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

NCT07688902 | Recruiting

• 1 other identifier: E2-26-14590
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Partial Rotator Cuff Tears; Rotator Cuff Tendinopathy; Shoulder Pain Chronic; Supraspinatus Tendon Tear

Keywords

Dextrose injection; Prolotherapy; Intralesional injection; Perilesional injection; Partial rotator cuff tear; Supraspinatus tendon; Ultrasound-guided injection; Shoulder Pain and Disability Index; Numeric Rating Scale; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• Change in Shoulder Pain Intensity Assessed by Numeric Rating Scale

  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

Secondary Outcomes (4)

• Change in Shoulder Pain and Disability Assessed by the Shoulder Pain and Disability Index

  Baseline, 9 weeks, and 12 weeks after treatment

• Change in Health-Related Quality of Life Assessed by the Short Form-12 Health Survey

  Baseline, 9 weeks, and 12 weeks after treatment

• Change in Supraspinatus Tendon Thickness Assessed by Ultrasonography

  Baseline and 12 weeks after treatment

• Change in Partial Rotator Cuff Defect Size Assessed by Ultrasonography

  Baseline and 12 weeks after treatment

Study Arms (2)

Intralesional 5% Dextrose Injection

EXPERIMENTAL

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.

Procedure: Intralesional 5% Dextrose Injection

Perilesional 5% Dextrose Injection

ACTIVE COMPARATOR

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.

Procedure: Perilesional 5% Dextrose Injection

Interventions

Intralesional 5% Dextrose Injection PROCEDURE

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.

Intralesional 5% Dextrose Injection

Perilesional 5% Dextrose Injection PROCEDURE

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.

Perilesional 5% Dextrose Injection

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Shoulder Pain

Interventions

Glucose

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• ESRA Ülgen Kıratlıoğlu

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esra Ülgen Kıratlıoğlu, MD

CONTACT

+905079614194; esraulgen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and the outcomes assessor will be blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Participants will be randomized into two parallel groups: intralesional 5% dextrose injection and perilesional 5% dextrose injection.

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 7, 2026
• Study Start: February 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)