The aim of this prospective, randomized, controlled, single-blind study was to evaluate the effects of dextrose prolotherapy on pain and functional outcomes in patients with chronic rotator cuff disease.
Rotator cuff disease is a major cause of shoulder pain and disability. Non-surgical treatments aimed at reducing pain and improving function include therapeutic exercises, nonsteroidal anti-inflammatory drugs, and subacromial corticosteroid injections. However, some patients remain symptomatic despite these conservative treatments. Prolotherapy has recently gained increasing attention as a treatment option for various musculoskeletal conditions. In patients with chronic rotator cuff disease resistant to conventional treatment, regenerative injection approaches such as dextrose prolotherapy may offer potential clinical benefits. In this prospective, randomized, controlled, single-blind interventional study, 60 patients with shoulder pain due to rotator cuff disease who met the eligibility criteria were enrolled. Participants were randomly assigned to one of two groups using computer-generated random numbers. In the dextrose prolotherapy group, prolotherapy injections were administered at baseline, week 3, and week 6 using an ultrasound-guided marking technique under aseptic conditions. In the control group, saline injections were administered at the same time points. Both groups received a standardized home exercise program. Participants were evaluated at baseline and at the 1-month and 3-month follow-ups using the Visual Analog Scale (VAS) for activity-related, resting, and night pain, the Shoulder Pain and Disability Index (SPADI), the UCLA Shoulder Rating Scale, shoulder active range of motion, and the Ultrasound Shoulder Pathology Rating Scale (USPRS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Dextrose prolotherapy injections were administered at baseline, week 3, and week 6 using an ultrasound-guided marking technique. A 15% dextrose solution was prepared using 30% dextrose, saline, and 1% lidocaine. Extra-articular injections were administered with a 27-gauge needle using the peppering technique at five previously marked anatomical points, including the long head of the biceps tendon in the bicipital groove, the subscapularis insertion at the lesser tuberosity, the supraspinatus insertion at the greater tuberosity, the infraspinatus insertion at the greater tuberosity, and the coracoid process region. One milliliter was injected at each point. Subacromial injection was performed via a posterior approach using a 21-gauge needle, and 4 mL of solution was injected into the subacromial bursa. All participants also received a standardized home exercise program.
Saline injections were administered at baseline, week 3, and week 6 using the same ultrasound-guided marking technique and anatomical targets as the prolotherapy group. Extra-articular injections were administered superficially at approximately 0.5-1 cm depth using a 26-gauge needle at five previously marked sites to mimic the prolotherapy protocol. One milliliter was injected at each site. Subacromial injection was performed via a posterior approach using a 21-gauge needle, and 4 mL of saline solution was injected into the subacromial bursa. All participants also received a standardized home exercise program.
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Istanbul, Fatih, Turkey (Türkiye)
Change in activity-related pain measured by the Visual Analog Scale (VAS)
Activity-related pain measured using a 10-cm Visual Analog Scale (VAS). Scores range from 0 to 10, where 0 indicates no pain and 10 represents the worst imaginable pain.
Time frame: Baseline, 1 month, and 3 months
Change in rest pain measured by the Visual Analog Scale (VAS)
Resting shoulder pain measured using a 10-cm Visual Analog Scale (VAS). Scores range from 0 to 10, where 0 indicates no pain and 10 represents the worst imaginable pain.
Time frame: Baseline, 1 month, and 3 months
Change in night pain measured by the Visual Analog Scale (VAS)
Night shoulder pain measured using a 10-cm Visual Analog Scale (VAS). Scores range from 0 to 10, where 0 indicates no pain and 10 represents the worst imaginable pain.
Time frame: Baseline, 1 month, and 3 months
Change in shoulder pain and disability measured by the Shoulder Pain and Disability Index (SPADI)
Shoulder pain and disability measured using the Shoulder Pain and Disability Index (SPADI). The SPADI consists of 13 items divided into pain (5 items) and disability (8 items) subscales. Scores range from 0 to 100, with higher scores indicating greater pain and functional impairment.
Time frame: Baseline, 1 month, and 3 months
Change in shoulder function measured by the UCLA Shoulder Rating Scale
Shoulder function assessed using the UCLA Shoulder Rating Scale. The scale evaluates pain, function, active forward flexion, strength of forward flexion, and patient satisfaction. Scores range from 0 to 35, with higher scores indicating better shoulder function.
Time frame: Baseline, 1 month, and 3 months
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Change in rotator cuff structural pathology measured by the Ultrasound Shoulder Pathology Rating Scale (USPRS)
Rotator cuff structural abnormalities assessed using the Ultrasound Shoulder Pathology Rating Scale (USPRS) based on ultrasonographic findings. Higher scores indicate greater structural pathology.
Time frame: Baseline, 1 month, and 3 months
Change in shoulder active range of motion (ROM)
Active shoulder range of motion measured using a goniometer, including flexion, abduction, internal rotation, and external rotation. Higher values indicate improved shoulder mobility.
Time frame: Baseline, 1 month, and 3 months