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CTRI Number  CTRI/2021/09/036418 [Registered on: 10/09/2021] Trial Registered Prospectively
Last Modified On: 10/09/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Peripheral nerve blocks for coccydynia pain 
Scientific Title of Study   Posterior tibial nerve blocks for the treatment of coccydynia pain: A Prospective cohort study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  PRAVEEN TALAWAR 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Department of Anaesthesiology Medical College Building Level 6 AIIMS Rishikesh Virbhadra Marg Pashulok Rishikesh
Department of Anaesthesiology 6th Floor Medical College Building Virbhadra Marg Pashulok Rishikesh dehradun
Dehradun
UTTARANCHAL
249203
India 
Phone  9654162941   
Fax    
Email  praveenrt64@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  PRAVEEN TALAWAR 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Department of Anaesthesia Medical College Building Level 6 AIIMS Rishikesh Virbhadra Marg Rishikesh
Department of Anaesthesiology 6th Floor Medical College Building Virbhadra Marg Pashulok Rishikesh dehradun
Dehradun
UTTARANCHAL
249203
India 
Phone  9654162941   
Fax    
Email  praveenrt64@gmail.com  
 
Details of Contact Person
Public Query
 
Name  PRAVEEN TALAWAR 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Department of Anaesthesiology Medical College Building Level 6 AIIMS Rishikesh Virbhadra Marg
Department of Anaesthesiology 6th Floor Medical College Building Virbhadra Marg Pashulok Rishikesh dehradun
Dehradun
UTTARANCHAL
249203
India 
Phone  9654162941   
Fax    
Email  praveenrt64@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Rishikesh 
 
Primary Sponsor  
Name  AIIMS Rishikesh  
Address  All India Institute of Medical Sciences, Rishikesh Virbhadra Marg Pashulok Rishikesh 249202 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Praveen Talawar  AIIMS Rishikesh  Department of Anaesthesiology Level 6 Medical College Building Virbhadra Marg Pashulok AIIMS Rishikesh
Dehradun
UTTARANCHAL 
9654162941

praveenrt64@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G549||Nerve root and plexus disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable   Single Arm study 
Intervention  posterior tibial nerve blocks in the treatment of coccidynia pain  0.3% lignocaine with 20mg of triamcilone in 5ml volume (Totally patient will receive 40mg of triamcilone with 10ml of 0.3% lignocaine on both sides)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of bilateral posterior tibial nerve blocks in the treatment of coccidynia pain in terms of
1.Pain relief as assessed by Numerical Rating Scale (NRS) on a scale of 1-10 (Annexure I)
2.Global Perceived Effects (Annexure-II)
3.Physical functioning as assessed by Modified Oswestry Disability scale (Annexure –III)
 
Immediately after the procedure
15 days after the procedure
1 month after the procedure
2 months after the procedure
3 months after the procedure  
 
Secondary Outcome  
Outcome  TimePoints 
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

at 15 days

at 1 month

at 2 month

at 3 month after the procedure 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.
 
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