Effects of Dextrose Prolotherapy in Rotator Cuff Disease

NCT ID: NCT04805242

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-18
• Study Completion Date: 2021-11-12

Brief Summary

The aim of this prospective, randomized, controlled, single-blind study is to determine the effects of dextrose prolotherapy on shoulder pain and functions in patients with chronic rotator cuff disease.

Detailed Description

Rotator cuff disease is a major cause of shoulder pain and disability. Non-surgical treatments to reduce pain and improve function have included therapeutic exercises, NSAIDs, subacromial corticosteroid injections. However, some patients are resistant to these conservative treatments. In recent years, prolotherapy has increased in popularity for the treatment of musculosketal conditions. Regenerative injection methods can be applied in resistant chronic rotator cuff disease. In this prospective, randomized controlled, single blind, interventional study, a total of 60 patients with shoulder pain due to rotator cuff disease who meet eligibility criteria will be enrolled in the study. Eligible participants will be randomly assigned to one of the two groups using computer-generated random numbers. In the dextrose prolotherapy group, ultrasound-guided prolotherapy injections will be applied under aseptic conditions at 0, 3, and 6 weeks. In the salin injection group, salin injections will be applied under aseptic conditions at 0, 3, and 6 weeks. Home exercise program will be apply to both groups. Participants are going to evaluate before injection, and at the 1-month follow-up and 3-month follow-up using the visual analog scale (VAS) scores for pain during activity, at rest, and at night, with the Shoulder Pain and Disability Index (SPADI) change in pain and disability score, with The University of California and Los Angeles Rating Score (UCLA) change in pain and functional score and the change in the Ultrasound Shoulder Pathology Rating Scale (USPRS).

Conditions

Rotator Cuff Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dextrose prolotherapy groups

In the first group, dextrose prolotherapy injection will be applied.

Group Type: ACTIVE_COMPARATOR

Dextrose Prolotherapy Injection

Intervention Type: OTHER

Subacromial injection: 5 cc solution (15% dextrose + saline + 1% lidocaine solution) will be injected into the subacromial bursa using a sterile 21 gauge injector.

Extra-articular injection: Previously marked using a sterile 27 gauge injector (dental needle); A total of 10 cc solution (15% dextrose + saline + 1% lidocaine solution) will be injected into the infraspinatus, teres minor, supraspinatus insertion on the tuberculum majus, the subscapularis insertion on the tuberculum minus, the coracoid process and the long head of the biceps.

As a home exercise program, shoulder range of motion and stretching, shoulder isometric and isotonic strengthening exercises will be given at least three days a week with 3 sets of 10 repetitions.

Saline groups

In the second group, physiological saline injection will be applied.

Group Type: SHAM_COMPARATOR

Saline Injection

Intervention Type: OTHER

Subacromial injection: 5 cc solution (saline + 1% lidocaine solution) will be injected into the subacromial bursa using a sterile 21 gauge injector.

Extra-articular injection: 5 cc solution (saline + 1% lidocaine solution) will be injected to the attachment areas of the previously marked tendons to the bone using a sterile 30 gauge injector.

As a home exercise program, shoulder range of motion and stretching, shoulder isometric and isotonic strengthening exercises will be given at least three days a week with 3 sets of 10 repetitions.

Interventions

Dextrose Prolotherapy Injection

Subacromial injection: 5 cc solution (15% dextrose + saline + 1% lidocaine solution) will be injected into the subacromial bursa using a sterile 21 gauge injector.

Extra-articular injection: Previously marked using a sterile 27 gauge injector (dental needle); A total of 10 cc solution (15% dextrose + saline + 1% lidocaine solution) will be injected into the infraspinatus, teres minor, supraspinatus insertion on the tuberculum majus, the subscapularis insertion on the tuberculum minus, the coracoid process and the long head of the biceps.

As a home exercise program, shoulder range of motion and stretching, shoulder isometric and isotonic strengthening exercises will be given at least three days a week with 3 sets of 10 repetitions.

Intervention Type: OTHER

Saline Injection

Subacromial injection: 5 cc solution (saline + 1% lidocaine solution) will be injected into the subacromial bursa using a sterile 21 gauge injector.

Extra-articular injection: 5 cc solution (saline + 1% lidocaine solution) will be injected to the attachment areas of the previously marked tendons to the bone using a sterile 30 gauge injector.

As a home exercise program, shoulder range of motion and stretching, shoulder isometric and isotonic strengthening exercises will be given at least three days a week with 3 sets of 10 repetitions.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Shoulder pain for more than 3 months
• Being resistant to conservative treatment for at least 3 months
• Being in the age range of 30-65
• Presence of rotator cuff disease detected in current magnetic resonance imaging and confirmed by clinical examination.

Exclusion Criteria

• Presence of rheumatic disease or other systemic inflammatory diseases
• Having a diagnosis of uncontrolled diabetes mellitus
• Evidence of infection (systemically or locally on the shoulder)
• The presence of a previous operation on the shoulder
• Bleeding tendency (acquired or hereditary) [INR> 2 in the patient using coumadin]
• Injected shoulder within the previous 8 weeks
• The presence of local anesthesia and corn allergy
• Passive shoulder abduction <100 ° or external rotation <25 °
• Rotator cuff calcification diameter> 0.8cm in current direct graph or Usg
• Presence of serious comorbidity

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Selim Sezikli

MD, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Selim Sezikli, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Demirhan Diracoglu, Prof.

Role: STUDY_DIRECTOR

Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Locations

Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Istanbul, Fatih, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Shoulder Prolotherapy

Identifier Type: -

Identifier Source: org_study_id