Shoulder Impingement SyndromesNCT07688226
Effect of Therapeutic Ultrasound Combined With Exercise on Subacromial Impingement Syndrome
A study testing Continuous Ultrasound + Exercises, Pulsed Ultrasound + Exercises and Exercises Only in people with Shoulder Impingement Syndromes, run by University of Sao Paulo General Hospital.
Trial summary
The aim of this study is to analyze the effects of Therapeutic Ultrasound combined with a Therapeutic Exercises program on pain reduction and improvement of function, range of motion (ROM), and functionality in individuals with Subacromial Impingement Syndrome. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Shoulder Impingement Syndromes
- What is being tested?
- Continuous Ultrasound + Exercises, Pulsed Ultrasound + Exercises and Exercises Only
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2020
- 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
- Age between 30 and 75 years.
- Clinical diagnosis compatible with subacromial pain syndrome.
- Shoulder pain greater than 30 mm on the Visual Analog Scale.
- Pain located in the anterolateral region of the shoulder, worsened during elevation of the upper limb.
- At least three positive clinical tests among the following: Neer impingement sign, Hawkins-Kennedy impingement sign, painful arc between 60° and 120° of abduction, Jobe/empty can test, and resisted external rotation/infraspinatus test.
- Ultrasonographic confirmation of findings compatible with subacromial pain syndrome.
- Signed informed consent form.
Who cannot join
- Previous surgery on the affected shoulder.
- Suspected massive rotator cuff tear.
- Positive drop-arm test.
- Glenohumeral instability.
- History of shoulder dislocation or subluxation.
- Adhesive capsulitis/frozen shoulder.
Show all 16Show fewer
- Recent shoulder trauma.
- Previous shoulder fracture with functional impairment.
- Cervical radiculopathy with neurological signs.
- Active inflammatory rheumatologic disease.
- Uncontrolled hypertension.
- Neoplasia.
- Corticosteroid injection within the previous six months.
- Physical therapy treatment for the shoulder within the previous six months.
- Continuous use of analgesic or anti-inflammatory medication that could not be discontinued.
- Contraindications to therapeutic ultrasound.
About this study
Official title: Effects of Therapeutic Ultrasound Combined With Exercise in the Rehabilitation of Individuals Diagnosed With Subacromial Impingement Pain Syndrome: a Randomized, Controlled, Double-blind Clinical Trial.
The aim of this study is to analyze the effects of Therapeutic Ultrasound combined with a Therapeutic Exercises program on pain reduction and improvement of function, range of motion (ROM), and functionality in individuals with Subacromial Impingement Syndrome. The main questions it aims to answer are:
Can the application of therapeutic ultrasound combined with exercise reduce pain and improve the ability to perform daily activities (functionality) in patients with Subacromial Impingement Syndrome? Does combining therapeutic ultrasound with exercise improve pain and functionality in patients with Subacromial Impingement Syndrome more effectively than using exercise alone to treat this syndrome? Researchers compared the application of therapeutic ultrasound combined with therapeutic exercises with placebo ultrasound (equipment programmed similarly to active ultrasound but emitting ultrasound waves) plus therapeutic exercises to determine if adding active ultrasound to the treatment is more effective than performing exercises alone in treating patients with Subacromial Impingement Syndrome.
Read more
Patients should be evaluated before the start of treatment, eight weeks after the start of treatment, and six months after the end of treatment.
Patients will receive therapeutic ultrasound or placebo combined with exercise 3 times a week for 8 weeks.
Read the detailed description
Introduction: Subacromial impingement syndrome (SIS)/Subacromial pain syndrome (SPS) is among the most common causes of pain and reduced shoulder functionality, characterized by repetitive impingement of structures located in the subacromial space, which anatomically comprises, superiorly, the acromion and inferiorly, the shoulder joint capsule and the subacromial bursa. Management of pathology includes numerous interventions, depending on the intensity of the pain and anatomopathological classification, involving conservative treatment (medications and physiotherapy) or surgical treatment in more severe cases. Objective: To verify the effects of therapeutic ultrasound (TUS), in continuous (USC) and pulsed (USP) modes, associated with a standardized therapeutic exercise (TE) program, on pain, range of motion, and functionality in individuals with shoulder pain associated with subacromial impingement syndrome (SIS). Methods: A randomized, controlled, double-blind clinical trial was conducted with 120 participants of both sexes, aged 30 to 75 years, with a clinical and ultrasound diagnosis compatible with subacromial impingement syndrome/rotator cuff-related shoulder pain. Participants were divided into four groups: (USC+TE), (USP+TE), placebo-controlled TUS associated with exercises (USPPL+TE), and isolated therapeutic exercises (TE)
- Conditions
- Shoulder Impingement Syndromes
- Being tested
- Continuous Ultrasound + Exercises, Pulsed Ultrasound + Exercises, Placebo Ultrasound + Exercises, Exercises Only
- Keywords
- Theraputic Ultrasound, Therapeutic Exercises, Rehabilitation, Physical Therapy
- 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.
Continuous Ultrasound + ExercisesDevice
Continuous therapeutic ultrasound applied to the shoulder region according to the study protocol combined with Standardized exercise program including stretching, strengthening, and motor control exercises for participants with subacromial pain syndrome.
Pulsed Ultrasound + ExercisesDevice
Pulsed therapeutic ultrasound applied to the shoulder region according to the study protocol combined with standardized exercise program including stretching, strengthening, and motor control exercises for participants with subacromial pain syndrome..
Placebo Ultrasound + ExercisesDevice
Sham ultrasound applied using the same procedures as active ultrasound, without delivery of therapeutic energy combined with standardized exercise program including stretching, strengthening, and motor control exercises for participants with subacromial pain syndrome.
Exercises OnlyOther
Standardized exercise program including stretching, strengthening, and motor control exercises for participants with subacromial pain syndrome.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Ultrasound + Exercises | Experimental | Participants will receive continuous therapeutic ultrasound combined with a standardized exercise program for the treatment of subacromial pain syndrome. The exercise program will include stretching, strengthening, and motor control exercises according to the study protocol. Receives: Device: Continuous Ultrasound + Exercises |
| Pulsed Ultrasound + Exercises | Experimental | Participants will receive pulsed therapeutic ultrasound combined with a standardized exercise program for the treatment of subacromial pain syndrome. The exercise program will include stretching, strengthening, and motor control exercises according to the study protocol. Receives: Device: Pulsed Ultrasound + Exercises |
| Placebo Ultrasound + Exercises | Experimental | Participants will receive placebo therapeutic ultrasound combined with a standardized exercise program for the treatment of subacromial pain syndrome. The exercise program will include stretching, strengthening, and motor control exercises according to the study protocol. Receives: Device: Placebo Ultrasound + Exercises |
| Exercises Only | Experimental | Participants will receive only a standardized exercise program for the treatment of subacromial pain syndrome. The exercise program will include stretching, strengthening, and motor control exercises according to the study protocol. Receives: Other: Exercises Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain intensity was assessed using the Visual Analog Scale (VAS), separately for pain at rest and pain during activities of daily living (ADLs). The VAS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Measured: Baseline, Week 12, and Day 240.
Shoulder pain and disability
Shoulder pain and disability were assessed using the Shoulder Pain and Disability Index (SPADI). The questionnaire consists of 13 items distributed across two domains: pain, with five items, and disability/function, with eight items. Each item is scored from 0 to 10. The total score and domain scores are converted into a percentage scale ranging from 0 to 100, with higher scores indicating worse shoulder pain and disability.
Measured: Baseline, Week 12, and Day 240.
Secondary outcomes (1)
Functional shoulder performance
Functional shoulder performance was assessed using the Modified University of California at Los Angeles Shoulder Rating Scale (Modified UCLA Shoulder Rating Scale). The scale includes five domains: pain, function, active forward flexion range of motion, manual strength testing for forward flexion, and patient satisfaction. The total score ranges from 0 to 35 points, with higher scores indicating better shoulder function.
Measured: Baseline, Week 12, and Day 240.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study startJan 2017
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Impingement SyndromesStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raquel A. Casarotto, University of Sao Paulo General Hospital
- Investigators
- Raquel Aparecida Casarotto Casarotto, Associate Professor, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688226
- Sponsor's protocol ID
- 88222424.4.0000.0068
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected individual data underpinning the results of a publication will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Therapeutic Ultrasound Combined With Exercise in the Rehabilitation of Individuals Diagnosed With Subacromial Impingement Pain Syndrome: a Randomized, Controlled, Double-blind Clinical Trial.
- ClinicalTrials.gov ID
- NCT07688226
- Acronym / sponsor ID
- 88222424.4.0000.0068
- Conditions
- Shoulder Impingement Syndromes
- Keywords
- Theraputic Ultrasound, Therapeutic Exercises, Rehabilitation, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 7 Jul 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.
The aim of this study is to analyze the effects of Therapeutic Ultrasound combined with a Therapeutic Exercises program on pain reduction and improvement of function, range of motion (ROM), and functionality in individuals with Subacromial Impingement Syndrome. The main questions it aims to answer are:
Can the application of therapeutic ultrasound combined with exercise reduce pain and improve the ability to perform daily activities (functionality) in patients with Subacromial Impingement Syndrome? Does combining therapeutic ultrasound with exercise improve pain and functionality in patients with Subacromial Impingement Syndrome more effectively than using exercise alone to treat this syndrome? Researchers compared the application of therapeutic ultrasound combined with therapeutic exercises with placebo ultrasound (equipment programmed similarly to active ultrasound but emitting ultrasound waves) plus therapeutic exercises to determine if adding active ultrasound to the treatment is more effective than performing exercises alone in treating patients with Subacromial Impingement Syndrome.
Patients should be evaluated before the start of treatment, eight weeks after the start of treatment, and six months after the end of treatment.
Patients will receive therapeutic ultrasound or placebo combined with exercise 3 times a week for 8 weeks.
Detailed description
Introduction: Subacromial impingement syndrome (SIS)/Subacromial pain syndrome (SPS) is among the most common causes of pain and reduced shoulder functionality, characterized by repetitive impingement of structures located in the subacromial space, which anatomically comprises, superiorly, the acromion and inferiorly, the shoulder joint capsule and the subacromial bursa. Management of pathology includes numerous interventions, depending on the intensity of the pain and anatomopathological classification, involving conservative treatment (medications and physiotherapy) or surgical treatment in more severe cases. Objective: To verify the effects of therapeutic ultrasound (TUS), in continuous (USC) and pulsed (USP) modes, associated with a standardized therapeutic exercise (TE) program, on pain, range of motion, and functionality in individuals with shoulder pain associated with subacromial impingement syndrome (SIS). Methods: A randomized, controlled, double-blind clinical trial was conducted with 120 participants of both sexes, aged 30 to 75 years, with a clinical and ultrasound diagnosis compatible with subacromial impingement syndrome/rotator cuff-related shoulder pain. Participants were divided into four groups: (USC+TE), (USP+TE), placebo-controlled TUS associated with exercises (USPPL+TE), and isolated therapeutic exercises (TE)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Continuous Ultrasound + Exercises | Experimental | Device: Continuous Ultrasound + ExercisesParticipants will receive continuous therapeutic ultrasound combined with a standardized exercise program for the treatment of subacromial pain syndrome. The exercise program will include stretching, strengthening, and motor control exercises according to the study protocol. |
| Pulsed Ultrasound + Exercises | Experimental | Device: Pulsed Ultrasound + ExercisesParticipants will receive pulsed therapeutic ultrasound combined with a standardized exercise program for the treatment of subacromial pain syndrome. The exercise program will include stretching, strengthening, and motor control exercises according to the study protocol. |
| Placebo Ultrasound + Exercises | Experimental | Device: Placebo Ultrasound + ExercisesParticipants will receive placebo therapeutic ultrasound combined with a standardized exercise program for the treatment of subacromial pain syndrome. The exercise program will include stretching, strengthening, and motor control exercises according to the study protocol. |
| Exercises Only | Experimental | Other: Exercises OnlyParticipants will receive only a standardized exercise program for the treatment of subacromial pain syndrome. The exercise program will include stretching, strengthening, and motor control exercises according to the study protocol. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 30 and 75 years.
- Clinical diagnosis compatible with subacromial pain syndrome.
- Shoulder pain greater than 30 mm on the Visual Analog Scale.
- Pain located in the anterolateral region of the shoulder, worsened during elevation of the upper limb.
- At least three positive clinical tests among the following: Neer impingement sign, Hawkins-Kennedy impingement sign, painful arc between 60° and 120° of abduction, Jobe/empty can test, and resisted external rotation/infraspinatus test.
Key exclusion criteria (16 listed)
- Previous surgery on the affected shoulder.
- Suspected massive rotator cuff tear.
- Positive drop-arm test.
- Glenohumeral instability.
- History of shoulder dislocation or subluxation.
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 |
|---|---|---|
| Continuous Ultrasound + ExercisesContinuous therapeutic ultrasound applied to the shoulder region according to the study protocol combined with Standardized exercise program including stretching, strengthening, and motor control exercises for participants with subacromial pain syndrome. | Device | Continuous Ultrasound + Exercises |
| Pulsed Ultrasound + ExercisesPulsed therapeutic ultrasound applied to the shoulder region according to the study protocol combined with standardized exercise program including stretching, strengthening, and motor control exercises for participants with subacromial pain syndrome.. | Device | Pulsed Ultrasound + Exercises |
| Placebo Ultrasound + ExercisesSham ultrasound applied using the same procedures as active ultrasound, without delivery of therapeutic energy combined with standardized exercise program including stretching, strengthening, and motor control exercises for participants with subacromial pain syndrome. | Device | Placebo Ultrasound + Exercises |
| Exercises OnlyStandardized exercise program including stretching, strengthening, and motor control exercises for participants with subacromial pain syndrome. | Other | Exercises Only |
Primary outcome
Pain Intensity
Time frame: Baseline, Week 12, and Day 240.
Pain intensity was assessed using the Visual Analog Scale (VAS), separately for pain at rest and pain during activities of daily living (ADLs). The VAS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Shoulder pain and disability
Time frame: Baseline, Week 12, and Day 240.
Shoulder pain and disability were assessed using the Shoulder Pain and Disability Index (SPADI). The questionnaire consists of 13 items distributed across two domains: pain, with five items, and disability/function, with eight items. Each item is scored from 0 to 10. The total score and domain scores are converted into a percentage scale ranging from 0 to 100, with higher scores indicating worse shoulder pain and disability.
1 secondary outcome
Functional shoulder performance
Time frame: Baseline, Week 12, and Day 240.
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 7 Jul 2026.
- Individual participant dataSharing planned: Yes. All collected individual data underpinning the results of a publication will be made available.
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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.
Raquel Aparecida Casarotto Casarotto, Associate Professor principal investigator
University of Sao Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Ultrasound + Exercises, Pulsed Ultrasound + Exercises and Exercises Only in people with Shoulder Impingement Syndromes, run by University of Sao Paulo General Hospital.
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 7 inclusion and 16 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 7 Jul 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?
Pain Intensity (time frame: Baseline, Week 12, and Day 240.). The study lists 2 primary outcomes in all. 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 7 Jul 2026.