Assessment of efficacy and safety of metabolic therapy in treatment of recurrent vertebrogenic lumbosacral radiculopathy
F.A. KHABIROV1,2, T.I. KHAYBULLIN1,2, E.V. GRANATOV2
KSMA ― Branch Campus of the FSBEI FPE RMACPE MOH Russia, 36 Butlerov Str., Kazan, Russian Federation, 420012
Republican Clinical Neurology Center of the MH of RT, 13 Vatutin Str., Kazan, Russian Federation, 420021
Khabirov F.A. — D. Med. Sc., Professor, Head of the Department of Neurology and Manual therapy, Chief Physician of Republican Clinical Neurology Center, tel. (843) 278-88-29, e-mail: rkdcdz@rkbvl.ru
Khaybullin T.I. — Cand. Med. Sc., Associate Professor of the Department of Neurology and Manual therapy, neurologist, tel. (843) 278-88-29, e-mail: timuur@gmail.com
Granatov E.V. — Cand. Med. Sc., neurologist, tel. (843) 278-88-29, e-mail: rkdcdz@rkbvl.ru
Assessment of efficacy and safety of metabolic therapy (MT), including niacinamide, cocarboxylase, cyanocobalamin, disodium adenosine triphosphate trihydrate in treatment of recurrent vertebrogenic lumbosacral radiculopathies (RVLR) is conducted. This placebo-controlled clinical trial enrolled 40 patients with RVLR L5 and/or S1 who were randomized to 2 parallel groups. In group 1 (G1: n=20, age 44,3 (7,98) years, M/F — 55/45%) patients were treated with MT and basic therapy (diclofenac sodium 100 mg/day №10 + tizanidine 6 mg/day №24), in group 2 (G2: n=20, age 45,3 (8,25) years, M/F — 60/40%) patients received placebo (0,9% NaCl solution) and basic therapy. Before and after 30 days of treatment the condition of patients was examined clinically on a 5-point verbal rating scale (5 BVSH), Oswestry disability index (ERI) and by means of neurophysiological methods. After treatment in G1 was registered marked improvement on 5-PVRS (p=0,046) and ODI (in G1 it declined from 42[36;49]% to 26[18;34]%, in G2 from 38[30;50]% to 34[24;38]%; p=0,04). More significant regression of total neurophysiological abnormalities was observed in G1 (77,8 vs. 35,3%; p=0,02). Also, it was not possible to identify significant between-group differences in the regression of certain neurophysiological abnormalities (p>0,05) and complete leveling of neurophysiological abnormalities (22,2 vs. 5,9%; p=0,35). Tolerability and safety of treatment in both groups was satisfactory. Therefore, MT added to basic therapy increases treatment efficacy of RVLR.
Key words: radiculopathy, metabolic therapy, treatment, efficacy, safety.
REFERENCES
- Khabirov F.A., Kochergina O.S., Granatov E.V. et al. Clinical and neurophysiological evaluation of the efficacy of L-lysine escinate in the combination therapy of acute compression-ischemic radiculopathies. Nevrologicheskiy vestnik, 2012, 44 (4), pp. 60-64 (in Russ.).
- Khabirov F.A. Rukovodstvo po klinicheskoy nevrologii pozvonochnika [A guide to clinical neurology of the spine]. Kazan, 2006. 518 p.
- Barr K. Electrodiagnosis of lumbar radiculopathy. Physical medicine and rehabilitation clinics of North America, 2013, 24 (1), pp. 79-91. DOI:10.1016/j.pmr.2012.08.011.
- Chang C.W., Lien I.N. Spinal nerve stimulation in the diagnosis of lumbosacral radiculopathy. American Journal of Physical Medicine & Rehabilitation, 1990, 69 (6), pp. 318-322. DOI:10.1097/00002060-199012000-00008.
- Kamitani K., Baba H., Shimada T., Chiba H. Electrophysiologic analysis of the lumbosacral radiculopathy using nerve root conduction velocity (NRCV) and cauda equina action potentials (CEAP). Nihon Seikeigeka Gakkai zasshi, 1993, 67 (7), pp. 631-643. (In Japan).
- Sabbahi M.A., Khalil M. Segmental H-reflex studies in upper and lower limbs of patients with radiculopathy. Archives of physical medicine and rehabilitation, 1990, 71 (3), pp. 223-227.
- Banerjee T.K., Mostofi M.S., Us O., et al. Magnetic stimulation in the determination of lumbosacral motor radiculopathy. Electroencephalography and Clinical Neurophysiology (Evoked Potentials Section), 1993, 89 (4), pp. 221-226. DOI: 10.1016/0168-5597(93)90099.
- Mondelli M., Aretini A., Arrigucci U., et al. Sensory nerve action potential amplitude is rarely reduced in lumbosacral radiculopathy due to herniated disc. Clinical Neurophysiology, 2013, 124 (2), pp. 405-409. DOI:10.1016/j.clinph.2012.07.020.
- Beyaz E.A., Akyüz G., Us O. The role of somatosensory evoked potentials in the diagnosis of lumbosacral radiculopathies. Electromyography and clinical neurophysiology, 2009, 49 (4), pp. 131-142.
- Fisher M.A., Bajwa R., Somashekar K.N. Routine electrodiagnosis and a multiparameter technique in lumbosacral radiculopathies. Acta Neurologica Scandinavica, 2008, 118 (2), pp. 99-105. DOI:10.1111/j.1600-0404.2007.00987.x.
- Botez S.A., Zynda-Weiss A.M., Logigian E.L. Diffuse age-related lumbar MRI changes confound diagnosis of single (L5) root lesions. Muscle & nerve, 2014, 50 (1), pp. 135-137. DOI:10.1002/mus.24170.
- Carter G.T., Fritz R.C. Electromyographic and lower extremity short time to inversion recovery magnetic resonance imaging findings in lumbar radiculopathy. Muscle & nerve, 1997, 20 (9), pp. 1191-1193. DOI: 10.1002/(SICI)1097-4598(199709)20:9<1191::AID-MUS18>3.0.CO;2-W.
- Levin O.S., Moseĭkin I.A. Vitamin B complex (milgamma) in the treatment of vertebrogenic lumbosacral radiculopathy. Zhurnal nevrologii i psikhiatrii imeni SS Korsakova/ /Ministerstvo zdravookhraneniia i meditsinskoi promyshlennosti Rossiiskoi Federatsii, Vserossiiskoe obshchestvo nevrologov [i] Vserossiiskoe obshchestvo psikhiatrov, 2008, 109 (10), pp. 30-35 (in Russ.).
- Pareek A., Chandurkar N., Chandanwale A.S., et al. Aceclofenac-tizanidine in the treatment of acute low back pain: a double-blind, double-dummy, randomized, multicentric, comparative study against aceclofenac alone. European Spine Journal, 2009, 18 (12), pp. 1836-1842. DOI 10.1007/s00586-009-1019-4.
- Mkrtumyan A.M., Podachina S.V., Doskina E.V., Ablina K.N. Effective treatment of diabetic neuropathy with the complex preparation of cocarine. Effektivnaya farmakoterapiya, 2015, 43, pp. 44-50 (in Russ.).
- Fairbank J.C., Pynsent P.B. The Oswestry disability index. Spine, 2000, 25 (22), pp. 2940-2953. DOI: 10.1097/00007632-200011150-00017.
- Cherepanov E.A. Russian version of the Oswestry questionnaire: validity and reliability of the test. Vestnik travmatologii i ortopedii im. N.N. Priorova, 2011, 1, pp. 73-79 (in Russ.).