Comparison of Osteopathic Manual Therapy and Ganglion Impar Block in Patients With Chronic Coccydynia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Patient Global Impression of Change (PGIC) score
研究概览
简要总结
Chronic coccydynia is a condition characterized by persistent pain in the coccyx region that can significantly impair sitting tolerance, daily activities, and quality of life. Various conservative and interventional treatment options have been described, including manual therapy techniques and ganglion impar block. However, the comparative effectiveness of these approaches remains unclear.
The aim of this randomized controlled study is to compare the effects of osteopathic manual therapy and ganglion impar block on pain intensity and functional disability in patients with chronic coccydynia. Participants will be randomly assigned to one of the two treatment groups. Pain severity will be assessed using the Numeric Rating Scale (NRS), and functional status will be evaluated with the Oswestry Disability Index (ODI) at baseline, week 3, and month 3.
The results of this study are expected to provide evidence regarding the relative effectiveness of these two commonly used treatment methods and to guide clinicians in selecting appropriate management strategies for patients with chronic coccydynia.
详细描述
Chronic coccydynia is a multifactorial pain syndrome affecting the coccygeal region and is often associated with trauma, prolonged sitting, obesity, or idiopathic causes. Patients frequently report severe localized pain that worsens with sitting and transitions from sitting to standing. Conservative treatment options include physical therapy modalities and manual therapy techniques, while interventional procedures such as ganglion impar block are commonly used in refractory cases.
This prospective randomized controlled trial aims to compare the clinical effectiveness of osteopathic manual therapy and ganglion impar block in patients with chronic coccydynia. Eligible patients will be randomly allocated into two groups. The osteopathic manual therapy group will receive standardized manual therapy sessions targeting pelvic alignment, sacrococcygeal mobility, and surrounding soft tissue structures. The ganglion impar block group will undergo fluoroscopy-guided ganglion impar injection performed under sterile conditions.
The outcome measures will include pain intensity assessed by the Numeric Rating Scale (NRS) and functional disability assessed by the Oswestry Disability Index (ODI). Assessments will be performed at baseline, week 3, and month 3 follow-up.
The study is conducted at Medicana Zincirlikuyu Hospital in collaboration with Istanbul Atlas University. Ethical approval has been obtained from the Istanbul Atlas University Clinical Research Ethics Committee. The findings of this trial will contribute to the evidence base regarding non-surgical management options for chronic coccydynia.
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
- None
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
- 否
入选标准
- •Age 18-75 years
- •Chronic coccygodynia ≥3 months
- •Baseline NRS ≥4
- •Failure of prior conservative treatment
- •Imaging excludes fracture, infection, or malignancy
- •Ability to provide written informed consent
排除标准
- •Acute coccygodynia
- •Prior spinal or coccygeal surgery
- •Malignancy
- •Pelvic fracture
- •Pregnancy
- •Coagulation disorder
- •Severe psychiatric disease
- •Prior osteopathic manual therapy or ganglion impar block
研究组 & 干预措施
Osteopathic Manual Therapy
Participants received osteopathic manual therapy targeting the coccygeal and sacrococcygeal region. Techniques included myofascial release, ligamentous tension balancing, and gentle mobilization. Treatment was applied once weekly for 3 weeks.
干预措施: Osteopathic Manual Therapy (Procedure)
Ganglion Impar Block
Participants received a single ganglion impar block performed under fluoroscopic guidance using local anesthetic with corticosteroid. No additional manual therapy was applied.
干预措施: Ganglion Impar Block (Procedure)
结局指标
主要结局
Patient Global Impression of Change (PGIC) score
时间窗: 3 weeks and 3 months
Patient Global Impression of Change (PGIC; 7-point scale from 1 = very much improved to 7 = very much worse; lower scores indicate better outcome). Mean PGIC score will be compared between groups.
Oswestry Disability Index (ODI) change at 3 weeks
时间窗: Baseline and 3 weeks
Change in functional disability measured by the Oswestry Disability Index (ODI, 0-100; higher scores indicate worse disability). Mean change from baseline to 3 weeks will be compared between groups.
Numeric Rating Scale (NRS) pain change at 3 weeks
时间窗: Baseline and 3 weeks
Change in pain intensity measured by the Numeric Rating Scale (NRS, 0-10; 0 = no pain, 10 = worst imaginable pain; higher scores indicate worse pain). Mean change from baseline to 3 weeks will be compared between groups.
Numeric Rating Scale (NRS) pain change at 3 months
时间窗: Baseline and 3 months
Change in pain intensity measured by the Numeric Rating Scale (NRS, 0-10; higher scores indicate worse pain). Mean change from baseline to 3 months will be compared between groups.
Oswestry Disability Index (ODI) change from baseline
时间窗: Baseline and 3 months
Change in functional disability measured by the Oswestry Disability Index (ODI, 0-100; 0 = no disability, 100 = maximum disability; higher scores indicate worse disability). Mean change from baseline to 3 months will be compared between groups.
次要结局
- Oswestry Disability Index (ODI) change at 3 weeks(Baseline and 3 weeks)
- Numeric Rating Scale (NRS) pain change at 3 weeks(Baseline and 3 weeks)
- Numeric Rating Scale (NRS) pain change at 3 months(Baseline and 3 months)
- Patient Global Impression of Change (PGIC) score(3 weeks and 3 months)
研究者
Bilinç Doğruöz Karatekin
Associate professor
Istanbul Medeniyet University