Effects of Dextrose Prolotherapy in Rotator Cuff Disease

Istanbul University

Status: Completed

Conditions: Rotator Cuff Disease

Treatments: Other: Dextrose Prolotherapy Injection; Other: Saline Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04805242

Shoulder Prolotherapy

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Dextrose prolotherapy groups

Active Comparator group

Description:

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

Treatment:

Other: Dextrose Prolotherapy Injection

Saline groups

Sham Comparator group

Description:

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

Treatment:

Other: Saline Injection