Effect of Dextrose Injection in Rotator Cuff Tendinopathy of The Shoulder

Phase 3

Conditions: Rotator cuff tendinopathy of the shoulder.
Injury of muscle(s) and tendon(s) of the rotator cuff of shoulder
S46.0

Registration Number: IRCT20230821059204N2

Lead Sponsor: Mazandaran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 66

Inclusion Criteria

Adults (over 20 years)
Chronic shoulder pain for more than six months
Shoulder ultrasound of the supraspinatus tendon showing chronic tendinopathy such as a tear or tendinosis
The average intensity of shoulder pain is more than 3 points on the ten-point Visual Analog Scale (VAS)
Agreeing and complying with our study protocol
The possibility of signing an informed consent form

Exclusion Criteria

Associated with adhesive capsulitis and limited range of motion of the shoulder
Shoulder joint replacement
Shoulder surgery or arthroscopy of the injured shoulder within the past year
Injection of steroid, hyaluronic acid or platelet-rich plasma or any type of prolotherapy injection in the shoulder joint within the last three months
Neurological disease that causes weakness on the affected side
Impaired cognitive function and inability to complete the questionnaire
Concurrent participation in another clinical trial

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Average score in the Shoulder Pain and Disability Index (SPADI) of the injured shoulder. Timepoint: At the beginning of the study before the start of the intervention and at the end of the second and sixth weeks after the intervention. Method of measurement: The Shoulder Pain and Disability Index (SPADI) is a self-administered assessment tool used to measure shoulder pain and disability. It has five pain items and eight disability items measured on the Visual Analogue Score. Pain and disability subscales are calculated as the mean of the corresponding items on a 0-100 scale, with the highest score indicating the most severe pain and disability. In this study, the total outcome score used for statistical analysis will be calculated as the sum of pain and disability subscales.

Secondary Outcome Measures

Name	Time	Method
Active range of motion of the shoulder. Timepoint: At the beginning of the study before the start of the intervention and at the end of the second and sixth weeks after the intervention. Method of measurement: Active shoulder range of motion, i.e., forward flexion, internal rotation, external rotation, and abduction in standing position, will be assessed using a goniometer. Patients will move their shoulders slowly until they reach an angle at which pain is felt, and this movement will be performed three times to record the average value of the angle.;Supraspinatus tendon thickness. Timepoint: At the beginning of the study before the start of the intervention and at the end of the second and sixth weeks after the intervention. Method of measurement: Using ultrasound, the maximum thickness of the supraspinatus tendon will be measured in millimeters.