| CTRI Number |
CTRI/2025/07/091014 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
12/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Pulsed radiofrequency Of Cervical nerves for Managing Post Amputation pain or phantom limb pain |
|
Scientific Title of Study
|
Pulsed radiofrequency adjacent to Cervical Dorsal Root ganglion for refractory phantom limb pain: An Interventional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ravi Shankar Sharma |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS , Rishikesh |
| Address |
AAM Bagh Rishikesh
Room no 16, OPD block , Ground Floor , AIIMS Rishikesh, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9993116929 |
| Fax |
|
| Email |
drravishankarsharma4u@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ravi Shankar Sharma |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS , Rishikesh |
| Address |
AAM Bagh Rishikesh
Room no 16, OPD block , Ground Floor , AIIMS Rishikesh, Rishikesh
UTTARANCHAL
249203
India |
| Phone |
9993116929 |
| Fax |
|
| Email |
drravishankarsharma4u@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ravi Shankar Sharma |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS , Rishikesh |
| Address |
AAM Bagh Rishikesh
Room no 16, OPD block , Ground Floor , AIIMS Rishikesh, Rishikesh
UTTARANCHAL
249203
India |
| Phone |
9993116929 |
| Fax |
|
| Email |
drravishankarsharma4u@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Rishikesh Shivaji Nagar, Rishikesh, Uttarakhand 249203, India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Rishikesh |
| Address |
Shivaji Nagar, Rishikesh, Uttarakhand 249203 |
| 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 Ravi Shankar Sharma |
OPD no 16 and O T no 6 Department of Anaesthesiology, Pain Medicine Division. |
Shivaji Nagar Rishikesh Uttarakhand 249203 India
Dehradun
UTTARANCHAL |
9993116929
drravishankarsharma4u@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee All India Institute of Medical Sciences Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G546||Phantom limb syndrome with pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable as it is single arm study |
Not Applicable |
| Intervention |
Pulsed Radiofrequency Ablation (PRFA) near Cervical Dorsal Root Ganglion |
Following informed written consent under fluoroscopic guidance Radiofrequency cannula (22G , 100 mm) will be placed in the cervical foramina at the affected Foraminal level. Following this contrast agent will be injected to identify the nerve root and Dorsal root ganglion. Following DRG identification 2 cycles of pulsed radiofrequency at temperature 42 degree Celsius for 120 second will be given. Motor and sensory testing will be done prior to this procedure. Following procedure pain will be evaluated using numerical rating scale. on a range of 1 to 10. following Procedure follow up will be done at 3 month. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
The patients aged between 18 to 65 years who have undergone upper limb amputation and presently suffering from phantom limb pain will be included in the study. These patients will undergo Pulsed radiofrequency ablation of Cervical Dorsal root ganglion and follow up period will be done at 3 month following the procedure in terms of pain reduction and improvement in quality of life. |
|
| ExclusionCriteria |
| Details |
Age less than 18 years and more than 65 years
Allergy to local Anesthetics
Deranged coagulation profile
Both upper and lower limb amputee. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Determine the effects of Pulsed Radiofrequency ablation on cervical Dorsal root ganglion with Phantom limb pain in terms of pain relief as assessed by Numerical rating scale .
|
Pain Reduction will be assessed at baseline at 1 month and at 3 months following procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To quantify medication regimen using Medication Quantification Scale
|
At 3 months |
to Measure patients health status Global Perceived effect using 7 point Likert scale.
|
at 3 months |
Emotional functioning of these patients using Hospital anxiety and depression scale (HADS).
|
At 3 months Interval |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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 1 |
|
Date of First Enrollment (India)
|
25/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Phantom limb pain is
defined as painful sensation referring to missing limb. Multiple modalities
including medical and interventional therapies has been tried so far with
minimal success. This study aimed to evaluate the effect of pulsed
radiofrequency (PRF) adjacent to cervical dorsal root ganglion (DRG) in
patients with upper extremity phantom limb pain. The pain reduction will be assessed in terms of Numerical rating score at Baseline at 1 month following procedure and at 3 months following procedure. |