Subacromial Impingement SyndromeNCT04779190
Physical Therapy in Shoulder Impingement Syndrome
A study testing Low-level laser therapy, Therapeutic ultrasound and Home-based exercise in people with Subacromial Impingement Syndrome, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effects of low-level laser therapy (LLLT) and therapeutic ultrasound combined with home-based exercise in comparison with home-based exercise alone in patients with subacromial impingement syndrome (SIS). Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Subacromial Impingement Syndrome
- What is being tested?
- Low-level laser therapy, Therapeutic ultrasound and Home-based exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Mar 2021to 10 Jul 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of subacromial impingement syndrome based on physical examinations
- Persistent pain in one shoulder for at least 2 months
- No passive shoulder range of motion limitations
- Failure of improvement in pain after analgesic medications
Who cannot join
- History of malignancy and systemic rheumatic diseases
- Evidence of systemic or local infection
- Presence of major trauma at the affected shoulder
- History of shoulder surgery
- Rotator cuff lesions in the form of either calcific tendinosis or full-thickness tear as confirmed on MRI scanning
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Istanbul
About this study
Official title: Low-level Laser Therapy Versus Ultrasound Therapy Combined With Exercise in Patients With Subacromial Impingement Syndrome
The aim of this study is to evaluate the effects of low-level laser therapy (LLLT) and therapeutic ultrasound combined with home-based exercise in comparison with home-based exercise alone in patients with subacromial impingement syndrome (SIS). Participants are going to evaluate before training, and at the 1-month follow-up and 3-month follow-up using the visual analog scale (VAS) scores for pain during activity, at rest, and at night, and the Shoulder Pain and Disability Index (SPADI).
Read the detailed description
SIS is an important cause of pain and disability and affects activities of daily living. Therefore, a major goal of SIS treatment is to reduce pain and improve upper extremity function. In this prospective, randomized controlled, single-blind, interventional trial, a total of 60 patients with SIS who met the eligibility criteria are going to enrolled in the study. Eligible participants are going to randomly assign to one of the three groups by an independent blinded researcher, using a computer-generated random numbers and allocation ratio of 1:1:1: the LLLT group (LG, n = 20), the ultrasound therapy group (UG, n = 20), and the control group (CG, n = 20). Participants are going to evaluate before training, and at the 1-month follow-up and 3-month follow-up using the visual analog scale (VAS) scores for pain during activity, at rest, and at night, and the Shoulder Pain and Disability Index (SPADI).
- Conditions
- Subacromial Impingement Syndrome
- Being tested
- Low-level laser therapy, Therapeutic ultrasound, Home-based exercise
- 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.
Low-level laser therapyDevice
Gallium-aluminum-arsenide diode laser device
Therapeutic ultrasoundDevice
Therapeutic pulsed ultrasound with a frequency of 1 MHz
Home-based exerciseOther
Home-based exercises 3 days a week; each exercise comprises one set with 5 repetitions over 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Low-level laser therapy | Experimental | In the low-level laser therapy group, each patient are going to receive low-level laser therapy and cold-pack therapy and perform a home-based exercise program 5 times a week, once a day for 15 sessions. Receives: Device: Low-level laser therapy; Other: Home-based exercise |
| Therapeutic ultrasound | Experimental | In the therapeutic ultrasound group, each patient are going to receive therapeutic ultrasound and cold-pack therapy and perform a home-based exercise program 5 times a week, once a day for 15 sessions. Receives: Device: Therapeutic ultrasound; Other: Home-based exercise |
| Control | Active comparator | Participants are going to perform a home-based exercise program and receive cold-pack therapy 5 times a week, once a day for 15 sessions. Receives: Other: Home-based exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline activity pain score at 1-months and 3-months
Visual Analogue Scale-Activity pain (0-10 point). Higher scores mean a worse outcome
Measured: Baseline, 1-month, 3-month
Secondary outcomes (3)
Change from baseline rest pain score at 1-months and 3-months
Visual Analogue Scale-Rest pain (0-10 point). Higher scores mean a worse outcome
Measured: Baseline, 1-month, 3-month
Change from baseline Shoulder Pain and Disability Index at 1-months and 3-months
Shoulder Pain and Disability Index (SPADI) measures shoulder pain and shoulder disability. Total score ranges from 0 to 130, where a higher score indicates a worsening status. Each item is scored with the VAS, which ranges from 0 (no pain or no difficulty) to 10 (worst pain imaginable or very difficult, help required)
Measured: Baseline, 1-month, 3-month
Change from baseline night pain score at 1-months and 3-months
Visual Analogue Scale- Night pain (0-10 point). Higher scores mean a worse outcome
Measured: Baseline, 1-month, 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start4 Mar 2021
- Primary completion10 Jul 2021
- Study completion10 Jul 2021
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.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ekin Ilke Sen, Istanbul University
- Investigators
- Nalan Capan, Study director, Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779190
- Sponsor's protocol ID
- IstanbulU-2017-855
- Status last verified
- Jul 2021
- First submitted
- 26 Feb 2021
- Last updated
- 16 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-level Laser Therapy Versus Ultrasound Therapy Combined With Exercise in Patients With Subacromial Impingement Syndrome
- ClinicalTrials.gov ID
- NCT04779190
- Acronym / sponsor ID
- IstanbulU-2017-855
- Conditions
- Subacromial Impingement Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 10 Jul 2021 (actual)
- Study completion
- 10 Jul 2021 (actual)
- First posted
- 3 Mar 2021 (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.
The aim of this study is to evaluate the effects of low-level laser therapy (LLLT) and therapeutic ultrasound combined with home-based exercise in comparison with home-based exercise alone in patients with subacromial impingement syndrome (SIS). Participants are going to evaluate before training, and at the 1-month follow-up and 3-month follow-up using the visual analog scale (VAS) scores for pain during activity, at rest, and at night, and the Shoulder Pain and Disability Index (SPADI).
Detailed description
SIS is an important cause of pain and disability and affects activities of daily living. Therefore, a major goal of SIS treatment is to reduce pain and improve upper extremity function. In this prospective, randomized controlled, single-blind, interventional trial, a total of 60 patients with SIS who met the eligibility criteria are going to enrolled in the study. Eligible participants are going to randomly assign to one of the three groups by an independent blinded researcher, using a computer-generated random numbers and allocation ratio of 1:1:1: the LLLT group (LG, n = 20), the ultrasound therapy group (UG, n = 20), and the control group (CG, n = 20). Participants are going to evaluate before training, and at the 1-month follow-up and 3-month follow-up using the visual analog scale (VAS) scores for pain during activity, at rest, and at night, and the Shoulder Pain and Disability Index (SPADI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-level laser therapy | Experimental | Device: Low-level laser therapy, Other: Home-based exerciseIn the low-level laser therapy group, each patient are going to receive low-level laser therapy and cold-pack therapy and perform a home-based exercise program 5 times a week, once a day for 15 sessions. |
| Therapeutic ultrasound | Experimental | Device: Therapeutic ultrasound, Other: Home-based exerciseIn the therapeutic ultrasound group, each patient are going to receive therapeutic ultrasound and cold-pack therapy and perform a home-based exercise program 5 times a week, once a day for 15 sessions. |
| Control | Active comparator | Other: Home-based exerciseParticipants are going to perform a home-based exercise program and receive cold-pack therapy 5 times a week, once a day for 15 sessions. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of subacromial impingement syndrome based on physical examinations
- Persistent pain in one shoulder for at least 2 months
- No passive shoulder range of motion limitations
- Failure of improvement in pain after analgesic medications
Key exclusion criteria (5 listed)
- History of malignancy and systemic rheumatic diseases
- Evidence of systemic or local infection
- Presence of major trauma at the affected shoulder
- History of shoulder surgery
- Rotator cuff lesions in the form of either calcific tendinosis or full-thickness tear as confirmed on MRI scanning
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 |
|---|---|---|
| Low-level laser therapyGallium-aluminum-arsenide diode laser device | Device | Low-level laser therapy |
| Therapeutic ultrasoundTherapeutic pulsed ultrasound with a frequency of 1 MHz | Device | Therapeutic ultrasound |
| Home-based exerciseHome-based exercises 3 days a week; each exercise comprises one set with 5 repetitions over 4 weeks. | Other | Control, Low-level laser therapy, Therapeutic ultrasound |
Primary outcome
Change from baseline activity pain score at 1-months and 3-months
Time frame: Baseline, 1-month, 3-month
Visual Analogue Scale-Activity pain (0-10 point). Higher scores mean a worse outcome
3 secondary outcomes
Change from baseline rest pain score at 1-months and 3-months
Time frame: Baseline, 1-month, 3-month
Change from baseline Shoulder Pain and Disability Index at 1-months and 3-months
Time frame: Baseline, 1-month, 3-month
Change from baseline night pain score at 1-months and 3-months
Time frame: Baseline, 1-month, 3-month
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 16 Jul 2021.
Related trials for Subacromial Impingement Syndrome
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Spencer vs Positional Release Techniques for Chronic Subacromial Impingement
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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.
Nalan Capan study director
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-level laser therapy, Therapeutic ultrasound and Home-based exercise in people with Subacromial Impingement Syndrome, run by Istanbul 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 5 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 16 Jul 2021. 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?
Change from baseline activity pain score at 1-months and 3-months (time frame: Baseline, 1-month, 3-month). 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 16 Jul 2021.