| CTRI Number |
CTRI/2025/12/098701 [Registered on: 09/12/2025] Trial Registered Prospectively |
| Last Modified On: |
08/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare two treatments for tailbone pain: numbing shots vs. a special nerve treatment in order to relief pain and improve functions. |
|
Scientific Title of Study
|
Effectiveness of fluoroscopy-guided pulsed radiofrequency ablation in comparison with local anaesthetic and steroid block of ganglion impar in improving pain and functions in patients with coccydynia: a randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rahul Ch Marak |
| Designation |
Postgraduate Resident |
| Affiliation |
RIMS Imphal Manipur |
| Address |
Department of Physical Medicine and Rehabilitation Regional Institute of Medical Sciences Imphal Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
8014826724 |
| Fax |
|
| Email |
rahuto@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Longjam Nilachandra Singh |
| Designation |
Prof and Head of Department Physical Medicine and Rehabilitation |
| Affiliation |
RIMS Imphal Manipur |
| Address |
Department of Physical Medicine and Rehabilitation Regional Institute of Medical Sciences Imphal Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
7005018045 |
| Fax |
|
| Email |
drnilalong@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Longjam Nilachandra Singh |
| Designation |
Prof and Head of Department Physical Medicine and Rehabilitation |
| Affiliation |
RIMS Imphal Manipur |
| Address |
Department of Physical Medicine and Rehabilitation Regional Institute of Medical Sciences Imphal Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
7005018045 |
| Fax |
|
| Email |
drnilalong@gmail.com |
|
|
Source of Monetary or Material Support
|
| Regional Institute of Medical Sciences, Lamphelpat, Imphal, Manipur |
|
|
Primary Sponsor
|
| Name |
Dr Rahul Ch Marak |
| Address |
Department of Physical Medicine and Rehabilitation Regional Institute Of Medical Sciences Imphal Manipur |
| Type of Sponsor |
Other [self] |
|
|
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 Rahul Ch Marak |
Regional institue of medical sciences |
Department of Physical Medicine and Rehabilitation
Imphal West
MANIPUR |
8014826724
rahuto@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Boards RIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M533||Sacrococcygeal disorders, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ganglion Impar block |
A mixture of 1ml of triamcinolone acetonide(40mg/ml) and 1ml of 0.5% bupivacaine will be injected into the ganglion impar under fluoroscopy guidance |
| Intervention |
Pulsed radiofrequency ablation |
Pulsed radiofrequency ablation of ganglion impar under fluoroscopy guidance |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are aged between 20 years to 60 years, has coccydynia who has not had relief of symptoms even after 6 months of conservative treatment, has NPRS more than or equal to 4, functional impairment (ODI more than 20%), has positive diagnostic block( more than 50% improvement in pain) |
|
| ExclusionCriteria |
| Details |
Patients who are pregnant, has history of injection with steroids in and around coccyx in the last 3 months, cognitive impairment, prior history of coccygectomy or pelvic surgery, cardiac pacemaker, uncontrolled diabetes and hypertension systemic diseases, coagulation disorder, has local infections, has allergy to anaesthetic medication and steroid used, and who has tumors of the pelvic region |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Numeric pain rating scale 2. Oswestry Disability Index |
baseline, 1st week, 4th week, 12th week and 24th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
19/12/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Coccydynia is a chronic pain condition affecting the coccyx, leading to significant discomfort, functional impairment, and reduced quality of life. Diagnosis is based on proper history, clinical evaluation and imaging findings. The primary goal of treatment is to relieve pain, improve function and enhance quality of life while minimising side effects. Pulsed radiofrequency ablation of the ganglion impar has emerged as a promising treatment for chronic coccydynia due to its ability to provide long lasting relief with minimal complications. However, its efficacy compared to conventional ganglion impar block remains an area of active research. The objective is to determine the effectiveness of fluoroscopy-guided pulsed radiofrequency ablation of the ganglion impar in comparison to local anaesthetic and steroid block of the ganglion impar in improving pain and functions in patients with coccydynia. This study, a single-blinded randomized controlled trial, will be conducted in the Department of Physical Medicine and Rehabilitation, RIMS, Imphal. A total of 28 patients with coccydynia attending the PMR OPD will be selected and randomized into two groups. Outcomes will be assessed using the Numeric pain rating scale (NPRS) and Oswestry Disability Index (ODI) at baseline and postintervention at 1st, 4th, 12th and 24th weeks. Statistical analysis will include chi-square test, independent t-test, and repeated measures ANOVA, with a p-value <0.05 considered statistically significant. Ethical approval will be taken from the Research Ethics Board, RIMS, Imphal, for this clinical study and will be registered in the Clinical Trials Registry of India (CTRI). All the participants will be informed about the nature of the study, and willing participants will be asked to sign the informed written consent form. Privacy and confidentiality of participants will be maintained by identifying the patients using MRD numbers, and they will be informed that they can withdraw from the study at any time. |