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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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