|Year : 2020 | Volume
| Issue : 2 | Page : 75-78
Efficacy of gabapentin in the management of failed back surgery syndrome: A scoping review of literature
Vishal Kumar, Amit Kumar Salaria, Ashish Dagar, Saurabh Aggarwal, Prasoon Kumar, Sarvdeep Singh Dhatt
Department of Orthopaedics, PGIMER, Chandigarh, India
|Date of Submission||29-Mar-2020|
|Date of Decision||19-May-2020|
|Date of Acceptance||23-Jun-2020|
|Date of Web Publication||10-Sep-2020|
Amit Kumar Salaria
Department of Orthopaedics, PGIMER, Sector - 12, Chandigarh - 160 012
Source of Support: None, Conflict of Interest: None
Failed Back surgery syndrome or persistent low back pain following lumbar surgery is a known complication of lumbosacral spine surgery. The incidence of FBSS ranges from 5% to 10% postlumbosacral surgery. It is characterized by disabling pain resistant to usual analgesic and physiotherapy. Epidural fibrosis is found to be the most common cause of FBSS. Various treatment modalities such as spinal canal stimulation, epidural corticosteroids injection, Non steriodal antiinflammatory drugs, opioids, and repeat surgery have been tried for the management of FBSS, but none of them have shown a promising result. The second surgery in such patients has a poor success rate of only 30%–35%. 15%–20% patients even reported worsening of symptoms after a second surgery. Gabapentin which is an analog of gamma-aminobutyric acid has shown good results in few studies in reducing pain in patients with failed back surgery syndrome FBSS. Few case reports and randomized control trials published in recent past has shown good efficacy of gabapentin in reducing low back pain as well as leg pain associated with failed back surgery syndrome FBSS. To conclude, gabapentin can be tried in a patient with FBSS, but its efficacy needs to be established with a large multicentric study.
Keywords: Epidural fibrosis, failed back surgery syndrome, gabapentin, radiculopathy, recurrent low back pain
|How to cite this article:|
Kumar V, Salaria AK, Dagar A, Aggarwal S, Kumar P, Dhatt SS. Efficacy of gabapentin in the management of failed back surgery syndrome: A scoping review of literature. J Orthop Dis Traumatol 2020;3:75-8
|How to cite this URL:|
Kumar V, Salaria AK, Dagar A, Aggarwal S, Kumar P, Dhatt SS. Efficacy of gabapentin in the management of failed back surgery syndrome: A scoping review of literature. J Orthop Dis Traumatol [serial online] 2020 [cited 2020 Sep 22];3:75-8. Available from: http://www.jodt.org/text.asp?2020/3/2/75/294724
| Introduction|| |
Failed back surgery syndrome (FBSS) or postlumbar surgery syndrome is persistent or recurring low back pain with or without lower limb radiation following previous surgery for lumbar pathology. However, there are many other causes for persistent low back pain which may not be related to surgery; herniated disc at nonsurgical site, spinal canal stenosis, facet joint arthrosis, or spondylosis, making FBSS a misnomer. Actual cause of surgery-related pain could be residual disc, epidural scarring, discitis, osteomyelitis, or arachnoiditis. Postoperatively, the patient continues to experience intolerable pain which could lead to functional disability. The second surgery may be indicated, especially in cases with epidural fibrosis and residual disc, but the success rate following such surgeries is not very good.,,
Different treatment modalities have been tried to manage patients with FBSS, but none of them have been found to be completely effective. These include medication,,,, exercises and physiotherapy,, spinal cord stimulation,,,, epidural adhesiolysis,,, injection therapy,,, radiofrequency therapy, and surgery.,,,,,,, Analgesic agents including Non Steroidal Anti Inflammatory drugs (NSAIDs) and opioids and neuromodulators have been tried to control pain in these cases., One such agent is gabapentin which is an analog of gamma-aminobutyric acid (GABA). Initially approved as an anticonvulsant, it was later found to be effective in treating neuropathic pain., It regulates the conductance of voltage-gated calcium channels and hence reduces presynaptic release of excitatory neurotransmitter in the dorsal horn which is related to pain generation. However, there is still no clear cut consensus regarding the effectiveness of gabapentin in patients with FBSS, and the present descriptive review was conducted to assess its efficacy for the same by analyzing the evidence present in the literature.
| Methods|| |
The literature search was conducted based on PRISMA guidelines and checklist. The databases of PubMed, Scopus, EMBASE, and Cochrane central registration of controlled trials were searched on March 1, 2019, using standard medical subject heading terms Gabapentin and FBSS. All the relevant searches were read by three independent reviewers, and studies with data regarding the use of gabapentin as a treatment modality of FBSS were selected. References and citations of relevant articles were checked for additional studies.
Data were extracted from each included study, and the study design, study population, interventions, duration of therapy, follow-up duration, dropout number, and parameter used to assess the outcomes were tabulated.
| Results|| |
There were only six hits with the search on all databases.,,,,, Full texts were read and among these, five studies were found relevant and eligible for inclusion. Three of them were randomized control trial (RCT) and two were case reports published in the past two decades.,,,,, In the three RCTs, the study population were randomized into two groups by computer-based algorithm and the two groups were similar with regard to age, sex ratio, time elapsed since surgery, and duration of pain. The visual analog score (VAS) for pain was one of the parameters used to analyze the effectiveness of therapy in all three RCTs.,, The study population ranged from age 42 to 58 years with male: female ratio of 9:12. The total number of patients randomized in each study varied from 32 to 44. Intervention in the control group for each of the RCT was different.
The first RCT published by Beyazit Zencirci in the year 2010 compares the analgesic efficacy of oral gabapentin added to standard epidural corticosteroids with epidural corticosteroids alone in patients with FBSS. All the patients included in the study had a history of previous lumbar surgery with duration of symptoms more than 6 weeks. Of the 42 patients who met the inclusion criteria, 23 were female and 19 were male, they were randomly assigned to two treatment groups. After a single dose of epidural methylprednisolone, one group (Group K) patient received naproxen with tizanidine and in the second group (Group G) gabapentin was added to the same treatment regime continued for a month. It was observed that compared with Group K cases (4.50 ± 1.60 day), the pain level regressed earlier in Group G cases (3.45 ± 1.70 day) and VAS score continued to be significantly lower in Group G patients at 1-, 3-, and 6-month follow-up.
Another RCT published by Khosravi et al. in the year 2014 compares the efficacy of gabapentin with that of naproxen in cases with FBSS. Of the 40 patients meeting the inclusion criteria, 17 were male and 23 were female and were randomized into two treatment groups with 20 patients in each group using computer-generated algorithm. A baseline VAS score was recorded separately for back pain and leg pain and was comparable in two groups. The first group (Group G) was started on a daily dose of gabapentin 300 mg and dose was increased at the end of every week by 300 mg to reach a maximum dose of 1800 mg at 6 weeks which was continued for the next 6 months. Similarly, the second group (Group N) was started with naproxen 250 mg and dose was increased weekly by 250 mg to reach a maximum dose of 1500 mg at 6 weeks. On follow–up, VAS scores were assessed every 2 weeks until 8 weeks and then every month until 6 months. Back pain showed a significant response to gabapentin therapy, the VAS score decreased by 20.5 % at 6 weeks (from 6.8 to 5.4 ) and to 27.2% by the end of study at 6 months (4.9, P < 0.001). In the Naproxen group, VAS score for back pain increased from 6.55 to 7.15 at 6 weeks and further to 8.0 at the end of the study. Leg pain VAS score for group G decreased by 39.2 % at 6 weeks (from 5.6-3.4) and by 73.3 % (to 1.55 ) by the end of study (P < 0.001). In Group N, VAS score for leg pain decreased from 5.8 to 5.3 at 6 weeks and continued to decrease until 12 weeks after which it increased to reach a value of 6.35 at the end of the study.
The third and most recent RCT published in 2019 by Gewandter et al. compares the efficacy of extended-release gabapentin with placebo therapy. The primary outcome measure used was the numeric rating scale (0–10). It was a double-blinded study with 32 patients randomized to receive extended-release gabapentin and then placebo or placebo and then extended-release gabapentin with a washout period of 10 days in between. This study does not show any difference between the numerical rating scale scores of two groups and hence failed to demonstrate any effect of extended-release gabapentin for pain associated with FBSS.
A case report of two cases published in 2001 showed significant improvement in the VAS score of both the patients (9 to 2) in pain associated with FBSS treated with gabapentin over a period of 6 months. Another case report published in 2011 by S.T. Chang also shows a significant improvement in the VAS score (8 to 3) following gabapentin therapy in a young male with pain associated with FBSS. [Table 1] shows the demographic details of the various patients recruited in the study. [Table 2] depicts the VAS scores before and after treatment with gabapentin.
|Table 2: Comparison of patients visual analog score before and after treatment|
Click here to view
| Discussion|| |
FBSS concerns 10%–40% of patients with lumbosacral spinal surgery., One of the most frequent causes of FBSS is epidural fibrosis.,, Other causes may be inadequate surgical technique, residual disc, wrong level surgery, vertebral instability, recurrent disc herniation, arachnoiditis, and infection. Success rate of reoperation for recurrent disc herniation is comparable to first surgery. In patients with epidural fibrosis, the success rate is only 30%–35%. Symptoms may worsen in 15%–20% of cases post reoperation., Due to this poor surgical success rate, there is a need for alternative therapeutic modalities like pharmacological treatment. One of such pharmacological agent is gabapentin which is GABA analog and regulates the voltage-gated calcium channel and reduces presynaptic release of excitatory neurotransmitter in the dorsal horn.
There are some reports of using high-dose gabapentin for chronic radiculopathy with success. [40,41] Gabapentin has also shown efficacy in patients with neuropathic pain syndrome., Very few studies have been published regarding the use of gabapentin in a subset of patients with FBSS. Beyazit Zencirci demonstrated the benefit of adding gabapentin to standard epidural corticosteroid injection. Similarly, Khosravi et al. showed that in comparison to naproxen, gabapentin significantly improves the pain score for patients with FBSS. Two case reports published in the past by Debra L. Braverman and S.T. Chang also demonstrated the efficacy of gabapentin in patients with FBSS. However, a recently published study by Gewandter et al. failed to demonstrate any effect of extended-release gabapentin for pain associated with FBSS. All the studies published till now are single-center studies with a small number of cases; a large multicentric study is needed to establish the efficacy of gabapentin in patients with FBSS.
| Conclusion|| |
Very few studies have been published in the past regarding the efficacy of gabapentin in FBSS, the number of cases in such literature was also less. We have done a scoping review of the available literature comparing the efficacy of gabapentin as an adjunct or alone in the management of FBBS in symptoms of persistent back pain and leg pain, and gabapentin has definitely shown a beneficial effect in the management of FBBS, especially FBSS-associated leg pain. Patients of FBSS with refractory pain should be given a trial of gabapentin either alone or as an adjunct to other therapy. However, a large multicentric study is needed to establish the efficacy of gabapentin in patients with FBSS.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
North RB, Campbell JN, James CS, Conover-Walker MK, Wang H, Piantadosi S, et al
. Failed back surgery syndrome: 5-year follow-up in 102 patients undergoing repeated operation. Neurosurgery 1991;28:685-90.
Rigoard P, Desai MJ, Taylor RS. Failed back surgery syndrome: what's in a name? A proposal to replace “FBSS” by “POPS”. Neurochirurgie 2015;61:S16-21.
Fiume D, Sherkat S, Callovini GM, Parziale G, Gazzeri G. Treatment of the failed back surgery syndrome due to lumbo-sacral epidural fibrosis. Acta Neurochirurgica 1995;64:116-8.
Fritsch EW, Heisel J, Rupp S. The failed back surgery syndrome: reasons, intraoperative findings, and long-term results: A report of 182 operative treatments. Spine 1996;21:626-33.
Braverman DL, Slipman CW, Lenrow DA. Using gabapentin to treat failed back surgery syndrome caused by epidural fibrosis: A report of 2 cases. Arch Phys Med Rehabil 2001;82:691-3.
Cho JH, Lee JH, Song KS, Hong JY. Neuropathic pain after spinal surgery. Asian Spine J 2017;11:642-52.
Khosravi MB, Azemati S, Sahmeddini MA. Gabapentin versus naproxen in the management of failed back surgery syndrome; a randomized controlled trial. Acta Anaesthesiol Belg 2014;65:31-7.
Zencirci B. Analgesic efficacy of oral gabapentin added to standard epidural corticosteroids in patients with failed back surgery. Clin Pharmacol 2010;2:207-11.
Canos A, Cort L, Fernández Y, Rovira V, Pallarés J, Barberá M, et al
. Preventive analgesia with pregabalin in neuropathic pain from “failed back surgery syndrome”: Assessment of sleep quality and disability. Pain Med 2016;17:344-52.
Anderson JT, Haas AR, Percy R, Woods ST, Ahn UM, Ahn NU. Chronic opioid therapy after lumbar fusion surgery for degenerative disc disease in a workers' compensation setting. Spine (Phila Pa 1976) 2015;40:1775-84.
Karahan AY, Sahin N, Baskent A. Comparison of effectiveness of different exercise programs in treatment of failed back surgery syndrome: A randomized controlled trial. J Back Musculoskelet Rehabil 2016;17:160722.
Kruse RA, Cambron J. Chiropractic management of postsurgical lumbar spine pain: A retrospective study of 32 cases. J Manipulative Physiol Ther 2011;34:408-12.
Taylor RS, Desai MJ, Rigoard P, Taylor RJ. Predictors of pain relief following spinal cord stimulation in chronic back and leg pain and failed back surgery syndrome: A systematic review and meta-regression analysis. Pain Pract 2014;14:489-505.
Kelly GA, Blake C, Power CK, O'Keeffe D, Fullen BM. The impact of spinal cord stimulation on physical function and sleep quality in individuals with failed back surgery syndrome: A systematic review. Eur J Pain 2012;16:793-802.
Frey ME, Manchikanti L, Benyamin RM, Schultz DM, Smith HS, Cohen SP. Spinal cord stimulation for patients with failed back surgery syndrome: A systematic review. Pain Physician 2009;12:379-97.
Kumar K, North R, Taylor R, Sculpher M, Van den Abeele C, Gehring M, et al
. Spinal Cord Stimulation versus. Conventional medical management: A prospective, randomized, controlled, multicenter study of patients with failed back surgery syndrome (PROCESS Study). Neuromodulation 2005;8:213-8.
Epter RS, Helm S 2nd
, Hayek SM, Benyamin RM, Smith HS, Abdi S. Systematic review of percutaneous adhesiolysis and management of chronic low back pain in post lumbar surgery syndrome. Pain Physician 2009;12:361-78.
Helm Ii S, Benyamin RM, Chopra P, Deer TR, Justiz R. Percutaneous adhesiolysis in the management of chronic low back pain in post lumbar surgery syndrome and spinal stenosis: a systematic review. Pain Physician 2012;15:E435-62.
Manchikanti L, Manchikanti KN, Gharibo CG, Kaye AD. Efficacy of percutaneous adhesiolysis in the treatment of lumbar post surgery syndrome. Anesth Pain Med 2016;6:e26172.
Devulder J, Deene P, De Laat M, Van Bastelaere M, Brusselmans G, Rolly G. Nerve root sleeve injections in patients with failed back surgery syndrome: A comparison of three solutions. Clin J Pain 1999;15:132-5.
Fredman B, Zohar E, Ben Nun M, Iraqi R, Jedeikin R, Gepstein R. The effect of repeated epidural sympathetic nerve block on “failed back surgery syndrome” associated chronic low back pain. J Clin Anesth 1999;11:46-51.
Manchikanti L, Singh V, Cash KA, Pampati V, Datta S. Preliminary results of a randomized, equivalence trial of fluoroscopic caudal epidural injections in managing chronic low back pain: Part 3-Post surgery syndrome. Pain Physician 2008;11:817-31.
Hussain AM, Afshan G. Use of pulsed radiofrequency in failed back surgery syndrome. J Coll Physicians Surg Pak 2007;17:353-5.
Arts MP, Kols NI, Onderwater SM, Peul WC. Clinical outcome of instrumented fusion for the treatment of failed back surgery syndrome: a case series of 100 patients. Acta Neurochir (Wien) 2012;154:1213-7.
Biondi J, Greenberg BJ. Redecompression and fusion in failed back syndrome patients. J Spinal Disord 1990;3:362-9.
Duggal N, Mendiondo I, Pares HR, Jhawar BS, Das K, Kenny KJ, et al
. Anterior lumbar interbody fusion for treatment of failed back surgery syndrome: an outcome analysis. Neurosurgery 2004;54:636-43.
Markwalder TM, Battaglia M. Failed back surgery syndrome. Part II: Surgical techniques, implant choice, and operative results in 171 patients with instability of the lumbar spine. Acta Neurochir (Wien) 1993;123:129-34.
Skaf G, Bouclaous C, Alaraj A, Chamoun R. Clinical outcome of surgical treatment of failed back surgery syndrome. Surg Neurol 2005;64:483-8, discussion 488-9.
Delamarter R, Zigler J, Janssen M. Total disc replacement in the failed back surgery patient: analysis of prospective, randomized and continued access cohorts. Spine J 2011;11:S151.
Rosner H, Rubin L, Kestenbaum A, Gabapentin adjunctive therapy in neuropathic pain states. Clin J Pain 1996;12:56-8.
Serpell MG, Gabapentin in neuropathic pain syndrome: A randomized, double-blind, placebo-controlled trial. Pain 2002;99:557-66.
Gee NS, Brown JP, Offord J, Thurlow R, Woodruff GN, The novel anticonvulsant drug, gabapentin (neurontin), binds to the alpha 2 delta subunit of a calcium channel. J Biol. Chem1996;271:5768-76.
Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Ioannidis JP, et al
. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: Explanation and elaboration. BMJ 2009;339:b2700.
Gewandter JS, Frazer ME, Cai X, Chiodo VF, Rast SA, Dugan M, et al
. Extended-release gabap
entin for failed back surgery syndrome: Results from a randomized double-blind cross-over study. Pain 2019;160:1029-36.
Wu YT, Lai MH, Lu SC, Chang ST. Beneficial response to gabapentin portraying with interval change of brain SPECT imaging in a case with failed back surgery syndrome. J Clin Pharm Ther 2011;36:525-8. doi:10.1111/j.1365-2710.2010.01200.x.
Ganty P, Sharma M. Failed back surgery syndrome: A suggested algorithm of care. Br J Pain 2012;6:153-61.
Eldab S, Failed back surgery syndrome: Are our patients getting a fair deal? Br J Pain 2012;6:140-1.
Manchikanti L, Singh V, Cash KA, Pampati V, Datta S. Management of pain of post lumbar surgery syndrome: one-year results of a randomized, double-blind, active controlled trial of fluoroscopic caudal epidural injections. Pain Physician 2010;13:509-21.
Bundschuh CV, Modic MT, Ross JS, Masaryk TJ, Bohlman H. Epidural fibrosis and recurrent disk herniation in the lumbar spine: MR imaging assessment. AJR Am J Roentgenol 1988;150:923-32.
Yildirim K, Sisecloglu M, Karatay S, Erdal A, Levent A, Ugur M, et al
., The effectiveness of gabapentin in patients with chronic radiculopathy. Pain Clinic 2003;15:213-8.
[Table 1], [Table 2]