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

2026년 6월 30일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

30

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Esra Ülgen Kıratlıoğlu, MD
  • 전화번호: +905079614194
  • 이메일: esraulgen@gmail.com

연구 장소

  • 터키 (Türkiye)
      • Ankara, 터키 (Türkiye)
        • 모병
        • Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
절차: 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.
활성 비교기: 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.
절차: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Shoulder Pain Intensity Assessed by Numeric Rating Scale
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Shoulder Pain and Disability Assessed by the Shoulder Pain and Disability Index
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Ankara City Hospital Bilkent

수사관

  • 수석 연구원: ESRA Ülgen Kıratlıoğlu, Ankara City Hospital Bilkent

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 2월 1일

기본 완료 (추정된)

2026년 10월 1일

연구 완료 (추정된)

2026년 10월 1일

연구 등록 날짜

최초 제출

2026년 6월 30일

QC 기준을 충족하는 최초 제출

2026년 6월 30일

처음 게시됨 (실제)

2026년 7월 7일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 7일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 30일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • E2-26-14590

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Intralesional 5% Dextrose Injection에 대한 임상 시험

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위치

3
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