Effect of Therapeutic Ultrasound Combined With Exercise on Subacromial Impingement Syndrome
30 de junio de 2026 actualizado por: Raquel A. Casarotto, University of Sao Paulo General Hospital
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.
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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)
Tipo de estudio
Intervencionista
Inscripción (Actual)
120
Fase
- No aplica
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Continuous Ultrasound + Exercises
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.
|
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.
|
|
Experimental: Pulsed Ultrasound + Exercises
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.
|
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..
|
|
Experimental: Placebo Ultrasound + Exercises
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.
|
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.
|
|
Experimental: Exercises Only
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.
|
Standardized exercise program including stretching, strengthening, and motor control exercises for participants with subacromial pain syndrome.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pain Intensity
Periodo de tiempo: 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.
|
Baseline, Week 12, and Day 240.
|
|
Shoulder pain and disability
Periodo de tiempo: 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.
|
Baseline, Week 12, and Day 240.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Functional shoulder performance
Periodo de tiempo: Baseline, Week 12, and Day 240.
|
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.
|
Baseline, Week 12, and Day 240.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Raquel Aparecida Casarotto Casarotto, Associate Professor, University of Sao Paulo
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de enero de 2017
Finalización primaria (Actual)
1 de diciembre de 2020
Finalización del estudio (Actual)
1 de diciembre de 2020
Fechas de registro del estudio
Enviado por primera vez
24 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
30 de junio de 2026
Publicado por primera vez (Actual)
7 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
7 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
30 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 88222424.4.0000.0068
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
All collected individual data underpinning the results of a publication will be made available.
Marco de tiempo para compartir IPD
The study data are in the final stage of analysis and will be made publicly available from October 2026 to October 2029.
Criterios de acceso compartido de IPD
Os dados do estudo serão disponibilizados através de contato com a pesquisadora Patrícia Pereira Alfredo.
Estarão disponíveis as tabelas e dados sociodemográficos, bem como a metodologia de análise estatística realizada.
Tipo de información de apoyo para compartir IPD
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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