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 Table of Contents  
ORIGINAL ARTICLE
Year : 2022  |  Volume : 1  |  Issue : 1  |  Page : 21-25

A new diagnostic and therapeutic method for the conservative management of sciatica: A randomized placebo-controlled trial


Department of Orthopaedics, Rohilkhand Medical College and Hospital, Bareilly, Uttar Pradesh, India

Date of Submission19-Feb-2022
Date of Decision15-May-2022
Date of Acceptance02-Nov-2022
Date of Web Publication23-Jan-2023

Correspondence Address:
Varun Kumar Agarwal
Department of Orthopaedics, Rohilkhand Medical College and Hospital, Bareilly - 243 006, Uttar Pradesh
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/juoa.juoa_2_22

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  Abstract 


Background: The term “Sciatica” is commonly used for describing nerve pain in the leg which is caused due to the irritation or compression of the sciatic nerve. It is a source of disability and can interfere with the physical occupation aspect. Estimates for the lifetime incidence of sciatica range from 13% to 40%. Two common nonsurgical interventions used are physical therapy and epidural steroid injections. Pain is regulated by a subset of voltage-gated sodium channels, (NaV1.3, NaV1.7, NaV1.8, and NaV1.9). For this character of sodium channels in neurological pain, a peripheral nerve block is an upcoming treatment other than conventional treatment options such as steroid injections or opioids, analgesics. Methods: We conducted a randomized placebo-controlled trial in which after the application of injection we compared Visual Analog Scale Score, subjective satisfaction scale, straight leg raise (SLR) test preinjection and postinjection at 10 min, 1 week, and at 1 month. Results: In our study, a total of 92 patients were taken for the study: 66 patients in drug mixture group and 26 patients in the placebo group. The present study showed relief from pain up to the maximum follow-up period of 1 month; it also showed improvement in the SLR and also a better patient satisfaction, without any complications. Conclusion: In conclusion, peripheral sodium-channel block can be considered as a diagnostic as well as an option for short-term relief from pain in the patient suffering from sciatica, allowing physiotherapy, and rehabilitation exercises.

Keywords: Placebo, sciatica, sodium channel


How to cite this article:
Malik V, Agarwal VK. A new diagnostic and therapeutic method for the conservative management of sciatica: A randomized placebo-controlled trial. J Uttaranchal Orthop Assoc 2022;1:21-5

How to cite this URL:
Malik V, Agarwal VK. A new diagnostic and therapeutic method for the conservative management of sciatica: A randomized placebo-controlled trial. J Uttaranchal Orthop Assoc [serial online] 2022 [cited 2023 Feb 5];1:21-5. Available from: http://www.juoa.org/text.asp?2022/1/1/21/368387




  Introduction Top


The term “Sciatica” is commonly used for describing nerve pain in the leg which is caused due to the irritation or compression of the sciatic nerve.[1] Sciatica has also been commonly referred to as lumbar radicular pain and accompanies about 10% of cases of low backache. It is a source of disability and can interfere with the physical occupation aspect. Estimates for the lifetime incidence of sciatica range from 13% to 40%.[2]

Sciatica pain is generally localized to the lumbar (L) and sacral (S) roots with maximum pathology being at the level of L4 L5 and L5 S1.[3] Intervertebral disc herniation causes nerve root compression which has been attributed to be the most common cause of sciatica.[4] This nerve root compression then can cause inflammation, pain, and numbness in the affected leg.[5] Sciatica pain generally originates from the lower back through the hips and buttocks down each leg and is mainly diagnosed on the basis of history taking and physical examination.[5] Physical examination alone today is not totally relevant, history taken from the patient can be related to the cause, patient perception, to the location and severity of the condition in the affected limb.[6] The sciatic nerve is a branch of the sacral plexus L4-S3, which is the largest branch of the sacral plexus.[7] It courses below the gluteal muscle and then goes down the leg posteriorly, just above the popliteal crease it divides into the tibial and common peroneal nerve (CPN). The tibial nerve supplies the posterior aspect of the lower leg and plantar surface of the foot while CPN supplies the anterior aspect of the lower leg and dorsal surface of the foot. The tibial nerve then becomes sural and posterior tibial nerves, while the CPN terminates as deep and superficial peroneal nerves.

The role played by the sodium channels in the transmission of nociceptive and neuropathic pain is widely understood. It is seen that in the neuropathic state the expressions of certain channels are altered, and these alterations underlie the pliancy in responses that occur to generate an inappropriate pain signal from normally insignificant inputs. It has also been gradually observed that a large number of drugs with an unidentified mechanism of action that was developed for conditions with no relation to pain, have found use in the treatment of neurogenic pain through a mechanism that involves blocking of sodium channels.[8]

Pain is regulated by a subset of voltage-gated sodium channels, (NaV1.3, NaV1.7, NaV1.8, and NaV1.9).[9] The expression of sodium channels is also modified in the experimental models conducted for inflammatory pain. The complexity of these channels and the energetic nature of their response have made them the principal targets for pharmacological manipulation for finding out newer therapies for pain.

The nerve block techniques are desirable because they block all the peripheral divisions of the sciatic nerve. This technique is beneficial as compared to other injection techniques such as epidural steroid, as this technique does not require any specific machinery or setup, is easy to perform as injection can be placed in the outpatient department and does not require any specialized training. It is highly effective and safe, has quick onset and possibly prevents progression to chronic pain.


  Methods Top


A study of 92 patients were carried out in the outpatient department of orthopedics surgery, over a period of 1 year. This study was carried out to assess the effect of peripheral sodium channel blocker in sciatica and it was compared with placebo. The inclusion criteria in this study were patients whose age is 18 years and above, patient willing to take the injection/block, patients having radicular pain to lower limbs, with prolapsed intervertebrate disc at L4–L5 or L5–S1 as per magnetic resonance imaging. The exclusion criteria included those patients who had uncontrolled diabetes mellitus, any neurological deficit, allergic to lignocaine, and pregnant and lactating females. Randomization was done by using the dice roll method even rolls were given the drug mixture and the odd rolls were given the placebo (Normal Saline).

Materials taken were injection loxicard 2% (1.5 ml), clonidine 30 μg (0.2 ml), Depomedrol 40 mg (2 ml), distilled water (4 ml), normal saline - 7.7 ml, and disposable syringe - 10 ml, One dice.

Informed and written consent was taken. Drug sensitivity was done with 2% lignocaine 0.1 ml intradermally. The cocktail injection consisting of 1.5 ml loxicard, 0.2 ml of clonidine, 2 ml of depomedrol, and 4 ml of distilled water was prepared. The patient's lateral and medial malleoli was wiped with a spirit swab and painted with betadine. The needle was inserted in the cleaned area just behind the medial malleoli for the posterior tibial nerve [Figure 1], 1 cm in front and below the lateral malleolus for deep peroneal [Figure 2], just behind the lateral malleolus for the sural nerve [Figure 3] and the drug was delivered around these points of the affected limb.
Figure 1: Clinical picture showing instillation of injection at marked point just behind medial malleoli

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Figure 2: Clinical picture showing instillation of injection at marked point 1 cm front and below lateral malleoli

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Figure 3: Clinical picture showing instillation of injection at marked point just behind lateral malleoli

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Patients were followed up after 10 min postinjection, at 1 week, and at 1 month. On each visit, functional outcome was assessed on the basis of Visual Analog Scale (VAS) score for pain (1–10), subjective satisfaction on a scale of 1–5, and straight leg raise (SLR) painful for how many degrees.

Statistical methods

The data were entered on a Microsoft Excel spreadsheet and imported into the SPSS Inc., Chicago, IL version 22.0 for Windows (India). Data were present in frequency, percentage, graphical form, mean, and standard deviation. The Chi-square test was performed to find the association in between the different variables in different groups. Student's independent t-test was performed to find the significant difference in different variables between the groups. P < 0.05 was considered statistically significant.


  Results Top


A total of 92 patients were taken for the study: 66 patients in the drug mixture group and 26 patients in the placebo group. The mean VAS [Figure 4] of patients at preinjection in the drug mixture group was 8.58 ± 1.14 and in placebo group was 8.73 ± 1.04, Mean VAS of patients at 10 min in the drug mixture group was 7.88 ± 1.14 and in placebo group was 8.31 ± 1.32, mean VAS of patients at 1 week in drug mixture group was 2.97 ± 1.57 and in placebo group was 8.69 ± 1.05, mean VAS of patients at 1 month in drug mixture group was 4.64 ± 2.69 and in the placebo group was 8.69 ± 1.05. Mean VAS was decrease more in the drug mixture group as compared to placebo group from preinjection to 1 month at different follow-up time and there was a significant difference in VAS of patients at different time intervals in between the drug mixture group and placebo group except at preinjection.
Figure 4: Mean VAS at preinjection, 10 min, 1 week and 1 month in drug mixture group and placebo group. VAS: Visual analagoue scale

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Mean subjective satisfaction [Figure 5] of patients at preinjection in the drug mixture group was 1.0 ± 0 and in the placebo group was 1.0 ± 0; mean subjective satisfaction of patients at 10 min in drug mixture group was 3.4 ± 1.1 and in the placebo group was 1.4 ± 0.7, mean subjective satisfaction of patients at 1 week in drug mixture group was 4.4 ± 0.8 and in placebo group was 1.4 ± 0.6, mean subjective satisfaction of patients at 1 month in drug mixture group was 3.6 ± 1.4 and in the placebo group was 1.3 ± 0.5. Mean subjective satisfaction was increase more in the drug mixture group as compared to the placebo group at preinjection to 1-month follow-up and there was significant difference in subjective satisfaction of patients at different time intervals in between the drug mixture group and placebo group.
Figure 5: Mean subjective satisfaction at preinjection, 10 min, 1 week and 1 month in drug mixture group and placebo group

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Mean SLR in degrees [Figure 6] of patients at preinjection in the drug mixture group was 53.9 ± 10.2 and in the placebo group was 43.1 ± 8.4, mean SLR in degrees of patients at 10 min in the drug mixture group was 57.1 ± 9.9 and in placebo group was 43.5 ± 8.9, at 1 week in drug mixture group was 62.1 ± 7.7 and in placebo group was 43.5 ± 8.9, and at 1 month in the drug mixture group was 57.1 ± 9.9 and in the placebo group was 43.5 ± 8.9. Mean SLR in degrees was increase more in the drug mixture group as compared to placebo group at preinjection to 1-month follow-up and there was significant difference in SLR in degrees of patients at different time intervals in between the drug mixture group and placebo group except at preinjection.
Figure 6: Mean SLR in degrees at preinjection, 10 min, 1 week and 1 month in drug mixture group and placebo group. SLR: Straight leg raise

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  Discussion Top


In a study conducted by Murakibhavi and Khemka[10] to study the effect of caudal epidural steroid injection on a total of 100 patients, in which he assessed the effect of epidural injection at a time of 3 weeks and at 6 months by assessing the pain relief of the patients and improvement in SLR. The author found that injection gave pain relief in about 46 patients at a period of 3 week, and in a total of 43 patients at 6 months' follow-up. The VAS take by the author in his study preinjection was 8.06 ± 1 with the VAS score at 3 weeks was taken to be 2.02 ± 1.6 and the VAS at the time of final follow-up 6 months was found to be 2.69 ± 0.8. In our study, VAS score at 10 min postinjection was found to decrease from a mean of 8.58 ± 14 to 7.88 ± 1.14, mean VAS of patients at 1 week was 2.97 ± 1.57, and mean VAS of patients at 1 month was 4.64 ± 2.69. The author also reported an improvement in the SLR at a period of 3 weeks' follow-up and that the improvement was continued till 6 months.

In our study, at 1-week follow-up, pain relief was seen in a total of 62 patients, and as or maximum follow-up was for a period of 1 months, a total of 40 patients reported relief from pain. In our study, we also found improvement in the SLR at period of 1 week and at 1 month. In our study, no complication was seen in any patient after the administration of block.

In a similar study by Gore and Nadkarni,[11] a total of 67 patients were taken with age ranging from 30 to 65 years, of which 38 were male and rest 29 females. The exclusion criteria of the patient having neurological deficit were common in both the studies. In the present study, the duration of pain relief was noted at 10 min, after 1 week and after 1 month, whereas in Gore and Nadkarni, where the effect of pain relief was noted at only 10 and 30 min postinjection. In the present study, a mixture of the drug was used comprising of three drugs lignocaine, clonidine, and methylprednisolone in comparison to Gore and Nadkarni[11] where the author only used lignocaine 2%. In the present study, VAS score at 10 min postinjection was found to decrease from a mean of 8.58 ± 1.14 to 7.88 ± 1.14 as compared to Gore and Nadkarni[11] in which VAS decreased from 7 to 1 after 10 min postinjection for a period of 30 min.

The duration of pain relief attributed in Gore and Nadkarni[11] was for a period of 3–36 h, whereas in the present study, it was seen for a period of up to 1 month. The difference in the efficacy period is a clear indicator of the fact that the use of peripheral adjuncts with sodium channel blockers such as lignocaine when combined with certain drugs such as depomedrol and clonidine work to increase the duration of the block well beyond the normal timeline which gives an additive effect.

In the current study, a control group of placebo was also taken to get a clear perspective of the effect of the cocktail injection in the affected patients receiving the injection. The effect of the injection was seen at different time intervals of 10 min, 1 week, and 1 month and comprising of various parameters such as VAS score, SLR test, tingling sensation or numbness in the thigh or leg, and the overall satisfaction of the patient.

The relief of pain after 10 min of administration of the injection was seen in a total of 59 patients in the drug group and in a total of 7 patients in the placebo group. Relief from pain at 1-week time was seen in a total of 62 patients in the drug mixture group and only in one patient in the placebo group. Relief from pain was seen at 1-month postinjection in 40 patients and no patient in the placebo group showed any relief from pain.

The comparison carried out in the present study with a placebo control group has provided us with the data which shows that the injection given with the drug mixture group showed better relief from pain at the respective time intervals as compared to the placebo group with patient having decreased numbness and tingling sensation in the thigh and leg as compared to the placebo group and also patients had improved SLR in patients with drug mixture group. The comparison of the current study and the study conducted by Gore and Nadkarni[11] is shown in [Table 1].
Table 1: Comparison of findings of the current study with the study conducted by Gore and Nadkarni[11]

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  Conclusion Top


It was observed that patients who underwent peripheral sodium channel block injection had a better functional outcome as per the improvement seen in the VAS as compared to a placebo. There was also improvement in the patient's day-to-day activity and overall satisfaction of the patient following the injection as compared to a placebo. This injection can be used in cases of sciatic pain currently on conservative management, as an adjunct for providing symptomatic relief from pain for a longer duration, allowing physiotherapy and rehabilitation exercises.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Tubach F, Beauté J, Leclerc A. Natural history and prognostic indicators of sciatica. J Clin Epidemiol 2004;57:174-9.  Back to cited text no. 1
    
2.
Verheijen E, Munts AG, van Haagen O, de Vries D, Dekkers O, van den Hout W, et al. Transforaminal epidural injection versus continued conservative care in acute sciatica (TEIAS trial): Study protocol for a randomized controlled trial. BMC Neurol 2019;19:216.  Back to cited text no. 2
    
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Borczuk P. An evidence-based approach to the evaluation and treatment of low back pain in the emergency department. Emerg Med Pract 2013;15:1-23.  Back to cited text no. 3
    
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Porchet F, Wietlisbach V, Burnand B, Daeppen K, Villemure JG, Vader JP. Relationship between severity of lumbar disc disease and disability scores in sciatica patients. Neurosurgery 2002;50:1253-9.  Back to cited text no. 4
    
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Valat JP, Genevay S, Marty M, Rozenberg S, Koes B. Sciatica. Best Pract Res Clin Rheumatol 2010;24:241-52.  Back to cited text no. 5
    
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Vroomen PC, de Krom MC, Knottnerus JA. Diagnostic value of history and physical examination in patients suspected of sciatica due to disc herniation: A systematic review. J Neurol 1999;246:899-906.  Back to cited text no. 6
    
7.
Giuffre BA. Anatomy, sciatic nerve. In: StatPearls. U.S: National Library of Medicine; 2021. Available from: http://www.ncbi.nlm.nih.gov/books/NBK482431/. [Last accessed on 2021 Jul 10].  Back to cited text no. 7
    
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Black JA, Hains BC, Dib-Hajj SD, Waxman SG. Voltage-gated sodium channels and pain associated with nerve injury and neuropathies. In: Sodium Channels, Pain, and Analgesia. Basel: Birkhäuser; 2005. p. 1-21.  Back to cited text no. 8
    
9.
Yu FH, Catterall WA. Overview of the voltage-gated sodium channel family. Genome Biol 2003;4:207.  Back to cited text no. 9
    
10.
Murakibhavi VG, Khemka AG. Caudal epidural steroid injection: A randomized controlled trial. Evid Based Spine Care J 2011;2:19-26.  Back to cited text no. 10
    
11.
Gore S, Nadkarni S. Sciatica: Detection and confirmation by new method. Int J Spine Surg 2014;8:15.  Back to cited text no. 11
    


    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6]
 
 
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