Comparing the Treatment Outcomes of Two Interventional Pain Procedures in Chronic Coccygodynia
Comparison of Treatment Outcomes in Chronic Coccygodynia Patients Treated With Ganglion Impar Blockade Versus Caudal Epidural Steroid Injection: A Prospective Randomized Comparison Study
Coccygodynia is a disabling pain in the coccyx exacerbated by sitting or rising from sitting. The pain is often pulling or lancinating in quality, may radiate to the sacrum or buttock, and may coexist with lower back pain. Contributing of many physiologic and psychological factors to its etiology, it may be traumatic or idiopathic in origin. Many risk factors are known such as trauma, female gender and obesity. Despite the identification of chronic coccygeal pain hundreds of years ago, its treatment can be difficult and sometimes controversial because of the multifactorial nature of coccygeal pain. Most cases of coccygodynia resolve within weeks to months with or without conservative treatment, but for a few patients, the pain can become chronic and debilitating. First-line treatment options include analgesic drugs, cushion, sit baths, and manuel therapy. Interventional procedures for pain management can be applied to patients who have no response to other conservative modalities. Ganglion impar block and caudal epidural steroid injection are two treatment options for chronic coccygodynia and both of them can be applied by guidance of fluoroscopy and ultrasonography. Radiofrequency ablation is the other option for treatment and eventually, surgical intervention can be done for patients who have refractory pain despite other treatments.
Although efficacy of two interventional procedure for chronic coccygodynia, ganglion impar block and caudal epidural steroid injection, has been well known, no study is exist comparing the efficacy of them. We aimed to compare the efficacy of ganglion impar block and caudal epidural steroid injection in chronic coccygodynia.
調査の概要
状態
詳細な説明
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Istanbul、七面鳥、34899
- Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patients diagnosed with chronic coccygodynia between the ages of 18 and 65
- Intractable pain over the coccyx despite conservative treatment
Exclusion Criteria:
- History of ganglion impar blockade and/or caudal epidural steroid injection carried out in the last 3 months
- History of lumbar surgery
- Systemic and/or local infections
- Malignancy
- Bleeding diathesis
- Acute fracture
- Known allergy to contrast material and/or local anesthetic substances
- Known history of any psychiatric disorder
- History of pregnancy
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Ganglion impar block group
Fluoroscopy-guided ganglion impar block is applied to patients in this group.
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Fluoroscopy guidance is used for correct visualization of injection site, and so obtained more successful results.
Patients are placed in the prone position.
Injection site is cleaned thrice with povidone iodine %10 solution and covered with sterile drapes.
Being most commonly used technic, transsacrococcygeal technique, a 22-gauge, 1.5-inch spinal needle is advanced through the sacrococcygeal disk and positioned carefully anterior to the sacrococcygeal junction.
Injection of contrast results in a classical comma sign.
A mixture of steroid and local anesthetic is given.
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アクティブコンパレータ：Caudal epidural steroid injection group
Fluoroscopy-guided caudal epidural steroid injection is applied to patients in this group.
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Fluoroscopy guidance is used for correct visualization of injection site, and so obtained more successful results.
Patients are placed in the prone position.
Injection site is cleaned thrice with povidone iodine %10 solution and covered with sterile drapes.
An 18-gauge epidural needle (Tuohy) is advanced at an angle of 45° to the skin until a 'give-way' sensation is felt and position of the needle is confirmed by lateral and anteroposterior fluoroscopic images.
Then 5 ml of iohexol solution is injected through it to confirm the position.
A properly placed needle would produce a classical 'inverted fern tree' appearance in anteroposterior view after dye injection or a 'filling defect'.
The needle is introduced up to S3 level for proper spread of the drug.
A mixture of steroid and local anesthetics is given.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in pain severity of patients from baseline to each checkpoints
時間枠：from pre-interventional time to post-interventional 1st hour, 3rd week, 3rd month
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Defining the change in Numeric Rating Scale (NRS) score
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from pre-interventional time to post-interventional 1st hour, 3rd week, 3rd month
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in number of patients with neuropathic pain from baseline to each checkpoints
時間枠：from pre-interventional time to post-interventional 3rd week, 3rd month
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Defining the change in number of patients with neuropathic pain using Leeds Assessment of Neuropathic Symptoms and Signs Scale (LANSS)
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from pre-interventional time to post-interventional 3rd week, 3rd month
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Change the patient reported quality of life assessment from baseline to each checkpoints
時間枠：from pre-interventional time to post-interventional 3rd week, 3rd month
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Defining the change in quality of life scores of patients using Short Form 12 Health Survey (SF-12)
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from pre-interventional time to post-interventional 3rd week, 3rd month
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Savaş Şencan, MD、Marmara University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 09.2019.395
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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