| CTRI Number |
CTRI/2023/04/051441 [Registered on: 10/04/2023] Trial Registered Prospectively |
| Last Modified On: |
06/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Efficacy of low volume versus high volume injection of epidural steroids ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison of the efficacy of low-volume versus high-volume injection of epidural
steroids in the management of back pain |
|
Scientific Title of Study
|
A comparison on the efficacy of low volume versus high volume injection of epidural steroids in the management of back pain and radiculopathy associated with lumbar degenerative disc disease - A Randomised superiority clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raju Karuppal |
| Designation |
Additional professor of Orthopaedics |
| Affiliation |
Govt. Medical College Kozhikode |
| Address |
Dr.Raju Karuppal
Additional Professor
Department of Orthopaedics, 2nd floor, NMCH
Govt. Medical College Kozhikode,
Kozhikode
KERALA
673008
India |
| Phone |
|
| Fax |
|
| Email |
drrajuortho@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Raju Karuppal |
| Designation |
Additional Professor |
| Affiliation |
Govt. Medical College Kozhikode |
| Address |
Department of Orthopaedics, 2nd floor, NMCH
Govt. Medical College Kozhikode, Kerala
Kozhikode
KERALA
673008
India |
| Phone |
|
| Fax |
|
| Email |
drrajuortho@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Raju Karuppal |
| Designation |
Additional Professor |
| Affiliation |
Govt. Medical College Kozhikode |
| Address |
Department of Orthopaedics, 2nd floor, NMCH
Govt. Medical College Kozhikode, Kerala
PIN 673008
Kozhikode
KERALA
673602
India |
| Phone |
|
| Fax |
|
| Email |
drrajuortho@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Government medical college Kozhikode |
| Address |
Government medical college Kozhikode, Medical College PO
PIN 673008, KERALA, INDIA |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Raju Karuppal |
Government Medical college Kozhikode |
Department of Orthopaedics,
Government Medical college Kozhikode, Medical College PO, PIN 673008
Kozhikode
KERALA |
9447330002
drrajuortho@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GOVERNMENT MEDICAL COLLEGE KOZHIKODE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: M511||Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Caudal epidural
steroid injection |
The first group (Low volume group) will be treated with a
dose of 80 mg triamcinolone in a 3 ml solution
Duration of intervention : 30 minutes |
| Comparator Agent |
Caudal epidural steroid injection |
Second group-(High volume group)
will be treated with 80 mg triamcinolone in a 10 ml solution.
Duration of intervention: 30 minutes |
|
|
Inclusion Criteria
|
| Age From |
25.00 Day(s) |
| Age To |
50.00 Day(s) |
| Gender |
Both |
| Details |
1. Adult patients (aged 25-50 Years), capable of providing consent and complying with the outcome
instruments
2. Single-level lumbar disc herniation diagnosed by MRI
3. Lower lumbar disc herniation diagnosed by MRI (L4/L5 or L5S1).
4. Signs and symptoms consistent with the nerve root irritation
5. Patients with lumbar radicular pain, irrespective of neurological signs.
6. Patients have refractory pain, even after treatment with NSAIDs, opioids, and/or physical
therapies for more than two weeks duration.
7. Failure after a minimum of 6 weeks of conservative treatment |
|
| ExclusionCriteria |
| Details |
Patient’s reluctance and lack of compliance, does not provide informed consent for the
study
2. Patients with previous back surgery at the affected segmental level and radiologically
proven facet syndrome
3. Multiple level lumbar disc herniation diagnosed by MRI
4. Patients with a severe motor deficit, segmental instability, spinal deformities.
5. Any systemic infection or local infection at the injection site
6. Patients presenting with cauda equina syndrome
7. Patients on anticoagulation therapy or having any bleeding disorder
8. Patients with congestive heart failure or uncontrolled blood sugars
9. Pregnant females or ongoing breastfeeding females
10. Patients with underlying malignancy
11. Patients are not excluded based on the duration of pain alone.
12. Patients who are allergic to any component of the medicine? |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of low volume
corticosteroid injections in the treatment of low
back pain and radiculopathy associated with
lumbar degenerative diseases with that of
conventional high-volume injection. |
1. Pre injection
2. Post injection
At 3 weeks, 6 weeks, and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the side effects, if any, of low-volume versus high-volume corticosteroid injections
in the treatment of low back pain. |
During the injection and in the next 24 hours after the injection |
|
|
Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
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)
|
01/05/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1.Kumar VP, Karuppal R. Comparison between clinical, magnetic resonance imaging, and arthroscopic findings in meniscal and cruciate ligament injuries: A cross-sectional study. Apollo Medicine. 2022 Jul 1;19(3):137. 2.Fazil VM, Surendran S, Karuppal R, Gopinathan P, Marthya A. Mini-open transverse flexor crease incision versus limited longitudinal palmar incision carpal tunnel release: A short term outcome study. Journal of Orthopaedics. 2022 Jan 1;29:15-21. 3.Vishnu M, Mathew J, Karuppal R, Prasad A. Relapse Pattern in Club Foot Treated with Ponseti Technique-A Prospective Observational Study from Kerala, India. 4.OP Jamshad, Jacob Mathew, Raju Karuppal Functional and Radiological Outcome of Unstable Intertrochanteric Fracture in Old Age Treated with Proximal Femoral Nail Antirotation-2. Journal of Clinical and Diagnostic Research. 2021 Apr, Vol-15(4): RC05-RC07 5. Surendran S, Patinharayil G, Karuppal R, Marthya A, Fazil M, Ali SM. Arthroscopic capsular release and continuous upper arm brachial block in frozen shoulder–A midterm outcome analysis. Journal of Orthopaedics. 2020 Sep 1;21:459-64. 6. Mathew J, Karuppal R, Somasundaran S, Sinildas PD. Single Event Multilevel Surgery for Crouch Gait in Cerebral Palsy-An Evaluation Using Functional Mobility Score-A Retrospective Analysis. 7. Sibin Surendran D, Karuppal R, Marthya A. Parenteral tranexamic acid reduces postoperative blood loss and transfusion rates after total knee arthroplasty: A prospective randomized controlled trial. 8. Sajeev S, Karuppal R. A prospective study to evaluate the efficacies of low volume and high volume caudal epidural steroid injections in the treatment of lumbar degenerative disc disease. International Journal of Research in Medical Sciences. 2017 Aug;5(8):3493. 9. Sibin Surendran D, Karuppal R, Valoor HT. The management of proximal pole scaphoid nonunion with avascular necrosis using 1, 2 intercompartmental supraretinacular arterial bone graft and radial styloidectomy: A midterm outcome study. International Journal of Orthopaedics. 2018;4(4):138-43. 10. Karuppal R, Somasundaran S. Functional outcomes of the stable elastic intramedullary nailing for the fractures of femur in children. Indian Journal of Orthopaedics Surgery. 2018 Jan 15;3(4):330-4. 11. Karuppal R, Somasundaran S. Functional outcome of Ilizarov ring fixation in infected non-union tibia: A prospective study. International Journal of Orthopaedics. 2017;3(2):191-4. 12. Madhu LN, Raman RV, Karuppal R, Thottath J, Hareendranath S, Juvaina P, Mothampally S, Menon II. MAGNETIC RESONANCE IMAGING ARTHROGRAM FINDINGS IN RECURRENT DISLOCATION OF SHOULDER. JOURNAL OF EVOLUTION OF MEDICAL AND DENTAL SCIENCES-JEMDS. 2017 Jun 1;6(44):3452-8. 13. Karuppal R, Surendran S. Scaphoid non-union and results of the Match stick strut graft technique. IJSR. APRIL - 2017; VOLUME-6 (4). |