Subacromial Impingement SyndromeNCT07586800
High-Intensity Laser Therapy Versus Multimodal Physiotherapy in Subacromial Impingement Syndrome
A study testing High-Intensity Laser Therapy and Multimodal Physiotherapy in people with Subacromial Impingement Syndrome and Shoulder Pain, run by Tulay Yildirim.
Trial summary
This randomized controlled trial aimed to compare the short-term effectiveness of high-intensity laser therapy (HILT) and a multimodal physiotherapy program in patients with subacromial impingement syndrome (SIS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Subacromial Impingement Syndrome, Shoulder Pain, Rotator Cuff Disease
- What is being tested?
- High-Intensity Laser Therapy and Multimodal Physiotherapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Dec 2017
- 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
- Adults aged 18 to 65 years
- Clinically and radiologically confirmed subacromial impingement syndrome
- Shoulder pain lasting at least 1 month and less than 6 months
- At least one positive impingement test (Neer, Hawkins-Kennedy, painful arc, or Jobe test)
- MRI findings consistent with stage I-II rotator cuff changes
Who cannot join
- Previous shoulder surgery or trauma
- Inflammatory rheumatic disease
- Recent myocardial infarction
- Active infection
- Previous physiotherapy or corticosteroid injection within the last 6 months
- Pregnancy
Show all 13Show fewer
- Calcific tendinitis
- Adhesive capsulitis
- Cervical radiculopathy
- Neurological disorders affecting the shoulder
- Full-thickness rotator cuff tear
- Contraindications to electrotherapy or laser therapy
- -
About this study
Official title: Short-Term Effects of High-Intensity Laser Therapy Compared With Multimodal Physiotherapy in Subacromial Impingement Syndrome: A Randomized Controlled Trial
This randomized controlled trial aimed to compare the short-term effectiveness of high-intensity laser therapy (HILT) and a multimodal physiotherapy program in patients with subacromial impingement syndrome (SIS). Ninety-four participants were allocated to either HILT or combined physiotherapy, and both groups received an identical supervised exercise program. Primary outcome measures included shoulder pain assessed using the visual analogue scale (VAS). Secondary outcomes included shoulder function, disability, and quality of life. Outcomes were evaluated at baseline, post-treatment, and short-term follow-up.
Read the detailed description
Subacromial impingement syndrome (SIS) is one of the most common causes of shoulder pain and functional limitation. Conservative treatment strategies, particularly exercise-based rehabilitation, are recommended as first-line therapy. High-intensity laser therapy (HILT) has recently gained attention because of its potential analgesic and anti-inflammatory effects; however, its comparative effectiveness against multimodal physiotherapy remains unclear.
This single-centre, assessor-blinded randomized controlled trial was conducted at the Department of Physical Medicine and Rehabilitation, Inonu University Hospital, Malatya, Türkiye. Adults aged 18-65 years with clinically and radiologically confirmed SIS were enrolled. Participants were allocated to either a high-intensity laser therapy group or a combined conventional physiotherapy group. Both groups additionally participated in an identical supervised exercise program.
The HILT group received class IV Nd:YAG laser therapy (1064 nm), whereas the control group received hot pack therapy, transcutaneous electrical nerve stimulation, and therapeutic ultrasound. Treatment duration was three weeks.
The primary outcome measure was pain intensity assessed using the visual analogue scale (VAS). Secondary outcomes included the Constant-Murley Score, Shoulder Pain and Disability Index (SPADI), and Short Form-36 quality-of-life assessment. Outcomes were evaluated at baseline, post-treatment, and short-term follow-up.
The study was approved by the Inonu University Clinical Research Ethics Committee (Approval No: 2015/123). The trial was retrospectively submitted for registration at ClinicalTrials.gov.
- Being tested
- High-Intensity Laser Therapy, Multimodal Physiotherapy
- Keywords
- High-Intensity Laser Therapy, HILT, Physiotherapy, Shoulder Rehabilitation, Exercise Therapy, Randomized Controlled Trial
- Medical subject headings
- Shoulder Impingement Syndrome, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Laser TherapyDevice
Class IV Nd:YAG laser therapy (1064 nm wavelength) administered to the shoulder region for treatment of subacromial impingement syndrome.
Multimodal PhysiotherapyOther
Combined physiotherapy program consisting of hot pack therapy, transcutaneous electrical nerve stimulation, and therapeutic ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Laser Therapy | Experimental | Participants received class IV Nd:YAG high-intensity laser therapy three times weekly for three weeks in addition to a supervised exercise program. Receives: Device: High-Intensity Laser Therapy |
| Multimodal Physiotherapy | Active comparator | Participants received hot pack therapy, transcutaneous electrical nerve stimulation, and therapeutic ultrasound combined with a supervised exercise program. Receives: Other: Multimodal Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain Intensity Assessed by Visual Analogue Scale (VAS)
Pain intensity at rest, during movement, and at night assessed using a 10-cm visual analogue scale.
Measured: Baseline, 3 weeks, and 7 weeks
Secondary outcomes (2)
Shoulder Function Assessed by Constant-Murley Score
Shoulder functional status assessed using the Constant-Murley Score.
Measured: Baseline, 3 weeks, and 7 weeks
Shoulder Disability Assessed by SPADI
Shoulder Pain and Disability Index (SPADI) used to assess disability related to shoulder pain.
Measured: Baseline, 3 weeks, and 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start1 Jan 2016
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
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
- Participants were assigned to either high-intensity laser therapy or multimodal physiotherapy, with both groups receiving an identical supervised exercise program.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulay Yildirim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tulay Yildirim, Inonu University
- Investigators
- Tulay Yildirim, MD, Principal investigator, Inonu University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586800
- Sponsor's protocol ID
- IUFM-PMR-2015-123
- Other IDs
- 2015/123
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 14 May 2026
- 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 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Effects of High-Intensity Laser Therapy Compared With Multimodal Physiotherapy in Subacromial Impingement Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07586800
- Acronym / sponsor ID
- IUFM-PMR-2015-123
- Keywords
- High-Intensity Laser Therapy, HILT, Physiotherapy, Shoulder Rehabilitation, Exercise Therapy, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Tulay YildirimUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 14 May 2026 (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.
This randomized controlled trial aimed to compare the short-term effectiveness of high-intensity laser therapy (HILT) and a multimodal physiotherapy program in patients with subacromial impingement syndrome (SIS). Ninety-four participants were allocated to either HILT or combined physiotherapy, and both groups received an identical supervised exercise program. Primary outcome measures included shoulder pain assessed using the visual analogue scale (VAS). Secondary outcomes included shoulder function, disability, and quality of life. Outcomes were evaluated at baseline, post-treatment, and short-term follow-up.
Detailed description
Subacromial impingement syndrome (SIS) is one of the most common causes of shoulder pain and functional limitation. Conservative treatment strategies, particularly exercise-based rehabilitation, are recommended as first-line therapy. High-intensity laser therapy (HILT) has recently gained attention because of its potential analgesic and anti-inflammatory effects; however, its comparative effectiveness against multimodal physiotherapy remains unclear.
This single-centre, assessor-blinded randomized controlled trial was conducted at the Department of Physical Medicine and Rehabilitation, Inonu University Hospital, Malatya, Türkiye. Adults aged 18-65 years with clinically and radiologically confirmed SIS were enrolled. Participants were allocated to either a high-intensity laser therapy group or a combined conventional physiotherapy group. Both groups additionally participated in an identical supervised exercise program.
The HILT group received class IV Nd:YAG laser therapy (1064 nm), whereas the control group received hot pack therapy, transcutaneous electrical nerve stimulation, and therapeutic ultrasound. Treatment duration was three weeks.
The primary outcome measure was pain intensity assessed using the visual analogue scale (VAS). Secondary outcomes included the Constant-Murley Score, Shoulder Pain and Disability Index (SPADI), and Short Form-36 quality-of-life assessment. Outcomes were evaluated at baseline, post-treatment, and short-term follow-up.
The study was approved by the Inonu University Clinical Research Ethics Committee (Approval No: 2015/123). The trial was retrospectively submitted for registration at ClinicalTrials.gov.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were assigned to either high-intensity laser therapy or multimodal physiotherapy, with both groups receiving an identical supervised exercise program.
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Laser Therapy | Experimental | Device: High-Intensity Laser TherapyParticipants received class IV Nd:YAG high-intensity laser therapy three times weekly for three weeks in addition to a supervised exercise program. |
| Multimodal Physiotherapy | Active comparator | Other: Multimodal PhysiotherapyParticipants received hot pack therapy, transcutaneous electrical nerve stimulation, and therapeutic ultrasound combined with a supervised exercise program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 to 65 years
- Clinically and radiologically confirmed subacromial impingement syndrome
- Shoulder pain lasting at least 1 month and less than 6 months
- At least one positive impingement test (Neer, Hawkins-Kennedy, painful arc, or Jobe test)
- MRI findings consistent with stage I-II rotator cuff changes
Key exclusion criteria (13 listed)
- Previous shoulder surgery or trauma
- Inflammatory rheumatic disease
- Recent myocardial infarction
- Active infection
- Previous physiotherapy or corticosteroid injection within the last 6 months
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 |
|---|---|---|
| High-Intensity Laser TherapyClass IV Nd:YAG laser therapy (1064 nm wavelength) administered to the shoulder region for treatment of subacromial impingement syndrome. | Device | High-Intensity Laser Therapy |
| Multimodal PhysiotherapyCombined physiotherapy program consisting of hot pack therapy, transcutaneous electrical nerve stimulation, and therapeutic ultrasound. | Other | Multimodal Physiotherapy |
Primary outcome
Shoulder Pain Intensity Assessed by Visual Analogue Scale (VAS)
Time frame: Baseline, 3 weeks, and 7 weeks
Pain intensity at rest, during movement, and at night assessed using a 10-cm visual analogue scale.
2 secondary outcomes
Shoulder Function Assessed by Constant-Murley Score
Time frame: Baseline, 3 weeks, and 7 weeks
Shoulder Disability Assessed by SPADI
Time frame: Baseline, 3 weeks, and 7 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 14 May 2026.
- 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.
Tulay Yildirim, MD principal investigator
Inonu University Faculty of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Laser Therapy and Multimodal Physiotherapy in people with Subacromial Impingement Syndrome and Shoulder Pain, run by Tulay Yildirim.
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 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Shoulder Pain Intensity Assessed by Visual Analogue Scale (VAS) (time frame: Baseline, 3 weeks, and 7 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 14 May 2026.