Effects of Dextrose Prolotherapy in Rotator Cuff Disease

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

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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Disease
• Intervention / Treatment: Other: Dextrose prolotherapy injection; Other: Saline injection

Detailed Description

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
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Fatih
    • Istanbul, Fatih, Turkey (Türkiye), 34034
      • Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 30 and 65 years
• Shoulder pain lasting longer than 3 months
• Resistance to conservative treatment for at least 3 months
• Diagnosis of rotator cuff disease confirmed by clinical examination and magnetic resonance imaging (MRI)

Exclusion Criteria:

• Presence of rheumatic disease or other systemic inflammatory diseases
• Uncontrolled diabetes mellitus
• Local or systemic infection
• History of previous shoulder surgery
• Bleeding tendency (acquired or hereditary) or use of anticoagulant therapy with INR >2
• Shoulder injection within the previous 8 weeks
• Allergy to local anesthetics
• Passive shoulder abduction <100° or external rotation <25°
• Rotator cuff calcification with diameter >0.8 cm detected on radiography or ultrasonography
• Presence of severe comorbid disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dextrose prolotherapy; Participants in this group received dextrose prolotherapy injections in addition to a standardized home exercise program.	Other: Dextrose prolotherapy injection; 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.
Placebo Comparator: Saline groups; Participants in this group received saline injections in addition to a standardized home exercise program.	Other: Saline injection; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 1 month, and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline, 1 month, and 3 months
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.	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.	Baseline, 1 month, and 3 months

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Study Director: Demirhan Diracoglu, Prof., Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation; Principal Investigator: Selim Sezikli, MD, Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2021
• Primary Completion (Actual): October 12, 2021
• Study Completion (Actual): November 12, 2021

Study Registration Dates

• First Submitted: March 12, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Shoulder Pain; Rotator Cuff Tendinopathy; Rotator Cuff Disease; Dextrose Prolotherapy; Regenerative Injection Therapy; Shoulder Tendinopathy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Joint Diseases; Arthralgia; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Shoulder Pain; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Sodium Chloride
• Other Study ID Numbers: Shoulder Prolotherapy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No