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|6 |Brief resume of the intended work: |

| |Need 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 |

| |Central gelatinous, nucleus pulposus |

| |Surrounding, annulus fibrosus |

| |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 American Academy 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 |

| | |

| |Failed back syndrome is a condition in which there is failure to improve satisfactorily after back surgery. It is characterized by |

| |intractable pain and various degree of functional disability after lumbar spine surgery. It is estimated that complication occur in 5-10% |

| |of patient after spinal surgeries.9 |

| |Surgical causes of failed back syndrome are |

| |Canal stenosis |

| |Internal disc disruption |

| |Spondylolisthesis |

| |Synovial cyst |

| |Vascular claudication |

| |Instability |

| |Pseudo meningiocele |

| |Pseudo arthrosis.10 |

| | |

| | |

| |Non surgical causes of failed back syndrome are |

| |Epidural fibrosis |

| |Degenerated disc |

| |Radiculopathy |

| |Facet syndrome |

| |SI joint syndrome |

| |Reflex symphathetic dystrophy |

| |Arachnoiditis |

| |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. |

| | |

| |Review 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 |

| |Objectives 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: |

| |Source of Data |

| |Padmashree physiotherapy clinic, Nagarbhavi circle, Bangalore. |

| |Padmashree diagnostic, vijaya nagar, Bangalore. |

| |ESI hospital, Rajaji nagar, Bangalore. |

| |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: |

| |Age between 20-60 years of age |

| |Subjects with IVDP in lumbar region diagnosed by orthopaedician or neurosurgeon by MRI scan report. |

| |Subjects who will undergo lumbar spinal surgeries (one or more than one surgeries) for lumbar disc pathology. |

| | |

| |Exclusion criteria: |

| |Subjects with TB spine. |

| |Subjects with trauma or injury to vertebrae. |

| |Subjects with space occupying lesion. |

| |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 |

| |7.4 Ethical Clearance:- |

| |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 |List of References: |

| |Pamele Levangie, Cynthia Norkin, Joint structure and function, Fourth edition, New Delhi, Jaypee Brothers, 2006, p-146. |

| |Andrew Cole,, Stanely Herring, The Low Back Hand Book, A Practical guide for the primary care clinician, First edition , New Delhi, Jaypee|

| |Brothers, 1997, p 2 , 20 ,253 , 259 , 270. |

| |Muzahim M.Taha, Muhammed Hameed Faedh,; Functional recovery for patient with lumbar sacral disc prolapse undergoing Laminectomy and |

| |Disectomy. European Journal of Scientific Research, 2010, Vol 45, (1), p (22-36). |

| |Battie MC, Viderman T, Parent E., Lumbar disc degeneration; epidemiology and genetic influences, Spine (phila pa 1976), Dec 2004, 1-29 (23),|

| |2679-2690. |

| |Michael. A. Adams, Peter. J. Roughley., What is Intervertebral Disc Degeneration, and what cause it, Spine 2006, 31(18), 2151-2161. |

| |David G Borenstein, Sam W Wiesel, Sutt Boden , Low Back and Neck Pain Comprehensive diagnosis and management, second edition, USA, |

| |Elsevier, 2004, p 43. |

| |GS Kulkarni., Text book of Orthopaedic and Trauma, Second edition, New Delhi, Jaypee, 2008,p 2818-2822, vol 2. |

| |Jayant Joshi, Prakash Kotwal, Essential of Orthopaedic and Applied Physiotherapy, First edition, New Delhi, Elsevier, 2007, p448-449. |

| |Ghasan Skaf MD, FRCS, Camel Bouclaous MS, Ali Alaraj MD, Roukoz Chamom, Clinical outcome of Surgical treatment of Failed Back Surgery |

| |Syndrome, Journal of surgical neurology , Dec 2005. Vol 64, Issue 6, 483-488. |

| |Flavio Frienkel Rodrigue, Diego Cassol Dozza, Claudio Russia, De Oliveria , Ricardo Gomes de Castro, Failed|

| |Back Surgery Syndrome, Causitic and etiology, Arquios De Neuro Psiquiatria, Sep 2006, Vol 64, no.36. |

| |Metchen Eseoglu, Hidayet Akdemir, Failed Back Surgery Syndrome in Lumbar Disc Herniation.: The retrospective analysis of success scoring of |

| |epidural fibrosis and recurrent cases in reoperation, European Journal of General medicine, 2010; 7 (2), 130-135. |

| |Samuel Turek, Orthopaedic Principle and their application, Fourth edition, New York, Lippincott, 1998, p1495. 2nd volume. |

| |Lina Talbot, Failed back surgery syndrome, British Medical journal, Oct 2003, 25; 327 (7421); 985-986. |

| |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 |

| |Brandy Miller, Robert Gatchel, Leland Lou, Anna Stouuell, Peter Polatin Interdisciplinary Treatment of Failed Back Surgery Syndrome (FBSS): |

| |A Comparison of FBSS and Non-FBSS Patients, Pain Practice, September2005, Volume 5, Issue 3, 190–202, |

| |Jerome Schofferman, Richard Herzog, Conor O veil, Paul Dreyfuss, Failed Back surgery: etiology and diagnostic evaluation, The Spine Journal,|

| |2003, Volume 3, issue 5, 400-405. |

| |Curtis Slipman et al, Etiologies of Failed Back Surgery Syndrome, Pain medicine, 2002, Volume 3, (3), 200-214. |

| |Chang- Myung Lee, Seung- Hwan Yown, John Cho, Chang- Taek Moon, The Factors Affecting the Favorable Outcomes in the Treatment of the Failed |

| |Back Surgery Syndrome, Journal Korean Neuro Surgery 2000, Volume 29, Number 2 (2/2000), 203-9. |

| |Park HC, Kim YS, Clinical Evaluation of Failed Back Surgery Syndrome (FBSS), Journal Korean Neuro Surgery, 1993, Volume 22, (1), 48-57.  |

| |John Ebenezar, Essential of orthopaedics for physiotherapists, First edition, New Delhi, Jaypee brother, 2005, p296. |

| |Wong, David A, Transfeldt, Ensor, Macnab's Backache, Fourth edition, USA, Lippincott Williams & Wilkins, 2007, p 80. |

| |Young Soo Kim, MD;Sung Uk Kuh, MD;Young Eun Cho, MD;Byung Ho Jin, MD and Dong Kyu Chin, MD, Clinical Analysis of Anterior Lumbar Interbody |

| |Fusion for Failed Back Surgery Syndrome, Journal Korean Neuro Surgery, 2001, Volume 30, Number 6, 734-42. |

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