6.1Need for the study
The intervertebral disc is made up of about 20 to 30 percent of the length of the vertebral column.1. It is composed of 3 parts
(i)Central gelatinous, nucleus pulposus
(ii)Surrounding, annulus fibrosus
(iii)Pair of vertebral end plate that sandwich the nucleus.2
Disc is comprised primarily of collagen [type I and type II] , water and proteoglycan.2
Disc herniation is the term given to any uneven out pouching (or) bulging of the posterior region of the intervertebral disc as seen on MRI scan.3
There are 3 main classification of disc herniation
- Protrusion [contained herniation (or) sub ligamentous herniation]
- Extrusion [non contained herniation (or) trans ligamentous herniation]
- Sequestration [free fragment]. 21
Disk degeneration increases with aging and is the most common in the lower lumbar spine. The highest risk factors are
- Genetic inheritance
- Environmental risk factors include high and repetitive mechanical loading
and cigarette smoking
- Heavy lifting
- Routine activities of ADL
- Upright posture.4,5
IVDP with sciatica is present in about 25 % of those with back problem.6
Patient with lumbar disc herniation present with repetitive low back pain, radiating to buttock. Pain is increased by flexion, sitting, straining, coughing, etc. Pain is decreased by rest and in semi fowler position. The radicular pain from the nerve root compression due to herniated disc is evidence by leg pain equal to or more than the back pain. Over 95% of lumbar disc herniation occurs at L4-L5 level, compressing L5 nerve root. The other levels are L5-S1 level, compressing S1 nerve root and L3-L4 level, compressing L4 nerve root.20.
Approximately 97% of painful lumbar spine condition resolves satisfactorily with aggressive conservative care.Only 1-3% of patient with degenerative condition of the lumbar spine require surgical treatment.2
The criteria for operative treatment agreed by American Association of Neurological Surgeon and AmericanAcademy of Orthopedic Surgeon are
- Radicular pain following a dermatome pattern
- Failure of 2 to 4 weeks of appropriate conservative treatment
- Limited SLR with reproduction of radicular pain
- Sensory loss to the dermatome to which leg pain radiates
- Motor loss in the clinically affected nerve
- A depressed tendon reflex appropriate to pain, motor and sensory loss. 7
Cauda equina syndrome is also an indication for operative treatment-
- loss of bladder and bowel control
- profound motor loss
- variable sensory loss.2
Following, are operative treatments for disc excision;
- Laminectomy –disc is excised through removal of spinous process and laminae from one or more vertebrae.8
- Interlaminar or Fenestration- prolapsed disc is excised through a space created between the laminae of two adjacent vertebrae after removing the ligamentum flavum.8
- Hemilaminectomy-only one side lamina is removed to take out the disc material.
- Spinal fusion- it also done to excise disc. 8
- Chemonucleolysis- injection of chymopapain into disc will effect dissolution of mucopolysaccharide of the disc, reduce intradiscal pressure and often effect complete relief of pain.12
Surgical causes of failed back syndrome are
a)Canal stenosis
b)Internal disc disruption
c)Spondylolisthesis
d)Synovial cyst
e)Vascular claudication
f)Instability
g)Pseudo meningiocele
h)Pseudo arthrosis.10
Non surgical causes of failed back syndrome are
a)Epidural fibrosis
b)Degenerated disc
c)Radiculopathy
d)Facet syndrome
e)SI joint syndrome
f)Reflex symphathetic dystrophy
g)Arachnoiditis
h)Psychological. 10
The onset of symptoms of failed back syndrome has been found to vary from 15 days to 48 month and the average was found on 8 month.11
Successful management of patient with failed back syndrome is achieved with proper operative diagnosis, adequate surgical procedure targeting underlying pathology.9
Though the prognosis after lumbar spine surgery is poor, follow up sessions are not followed appropriately, so there is a possibility of recurrence of symptoms due to surgical or non surgical causes. So the incidence of FBSS is scantily reported in literature.
Literature is only available on the Failed Back syndrome’s etiology, surgical and conservative treatment, but hardly there are any studies regarding the incidence of FBSS.Also once the incidence of FBSS is known, this study can further guide future intervention perspectives following the onset of Lumbar disc lesions which results in FBSS.
So the purpose of this study is to identify the incidence of failed back syndrome in subjects who will undergo laminectomy and followed for a period of one year.
Hypothesis:
As it is cohort study which is follow up study for more than one year for laminectomy subjects, hypothesis is not considered.
6.2Review of Literature:
Manca Eldable, Buchser Kumar, Taylor (2010)aimed to quantify the extend to which reduction in leg and back pain and disability over time translate into improvement in generic HRQOL as measured by the EuroQol- 5D and SF -36 instrument and disease specific outcome measure ODI, leg and back pain, VAS neuropathic patient with FBSS. They concluded that reduction in leg pain and functional disability is statistically significant associated with improvement in generic HRQOL.14
Metehan Eseoglu, Hidayet Akdmir (2009), analysed the recurrent cause of failed back surgery syndrome in post operative lumbar disc herniation, especially epidural fibrosis and recurrent case in reoperation. They found that recurrent disc herniation occur on the sane level, same side or opposite side is the most frequent cause for reoperation in patients with lumbar disc herniation surgery and epidural fibrosis formation is second frequent cause.11
Brandy Miller, Robert Gatchel, Leland Lou, Anna Stouuell, Peter Polatin (2005), conducted study to elucidate the difference between FBSS patient and other chronic lumbar pain patient to clarify the role of injection in interdisciplinary treatment particularly with failed back surgery syndrome patient. They found that non failed back surgery syndrome patient were associated with greater reduction in self reported pain and disability than failed back surgery syndrome patient. They also proved that the FBSS patient were significantly more improved on physical therapy measure including ADL, strength and fear of exercise.15
Ghaussan Skaf, Carmel Bouclaus, Ali Alaraj, Roukoz Chamoun (2005), under took study to report on the post surgical outcome after redo spinal surgery. They took 50 patients with FBSS and pathology was identified. The patients were treated by redo surgery which targeted at correcting the underlying pathology, removal of recurrent disc problem, release of adhesion with neural decompression and fusion with or without instrument. They found post surgical outcome, ODQ (Oswestry Disability Questionnaire) is reduced after surgery compared to before surgery. They concluded that FBSS management could be achieved with proper patient selection, correct preoperative diagnosis, and adequate surgical procedure targeting underlying pathology.9
Jerome Schofferman, Richard Herzog, Conor O veil, Paul Dreyfuss (2003) reported the most common diagnose of FBSS were foraminal stenosis (25%-29%), painful disc (20%), pseduoarthrosis(14%), neuropathic pain (10%), recurrent disc herniation(7%), facet joint (3%),sacroiliac joint (SIJ) pain (2%). Psychological factors include depression, anxiety disorder and substance abuse disorder may also contribute. They found that diagnostic injections are very useful for facet joint pain, SIJ pain and discogenic pain; they also confirmed a putative neural compression as a cause of pain. So they concluded that surgeon has to be aware of common cause of FBSS to minimize the problem.16
Curtis Slipman, Carl Shin, Rajeev Patel, Zacharia Isaac, David Lenrow (2002) reported the epidemiology data of non surgical and surgical etiologies of FBSS. They reviewed 267 charts. In that One hundred and ninety-seven (197) charts had a complete workup. Of these, 11 (5.6%) had an unknown etiology, and 186 had a known diagnosis. Twenty-three (23) various diagnoses were identified. They found that approximately there is an equal distribution between the incidences of nonsurgical and surgical diagnoses; 44.4% had nonsurgical diagnoses and 55.6% had surgical diagnoses. They identified that the most common diagnoses were spinal stenosis, internal disc disruption syndrome, recurrent/retained disc, and neural fibrosis.17
Young Soo Kim, Sung Uk Kuh, Young Eun Cho, Byung Ho Jin, Doung Kyu Chin (2001), evaluated the role of anterior lumbar inter body fusion in treatment of failed back syndrome. They took 15 patient with failed back syndrome, (6 cases with discitis, 5 cases adhesion, 3 cases instability, 1 cases recurrence, they treated that 15 patient with anterior lumbar inter body fusion. 11 cases got satisfactorily result, 3 patient improved slightly, one patient no improvement. So they concluded that anterior lumbar interbody fusion for FBS seems to be safe and favorable treatment in selective patients, due to low incidence of nerve injury and post operative infection.22
Chang- Myung Lee, Seung- Hwan Yown, John Cho, Chang- Taek Moon (2000) analyzed the factor affecting favorable outcome in the treatment of failed back surgery syndrome. They studied demographic data, etiologies, clinical manifestation, outcome according to method of operation, number of previous surgery and time interval between initial and final operation among 75 patients who diagnosed as FBSS. They concluded that the treatments outcome in FBSS was favorable in case of complete total laminectomy and spinal fusion with instrument, only one previous surgery and short time interval between initial and final operation.18
Park HC, Kim YS (1993) did study on 186 cases of FBSS who were admitted in clinic. He found that common cause of FBSS was resulted from in adequate surgery or surgical complication. In complete decompression cases initial operation was seemed to be major factor, next cause was due to inadequate patient selection. They found that FBSS was more prevalent when patient had only back pain without leg pain, other cause were post operative adhesion, discitis and inadequate diagnosis.19
6.3Objectives of the study:
To evaluate the incidence of failed back syndrome in subjects who will undergo Laminectomy with lumbar disc lesions.
7. / Materials and Methods:
7.1 Source of Data
1)Padmashree physiotherapy clinic, Nagarbhavi circle, Bangalore.
2)Padmashree diagnostic, vijaya nagar, Bangalore.
3)ESI hospital, Rajaji nagar, Bangalore.
4)CSI hospital, Kanchipuram.
7.2 Method of collection of data:
Population : - Subjects with IVDP (diagnosed by orthopaedician or neuro surgeon by MRI scan report).
Sample design :- Purposive sampling
Sample size :- 40
Type of Study : -Prospective cohort study.
Inclusion criteria:
1)Age between 20-60 years of age
2)Subjects with IVDP in lumbar region diagnosed by orthopaedician or neurosurgeon by MRI scan report.
3)Subjects who will undergo lumbar spinal surgeries (one or more than one surgeries) for lumbar disc pathology.
Exclusion criteria:
1)Subjects with TB spine.
2)Subjects with trauma or injury to vertebrae.
3)Subjects with space occupying lesion.
4)Subjects with carcinoma.
7.3 Methodology:
40 subjects will be taken who were diagnosed as IVDP patients by Orthopaedician or Neurosurgeon. Diagnosis is being confirmed by MRI scan. Informed consent will be taken.
Subjects who will undergo Laminectomy surgery for lumbar disc lesion will be taken as GROUP A.
Subjects who will not undergo Laminectomy surgery for lumbar disc lesion will be taken as GROUP B.
Demographic data consisting of name of the subject, age, gender, occupation, contact address, phone number, mail address, will be collected from the subject.
Data such as registered number, date and type of surgery for laminectomy subject, type of treatment for non laminectomy will be collected from the case sheet of the subjects.
A continuous follow up will be done for every consecutive month in both groups for more than one year, to evaluate the prognosis of the subjects whether there is resolution of previous symptoms or getting the recurrence of similar symptoms which is failed back syndrome.
Failed back syndrome can be confirmed in the subjects with the presentation of following clinical features.
-Pain
-Weakness
-Numbness
- Spasm
. -Bladder and bowel difficulty 13
From the above procedure incidence of failed back syndrome in each group will be noted and documented accordingly.
Statistics:
The data will be analyzed using
- Fisher exact test
- Relative risk ratio
As this study involve human subjects, the ethical clearance has been obtained from the ethical committee of Padmashree Institute of Physiotherapy, Nagarbhavi, Bangalore, as per ethical guidelines research from biomedical research on human subjects, 2000, ICMR, New Delhi.
8 /
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- Manca A, Eldabe S, Buchser E, Kumar K, Taylor RS, Relationship between health- related quality of life, pain, and functional disability in neuropathic pain patients with failed back surgery syndrome, Epub 2009,13(1):95-102
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