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NCT Number: NCT04805242

Effects of Dextrose Prolotherapy in Rotator Cuff Disease

The aim of this prospective, randomized, controlled trial was to evaluate the clinical and ultrasonographic effects of dextrose prolotherapy on pain, shoulder function, range of motion, and ultrasonographic findings in patients with MRI-confirmed chronic rotator cuff disease. Participants were randomly assigned to receive either dextrose prolotherapy or lidocaine-saline injections. Both groups followed a standardized home-based exercise program.

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Key information

Conditions

Rotator Cuff Disease Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Shoulder Pain Signs and Symptoms

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Istanbul, Fatih, 34034, Turkey (Türkiye)

About this study

Rotator cuff disease is a major cause of persistent shoulder pain and functional limitation. Although exercise therapy, nonsteroidal anti-inflammatory drugs, and subacromial corticosteroid injections are commonly used as first-line treatments, many patients remain symptomatic despite conservative management. Dextrose prolotherapy has emerged as a potential treatment option for chronic musculoskeletal disorders; however, evidence from randomized controlled trials in chronic rotator cuff disease remains limited and inconsistent.

This prospective, randomized, controlled trial enrolled 60 patients with MRI-confirmed chronic rotator cuff disease who met the eligibility criteria. Participants were randomly assigned using a computer-generated randomization sequence to receive either dextrose prolotherapy or lidocaine-saline injections. In the dextrose prolotherapy group, injections were administered at baseline, week 3, and week 6 using an ultrasound-guided anatomical marking technique under aseptic conditions. In the lidocaine-saline injection group, injections were administered at the same time points using the same ultrasound-guided anatomical marking technique and injection protocol. Both groups participated in a standardized home-based exercise program throughout the study.

Outcome assessments were performed at baseline and at 4 and 12 weeks after the final injection. The primary outcome was activity-related pain measured using the Visual Analog Scale (VAS). Secondary outcomes included pain at rest, nocturnal pain, the Shoulder Pain and Disability Index (SPADI), the UCLA Shoulder Rating Scale, active shoulder range of motion, and the Ultrasound Shoulder Pathology Rating Scale (USPRS). Outcome assessments were performed by an investigator blinded to treatment allocation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Full-thickness rotator cuff tear
  • Presence of severe comorbid disease

Treatment and study plan

Dextrose prolotherapy injection

Other

Dextrose prolotherapy injections were administered at baseline, week 3, and week 6 using an ultrasound-guided anatomical 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-based exercise program.

Lidocaine-saline injection

Other

Lidocaine-saline injections were administered at baseline, week 3, and week 6 using the same ultrasound-guided anatomical marking technique and anatomical targets as the prolotherapy group. Extra-articular injections were prepared using saline and 1% lidocaine and were administered superficially at approximately 0.5-1 cm depth using a 26-gauge needle at five previously marked sites to mimic the prolotherapy injection procedure. One milliliter was injected at each site. Subacromial injection was performed via a posterior approach using a 21-gauge needle, and 4 mL of lidocaine-saline solution was injected into the subacromial bursa. All participants also received a standardized home-based exercise program.

Primary outcomes

  1. Change in activity-related pain measured by the Visual Analog Scale (VAS)

    Time frame: Baseline, 4 weeks, and 12 weeks after the final injection

    Activity-related pain was measured using a 10-cm Visual Analog Scale (VAS). Scores range from 0 to 10, with 0 indicating no pain and 10 indicating the worst imaginable pain. Higher scores indicate greater pain severity.

Secondary outcomes

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

    Time frame: Baseline, 4 weeks, and 12 weeks after the final injection

    Resting shoulder pain was measured using a 10-cm Visual Analog Scale (VAS). Scores range from 0 to 10, with 0 indicating no pain and 10 indicating the worst imaginable pain. Higher scores indicate greater pain severity.

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

    Time frame: Baseline, 4 weeks, and 12 weeks after the final injection

    Night shoulder pain was measured using a 10-cm Visual Analog Scale (VAS). Scores range from 0 to 10, with 0 indicating no pain and 10 indicating the worst imaginable pain. Higher scores indicate greater pain severity.

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

    Time frame: Baseline, 4 weeks, and 12 weeks after the final injection

    Shoulder pain and disability were assessed using the Shoulder Pain and Disability Index (SPADI). The SPADI consists of 13 items divided into pain and disability subscales. Scores range from 0 to 100, with higher scores indicating greater pain and functional impairment.

  4. Change in shoulder function measured by the UCLA Shoulder Rating Scale

    Time frame: Baseline, 4 weeks, and 12 weeks after the final injection

    Shoulder function was 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.

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

    Time frame: Baseline, 4 weeks, and 12 weeks after the final injection

    Rotator cuff structural abnormalities were assessed using the Ultrasound Shoulder Pathology Rating Scale (USPRS) based on ultrasonographic findings. Higher scores indicate greater structural pathology.

  6. Change in shoulder active range of motion (ROM)

    Time frame: Baseline, 4 weeks, and 12 weeks after the final injection

    Active shoulder range of motion was measured using a goniometer, including flexion, abduction, internal rotation, and external rotation. Higher values indicate greater shoulder mobility.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 18, 2021
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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