Ultrasound-Guided Dextrose Prolotherapy for Coccydynia: A Prospective Study
Evaluation of the Effectiveness of Dextrose Prolotherapy on Pain Severity and Functional Status in Patients With Coccydynia: A Prospective Study
Coccydynia is a musculoskeletal condition characterized by pain in the coccygeal region, particularly exacerbated by sitting, and is associated with impaired quality of life and functional limitation. Although various conservative and interventional treatment options are available, there remains a need for effective and safe alternative therapies, especially in treatment-resistant cases.
Prolotherapy is a regenerative treatment modality that aims to reduce pain and improve function by stimulating tissue repair, particularly in ligamentous structures. While there is increasing evidence supporting its effectiveness in mechanical musculoskeletal pain conditions, the literature regarding its use in coccydynia is limited.
The aim of this study is to evaluate the effect of dextrose prolotherapy on pain severity and functional status in patients diagnosed with coccydynia. This study is designed as a prospective, single-arm, open-label interventional study. Patients will receive 15% dextrose prolotherapy according to a standardized protocol. Pain severity will be assessed using the Visual Analog Scale (VAS), and functional status will be evaluated using the Dallas Pain Questionnaire before treatment and at 1 month after completion of the treatment.
This study aims to provide more comprehensive data on the effectiveness and safety of prolotherapy in coccydynia and to contribute to the currently limited evidence in the literature.
研究概览
详细说明
Coccydynia is a musculoskeletal disorder characterized by localized pain in the coccygeal region, typically exacerbated by sitting and postural changes, and associated with impaired quality of life and functional limitation. Although various conservative and interventional treatment modalities have been described, a subset of patients remains symptomatic despite standard therapies. Considering the potential role of ligamentous dysfunction, repetitive microtrauma, and coccygeal instability in the pathophysiology of coccydynia, regenerative treatment approaches such as prolotherapy may provide clinical benefit.
Prolotherapy is a regenerative injection therapy that involves the administration of an irritant solution, most commonly hypertonic dextrose, to stimulate the body's natural healing response. The proposed mechanism includes induction of a mild, controlled inflammatory response, leading to increased fibroblast proliferation, collagen synthesis, and subsequent strengthening of ligamentous and periarticular structures. In conditions associated with ligamentous laxity or enthesopathy, prolotherapy is thought to enhance tissue repair and restore biomechanical stability. Increasing evidence suggests that prolotherapy may reduce pain and improve function in various chronic musculoskeletal conditions, particularly those with a mechanical or ligamentous component. However, evidence regarding its effectiveness in coccydynia remains limited.
This study is designed as a prospective, single-arm, open-label interventional study to evaluate the effectiveness and safety of dextrose prolotherapy in patients with chronic coccydynia. Adult patients (≥18 years) with mechanical or idiopathic coccydynia persisting for at least 3 months and unresponsive to conservative treatment will be included. Patients with pregnancy, malignancy, active infection, bleeding diathesis, uncontrolled hypertension or diabetes mellitus, or contraindications to prolotherapy will be excluded.
All participants will receive prolotherapy using a 15% dextrose solution prepared under sterile conditions. Injections will be performed under ultrasound (USG) guidance to ensure precise anatomical localization and to enhance procedural safety. During the procedure, the sacral hiatus, sacrococcygeal ligament, and coccygeal bony structures will be visualized, and bone landmarks will be used as references. The fibrous ligamentous attachments in the coccygeal and sacrococcygeal region will be targeted, and injections will be administered to 3-4 periosteal insertion points using a 27G needle, with a maximum of 0.5 mL per site and a total volume not exceeding 2-2.5 mL per session. The procedure will be repeated at 3-week intervals, with a total of 3 to 6 sessions depending on clinical response.
The primary outcome measure will be the change in pain severity assessed by the Visual Analog Scale (VAS). The secondary outcome measure will be the change in functional status evaluated using the Dallas Pain Questionnaire. Outcome assessments will be performed at baseline (pre-treatment) and at 1 month after completion of the treatment protocol.
Sample size was calculated based on a power analysis (α=0.05, power=0.80), which indicated that a minimum of 25 patients would be required. Considering a potential 15% dropout rate, a total of 30 patients will be enrolled.
Safety will be assessed by monitoring and recording any adverse events throughout the study period. All participants will be followed prospectively, and changes in clinical parameters will be analyzed to determine the effectiveness of the intervention.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Merve Dikici Yagli, M.D
- 电话号码:+905387192098
- 邮箱:mervedikici1992@gmail.com
研究联系人备份
- 姓名:Yunus Emrah Kosut, M.D
- 电话号码:+905355540389
- 邮箱:kosutyunus@gmail.com
学习地点
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Istanbul、土耳其(türkiye)
- 招聘中
- Gaziosmanpasa Research and Education Hospital
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接触:
- Merve Dikici Yaglı, M.D
- 电话号码:+905387192098
- 邮箱:mervedikici1992@gmail.com
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Age between 18 and 75 years
- Pain persisting for ≥3 months and refractory to conservative treatment
- Coccydynia of mechanical or idiopathic origin
Exclusion Criteria:
- Age <18 years or >75 years
- Pregnancy
- Allergy to the proliferant solution
- Active infection
- Use of anticoagulant medications
- Presence of malignancy
- Local abscess
- Hemorrhagic diathesis
- Certain types of septic arthritis
- Parafunctional habits
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Dextrose Prolotherapy
Participants will receive ultrasound-guided dextrose prolotherapy according to a standardized treatment protocol.
|
All participants will receive prolotherapy using a 15% dextrose solution prepared under sterile conditions.
Injections will be performed under ultrasound (USG) guidance to ensure precise anatomical localization and to enhance procedural safety.
During the procedure, the sacral hiatus, sacrococcygeal ligament, and coccygeal bony structures will be visualized, and bone landmarks will be used as references.
The fibrous ligamentous attachments in the coccygeal and sacrococcygeal region will be targeted, and injections will be administered to 3-4 periosteal insertion points using a 27G needle, with a maximum of 0.5 mL per site and a total volume not exceeding 2-2.5 mL per session.
The procedure will be repeated at 3-week intervals, with a total of 3 to 6 sessions depending on clinical response.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Visual Analog Scale
大体时间:Baseline and 1 month after completion of treatment
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Visual Analog Scale for Pain (VAS): Change in pain intensity assessed using the Visual Analog Scale (VAS).The VAS is a 10-cm horizontal scale ranging from 0 (no pain) to 10 (worst imaginable pain).Higher scores indicate greater pain intensity, and a reduction in VAS score represents clinical improvement.
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Baseline and 1 month after completion of treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Dallas Pain Questionnaire (DPQ)
大体时间:Baseline and 1 month after completion of treatment
|
The Dallas Pain Questionnaire (DPQ) is a validated instrument that evaluates the impact of chronic pain on functional status across four domains: daily activities, work and leisure activities, anxiety/depression, and social interest.
Scores range from 0 to 100, with higher scores indicating greater functional limitation and a higher degree of pain-related impairment, whereas lower scores reflect better functional capacity and lower levels of impairment.
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Baseline and 1 month after completion of treatment
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合作者和调查者
调查人员
- 首席研究员:Merve Dikici Yagli, M.D、Gaziosmanpasa Research and Education Hospital
出版物和有用的链接
一般刊物
- Mociu SI, Nedelcu AD, Lupu AA, Uzun AB, Iliescu DM, Ionescu EV, Iliescu MG. Prolotherapy as a Regenerative Treatment in the Management of Chronic Low Back Pain: A Systematic Review. Medicina (Kaunas). 2025 Sep 2;61(9):1588. doi: 10.3390/medicina61091588.
- Benditz A, Thoma R. Coccygodynia-Diagnosis and Treatment. Dtsch Arztebl Int. 2025 Nov 14;122(23):638-644. doi: 10.3238/arztebl.m2025.0154.
- Khan SA, Kumar A, Varshney MK, Trikha V, Yadav CS. Dextrose prolotherapy for recalcitrant coccygodynia. J Orthop Surg (Hong Kong). 2008 Apr;16(1):27-9. doi: 10.1177/230949900801600107.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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