SYNOPSIS
Rajiv Gandhi University of Health Sciences, Karnataka, Bangalore
“A comparative analysis of epidural steroid and non-invasive conservative management for lumbar disc herniations
-a prospective study”
Name of the candidate : Dr. Jubin Abraham Raju
Guide : Dr. Edward L. Nazareth
Co-Guide : Dr Harsharaj K
Course and Subject : M.S. (Orthopaedics)
DEPARTMENT OF ORTHOPAEDICS
FR. MULLER MEDICAL COLLEGE HOSPITAL
KANKANADY, MANGALORE – 575 002.
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE
ANNEXURE – II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1. / Name of the Candidate and Address[in block letters] / DR. JUBIN ABRAHAM RAJU
POSTGRADUATE RESIDENT
DEPARTMENT OF ORTHOPAEDICS
FR. MULLER MEDICAL COLLEGE
KANKANADY,MANGALORE 575 002
2. / Name of the Institution / FR MULLER MEDICAL COLLEGE
HOSPITAL KANKANADY,
MANGALORE 575 002
3. / Course of study and subject / M.S (ORTHOPAEDICS)
4. / Date of admission to Course / 09-04-2012
5. / TITLE OF THE TOPIC:
“A comparative analysis of epidural steroid and non-invasive conservative management for lumbar disc herniations-a prospective study”
6. / BRIEF RESUME OF THE INTENDED WORK:
6.1 NEED FOR THE STUDY:
It is a well recognized fact that back pain in a disc disease is not only because of compression on neural elements, but may also be due to chemical inflammation. Surgery aims at decompressing the pressure on neural elements and conservative treatment aims to combat the chemical radiculitis.
With the wide availability of MRI,clinical diagnosis and confirmation by MRI scan has been made easy. Many a times a disc lesion in MRI may influence the surgeon to operate and remove the offending disc.
However, many such patients may not actually need surgery and can be treated non-operatively.
This study aims at analyzing the effectiveness of conservative treatment and to compare the outcome of the two broad categories of conservative care - invasive (epidural steroid) and non-invasive in the treatment of diagnosed and confirmed case of lumbar disc herniations.
6.2 REVIEW OF LITERATURE:
O’Connell1 in 1951 in a clinical review of the five hundred cases of protrusions of the lumbar intervertebral discs treated by excision concluded that excision of a lumbar disc is required in only a small proportion of patients with this lesion.
Weber2 in 1983 in a well controlled ten year prospective study identified the benefits of excision of a lumbar disc.In 126 patients who were randomized into operatively and non-operatively treated groups, the result at 1 year were considerably better after operative treatment than after conservative treatment.However,after four years and ten years follow ups,there were no major difference between the two groups.
Carragee3 and Kim D3 in 1997 in a prospective analysis of magnetic resonance imaging findings in patients with sciatica and lumbar disc herniations correlated the outcome with disc fragment and canal morphology. This study also elaborates the clinical features and morphometric features of disc herniation in MRI and its relation to predict the outcomes of non operative treatment or surgical treatment.
Zentner J4 et al., in 1997 did an extensive study on the Efficacy of conservative treatment of lumbar disc herniation. In this study 322 patients with lumbar disc herniation were subjected to conservative treatment and were followed up for 2 years. 93% of patients showed improvement with respect to pain and 60% of the patients improved with respect to motor deficits.
Kakatkar6 et al., in 2012 analysed the data of 196 patients diagnosed as either disc herniation or lumbar canal stenosis clinically and confirmed radiologically. Patients were treated with translaminar epidural saline and steroid injection and followed up for 1 month, 6months and 12 months. They concluded that translaminar epidural steroid injection in lumbar canal stenosis and disc herniation had effective outcome at short term and long term basis in terms of pain tolerance and improvement in neurological symptoms
6.3 OBJECTIVES OF THE STUDY:
1) To compare and analyse the effects of non-operative treatment in established disc prolapse.
2) To compare and analyse epidural steroid with other modes of non-operative treatment.
3) To study the role of lifestyle (such as smokers and obese individuals) in the outcome of non-operative management of disc herniations.
7. / MATERIALS AND METHODS:7.1 SOURCE OF DATA:
The patients with established disc herniation(whose MRI reveals a disc herniation) will be drawn into the study from both elective and emergency groups who present at the department of Orthopaedics in Father Mullers Medical College,Mangalore for a period of 2 years. They would be followed up for 12 months.
7.2 METHOD OF COLLECTION OF DATA:
Study type:- A prospective cohort study
Duration:-2 Years
Sample size:-A minimum of 100 patients satisfying inclusion and exclusion criteria given below will be selected by purposive sampling.
Adult patients with established lumbar disc herniations treated non-operatively with either epidural steroid injection or other methods of non-surgical management at Father Muller Medical College Hospital will be evaluated and assessed for a period ranging between 6 weeks to 24 months.
All patients will be evaluated in the emergency/OPD by the resident on call and the patient would be admitted after thorough clinical evaluation.Standard radiographs of LS Spine,relevant blood tests will be done to rule out other causes of back pain.
Later, the patient will be subjected to MRI study to define the level of compression, extent of compression; size of disc herniated and type of disc herniation.The patients falling into exclusion criteria would be omitted out of the study.
However,the patients who will be included in the study will now be assesed as follows: their pain assessed with VAS score, disability by Oswestry disability index.
Study type:
A prospective cohort study of functional outcome following non-operative management in lumbar disc herniations in adults.
A sample size of patients will be selected using purposive sampling technique for each group for comparative study. All patients will undergo one of the management procedures.
Inclusion Criteria:
1. Symptomatic patients with disc herniations with positive MRI findings.
2. The patients above 18 years of age treated by only non-operative methods.
3. Patients who will be available for follow up for minimum period of 12months.
Exclusion criteria.
1. Patients below 18 years.
2. Patients with progressive neurological deficits.
3. Patients with associated listhesis,instability of the spine.
4. Patients with cauda equina lesions.
5. Patients with history of previous spine surgery
6. Patients associated with infection or discitis
7. Any condition that comes in the way of early mobilization of the patient.
Plan for data- analysis
Collected data will be analyzed by‘t’ test and Chi-Square test.
7.3
Does the study require any investigations or interventions to be conducted on patients or other humans?
No
7.4
Has ethical clearance been obtained from your institution?
Yes.
8. / LIST OF REFERENCES:
1. O’Connell.J.E.A. “Protrusions of lumbar intervertebral discs.” JBJS (Br)February 1951 33-B;8-30.
2. Lumbar disc herniation: “A controlled prospective study with 10years of observation.” Weber.H Spine(Phila Pa 1976)8:131-140,1983
3. Carragee EJ, Kim D –“A prospective analysis of Magnetic resonance imaging findings in patients with sciatica and lumbar disc herniations”. Spine(Phila Pa 1976)22:1650-1660;1997 July
4. Zentner J, Schneider B, Schramm J. “Efficacy of Conservative treatment of Lumbar disc
Herniation.” Journal of Neurosurgery science, September 1997 41(3): 263-8.
5. J.Wilson Mac Donald, G.Burt, D.Griffin, C.Glynn. “Epidural steroid injection for nerve root compression.” A Randomised control trial.JBJS (Br)March 2005 87 B (352-355)
6. Kakatkar V, Patil H, Kakatkar V. “Assessment of Functional Outcome of Trans Laminar Epidural Steroid Injection in Recalcitrant Radiculopathy.” The Journal of Maharashtra Orthopaedic association July 2012 7(3)2-5).
9. / SIGNATURE OF THE CANDIDATE:
10. / REMARK OF THE GUIDE:
11. / NAME AND DESIGNATION OF
(in block letters)
11.1 GUIDE / DR. EDWARD L. NAZARETH
PROFESSOR
DEPARTMENT OF ORTHOPAEDICS
FATHER MULLER MEDICAL
COLLEGE- KANKANADY
MANGALORE-575002
11.2 SIGNATURE
11.3 CO-GUIDE / DR. HARSHARAJ K
DEPARTMENT OF ORTHOPAEDICS
FATHER MULLER MEDICAL COLLEGE, KANKANADY
MANGALORE-575002
11.4 SIGNATURE
11.5 HEAD OF THE
DEPARTMENT / DR. JACOB CHACKO
PROFESSOR AND HOD
DEPARTMENT OF ORTHOPAEDICS
FATHER MULLER MEDICAL COLLEGE, KANKANADY
MANGALORE-575002
11.6 SIGNATURE
12. / 12.1 REMARKS OF THE CHAIRMAN AND DEAN
12.2 SIGNATURE