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

NCT ID: NCT07013708

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-05-24

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 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

Conditions

Tendinopathy; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Laser treatment

Patients diagnosed with laser-treated supraspinatus tendinopathy

Group Type: EXPERIMENTAL

Laser

Intervention Type: DEVICE

High frequency laser device

Placebo Group

Patients diagnosed with supraspinatus tendinopathy treated with placebo

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: OTHER

Same device but without pressing the ON button

Interventions

Laser

High frequency laser device

Intervention Type: DEVICE

Placebo

Same device but without pressing the ON button

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Católica de Ávila

OTHER

Sponsor Role: lead

Responsible Party

JORGE VELAZQUEZ SAORNIL

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidad Pontificia de Salamanca

Salamanca, , Spain

Countries

Spain

References

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

PMID: 19364757 (View on PubMed)

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Reference Type: RESULT

PMID: 25450903 (View on PubMed)

Tumilty S, Munn J, McDonough S, Hurley DA, Basford JR, Baxter GD. Low level laser treatment of tendinopathy: a systematic review with meta-analysis. Photomed Laser Surg. 2010 Feb;28(1):3-16. doi: 10.1089/pho.2008.2470.

Reference Type: RESULT

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Reference Type: RESULT

PMID: 37048665 (View on PubMed)

Elsodany AM, Alayat MSM, Ali MME, Khaprani HM. Long-Term Effect of Pulsed Nd:YAG Laser in the Treatment of Patients with Rotator Cuff Tendinopathy: A Randomized Controlled Trial. Photomed Laser Surg. 2018 Sep;36(9):506-513. doi: 10.1089/pho.2018.4476.

Reference Type: RESULT

PMID: 30188253 (View on PubMed)

Other Identifiers

02/06/2024

Identifier Type: -

Identifier Source: org_study_id