Effect of Therapeutic Ultrasound Combined With Exercise on Subacromial Impingement Syndrome

NCT07688226 | Completed

• 1 other identifier: 88222424.4.0000.0068
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Shoulder Impingement Syndromes

Keywords

Theraputic Ultrasound; Therapeutic Exercises; Rehabilitation; Physical Therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Functional shoulder performance

  Baseline, Week 12, and Day 240.

Study Arms (4)

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.

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.

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.

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.

Other: Exercises Only

Interventions

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.

Continuous Ultrasound + Exercises

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..

Pulsed Ultrasound + Exercises

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.

Placebo Ultrasound + Exercises

Exercises Only OTHER

Standardized exercise program including stretching, strengthening, and motor control exercises for participants with subacromial pain syndrome.

Exercises Only

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Raquel Aparecida Casarotto Casarotto, Associate Professor

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 7, 2026
• Study Start: January 1, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: The study data are in the final stage of analysis and will be made publicly available from October 2026 to October 2029.
• 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.