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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Ultrasound + Exercises | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline, Week 12, and Day 240. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raquel Aparecida Casarotto Casarotto, Associate Professor | University of Sao Paulo | Principal Investigator |
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All collected individual data underpinning the results of a publication will be made available.
The study data are in the final stage of analysis and will be made publicly available from October 2026 to October 2029.
Os dados do estudo serão disponibilizados através de contato com a pesquisadora PatrÃcia Pereira Alfredo. Estarão disponÃveis as tabelas e dados sociodemográficos, bem como a metodologia de análise estatÃstica realizada.
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| ID | Term |
|---|---|
| D019534 | Shoulder Impingement Syndrome |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070599 | Shoulder Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| Pulsed Ultrasound + Exercises | Device | 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.. |
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| Placebo Ultrasound + Exercises | Device | 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. |
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| Exercises Only | Other | Standardized exercise program including stretching, strengthening, and motor control exercises for participants with subacromial pain syndrome. |
|
| Baseline, Week 12, and Day 240. |
| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |