamanca

Salamanca, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type RESULT
PMID: 25408141 (View on PubMed)

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.

Reference Type RESULT
PMID: 27288517 (View on PubMed)

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.

Reference Type RESULT
PMID: 34099238 (View on PubMed)

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.

Reference Type RESULT
PMID: 36583575 (View on PubMed)

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.

Reference Type RESULT
PMID: 33076550 (View on PubMed)

Other Identifiers

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221123

Identifier Type: -

Identifier Source: org_study_id

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