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临床试验/NCT07428512
NCT07428512已完成不适用

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

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年7月9日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Visual Analog Scale

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

10% dextrose

Active Comparator

干预措施: dextrose (Drug)

5% dextrose

Active Comparator

干预措施: dextrose (Drug)

结局指标

主要结局

Visual Analog Scale

时间窗: 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.

Shoulder Range of Motion (ROM)

时间窗: 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.

Shoulder Pain and Disability Index (SPADI)

时间窗: 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.

Kinesiophobia

时间窗: 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.

次要结局

  • Short Form-12 (SF-12) questionnaire(baseline,after 1 month and 3 months changes)
  • Supraspinatus Muscle and Tendon Thickness(baseline,after 1 month and 3 months changes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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