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NCT Number: NCT07428512

Comparison of the Effectiveness of 5% and 10% Dextrose Treatments in Patients With Chronic Shoulder Pain: Ultrasound-Guided Perineural Injection

Chronic shoulder pain is a condition that typically lasts longer than three months and affects daily life. Among musculoskeletal system pathologies, shoulder pain ranks third after spine and knee pathologies. Patients with chronic shoulder pain often experience significant functional loss and reduced psychosocial well-being. Chronic shoulder pain may originate from instability, rotator cuff pathologies (calcific tendinitis, tendinopathy, full-thickness or partial tears), the acromioclavicular joint, adhesive capsulitis, or the glenohumeral joint. It results in pain, decreased joint range of motion, stiffness, limitations in activities of daily living, and ultimately disability. Musculoskeletal disorders constitute a significant health problem in the aging global population.

Treatment options include patient education, lifestyle modifications, exercise, physical therapy modalities, medical treatments, intra-articular injections, periarticular injections, and suprascapular nerve block. The suprascapular nerve is a large peripheral nerve containing both motor and sensory fibers. It originates from the ventral rami of the C5 and C6 cervical nerve roots and may occasionally receive contributions from the C4 nerve root. The nerve arises from the lateral aspect of the upper trunk of the brachial plexus, passes beneath the omohyoid and trapezius muscles, and reaches the supraspinous fossa by passing under the suprascapular notch. The suprascapular nerve gives motor branches to the supraspinatus muscle and sensory branches to the acromioclavicular joint, coracoclavicular ligament, and the posterior part of the subacromial bursa. Compared with intra-articular injections, suprascapular nerve block has been shown to provide faster and greater effectiveness. This increases patient adherence to exercise, facilitates a quicker return to activities of daily living, and helps prevent further chronicity of the condition.

A 5% dextrose solution is frequently used for perineural injections and has an osmolality similar to normal saline. Although its neural mechanism is not fully understood, it is thought to inhibit vanilloid receptor activation and block the release of substance P and calcitonin gene-related peptide (CGRP). Hypertonic dextrose (>10%) may trigger local inflammation and promote tissue regeneration and symptom relief, while also increasing fibroblast proliferation and stimulating collagen synthesis and tissue healing.

The primary aim of our study is to investigate and compare the effects of 5% and 10% dextrose injections around the suprascapular nerve on pain, joint range of motion, functionality, and kinesiophobia, and to determine their relative superiority. The secondary aim is to evaluate the effects of these injection treatments on supraspinatus muscle and tendon thickness, as well as quality of life, in association with improved adherence to exercise.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Training and Research Hospital

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients over 18 years old with shoulder pain for the past 6 months who have not responded to medical treatment, exercise, corticosteroid injections, or physical therapy modalities, and who are willing to participate in the study.

Exclusion criteria

  • Patients younger than 18 or older than 75 years
  • Patients with a history of surgery on the same shoulder
  • Patients with neurological and/or inflammatory diseases
  • Patients with serious systemic diseases such as malignancy, end-stage congestive heart failure, or uncontrolled diabetes
  • Patients with insufficient cognitive function

Treatment and study plan

Dextrose

Drug

Participants will receive ultrasound-guided perineural injections around the suprascapular nerve using either 5% or 10% dextrose solution. The injections aim to reduce pain, improve joint range of motion, enhance shoulder functionality, decrease kinesiophobia, and promote adherence to prescribed exercise programs. The 5% dextrose solution is isotonic, while the 10% dextrose solution is hypertonic and may additionally stimulate local tissue regeneration and collagen synthesis. Treatments will be administered under sterile conditions by an experienced clinician, and participants will be monitored for immediate and long-term effects on pain, muscle/tendon thickness, functional outcomes, and quality of life.

Primary outcomes

  1. Visual Analog Scale

    Time frame: baseline,after 1 month and 3 months changes

    Patients indicate their pain on a 100 mm line, where 0 represents "no pain" and 100 represents "unbearable pain." The distance from 0 to the patient's mark reflects pain severity.

  2. Shoulder Range of Motion (ROM)

    Time frame: baseline,after 1 month and 3 months changes

    Clinician-assessed using a standard goniometer. Passive flexion, abduction, internal rotation, and external rotation of the affected shoulder will be measured.

  3. Shoulder Pain and Disability Index (SPADI)

    Time frame: baseline,after 1 month and 3 months changes

    Includes two subscales: pain (5 items) and disability (8 items). Responses are scored from 0-10. Subscale scores are calculated as a percentage of the maximum possible score, with higher scores indicating increased pain and reduced shoulder function.

  4. Kinesiophobia

    Time frame: baseline,after 1 month and 3 months changes

    Assessed using the Tampa Scale of Kinesiophobia (17 items, 4-point Likert scale, total score 17-68). Higher scores indicate higher fear of movement.

Secondary outcomes

  1. Short Form-12 (SF-12) questionnaire

    Time frame: baseline,after 1 month and 3 months changes

    Assessed using the Short Form-12 (SF-12) questionnaire. The SF-12 evaluates physical and mental health dimensions, including physical functioning, social functioning, role limitations due to physical and emotional problems, mental health, energy/fatigue, pain, and general health perception.

  2. Supraspinatus Muscle and Tendon Thickness

    Time frame: baseline,after 1 month and 3 months changes

    Measured by ultrasound (LOGIQ 9 device).

    Supraspinatus tendon thickness: Measured in the Crass position, with the shoulder in extension, adduction, and external rotation. Measurement is taken 10 mm lateral to the intra-articular portion of the long head of the biceps tendon at the rotator interval.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 23, 2026
Registry last updated
Feb 23, 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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