Effect of Therapeutic Ultrasound Combined With Exercise on Subacromial Impingement Syndrome
30. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
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)
Studietype
Intervensjonell
Registrering (Faktiske)
120
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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..
|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain Intensity
Tidsramme: 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
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Functional shoulder performance
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Raquel Aparecida Casarotto Casarotto, Associate Professor, University of Sao Paulo
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. januar 2017
Primær fullføring (Faktiske)
1. desember 2020
Studiet fullført (Faktiske)
1. desember 2020
Datoer for studieregistrering
Først innsendt
24. juni 2026
Først innsendt som oppfylte QC-kriteriene
30. juni 2026
Først lagt ut (Faktiske)
7. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
7. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 88222424.4.0000.0068
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
All collected individual data underpinning the results of a publication will be made available.
IPD-delingstidsramme
The study data are in the final stage of analysis and will be made publicly available from October 2026 to October 2029.
Tilgangskriterier for IPD-deling
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-deling Støtteinformasjonstype
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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