跳至主要内容
临床试验/CTRI/2021/09/036418
CTRI/2021/09/036418尚未招募不适用

Posterior tibial nerve blocks for the treatment of coccydynia pain: A Prospective cohort study

AIIMS Rishikesh1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年1月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
To assess the efficacy of bilateral posterior tibial nerve blocks in the treatment of coccidynia pain in terms of

研究概览

简要总结

Coccydynia is a pain felt in the tailbone (coccyx), which is the last bone at the bottom of spine, It was originally attributed to the injury of the coccyx with inflammation of surrounding tissue by Simpson (1). The main clinical features are pain and tenderness in the area just above the buttocks, the pain may be dull and achy most of the time, with occasional sharp pains, it will be worse when sitting down, moving from sitting to standing, standing for long periods, during sex and defecation.

It is often for the patient to have difficulty in sleeping and carryout everyday activities such as driving or bending over. Some people also have back pain, shooting leg pains (sciatica) and painful buttocks and hips.

Common causes of coccydynia include; childbirth, an injury or accident such as fall, an injury or accident such as a fall, repeated or prolonged strain on the coccyx, poor posture, being overweight or underweight.  Less common causes can include a bony growth on the coccyx, the coccyx being too flexible or too rigid and arthritis. Rare but serious causes include infection and cancer.

Current guidelines strongly recommend conservative treatment and discourage surgical option due to the risk of long-term complications (2). Non-surgical options for the treatment of coccydynia include non-steroidal anti-inflammatory and analgesic medications, rest, hot baths, massage, and a ring-shaped cushion to protect the coccyx from repetitive trauma. Physical therapy modalities include shortwave diathermy to relieve pain and muscle spasms by deep tissue heating, interferential current to provide temporary relief.

 Ganglion impar block with local anaesthetic and steroids may be indicated if the conservative treatment fails. The Ganglion impar block is routinely performed in operation theatre set up in prone position with the help of fluoroscopy or ultrasound guidance.

 We hypothesize that our spinal nerves are pseudo unipolar and carry the information in bi-directional, therefore, blocking the peripheral nerves should block the pain due to coccidynia (3), the case report by Hammodi has shown prolonged relief of coccidynia pain with peripheral nerve (posterior tibial) injections (4).

The present study will examine the efficacy of peripheral nerve block (posterior tibial nerve) in treatment of coccidynia in patients attending our pain clinic.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Patient suffering from coccidynia due to any cause, which is not responding to conservative treatment with numerical rating scale of > 4/10 2.Duration of pain >3months.

排除标准

  • 1.Coagulopathy and/or patients on anticoagulants.
  • 2.Infection at the site of injection.
  • 3.Hypersensitivity to local anesthetic agent 4.History of any major comorbid medical conditions, those interfere with recording of study outcomes, and pregnancy.

结局指标

主要结局

To assess the efficacy of bilateral posterior tibial nerve blocks in the treatment of coccidynia pain in terms of

时间窗: Immediately after the procedure | 15 days after the procedure | 1 month after the procedure | 2 months after the procedure | 3 months after the procedure

1.Pain relief as assessed by Numerical Rating Scale (NRS) on a scale of 1-10 (Annexure I)

时间窗: Immediately after the procedure | 15 days after the procedure | 1 month after the procedure | 2 months after the procedure | 3 months after the procedure

2.Global Perceived Effects (Annexure-II)

时间窗: Immediately after the procedure | 15 days after the procedure | 1 month after the procedure | 2 months after the procedure | 3 months after the procedure

3.Physical functioning as assessed by Modified Oswestry Disability scale (Annexure –III)

时间窗: Immediately after the procedure | 15 days after the procedure | 1 month after the procedure | 2 months after the procedure | 3 months after the procedure

次要结局

  • 1.To assess spontaneous reporting of adverse effects and the incidence of complications due to the procedure(complications will be assessed immediately after the procedure)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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