Effects of Dextrose Prolotherapy in Rotator Cuff Disease

Rotator Cuff Disease Clinical Trial

Official title:

Effects of Dextrose Prolotherapy in Rotator Cuff Disease: A Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04805242
• Other study ID #: Shoulder Prolotherapy
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2021
• Est. completion date: November 12, 2021

Study information

• Verified date: June 2021
• Source: Istanbul University
• Contact: Selim Sezikli, MD
• Phone: +902124142000
• Email: selimsezikli[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 12, 2021
• Est. primary completion date: October 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Disease

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline activity pain score at 1-months and 3-months	Visual Analogue Scale-Activity pain (0-10 point). Higher scores mean a worse outcome	Baseline, 1-month, 3-month
Secondary	Change from baseline rest pain score at 1-months and 3-months	Visual Analogue Scale-Rest pain (0-10 point). Higher scores mean a worse outcome	Baseline, 1-month, 3-month
Secondary	Change from baseline night pain score at 1-months and 3-months	Visual Analogue Scale-Night pain (0-10 point). Higher scores mean a worse outcome	Baseline, 1-month, 3-month
Secondary	Change from baseline pain, disability at 1-months and 3-months	Shoulder Pain and Disability Index (SPADI) measures shoulder pain and disability. It consists of 2 chapters and 13 subtitles in total. The total score range in the scale varies between 0-130. High scores are associated with more pain, and disability, while low scores indicate well-being.	Baseline, 1-month, 3-month
Secondary	Change from baseline shoulder pain and function at 1-months and 3-months	UCLA Shoulder Rating Score (The University of California and Los Angeles Rating Score); Over a total of 35 points, pain, function, patient satisfaction, flexion muscle strength, flexion angle are evaluated. Pain and function are evaluated on a scale of 1-10 points each, active flexion angle, flexion muscle strength, and patient satisfaction on a scale of 1-5 points each. In total, 34-35 points are considered excellent, 29-33 points good, and values below 29 points are considered poor. This outcome measure is a composite outcome measure consisting of multiple measures.	Baseline, 1-month, 3-month
Secondary	Change from baseline rotator cuff structure at 1-months and 3-months	USPRS (Ultrasound Shoulder Pathology Rating Scale); It is a scale that enables the evaluation of rotator cuff structures using ultrasound. It is evaluated over 20 points. High scores indicate increased pathology severity.	Baseline, 1-month, 3-month
Secondary	Change from baseline shoulder flexion muscle strenght and flexion angle at 1-months and 3-months	UCLA Shoulder Rating Score (The University of California and Los Angeles Rating Score); Over a total of 35 points, pain, function, patient satisfaction, flexion muscle strength, flexion angle are evaluated. Pain and function are evaluated on a scale of 1-10 points each, active flexion angle, flexion muscle strength, and patient satisfaction on a scale of 1-5 points each. In total, 34-35 points are considered excellent, 29-33 points good, and values below 29 points are considered poor.	Baseline, 1-month, 3-month
Secondary	Change from baseline patient satisfaction at 1-months and 3-months	UCLA Shoulder Rating Score (The University of California and Los Angeles Rating Score); Over a total of 35 points, pain, function, patient satisfaction, flexion muscle strength, flexion angle are evaluated. Pain and function are evaluated on a scale of 1-10 points each, active flexion angle, flexion muscle strength, and patient satisfaction on a scale of 1-5 points each. In total, 34-35 points are considered excellent, 29-33 points good, and values below 29 points are considered poor.	Baseline, 1-month, 3-month