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
|
|
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
|
|
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
|
|
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. |