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Intralesional Versus Perilesional 5% Dextrose Injection in Partial Rotator Cuff Tears

30. Juni 2026 aktualisiert von: Esra Ülgen Kıratlıoğlu, Ankara City Hospital Bilkent

Comparison of Clinical and Ultrasonographic Outcomes of Intralesional and Perilesional 5% Dextrose Injection in Patients With Partial Rotator Cuff Tears: A Prospective Randomized Double-Blind Controlled Trial

This prospective, randomized, double-blind controlled clinical trial aims to compare the clinical and ultrasonographic outcomes of intralesional and perilesional 5% dextrose injection in patients with partial rotator cuff tears. Eligible participants will be randomized into two parallel groups. Both groups will receive ultrasound-guided 5% dextrose injection to the supraspinatus enthesis. In addition, one group will receive intralesional 5% dextrose injection, while the other group will receive perilesional 5% dextrose injection using the peppering technique. Injections will be performed in three treatment sessions at 21-day intervals. All participants will receive a home-based exercise program after completion of the injection treatments. Clinical outcomes will be assessed at baseline, 9 weeks, and 12 weeks after treatment, and ultrasonographic outcomes will be assessed at baseline and 12 weeks.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Rotator cuff tears are one of the leading causes of shoulder pain and functional limitation. Partial rotator cuff tears may become chronic and may not respond adequately to conventional conservative treatments such as activity modification, physical therapy, and nonsteroidal anti-inflammatory drugs.

Dextrose injection is a regenerative injection therapy that aims to stimulate tissue healing responses in chronic musculoskeletal disorders. It is thought to promote fibroblast activation, collagen synthesis, and proliferative healing processes in degenerative tendon, ligament, and enthesis lesions. Ultrasound guidance allows accurate and safe delivery of the injectate to the target tissue and enables objective follow-up of tendon morphology during the treatment process.

This study will include adult patients with partial rotator cuff tears diagnosed by clinical examination and imaging. Participants will be randomized into two groups using a computer-based random number system. The researcher performing the randomization will know the treatment allocation, while the participants and the physician assessing the clinical outcomes will be blinded to treatment groups.

Both groups will receive ultrasound-guided 5% dextrose injection to the supraspinatus enthesis. The intralesional group will additionally receive intralesional 5% dextrose injection, and the perilesional group will additionally receive perilesional 5% dextrose injection. Injections will be applied using the peppering technique, with 0.1-0.2 cc administered to each point. A total of three treatment sessions will be performed at 21-day intervals.

Clinical outcomes will include shoulder pain assessed by the Numeric Rating Scale, shoulder pain and disability assessed by the Shoulder Pain and Disability Index, and health-related quality of life assessed by the Short Form-12 Health Survey. Ultrasonographic outcomes will include supraspinatus tendon thickness and partial defect size. Clinical evaluations will be performed at baseline, 9 weeks, and 12 weeks after treatment. Ultrasonographic evaluations will be performed at baseline and 12 weeks.

Studientyp

Interventionell

Einschreibung (Geschätzt)

30

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Esra Ülgen Kıratlıoğlu, MD
  • Telefonnummer: +905079614194
  • E-Mail: esraulgen@gmail.com

Studienorte

  • Türkei (türkiye)
      • Ankara, Türkei (türkiye)
        • Rekrutierung
        • Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Diagnosis of partial rotator cuff tear by a specialist physician after appropriate clinical examination and imaging evaluation
  • Shoulder pain and functional limitation lasting for at least 3 months
  • Clinically confirmed shoulder impingement findings, defined as at least one positive test among Neer, Hawkins-Kennedy, or painful arc tests
  • Age between 18 and 75 years
  • Ability to comply with the study procedures and attend follow-up visits regularly
  • Willingness to participate in the study and provide written informed consent

Exclusion Criteria:

  • Advanced cognitive impairment or dementia preventing reliable completion of questionnaires
  • Refusal to participate in the study or inability to provide informed consent
  • Full-thickness rotator cuff tear
  • Major tendon pathology other than the supraspinatus tendon, such as full-thickness subscapularis tear or biceps tendon rupture
  • Advanced acromioclavicular joint osteoarthritis, marked impingement, or marked adhesive capsulitis
  • Advanced glenohumeral joint arthritis
  • Active infection, cellulitis, or dermatologic lesion at the injection site
  • Bleeding diathesis or anticoagulant use
  • Known allergy or intolerance to dextrose injection
  • Intra-articular shoulder injection, including steroid, platelet-rich plasma, or prolotherapy, within the last 3 months
  • Previous shoulder surgery
  • Uncontrolled diabetes mellitus, defined as HbA1c >8.5%, or severe endocrine or metabolic disorder
  • Immunosuppression or active infection
  • Rheumatologic shoulder involvement
  • Neurological disease affecting shoulder movements
  • Pregnancy
  • Active malignancy

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Intralesional 5% Dextrose Injection
Participants in this group will receive ultrasound-guided 5% dextrose injection to the supraspinatus enthesis. In addition, intralesional 5% dextrose injection will be applied to the partial rotator cuff tear using the peppering technique. Injections will be performed in three treatment sessions at 21-day intervals. All participants will receive a home-based exercise program after completion of the injection treatments.
Verfahren: Intralesional 5% Dextrose Injection
Ultrasound-guided 5% dextrose injection will be applied to the supraspinatus enthesis and additionally into the partial tear lesion using the peppering technique. A volume of 0.1-0.2 cc will be administered to each point. The treatment will consist of three sessions performed at 21-day intervals.
Aktiver Komparator: Perilesional 5% Dextrose Injection
Participants in this group will receive ultrasound-guided 5% dextrose injection to the supraspinatus enthesis. In addition, perilesional 5% dextrose injection will be applied around the partial rotator cuff tear using the peppering technique. Injections will be performed in three treatment sessions at 21-day intervals. All participants will receive a home-based exercise program after completion of the injection treatments.
Verfahren: Perilesional 5% Dextrose Injection
Ultrasound-guided 5% dextrose injection will be applied to the supraspinatus enthesis and additionally around the partial tear lesion using the peppering technique. A volume of 0.1-0.2 cc will be administered to each point. The treatment will consist of three sessions performed at 21-day intervals.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Shoulder Pain Intensity Assessed by Numeric Rating Scale
Zeitfenster: Baseline, 9 weeks, and 12 weeks after treatment
Shoulder pain intensity will be assessed using the Numeric Rating Scale. Night pain, worst daytime shoulder pain, and average shoulder pain will be evaluated on a 0-10 scale, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity.
Baseline, 9 weeks, and 12 weeks after treatment

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Shoulder Pain and Disability Assessed by the Shoulder Pain and Disability Index
Zeitfenster: Baseline, 9 weeks, and 12 weeks after treatment
Shoulder pain and disability will be assessed using the Shoulder Pain and Disability Index. The scale consists of 13 items in two domains: pain and disability. Each item is scored from 0 to 10, and the total score is converted to a 0-100 scale. Higher scores indicate greater pain and functional impairment.
Baseline, 9 weeks, and 12 weeks after treatment
Change in Health-Related Quality of Life Assessed by the Short Form-12 Health Survey
Zeitfenster: Baseline, 9 weeks, and 12 weeks after treatment
Health-related quality of life will be assessed using the Short Form-12 Health Survey. The questionnaire includes 12 items and provides physical component summary and mental component summary scores. Higher scores indicate better health-related quality of life.
Baseline, 9 weeks, and 12 weeks after treatment
Change in Supraspinatus Tendon Thickness Assessed by Ultrasonography
Zeitfenster: Baseline and 12 weeks after treatment
Supraspinatus tendon thickness will be measured in millimeters using shoulder ultrasonography with a high-frequency linear probe in a standardized position.
Baseline and 12 weeks after treatment
Change in Partial Rotator Cuff Defect Size Assessed by Ultrasonography
Zeitfenster: Baseline and 12 weeks after treatment
Partial rotator cuff defect size will be measured in millimeters using shoulder ultrasonography with a high-frequency linear probe in a standardized position.
Baseline and 12 weeks after treatment

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ankara City Hospital Bilkent

Ermittler

  • Hauptermittler: ESRA Ülgen Kıratlıoğlu, Ankara City Hospital Bilkent

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Februar 2025

Primärer Abschluss (Geschätzt)

1. Oktober 2026

Studienabschluss (Geschätzt)

1. Oktober 2026

Studienanmeldedaten

Zuerst eingereicht

30. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. Juni 2026

Zuerst gepostet (Tatsächlich)

7. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

7. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • E2-26-14590

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Individual participant data will not be shared due to privacy and ethical restrictions.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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