Effects of Dextrose Prolotherapy in Rotator Cuff Disease

NCT04805242 | Completed

• 1 other identifier: Shoulder Prolotherapy
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rotator Cuff Disease

Keywords

Rotator Cuff Disease; Dextrose Prolotherapy; Shoulder Pain; Regenerative Injection Therapy; Shoulder Tendinopathy; Rotator Cuff Tendinopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in rest pain measured by the Visual Analog Scale (VAS)

  Baseline, 1 month, and 3 months

• Change in night pain measured by the Visual Analog Scale (VAS)

  Baseline, 1 month, and 3 months

• Change in shoulder pain and disability measured by the Shoulder Pain and Disability Index (SPADI)

  Baseline, 1 month, and 3 months

• Change in shoulder function measured by the UCLA Shoulder Rating Scale

  Baseline, 1 month, and 3 months

• Change in rotator cuff structural pathology measured by the Ultrasound Shoulder Pathology Rating Scale (USPRS)

  Baseline, 1 month, and 3 months

Study Arms (2)

Dextrose prolotherapy

ACTIVE COMPARATOR

Participants in this group received dextrose prolotherapy injections in addition to a standardized home exercise program.

Other: Dextrose prolotherapy injection

Saline groups

PLACEBO COMPARATOR

Participants in this group received saline injections in addition to a standardized home exercise program.

Other: Saline injection

Interventions

Saline injection OTHER

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.

Saline groups

Dextrose prolotherapy injection OTHER

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.

Dextrose prolotherapy

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Istanbul, Fatih, 34034, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Pain

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Selim Sezikli, MD

  Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Demirhan Diracoglu, Prof.

  Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors were blinded to group allocation. The physician performing the injections was not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Model Details: Participants were randomized to receive either dextrose prolotherapy injections or saline injections in a parallel-group design.

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 18, 2021
• Study Start: March 18, 2021
• Primary Completion: October 12, 2021
• Study Completion: November 12, 2021
• Last Updated: March 10, 2026

Record last verified: 2024-07

Locations

TU (1)