TendinopathyNCT07261449
Effectiveness of Low-intensity Laser on Pain in Patients With Supraspinatus Tendinopathy.
A study testing Laser Group in people with Tendinopathy, run by Universidad Pontificia de Salamanca at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tendinopathy
- What is being tested?
- Laser Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 12 Sep 2023to 12 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Low-intensity Laser on Pain in Patients With Supraspinatus Tendinopathy. A Triple-Blind Randomized Controlled Trial.
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
- Being tested
- Placebo Group, Laser Group
- Keywords
- pain, range of motion, quality of life
- Medical subject headings
- Tendinopathy, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo GroupDevice
A placebo treatment is carried out on the shoulder, simulating the application of the laser.
Laser GroupDevice
Therapeutic laser treatment is performed on the shoulder.
| Study group | Role | What they receive |
|---|---|---|
| Laser treatment | Experimental | Laser treatment on tendinophaty shoulder. Receives: Device: Laser Group |
| Placebo Group | Placebo comparator | Placebo treatment on tendinophaty shoulder. Receives: Device: Placebo Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
intensity of pain.
measured using the VAS scale, where 0 is the least possible pain and 10 is the greatest possible pain
Measured: 3 months
Secondary outcomes (2)
Range of motion
Shoulder mobility in the joint ranges of flexion, extension, abduction, adduction, and external and internal rotation. Measurement in degrees using a goniometer.
Measured: 3 months
Patient quality of life
DASH questionnaire The score ranges from 0, which is equivalent to having no disability, to a maximum of 100, which is equivalent to having a very severe functional limitation.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start12 Sep 2023
- Primary completion24 Jul 2024
- Study completion12 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Pontificia de Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Velazquez, Universidad Pontificia de Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261449
- Sponsor's protocol ID
- 221123
- Status last verified
- Apr 2026
- First submitted
- 22 Nov 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data, including the data dictionary, will be shared with qualified researchers. The shared IPD will include the data needed to reproduce the study findings, such as the de-identified participant-level data underlying the results reported in the publication.
Publications
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.
PubMed 25408141Haik 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.
PubMed 27288517Romero-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.
PubMed 34099238Asensio-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.
PubMed 36583575Sanchez-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.
PubMed 33076550
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Low-intensity Laser on Pain in Patients With Supraspinatus Tendinopathy. A Triple-Blind Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07261449
- Acronym / sponsor ID
- 221123
- Conditions
- Tendinopathy
- Keywords
- pain, range of motion, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad Pontificia de SalamancaUniversity, hospital or other
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- 12 Jun 2025 (actual)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser treatment | Experimental | Device: Laser GroupLaser treatment on tendinophaty shoulder. |
| Placebo Group | Placebo comparator | Device: Placebo GroupPlacebo treatment on tendinophaty shoulder. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo GroupA placebo treatment is carried out on the shoulder, simulating the application of the laser. | Device | Placebo Group |
| Laser GroupTherapeutic laser treatment is performed on the shoulder. | Device | Laser treatment |
Primary outcome
intensity of pain.
Time frame: 3 months
measured using the VAS scale, where 0 is the least possible pain and 10 is the greatest possible pain
2 secondary outcomes
Range of motion
Time frame: 3 months
Patient quality of life
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Results publication: PubMed 25408141Redondo-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.
- Results publication: PubMed 27288517Haik 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.
- Results publication: PubMed 34099238Romero-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.
- Results publication: PubMed 36583575Asensio-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.
- Results publication: PubMed 33076550Sanchez-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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data, including the data dictionary, will be shared with qualified researchers. The shared IPD will include the data needed to reproduce the study findings, such as the de-identified participant-level data underlying the results reported in the publication.
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High-intensity Laser Therapy Versus Extracorporeal Shock Wave on Tendon Thickness and Occupation Ratio In Patients With Chronic Supraspinatus Tendinopathy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Group in people with Tendinopathy, run by Universidad Pontificia de Salamanca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intensity of pain. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07261449, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.