Ankara Training and Research Hospital
Ankara, Turkey (Türkiye)
NCT Number: NCT07428512
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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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Ankara, Turkey (Türkiye)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
Ankara City Hospital Bilkent
Other
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