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

30 juni 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

30

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

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

Studieorter

  • Turkiet (Türkiye)
      • Ankara, Turkiet (Türkiye)
        • Rekrytering
        • Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Procedur: 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.
Aktiv 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.
Procedur: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Shoulder Pain Intensity Assessed by Numeric Rating Scale
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Shoulder Pain and Disability Assessed by the Shoulder Pain and Disability Index
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Ankara City Hospital Bilkent

Utredare

  • Huvudutredare: ESRA Ülgen Kıratlıoğlu, Ankara City Hospital Bilkent

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 februari 2025

Primärt slutförande (Beräknad)

1 oktober 2026

Avslutad studie (Beräknad)

1 oktober 2026

Studieregistreringsdatum

Först inskickad

30 juni 2026

Först inskickad som uppfyllde QC-kriterierna

30 juni 2026

Första postat (Faktisk)

7 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

7 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • E2-26-14590

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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