Effects of Dextrose Prolotherapy in Rotator Cuff Disease: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in activity-related pain measured by the Visual Analog Scale (VAS)
研究概览
简要总结
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.
详细描述
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.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors were blinded to group allocation. The physician performing the injections was not blinded.
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Dextrose prolotherapy
Participants in this group received ultrasound-guided dextrose prolotherapy injections at baseline, week 3, and week 6 using an anatomical marking technique, in addition to a standardized home-based exercise program.
干预措施: Dextrose prolotherapy injection (Other)
结局指标
主要结局
Change in activity-related pain measured by the Visual Analog Scale (VAS)
时间窗: 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.
Change in activity-related pain measured by the Visual Analog Scale (VAS)
时间窗: Baseline, 1 month, and 3 months
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.
次要结局
- Change in rest pain measured by the Visual Analog Scale (VAS)(Baseline, 4 weeks, and 12 weeks after the final injection)
- Change in night pain measured by the Visual Analog Scale (VAS)(Baseline, 4 weeks, and 12 weeks after the final injection)
- Change in shoulder pain and disability measured by the Shoulder Pain and Disability Index (SPADI)(Baseline, 4 weeks, and 12 weeks after the final injection)
- Change in shoulder function measured by the UCLA Shoulder Rating Scale(Baseline, 4 weeks, and 12 weeks after the final injection)
- Change in rotator cuff structural pathology measured by the Ultrasound Shoulder Pathology Rating Scale (USPRS)(Baseline, 4 weeks, and 12 weeks after the final injection)
- Change in shoulder active range of motion (ROM)(Baseline, 4 weeks, and 12 weeks after the final injection)
- 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)
- Change in shoulder active range of motion (ROM)(Baseline, 1 month, and 3 months)
研究者
Selim Sezikli
MD, Principal Investigator
Istanbul University