| CTRI Number |
CTRI/2024/04/065591 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of sugar injection on breakdown of stuck nerves after surgery of lower back |
|
Scientific Title of Study
|
Effect of 10% dextrose as an adjuvant in lumbar epidural adhesiolysis : a prospective randomized controlled 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 |
Dhruv Jain |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
5011, Teaching Block, 5th Floor
Department of Anaesthesiology, Pain Medicine and Critical Care
AIIMS
South DELHI 110029 India |
| Phone |
07042129423 |
| Fax |
|
| Email |
dhruvjn@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dhruv Jain |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
5011, Teaching Block, 5th Floor
Department of Anaesthesiology, Pain Medicine and Critical Care
AIIMS
South DELHI 110029 India |
| Phone |
07042129423 |
| Fax |
|
| Email |
dhruvjn@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dhruv Jain |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
5011, Teaching Block, 5th Floor
Department of Anaesthesiology, Pain Medicine and Critical Care
AIIMS
South DELHI 110029 India |
| Phone |
07042129423 |
| Fax |
|
| Email |
dhruvjn@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
AIIMS, New Delhi |
| Address |
Ansari Nagar, New Delhi |
| 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 Dhruv Jain |
All India Institute of Medical Sciences, New delhi |
Pain OPD, 4th Floor, New RAK OPD, AIIMS South DELHI |
7042129423
dhruvjn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Epidural adhesiolysis and and steroid |
Epidural adhesiolysis will be carried out with a Racz catheter by injecting hyaluronidase 1500 uits. 80 mg triamcinolone will be injected through the catheter into the epidural space |
| Intervention |
Epidural adhesiolysis and dextrose |
Epidural adhesiolysis will be carried out with a Racz catheter by injecting hyaluronidase 1500 units. 10 ml of 10% dextrose will be injected through the catheter into the epidural space |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Low back with radicular pain more than 6 months with pain of 6 or more on 11 point NRS scale
2. Radicular pain present post lumbar spine surgery evident by MRI imaging and clinical examination
3. Failure to respond to conservative therapy and fluoroscopic guided epidural injections
4. Filling defects observed on contrast injection during previous epidural steroid injections |
|
| ExclusionCriteria |
| Details |
1. Pain due to facet joint, sacroiliac joint or myofascial pain
2. Sequestered disc
3. Foraminal stenosis
4. Allergy to contrast or local anesthetics
5. Pregnant patients
6. Bleeding or coagulation disorders
7. Uncontrolled systemic disorders
8. Opioid addiction of psychiatric disorders
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| NRS for pain (on scale of 0-10) |
Preprocedure
15 days, 1, 3 and 6 months post procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oswestry Disability Index score |
Preprocedure
15 days, 1, 3 and 6 months post procedure |
| Successful outcome |
Preprocedure
15 days, 1, 3 and 6 months post procedure |
| Reduction in medication usage |
Preprocedure
15 days, 1, 3 and 6 months post procedure |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
29/04/2024 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Low back pain is a debilitating condition with a lifetime prevalence of 50-80% and results in severe biopsychosocial impact. Compression of nerves is common in low back pain leading to severe radicular pain and can be due to disc degeneration, spinal stenosis, inflammation and epidural adhesions. Post lumbar laminectomy syndrome or failed back surgery syndrome can affect up to 40% of patients and epidural fibrosis is thought to contribute to 60% of such cases . Adhesiolysis is a commonly performed procedure for such conditions which releases the nerve from entrapment. It is performed by a specialized spring coiled catheter (Racz catheter) which breaks the fibrous tissue my mechanical means and use of hyaluronidase. Epidural steroids are given afterwards to reduce inflammation, but may cause side effects like increases blood sugar levels, hypertension, water retention, lowering of immunity and infections. Dextrose is now being commonly employed for chronic pain conditions. The postulated mechanisms of dextrose in managing chronic pain include tissue regeneration, sensorineural effect, reduction of sensitization and hydrodissection All these factors may help in adhesiolysis procedure and attenuation of pain. We hypothesize that epidural administration of 10% dextrose would result in better pain relief than steroid after epidural adhesiolysis in patients with chronic lumbar radicular pain | |