Subacromial Impingement SyndromeNCT06514105
Effect of High-intensity Laser Therapy on Supraspinatus Tendon Elasticity
A study testing Physiotherapy program and High intensity laser in people with Subacromial Impingement Syndrome, run by Adiyaman University at 1 site in Turkey (Türkiye).
Trial summary
Subacromial impingement syndrome, one of the most common causes of shoulder pain. In studies investigating the effectiveness of high-intensity laser in patients with subacromial impingement syndrome, it was stated that high-intensity laser reduced the complaints of patients in the early and late periods. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Subacromial Impingement Syndrome
- What is being tested?
- Physiotherapy program and High intensity laser
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jul 2024to 3 Mar 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Shoulder pain lasting more than 6 weeks.
- Diagnosed with subacromial impingement
- Being between the ages of 30-60
- Volunteering to participate in the study
Who cannot join
- Acute inflammatory disease affecting the shoulder area
- Presence of cervical radiculopathy
- Surgical intervention involving the shoulder and neck area
- Soft tissue or bone problems affecting the shoulder
- had any neurologic problems
- Patients who wish to withdraw from the study at any stage after volunteering
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adiyaman university
Adıyaman, Adıyaman Province, 02000
About this study
Official title: Effect of High-intensity Laser Therapy on Supraspinatus Tendon Elasticity in Subacromial Impingement Syndrome: A Double-blind Randomized Controlled Study
Subacromial impingement syndrome, one of the most common causes of shoulder pain. In studies investigating the effectiveness of high-intensity laser in patients with subacromial impingement syndrome, it was stated that high-intensity laser reduced the complaints of patients in the early and late periods. However, there is no research examining the effect of high-intensity laser on the supraspinatus tendon. Therefore, the investigators aimed to investigate the effect of high-intensity laser on the supraspinatus tendon using shear wave elastography.
Read the detailed description
Subacromial impingement syndrome, one of the most common causes of shoulder pain, occurs when the supraspinatus tendon, subacromial bursa or bicipital tendon becomes compressed between the acromion, coracoacromial ligament, coracoid process and/or acromioclavicular joint during shoulder movements. Several factors contribute to subacromial impingement syndrome, including weakening of the rotator cuff, capsular tension, poor scapulohumeral rhythm, and muscular imbalance in the upward rotation force of the scapula. Steroid and non-steroidal anti-inflammatory agents, physiotherapy applications, laser therapy, manual therapy, ESWT and active and passive normal joint movements involving the shoulder joint are frequently applied treatments in the treatment of subacromial impingement syndrome.
It is stated that high-intensity laser treatment can quickly produce photochemical and photothermic effects in deep tissue. Therefore, collagen production in tendons is promoted and blood flow, vascular permeability and cell metabolism can be increased. As a result of all these processes, tissue healing begins and painful stimuli decrease. In studies investigating the effectiveness of high-intensity laser in patients with subacromial impingement syndrome, it was stated that high-intensity laser reduced the complaints of patients in the early and late periods. However, there is no research examining the effect of high-intensity laser on the supraspinatus tendon. Therefore, in this study, the investigators aimed to investigate the effect of high-intensity laser on the supraspinatus tendon using shear wave elastography.
- Conditions
- Subacromial Impingement Syndrome
- Being tested
- Physiotherapy program, High intensity laser, Sham high intensity laser
- Keywords
- Elasticity Imaging Techniques, Physical Therapy Modalities, Rotator Cuff
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy programOther
All patients participating in the study will be included in the physiotherapy program. Physiotherapy program consist of hot-pack (for 15 minutes), ultrasound (Continuous ultrasound, for 5 minutes, 1-MHZ 1.5W/cm2, a 5-cm ultrasound head on the subacromial region),TENS (for 20 minutes with the BTL 4000 combined device) and exercise program (Stretching exercises for the rotator cuff, rhomboid muscles, levator scapula, serratus anterior and pectoaral muscles and strengthening the muscles around the shoulder with a resistance exercise band selected in a color appropriate to the patient's strength).
High intensity laserOther
High intensity laser will be applied using the BTL-6000 (BTL Company, UK) device. The first 5 sessions will be applied to the painful area by making circular movements from the center to the outside for 100 seconds at a power of 10W and a dose of 10 J/cm2 (analgesic effect). The last 5 sessions will be applied to the painful area with linear movements at 4W power and 100 J/cm2 dose (biostimulation effect) for 10 minutes and 25 seconds.
Sham high intensity laserOther
In sham application, the patient will be positioned on the treatment stretcher and the device will be turned on. The guide light of the high-intensity laser device, which gives the same color as the laser light, will be applied to the subacromial region in circular movements from outside to inside and from inside to outside.
| Study group | Role | What they receive |
|---|---|---|
| High intensity laser group | Active comparator | In addition to the physiotherapy program, high intensity laser application will be applied to the high intensity laser group. Receives: Other: Physiotherapy program; Other: High intensity laser |
| Control group | Active comparator | In addition to the physiotherapy program, sham high intensity laser application will be applied to the control group. Receives: Other: Physiotherapy program; Other: Sham high intensity laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elasticity Measurement
In patients diagnosed with subacromial impingement syndrome as a result of physical examination, the degree of elasticity of the supraspinatus tendon and supraspinatus muscle on the relevant side will be evaluated numerically by Shear Wave elastography. All patients will be scanned by an expert radiologist using a high-resolution broadband linear probe with a Samsung RS 85 Prestige device. While the patients are sitting comfortably and the arm is in a neutral position, the linear probe will be placed parallel to the supraspinatus tendon and the tendon will be displayed in the longitudinal direction. Velocity and elasticity values of the muscle in kPa will be measured using 3 mm diameter range of interest (ROIs) with the help of Shear Wave elastography in the supraspinatus tendon at a distance of 0.5-1.5 cm from the tuberculum majus. For each patient, the measurement will be repeated three times and the average of these three values will be recorded.
Measured: 2 weeks
Secondary outcomes (2)
Functional level
The functional level of the shoulder will be evaluated with the Shoulder Pain and Disability Scale. This scale consists of a total of 13 questions, where each question is scored between 0-10. The scores from the first 5 questions measure the pain level out of 50, and the scores from the next 8 questions measure the disability level out of 80. A high score from the scale indicates a high level of pain and disability.
Measured: 2 weeks
Pain assessment
The severity of patients' shoulder pain will be evaluated with a visual analog scale (VAS). VAS: The left end of a 10 cm straight line represents no pain, and the right end represents unbearable pain. The patient will be asked to mark the pain he feels on the VAS scale during the test, and then this value will be measured and recorded with the help of a ruler.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start22 Jul 2024
- Primary completion17 Feb 2025
- Study completion3 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial Impingement SyndromeStudies 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
- Model description
- The study was planned as double-blind, randomized controlled. There are two groups in the study. The groups consist of the control group and high intensity laser group.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esin Akbas, Adiyaman University
- Investigators
- Esin Akbaş, Principal investigator, Adiyaman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514105
- Sponsor's protocol ID
- ADU-FTR-EA-01
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-intensity Laser Therapy on Supraspinatus Tendon Elasticity in Subacromial Impingement Syndrome: A Double-blind Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06514105
- Acronym / sponsor ID
- ADU-FTR-EA-01
- Conditions
- Subacromial Impingement Syndrome
- Keywords
- Elasticity Imaging Techniques, Physical Therapy Modalities, Rotator Cuff
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Adiyaman UniversityUniversity, hospital or other
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 17 Feb 2025 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 23 Jul 2024 (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.
Subacromial impingement syndrome, one of the most common causes of shoulder pain. In studies investigating the effectiveness of high-intensity laser in patients with subacromial impingement syndrome, it was stated that high-intensity laser reduced the complaints of patients in the early and late periods. However, there is no research examining the effect of high-intensity laser on the supraspinatus tendon. Therefore, the investigators aimed to investigate the effect of high-intensity laser on the supraspinatus tendon using shear wave elastography.
Detailed description
Subacromial impingement syndrome, one of the most common causes of shoulder pain, occurs when the supraspinatus tendon, subacromial bursa or bicipital tendon becomes compressed between the acromion, coracoacromial ligament, coracoid process and/or acromioclavicular joint during shoulder movements. Several factors contribute to subacromial impingement syndrome, including weakening of the rotator cuff, capsular tension, poor scapulohumeral rhythm, and muscular imbalance in the upward rotation force of the scapula. Steroid and non-steroidal anti-inflammatory agents, physiotherapy applications, laser therapy, manual therapy, ESWT and active and passive normal joint movements involving the shoulder joint are frequently applied treatments in the treatment of subacromial impingement syndrome.
It is stated that high-intensity laser treatment can quickly produce photochemical and photothermic effects in deep tissue. Therefore, collagen production in tendons is promoted and blood flow, vascular permeability and cell metabolism can be increased. As a result of all these processes, tissue healing begins and painful stimuli decrease. In studies investigating the effectiveness of high-intensity laser in patients with subacromial impingement syndrome, it was stated that high-intensity laser reduced the complaints of patients in the early and late periods. However, there is no research examining the effect of high-intensity laser on the supraspinatus tendon. Therefore, in this study, the investigators aimed to investigate the effect of high-intensity laser on the supraspinatus tendon using shear wave elastography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study was planned as double-blind, randomized controlled. There are two groups in the study. The groups consist of the control group and high intensity laser group.
| Arm | Type | Receives |
|---|---|---|
| High intensity laser group | Active comparator | Other: Physiotherapy program, Other: High intensity laserIn addition to the physiotherapy program, high intensity laser application will be applied to the high intensity laser group. |
| Control group | Active comparator | Other: Physiotherapy program, Other: Sham high intensity laserIn addition to the physiotherapy program, sham high intensity laser application will be applied to the control group. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Shoulder pain lasting more than 6 weeks.
- Diagnosed with subacromial impingement
- Being between the ages of 30-60
- Volunteering to participate in the study
Key exclusion criteria (6 listed)
- Acute inflammatory disease affecting the shoulder area
- Presence of cervical radiculopathy
- Surgical intervention involving the shoulder and neck area
- Soft tissue or bone problems affecting the shoulder
- had any neurologic problems
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 |
|---|---|---|
| Physiotherapy programAll patients participating in the study will be included in the physiotherapy program. Physiotherapy program consist of hot-pack (for 15 minutes), ultrasound (Continuous ultrasound, for 5 minutes, 1-MHZ 1.5W/cm2, a 5-cm ultrasound head on the subacromial region),TENS (for 20 minutes with the BTL 4000 combined device) and exercise program (Stretching exercises for the rotator cuff, rhomboid muscles, levator scapula, serratus anterior and pectoaral muscles and strengthening the muscles around the shoulder with a resistance exercise band selected in a color appropriate to the patient's strength). | Other | Control group, High intensity laser group |
| High intensity laserHigh intensity laser will be applied using the BTL-6000 (BTL Company, UK) device. The first 5 sessions will be applied to the painful area by making circular movements from the center to the outside for 100 seconds at a power of 10W and a dose of 10 J/cm2 (analgesic effect). The last 5 sessions will be applied to the painful area with linear movements at 4W power and 100 J/cm2 dose (biostimulation effect) for 10 minutes and 25 seconds. | Other | High intensity laser group |
| Sham high intensity laserIn sham application, the patient will be positioned on the treatment stretcher and the device will be turned on. The guide light of the high-intensity laser device, which gives the same color as the laser light, will be applied to the subacromial region in circular movements from outside to inside and from inside to outside. | Other | Control group |
Primary outcome
Elasticity Measurement
Time frame: 2 weeks
In patients diagnosed with subacromial impingement syndrome as a result of physical examination, the degree of elasticity of the supraspinatus tendon and supraspinatus muscle on the relevant side will be evaluated numerically by Shear Wave elastography. All patients will be scanned by an expert radiologist using a high-resolution broadband linear probe with a Samsung RS 85 Prestige device. While the patients are sitting comfortably and the arm is in a neutral position, the linear probe will be placed parallel to the supraspinatus tendon and the tendon will be displayed in the longitudinal direction. Velocity and elasticity values of the muscle in kPa will be measured using 3 mm diameter range of interest (ROIs) with the help of Shear Wave elastography in the supraspinatus tendon at a distance of 0.5-1.5 cm from the tuberculum majus. For each patient, the measurement will be repeated three times and the average of these three values will be recorded.
2 secondary outcomes
Functional level
Time frame: 2 weeks
Pain assessment
Time frame: 2 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 10 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Esin Akbaş principal investigator
Adiyaman University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy program and High intensity laser in people with Subacromial Impingement Syndrome, run by Adiyaman University at 1 site in Turkey (Türkiye).
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 6 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 10 Jul 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 Turkey (Türkiye). 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?
Elasticity Measurement (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2025.