| CTRI Number |
CTRI/2021/08/035926 [Registered on: 25/08/2021] Trial Registered Prospectively |
| Last Modified On: |
15/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Stimulator-assisted ultrasound-guided nerve block versus ultrasound guided injection in low back pain relief |
|
Scientific Title of Study
|
Comparison of efficacy of nerve stimulation-assisted ultrasound-guided transforaminal injection versus ultrasound-guided transforaminal injection in patients with lumbar radicular pain: A Randomized Interventional Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jyotsna Punj |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS, New Delhi
South
DELHI
110029
India
South
DELHI
110029
India |
| Phone |
9810191116 |
| Fax |
|
| Email |
jyotsna_punj@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyotsna Punj |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS, New Delhi
South
DELHI
110029
India
South
DELHI
110029
India |
| Phone |
9810191116 |
| Fax |
|
| Email |
jyotsna_punj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyotsna Punj |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS, New Delhi
South
DELHI
110029
India
South
DELHI
110029
India |
| Phone |
9810191116 |
| Fax |
|
| Email |
jyotsna_punj@yahoo.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi, India
|
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
All India Institute Of Medical Sciences, Ansari Nagar East, New Delhi-110029 |
| Type of Sponsor |
Research institution |
|
|
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 Jyotsna Punj |
AIIMS New Delhi |
Pain Clinic or Pain OT/ Department of Anesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi
South
DELHI
South
DELHI |
9810191116
jyotsna_punj@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nerve stimulation-assisted ultrasound-guided transforaminal injection |
Group N: Nerve stimulation-assisted ultrasound-guided transforaminal injection with 2 mL of 1% lidocaine with 4 mg of dexamethasone sodium phosphate
|
| Comparator Agent |
Ultrasound-guided transforaminal injection |
Group U: Ultrasound-guided transforaminal injection with 2 mL of 1% lidocaine with 4 mg of dexamethasone sodium phosphate |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Low back pain with unilateral radicular pain with clinical-radiologic signs without paresis
2) VAS >3
3) 18 to 65 year
4) Who gives informed consent to inclusion in the study
5) Who has current CT or MR imaging of their lumbar spine available
6) Monosegmental dermotomal pain distribution
7) Failure of symptomatic treatment with NSAIDs or/and physiotherapy for at least 6 weeks
|
|
| ExclusionCriteria |
| Details |
1) History of drugs allergy including contrast media, steroid and anaesthetics
2) Body mass index of ≥35 kg/m2
3) Spinal infection or a local or systemic infection
4) Pregnant patient
5) Previous injections within 3 months
6) Uncontrolled diabetes
7) Spinal tumors
8) On anticoagulation therapy or uncorrectable coagulopathy
9) Underwent surgery in the lumbar region
10) Progressively neurological deficit, acute traumatic, infectious, or pathologic cases
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Scale (VAS) |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Visual Analogue Scale (VAS)
2. Number of needle attempts between the two groups
3. Contrast spread pattern between the two groups
4. Operation time between the two groups |
30 mins, 1 week and 3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/09/2021 |
| 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="2"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [jyotsna_punj@yahoo.com].
- For how long will this data be available start date provided 02-10-2023 and end date provided 02-10-2025?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The lifetime prevalence of low back and sciatic pain has been reported as 54–80% with annual prevalence ranging from 15 to 45%. Lumbar transforaminal injections (TFI) are routinely performed in the interventional management of spinal radicular pain. It provides better delivery of medication to the site of radiculopathy with minimal risk of dural puncture. Unfortunately, TFI under fluoroscopic guidance results in a rather high cumulative radiation dosage for patients and medical staff. The potential biological effects of a high x-ray dosage have deterministic and stochastic effects on skin, bone, parotid glands, and the lungs. In literature, both longitudinal and transverse approaches to perform ultrasound-guided transforaminal injection (UTFI) has been described. The different studies are inconclusive to the best approach with maximal efficacy. Nerve roots exit from the upper part of the intervertebral foramen below the pedicle. To improve the efficacy of UTFI, we hypothesized that if sensory and/or motor stimulation of nerve roots can be combined with UTFI, the efficacy of the procedure will increase. The study will be conducted with the primary objective of comparing Visual Analogue Scale (VAS) between the groups at the end of 1 month and secondary objectives of comparing VAS at each time period- 30 mins, 1 week and 3 months, number of needle attempts between the two groups, contrast spread pattern and operation time between the two groups. Fourty patients will be recruited satisfying the inclusion and exclusion criteria. Patients will be divided into two group: 1. Group N: Nerve stimulation-assisted ultrasound-guided transforaminal injection and 2. Group U: Ultrasound-guided transforaminal injection. Appropriate statistical analysis would be performed after compilation of data. |