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

NCT07013708 | Completed

• 1 other identifier: 02/06/2024
• Study Type: interventional
• Target: 80
• 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 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

Keywords

shoulder; laser; placebo; Tendinopathy

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale

  pain scale where 0 is the lowest possible pain score and 10 is the maximum possible pain score

  12 weeks

Secondary Outcomes (2)

• Range of movement

  12 weeks

• pain threshold

  12 weeks

Study Arms (2)

Laser treatment

EXPERIMENTAL

Patients diagnosed with laser-treated supraspinatus tendinopathy

Device: Laser

Placebo Group

ACTIVE COMPARATOR

Patients diagnosed with supraspinatus tendinopathy treated with placebo

Other: Placebo

Interventions

Laser DEVICE

High frequency laser device

Laser treatment

Placebo OTHER

Same device but without pressing the ON button

Placebo Group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Católica de Ávila: lead

Study Sites (1)

Universidad Pontificia de Salamanca

Salamanca, Spain

Location

Related Publications (8)

• So BCL, Lau SCT, Kwok WY, Tse DHT, Man SS. Investigating The Association Between Supraspinatus Tendon Abnormality, Shoulder Pain and Isokinetic Strength in Elite Swimmers: A Cross-Sectional Study. J Sports Sci Med. 2023 Mar 1;22(1):17-27. doi: 10.52082/jssm.2023.17. eCollection 2023 Mar.

  PMID: 36876175 RESULT

• Rodeo SA, Nguyen JT, Cavanaugh JT, Patel Y, Adler RS. Clinical and Ultrasonographic Evaluations of the Shoulders of Elite Swimmers. Am J Sports Med. 2016 Dec;44(12):3214-3221. doi: 10.1177/0363546516657823. Epub 2016 Aug 9.

  PMID: 27507844 RESULT

• Blevins FT. Rotator cuff pathology in athletes. Sports Med. 1997 Sep;24(3):205-20. doi: 10.2165/00007256-199724030-00009.

  PMID: 9327536 RESULT

• Lewis JS. Rotator cuff tendinopathy: a model for the continuum of pathology and related management. Br J Sports Med. 2010 Oct;44(13):918-23. doi: 10.1136/bjsm.2008.054817. Epub 2009 Apr 12.

  PMID: 19364757 RESULT

• Haslerud S, Magnussen LH, Joensen J, Lopes-Martins RA, Bjordal JM. The efficacy of low-level laser therapy for shoulder tendinopathy: a systematic review and meta-analysis of randomized controlled trials. Physiother Res Int. 2015 Jun;20(2):108-25. doi: 10.1002/pri.1606. Epub 2014 Dec 2.

  PMID: 25450903 RESULT

• 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.

  PMID: 19708800 RESULT

• Notarnicola A, Covelli I, Macchiarola D, Bianchi FP, Cassano GD, Moretti B. The Efficacy of Temperature-Controlled High-Energy Polymodal Laser Therapy in Tendinopathy of the Shoulder. J Clin Med. 2023 Mar 29;12(7):2583. doi: 10.3390/jcm12072583.

  PMID: 37048665 RESULT

• 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.

  PMID: 30188253 RESULT

MeSH Terms

Conditions

Tendinopathy; Pain

Interventions

Lasers

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: simple
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 10, 2025
• Study Start: June 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: May 24, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)