Effect of Therapeutic Ultrasound Combined With Exercise on Subacromial Impingement Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Impingement Syndromes
• Intervention / Treatment: Device: Continuous Ultrasound + Exercises; Device: Pulsed Ultrasound + Exercises; Device: Placebo Ultrasound + Exercises; Other: Exercises Only

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Continuous Ultrasound + Exercises; 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.	Device: Pulsed Ultrasound + Exercises; 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.	Device: Placebo Ultrasound + Exercises; 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.	Other: Exercises Only; Standardized exercise program including stretching, strengthening, and motor control exercises for participants with subacromial pain syndrome.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.	Baseline, Week 12, and Day 240.

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Raquel Aparecida Casarotto Casarotto, Associate Professor, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: June 24, 2026
• First Submitted That Met QC Criteria: June 30, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: June 30, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Rehabilitation; Physical Therapy; Theraputic Ultrasound; Therapeutic Exercises
• Additional Relevant MeSH Terms: Shoulder Injuries; Musculoskeletal Diseases; Wounds and Injuries; Joint Diseases; Shoulder Impingement Syndrome; Therapeutics; Physical Therapy Modalities; Patient Care; Rehabilitation; Aftercare; Continuity of Patient Care; Exercise Therapy
• Other Study ID Numbers: 88222424.4.0000.0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected individual data underpinning the results of a publication will be made available.
• IPD Sharing Time Frame: The study data are in the final stage of analysis and will be made publicly available from October 2026 to October 2029.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No