RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA
PROFORMA FOR REGISTRATION OF DISSERTATION
TOPIC
“PREDICTIVE VALUE OF THE DURATION OF SCIATICA ON THE FUNCTIONAL OUTCOME OF LUMBAR DISCECTOMY: A PROSPECTIVE COHORT STUDY ”
DR. J. FAISAL,
POSTGRADUATE,
DEPARTMENT OF ORTHOPAEDICS,
K.S.HEGDE MEDICAL ACADEMY,
MANGALORE
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE KARNATAKA
ANNEXURE- II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1 / Name of the candidate and address(in block letters) / DR. J. FAISAL,2/605A, SRI RAM NAGAR,
N.G.G.O.COLONY,
COIMBATORE,
TAMILNADU-641022
2 / Name of the institution / JUSTICE K.S.HEGDE CHARITABLE HOSPITAL,
UNIVERSITY ROAD,
DERALAKATTE,
MANGALORE-575018
KARNATAKA.
Ph: 0824-2204471 to 6
Fax: 0824-2204162
3 / Course of study and subject / M.S. ORTHOPAEDICS
4 / Date of admission to course / 14th June 2008
5 / Title of the topic / “PREDICTIVE VALUE OF THE DURATION OF SCIATICA ON THE FUNCTIONAL OUTCOME OF LUMBAR DISCECTOMY: A PROSPECTIVE COHORT STUDY”
6. / BRIEF RESUME OF THE INTENDED WORK:
6.1 Need for the study:
There is considerable interest in the optimum timing of lumbar discectomy for patients with sciatica. Most patients with sciatica respond well to conservative management. Weber, Holme and Amlie1 reported that 70% of patients with sciatica had a considerable reduction in pain within four weeks. However, surgery is necessary for 10% of patients with an incomplete resolution of symptoms 2,3.
It has been suggested that the probability of symptoms resolving with conservative treatment decreases progressively with time 4 . In many studies prolonged morbidity has been regarded as a negative predictor 5-11. However some have contradicted this impression 12-13.
So the need for the study is to analyse the association between the duration of sciatica over the functional outcome of lumbar discectomy.
6.2 Review of literature:
A. Nygaard OP, Kloster R, Solberg T 9 had done a prospective study of 132 consecutive patients who underwent surgery for lumbar disc herniation. The authors evaluated the prognostic value of different variables including the duration of symptoms over a period of 1-year after surgery. The analysis revealed that patients experiencing preoperative leg pain lasting more than 8 months correlates with an unfavorable postoperative outcome in patients with lumbar disc herniation .
B. Nygaard OP, Romner B, Trumpy JH10 Retrospectively analysed 93 consecutive patients operated for lumbar disc herniation in order to evaluate the prognostic value of symptoms, lumbar pain and sciatica. Surgical results were evaluated 1-3 years postoperatively by a questionaire. Patients with duration of the present attack of sciatica of less than 6 months had a significantly better result concerning outcome compared to patients with duration of 6-12 months and more than 12 months. They concluded that the duration of sciatica has value as predictive factors concerning the over-all result after surgery for lumbar disc herniation.
C. GAETANIPaolo ; AIMAREnrico ; PANELLALorenzo; DEBERNARDIAlberto ; TANCIONIFlavio ; RODRIGUEZ Y BAENARiccardo ;20 Analysed records of 403 patients treated for herniated lumbar disc disease in a retrospective observational study. It demonstrated that age and type of disc herniation, were significantly related to the patient's satisfaction with the outcome of surgery. Satisfaction with the outcome of surgery was not found to depend on the interval between clinical onset and the timing of surgery. The results of this study suggest that age and type of disc herniation are among the most important factors to consider when deciding whether or not to operate on a patient for herniated lumbar disc and not the duration of symptoms .
D. Hurme et al.6 studied , 219 patients with a lumbar disc herniation and sciatica with neurological findings, who underwent surgery at one level via conventional discectomy and extended interlaminar fenestration. These patients were placed into three groups based on when surgery was performed in time relation to the onset of symptoms which were < 30days, between 30 to 60 days, and > 60 days. 10 months follow up of 204 patients was preformed. All these patients were evaluated by an independent examiner. The outcome was evaluated using the Prolo scale . It was found to be that 60% of the patients had a favorable outcome at about 10 months post discectomy. Longer duration of pre-operative pain, sensory deficit, and smoking, were all unfavorable predictors of surgical outcome. Pain and sensory deficit from a disc herniation for over sixty days, without surgery, was shown to have a statistically worse outcome than for patients who had their surgery within the 60 days.
E. Rothoerl RD , et al.19 anlaysed various research studies in which the predictive value of duration of sciatica influenced on functional outcome of lumbar discectomy .His interpretation were
Research Investigation: / Publication Year / Maximum time allowed before discectomy chances for reduce sucess
Postacchini F / 1999 / 6 months
Dvorak J, et al. / 1988 / 4 months
Hurme M. & Alaranta H. / 1987 / 2 months
Rothoerl RD , et al. / 2002 / 2 months
Ng LC, & Sell P. / 2004 / < 12 months
Dauch WA , et al. / 1994 / 6 weeks
Average recommended trial of failed non-surgical treatment / 4.6 months
He concluded average recommended trial of failed non-surgical treatment is 4.6 months and after this time, the chances of having a successful discectomy will decrease.
F. Fairbank JC, Pynsent PB14 reviewed the versions of Oswestry Disability Index, which has been validated by document methods. Data from scores found in normal and back pain populations, provide curves for power calculations in studies using the Oswestry Disability Index, and maintain the Oswestry Disability Index as a gold standard outcome measure. All the published versions of the questionnaire were identified. A systematic review of this literature was made. The various reports of validation were collated and related to a version. These data provide both validation and standards for other users and indicate the power of the instrument for detecting change in sample populations. In the end of the study they conclded that Oswestry Disability Index remains a valid and vigorous measure and has been a worthwhile outcome measure.
6.3 Objectives of the study:
To study the predictive value of the duration of sciatica
on the functional out come of Primary Lumbar Discectomy using
Oswestry Disability Index (ODI) score
7. / MATERIALS AND METHODS
7.1 Source of data
Minimum of 50 patients with sciatica diagnosed to have single level Lumbar Intervertebral disc prolapse by Magnetic resonance imaging admitted in Justice K.S.Hegde Charitable hospital treated with Primary Lumbar Discectomy are taken for study after obtaining their consent.
7. 2 Method of collection of data
All patients with sciatica with Intervertebral disc prolapse will be clinically evaluated and analysed with Magnetic resonance imaging of the Lumbo-sacral spine. Laboratory investigations will be carried out in order to get fitness for surgery. Consent of the patient will be taken for surgical management.
These patients are divided into 3 sub cohorts depending on their duration of the sciatica < 6 months , 6-12 months , > 12 months respectively. We will record the absolute value of Oswestry Disability Index score in the pre-operative period and post-operative scores on 10th day, third month, sixth month, and one year . The Oswestry Disability Index score have been validated and their reliability and sensitivity to changes in functional status have been demonstrated 14 -17. A change of more than 10 points or 20 % is considered to be significant18 . Based on the change in the Oswestry Disability Index score and the duration of the sciatica the results will be analysed and the optimal timing for the surgery will be concluded.
Inclusion criteria:
Skeletally mature patients with sciatica with Magnetic resonance imaging confirming Intervertebral disc prolapse with compression over the exiting nerve root not responding to conservative management , undergoing Primary Lumbar Discectomy.
Exclusion criteria:
§ Failed back syndrome
§ Double level disc prolapse
§ High lumbar disc prolapse
§ Spinal Canal Stenosis
§ Metastasis
§ Associated with other pathological conditions
7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so please describe briefly.
Yes, investigations required are-
§ X-ray
§ Magnetic resonance imaging
§ Routine blood and urine investigations required for surgical
Intervention in the form of lumbar discectomy
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
Yes
8 / List of references-
1. Weber H, Holme I, Amlie E, The natural course of acute sciatica with nerve root symptoms in a double-blind placebo-controlled trial evaluating the effect of piroxicam. Spine 1993;18:1433-8 .
2. Saal JA, Saal JS, "Nonoperative Treatment of Herniated Lumbar Intervertebral Disc with Radiculopathy." Spine - 1989; 14(4):431-437 .
3. Naylor A.: The late results of laminectomy for lumbar disc prolapse. J Bone and Joint Surg. 56 (B): 17-239, 1974.
4. Postacchini F, "Management of herniation of the lumbar disc." J Bone Joint Surg - 1999; 81-B :567 -576 .
5. Dvorak J, et al. "The outcome of surgery for lumbar disc herniation." Spine -1988; 13:1418-22 .
6. Hurme M and Alaranta H "Factors predicting the result of surgery for lumbar intervertebral disc herniation. Spine - 1987; 12:933-938 .
7. Jonsson B, et al. "Patient-related factors predicting the outcome of decompressive surgery." Acta Orthop Scand Suppl - 1993; 251:69-70 .
8. Junge A, Dvorak J, Ahrens S. Predictors of bad and good outcomes of lumbar disc surgery: a prospective clinical study with recommendations for screening to avoid bad outcome. Spine 1994; 20:460-8.
9.Nygaard OP, Kloster R, Solberg T. Duration of leg pain as a predictor of outcome after surgery for lumbar disc herniation: a prospective cohort study with 1-year follow up. J Neurosurg. 2000 Apr;92(2 Suppl):131-4 .
10.Nygaard OP, Romner B, Trumpy JH. Duration of symptoms as a predictor of outcome after lumbar disc surgery. Acta Neurochir (Wien). 1994;128(1-4):53-6 .
11. Trief P, Grant W, Fredrickson B (2000) A prospective study of psychological predictors of lumbar surgery outcome. Spine 25:2616–2621 .
12.Hansenbring M. Chronifizierung bandscheibenbedingter Schmerzen: riskoftoren und gesanheitsforden des verhalten. New York: Schuatter, 1992.
13.Sorensen LV, Mors O, Skovlund O. Aprospective study of the importance of psychological and social factors for the outcome after surgery in patients with slipped lumbar disc operated upon for the first time. Acta Neurochir (Wein) 1987; 88: 119-25.
14. Fairbank JC, Davies JB, CouperJ, O’Brien JP. The oswestry low back pain disability questionnaire. Physiotherapy 1980; 66: 271-3.
15. Fischer R, Schumacher M, Thoden U. Verlauf nicht operierter lumbaler Bandscheibenvorfalle: radikulaire Storungenund computertomographiscle Befunde. Der Schmerz 1998; 2: 26-32.
16. Fisher K, Johnston M. Validation of the oswestry low back pain disability questionnaire, its sensitivity as a measure of change following treatment and its relationship with other aspects of the chronic pain experience. Physiotherapy Theory and Practice 1997; 13: 67-80.
17. Holt AE, Shaw NJ, Shett A, Greenough GC. The reliability of the low back outcome score for back pain. Spine 2002; 27: 206-10.
18. Tendon V, Campbell F, Ross ERS (1999) Posterior lumbar interbody fusion: association between disability and psychological disturbance in non-compensation patients. Spine 24:1833–1833.
19. Rothoerl RD, et al. “ When should conservative treatment for lumbar disc herniation be ceased and surgery considered ?” Neurosurg Rev- 2002; 25;162-165.
20.Surgery for herniated lumbar disc disease; factors influencing outcome measures. An analysis of 403 cases. Functional neurology 2004, Vol. 19, 43-49.
SIGNATURE OF THE CANDIDATE:
REMARKS OF THE GUIDE : / This is a valid study.
NAME AND DESIGNATION OF THE
GUIDE: / Dr.H Ravindranath Rai
Professor, Unit Head,
Department of Orthopaedics,
K.S. Hegde Medical Academy,
Deralakatte,
Mangalore
SIGNATURE OF THE
GUIDE:
CO-GUIDE:
SIGNATURE OF CO-GUIDE:
HEAD OF THE DEPARTMENT: / Dr.B. Jayaprakash Shetty
Professor and HOD
Department of Orthopaedics
K.S. Hegde Medical Academy
Deralakatte
Mangalore.
SIGNATURE OF THE HEAD OF THE
DEPARTMENT:
REMARKS OF CHAIRMAN AND
PRINCIPAL:
SIGNATURE
PROFORMA
NAME : SERIAL NO. :
AGE : ADDRESS :
PHONE NO :
SEX : M/F
OCCUPATION :
HOSPITAL I.P.NO.:
WARD :
Date Of Admission. : Date Of Discharge :
Date Of Surgery:
1. HISTORY
1.1 PRESENTING COMPLAINTS :
§ Pain
§ Weakness of lower limbs
§ Altered sensation of lower limbs
§ If any specify :
1.2 HISTORY OF PRESENTING ILLNESS :
A. Pain :
a. Onset :– sudden / gradual.
b. Precipitating factors – twist / fall / bending / lifting weight
c. Location - right / left / bilateral/back only / back > leg / leg > back / leg only
d. Progression – increasing / decreasing / same
e. Duration – days / weeks / months / if other
f. Character– cramping / dull aching / shooting
g. Nature -constant / periodic / occasional.
h. Aggravating factors – coughing / sneezing / sitting/standing / bending / walking.
i. Relieving factors – lying down / sitting down.
B. Altered Sensation in Lower Limbs:
a. Abnormal Sensations (Tingling /numbness) – present / absent.
b. Loss of sensation – present / absent.
If present: areas
C. Weakness of lower limbs :
a. Present / absent
b. Specify
D. Bowel / Bladder Disturbances :
a. Present / absent
b. Specify
E. Causes :
a. Trauma
b. Non apparent
1.3. PAST HISTORY :
- Episodes of similar pain – present / absent.
- Frequency
- Average duration of episodes
- Relieved by – specify
1.4. PERSONAL HISTORY:
- H/O diabetes mellitus / hypertension
- Bronchial asthma
- Tuberculosis
II. GENERAL PHYSICAL EXAMINATION:
- Built
- Nourishment
- General abnormality of the skeleton
- Other positive findings.
III. SYSTEMIC EXAMINATION :
- CVS
- RS
- P/A
- CNS
IV. LOCAL EXAMINATION:
i. Examination of Lumbo-sacral Spine
a. Gait
b. Loss of lumbar lordosis – present / absent
c. Scoliosis – present – right / left
- absent
d. Paraspinal spasm – present / absent
e. Tenderness – present /absent, if present specify
f. Limitation of movement – present /absent, if present specify
ii. Nerve Tension Signs
a. Straight leg raising test
b. Well leg raising test