TendinopathyNCT07013708
Effectiveness of Low-intensity Laser on Pain in Patients With Supraspinatus Tendinopathy
A study testing Laser in people with Tendinopathy and Pain, run by Universidad Católica de Ávila 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 30 to 65 years
- Conditions the study is for
- Tendinopathy, Pain
- What is being tested?
- Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2024to 24 May 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
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: Randomized Controlled Clinical 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 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
- Being tested
- Laser, Placebo
- Keywords
- shoulder, laser, placebo, Tendinopathy
- Medical subject headings
- Tendinopathy, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaserDevice
High frequency laser device
PlaceboOther
Same device but without pressing the ON button
| Study group | Role | What they receive |
|---|---|---|
| Laser treatment | Experimental | Patients diagnosed with laser-treated supraspinatus tendinopathy Receives: Device: Laser |
| Placebo Group | Active comparator | Patients diagnosed with supraspinatus tendinopathy treated with placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
pain scale where 0 is the lowest possible pain score and 10 is the maximum possible pain score
Measured: 12 weeks
Secondary outcomes (2)
Range of movement
joint mobility of the shoulder measured by digital goniometer
Measured: 12 weeks
pain threshold
pressure pain threshold measured by digital algometre
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start1 Jun 2024
- Primary completion30 Nov 2024
- Study completion24 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica de Ávila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JORGE VELAZQUEZ SAORNIL, Universidad Católica de Ávila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013708
- Sponsor's protocol ID
- 02/06/2024
- Status last verified
- Jun 2025
- First submitted
- 2 Jun 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36876175Rodeo 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.
PubMed 27507844Blevins FT. Rotator cuff pathology in athletes. Sports Med. 1997 Sep;24(3):205-20. doi: 10.2165/00007256-199724030-00009.
PubMed 9327536Lewis 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.
PubMed 19364757Haslerud 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.
PubMed 25450903Tumilty 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.
PubMed 19708800Notarnicola 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.
PubMed 37048665Elsodany 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.
PubMed 30188253
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. 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: Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT07013708
- Acronym / sponsor ID
- 02/06/2024
- Conditions
- Tendinopathy, Pain
- Keywords
- shoulder, laser, placebo, Tendinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universidad Católica de ÁvilaUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 24 May 2025 (actual)
- First posted
- 10 Jun 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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser treatment | Experimental | Device: LaserPatients diagnosed with laser-treated supraspinatus tendinopathy |
| Placebo Group | Active comparator | Other: PlaceboPatients diagnosed with supraspinatus tendinopathy treated with placebo |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
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 |
|---|---|---|
| LaserHigh frequency laser device | Device | Laser treatment |
| PlaceboSame device but without pressing the ON button | Other | Placebo Group |
Primary outcome
Visual Analogue Scale
Time frame: 12 weeks
pain scale where 0 is the lowest possible pain score and 10 is the maximum possible pain score
2 secondary outcomes
Range of movement
Time frame: 12 weeks
pain threshold
Time frame: 12 weeks
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 13 Jun 2025.
- Results publication: PubMed 36876175So 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.
- Results publication: PubMed 27507844Rodeo 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.
- Results publication: PubMed 9327536Blevins FT. Rotator cuff pathology in athletes. Sports Med. 1997 Sep;24(3):205-20. doi: 10.2165/00007256-199724030-00009.
- Results publication: PubMed 19364757Lewis 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.
- Results publication: PubMed 25450903Haslerud 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.
- Results publication: PubMed 19708800Tumilty 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.
- Results publication: PubMed 37048665Notarnicola 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.
- Results publication: PubMed 30188253Elsodany 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.
- Individual participant dataSharing planned: No
Related trials for Tendinopathy
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Synovial Tissue as a Biomarker in the Management of Pigmented Villonodular Synovitis
Synovitis Villonodular
Enrolling by invitation
High and Low Level Laser Therapy in De Quervain's Tenosynovitis
DeQuervain Tendinopathy
Recruiting
High-intensity Laser Therapy Versus Extracorporeal Shock Wave on Tendon Thickness and Occupation Ratio In Patients With Chronic Supraspinatus Tendinopathy
Supraspinatus Tendinopathy
Recruiting
Vibratory Anesthesia on Pain Following Corticosteroid Injections
Bilateral Arthritis of Wrist, Tendinopathy
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 in people with Tendinopathy and Pain, run by Universidad Católica de Ávila 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 5 inclusion and 13 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 13 Jun 2025. 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. 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?
Visual Analogue Scale (time frame: 12 weeks). 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 NCT07013708, which also lists 8 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 13 Jun 2025.