(Disc-Fx) in Patients

Shamov et al., J Spine Neurosurg 2014, 4:2 http://dx.doi.org/10.4172/2325-9701.1000181

Research Article

Effectiveness of Manual and Radiofrequency - Assisted Posterolateral Microtubular Decompressive Nucleotomy (Disc-Fx) in Patients with Chronic Discogenic Low Back Pain Shamov T1*, Rousseff RT2, Ivanov I3, Al-Hadjiu W1 and Eftimov T3

Journal of Spine & Neurosurgery a SciTechnol journal replacement and other innovative solutions for dynamic stabilization [4]. Surgical treatments lead to complications in 10 to 40%, according to different literature sources [5-7]. The microdiscectomy is the most used surgical technique for treatment of patients diagnosed with degenerative disc disease related problems. However, some studies demonstrated no difference in the outcomes of patients after microdiscectomy and conservatively treated patients on the fifth year after surgery [8,9]. Yet other studies suggest that accurate selection of patients with clear indications for operative treatment correspond with better late postoperative results in comparison with conservatively treated patients [10,11]. In patients with CDLBP but without significant nerve root compression and/or lumbar spinal stenosis, the minimally invasive techniques may be appropriate. These techniques reduce significantly the surgical complications. The main objects of surgical interestin these techniques are nucleus pulposus and annulus fibrosus.

Material and Methods: Fifty-eight patients diagnosed with CDLBP were divided into two groups: twenty-eight patients were operated by DiscFX and thirty patients (control group) were treated conservatively. The pain- determined disability in both groups was assessed over 6 months by Oswestry Low Back Pain Disability Questionnaire (OLBPDQ).

Interventions directed at the nucleus pulposus mainly aim to reduceits volume and thus to decrease the pressure within the disc. This may further enable remodeling of nucleus pulposus, repositioning of the prolapsed fragment and pain relief. Disk decompression is achieved via mechanical, chemical and physical methods. The most used minimally invasive method for mechanical disc decompression is automated percutaneous nucleotomy. The nucleus is excised by a forceps inserted into the disc through a small tube with or without endoscopic assistance.

Results: Statistically significant differences between the two patient groups were observed on the first week after the intervention (31.2 SD ± 8.8 versus 37.7 SD ± 14.8, p=0.049), on the first month (24.2 SD ± 6.4 versus 31.6 SD ± 11.1, р=0.003) and on the third month (12.2 SD ± 5.7 versus 17.4 SD ± 9.2, р=0.013). There was not statistically significant difference between the two groups on the sixth month.

Chemical agents for remodeling of the volume of nucleus pulposus include enzymes (chemonucleolysis), ozone (ozone nucleoplasty) and alcohol containing gels (Discogel). Their main effect is shrinking of nucleus pulposus as a result of protein disintegration and dehydration of its substance.

Conclusion: Our study confirms the short-term effectiveness of Disc-Fx procedure in patients with chronic low back pain. Further studies on its longterm results seem appropriate.

The third group of methods uses physical agents for nucleus remodeling. Percutaneous laser discectomy reduces nucleus pulposus volume by its laser vaporization. The radiofrequency disc ablation uses radiofrequency electricenergy which is absorbed by the nucleus substances and generates heat in the range of 50-70°C with consequent coagulation. The disc coblation is a radiofrequency method whereby the radiofrequency energy creates “plasma” (“a cloud” consisting of hyperactive ions) that causes protein defragmentation and reduces nucleus volume [12,13].

Abstract Objective: To evaluate the effectiveness of manual and radiofrequencyassisted posterolateral Microtubular decompressive nucleotomy (Disc-FX) in patients with chronic discogenic low back pain (CDLBP).

Keywords: Chronic discogenic low back pain; Disc-FX, Automated percutaneusnucleotomy; Nucleoplasty; Annuloplasty; Radiofrequency intradiscal procedures; Discography

Introduction Chronic discogenic low back pain (CDLBP) is a significant medical and social problem. Between 70-90% of the adult population of the planet at least once in their lives will suffer low back pain [1]. According to data published in United States, total annual medical expenses and compensation for sick leaves in these patientsapproach about $ 100 billion annually [2]. Around 10 % of these patients develop chronic pain persisting throughout life [3]. A variety of treatments of CDLBP are available, ranging from conservative approach and physiotherapy to invasive procedures like vertebral interbody fusion, posterior transpedicular fixation, total disc *Corresponding author: Todor Shamov, Consultant Neurosurgeon, Armed forces hospital “Jaber Al Ahmed”, city, Kuwait, Tel: +965 658 98 192, +359 898 667 552; E-mail: [email protected] Received: November 03, 2014 Accepted: December 19, 2014 Published: December 24, 2014

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Annulus fibrosus is also a target for minimally invasive techniques. These techniques are also directed at shrinking of annulus substance and remodeling of the collagen lamellas; in this way, annular tears and fissures are reduced. Other target structures in these procedures are pain conducting C-fibers located in the outer 1-2 mm of annulus. These procedures also have pain relieving effect. Two minimally invasive techniques are mainly applicable for this purpose: Intradiscal electrothermal therapy and Biacuplasty. Radiofrequency electric energy is used in both techniques [14]. All of above mentioned methods are minimally invasive, lowcost, easy for implementation and carry a low rate of complications. However, their effectivenesshas been disputed. High enough effectiveness was suggested for some recent minimally invasive techniques like disc coblation and Intradiscal electro thermal annuloplasty [15].

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Citation: Shamov T, Rousseff RT, Ivanov I, Al-Hadjiu W, Eftimov T (2014) Effectiveness of Manual and Radiofrequency - Assisted Posterolateral Microtubular Decompressive Nucleotomy (Disc-Fx) in Patients with Chronic Discogenic Low Back Pain. J Spine Neurosurg 4:2

doi:http://dx.doi.org/10.4172/2325-9701.1000181 Lately, technologies that combine some aspects and advantages of the above discussed methodsare being introduced in clinical practice. The technology Disc-Fx combines the decompression effects of automated percutaneous Nucleotomy with the nucleoplasty/ annuloplasty effects of modern radiofrequency treatments. A main advantage of this approach is that during the radiofrequency nucleoplasty, high temperatures are not reached, which decreases the side effects [16]. To the best of our knowledge, there are no prospective controlled studies on the effectiveness of this method in peer-reviewed literature. In this study, we decided to evaluate the effectiveness of manual and radiofrequency-assisted posterolateral Microtubular decompressive nucleotomy (Disc-Fx) in patients with chronic discogenic low back pain (CDLBP).

Clinical Material and Methods We studied 58 patients with chronic discogenic low back pain (chronic defined as continuing more than three months, according to Bogduk 2009) [17]. All patients were diagnosed, consulted and followed in the Spinal Clinic of Jaber Al-Ahmed Military Forces Hospital - Kuwait. The participants were divided into two groups. The first (active) group includes patients who underwent Disc-FX intervention and the second (control) group received conservative treatment only. The protocol of this study was approved by the hospital ethic commission and all patients were well informed about nature of the interventional procedure and its possible complications in accordance with declaration of Helsinki [18]. By its nature, this is a prospective controlled observational study. The patients were followed over a period of six months. The study lasted two years and it was closed on 1 September 2014. Additional demographic and clinical data are presented in Table 1. We applied the following inclusion criteria: - Age of the participants less than 55 years. - Unremitting low back pain over more than three months. - Pain intensity more than 5 points according to the Visual Analogue Scale and low back pain greater than leg pain. - Pain exacerbation by sitting and relief by lying down. - No neurological deficits and negative straight leg rising test (Lassegue). - No previous surgical interventions. - MRI signs of disc degeneration (2nd,3rd or 4th grade according to Pfirrmann classification [19]) at a single disc level. Posterior annular tears, fissures or T2 hyperintense”hot spots”. - Disc height reduction less than 30% and disc protrusion or contained disc extrusion less than 5 mm. - Positive one-level pain provocation discography in patients who were undergone on Disc-FX intervention. Exclusion criteria: - Acute infection. -Morbid obesity. -History of drug abuse. -Disc height reduction more than 30%. Volume 4 • Issue 2 • 1000181

-Intervertebral disc herniation equivalent to or greater than 5 mm or disc sequester in spinal canal. -X-ray data for spinal instability. -Structural spinal deformities or vertebral canal stenosis. All participants were followed over six months period and assessed using Oswestry Low Back Pain Disability Questionnaire (translated to Arabic and validated by Guermazi et al. [20]) at day 0, 1 week, 3 months and 6 months after inclusion in the study. All interventions were done in the operating theatre under monitoring of the vital indicators - blood pressure, pulse and oxygen saturation. The patient was placed in tre prone position. A peripheral venous line was inserted and peri-operative antibiotic prophylaxis by 2 g Cephasoline was applied in each patient. The skin and subcutaneous tissues at the puncture site were infiltrated with 2-3 ml Lidocain 1% (Braun™). Deep infiltration of the tissues along the trajectory towards the disc was also done. In particularly apprehensive or sensitive patients low fractionated doses of Fentanil or Dormicum were applied. To define the place of skin puncture and the trajectory of the working instruments we used around 30 degree oblique X-Ray projection to depict the “Scotty doc” image of the vertebral pedicle, superior articular process and transversal process. The safety area of disc penetration was defined by the Kambin triangle [21] (Figure 1). The skin entry point is usually located 7 to 9 cm aside from the midline. The inclination of the trajectory is 35-45 degree toward the sagittal plane. To approach the L5-S1 disc it was helpful to insert a pillow under the anterior superior iliac spine and to “swing” C-arm 30-40 degree cranially toward the axial plane in order to avoid the superimposition of the iliac crest image. The access and penetration into the disc was carried out by 18 G needle and after positioning of the needle tip in the center of the disc, provocative discography was done. For this purpose, we inject into the disc 1-4 ml normal saline or radiopaque contrast (Omnipaque 240 mg/ml, Nycomed™) and access patient reaction to the procedure, pain reproducibility and pain intensity as a quantity in milliliters yielding resistance. Pain reproduction from the disc stimulation must be concordant, exactly reproducing the patient’s habitual pattern of pain. The pain due to discography has to be significant (more than 5 point on a scale of 10). The pain usually occurs with a contrast volume of less than 3.5 ml. After performing of provocative discography, a guide wire is placed through the needle. A small skin incision of 3 mm is large enough to accommodate the introduction of the access cannula and soft tissue dilatator. The annulus is usually opened by the trephine, but blunt penetration into the annulus with the dilatator can also be achieved, dependent on the resistance felt at the annulus. Additional intra-annular or intradiscal free material is removed manually by forceps. The separate components of the introducing system and working instruments are shown in Figure 2. Further radiofrequency ablation of nucleus pulposus and radiofrequency annuloplasty may be accomplished using the radiofrequency generator Surgi-Max plus (Elliquence, LLC.) and the bipolar radiofrequency probe Trigger-flex (Elliquence, LLC.). The working frequency of the generator is in frequency diapason 1.7-4 MHz giving options for two working modalities: Bipolar-Turbo and Bipolar-Hemo. The ground electrode was applied cranially and contralateral to the position of the working instruments. • Page 2 of 6 •


doi:http://dx.doi.org/10.4172/2325-9701.1000181 Mean age

Men/Women ratio

L5-S1

L4-L5

L3-L4

Total

52 +/- 9.1

1.3 : 1 (16 / 12)

35% (10/28)

57% (16/28)

8% (2/28)

28

Control group

54 +/- 10.2

0.8 / 1 (13 / 17)

50% (15/30)

44% (13/30)

6% (2/30)

30

p-value

P=0.435

P=0.309

P=0.271

P=0.29

P=0.94

58

Disc-FX intervention

Table 1: Demographic data and clinic-anatomic distribution between both group patients.

Nucleoplasty is carried out using the Bipolar-Turbo working regimen. In this regimen, the operating frequency fed to the bipolar radiofrequency probe is modulated on prolonged energy burst for controlled soft tissue vaporization and maximum energy output 120 Watt. The hand piece Trigger-flex is connected via an irrigating system and allows flushing the cavity of the disc with normal saline. Annuloplasty is performed by using the Bipolar-Hemo working regimen. In this working modality the operating frequency fed to thebipolar radiofrequency probe is modulated on short burst of energy oscillations for non-ablative, controlled soft tissue contraction of annulus fibers and maximum energy output 40 Watt. The working tip of the radiofrequency probe is bending to facilitate the approach to the posterior part of the disc.

Figure 1: Oblique “Scotty doc” projection and the Parvitz-Kambin’s triangle defined by the superior articular process and the inferior endplate of the disc. 1- safety triangle of Kambin; 2- superior articular processus; 3- inferior endplate of the L4 disc.

Figure 2: Components of the introducing system and working instruments: 1 - spinal needle, 2 - guide wire, 3 disc trephine, 4 - dilator with a taper head, 5 - working cannula with a beveled surface, 6 - working cannula with a flat surface, 7- cannula fixer, 8 - bipolar radiofrequency probe -trigger-flex, 9 rongeur.

3a

3b

3c

Figure 3: X-ray images illustrating: a position of tip of the rongeur during mechanical disc decompression; b - position of the tip of the radiofrequency probe during the Bipolar-Turbo working regimen used for nucleoplasty; position of the tip of the radiofrequency probe during the Bipolar-Hemo working regimen used for annuloplasty.

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X-ray images illustrating the position of working instruments during the procedure are shown on Figures 3a-3c. One way ANOVA and Z -test for comparison of relative parts were used for statistical processing of the results.

Results Seventy two patients were initially included in this study. However, fourteen persons were lost for follow up. A MRI less than three months before the inclusion of patients in the study was available for every participant. In everyone patient was assessed the grade of disc degeneration according to Phirrmann’s classification. Moreover, annular tears in the posterior part of the disc, disc prolapses less than 5 mm and bright T2 “hot spots” in the annulus have been taken into consideration when we discussed the results in both groups of patients. All patients in both groups were divided into subcategories, depending of the degree of the disc degeneration and above mentioned neuro-radiologic characteristics. There weren’t statistically significant differences in terms of the number of subjects in both groups and in the subgroups according to disc degeneration severity. Results are presented in Table 2. The pain-determined functional capacity of our patients was assessed using Oswestry Low Back Pain Disability Questionnaire. A total of nine section of questionnaire were completed (the section concerning the sexual life of the patients was removed because of the particular ethnical and cultural peculiarities). The functional capacity was assessed at baseline, on the first week, on the first, third and sixth month after beginning of the following up. The mean hospital stay of patients underwent on Disc-FX intervention was eight hours as the mean hospital observational period after the procedure was five hours. We did not register any early or late postoperative complications. The comparative results for both groups of patients are presented in Table 3. Graphically the differences between the both groups patients are shown in Figure 4. As Figure 4 shows, statistically significant improvement was registered on the first week after the intervention, on the first month and on the third month while there were not differences in the • Page 3 of 6 •


doi:http://dx.doi.org/10.4172/2325-9701.1000181 PfirrmannІІ Contained disc < 5 mm Disc-FX Intervention

Pfirrmann ІІІ

Intradiscal prolapse

Contained disc < 5 mm

14% (4/28)

14% (4/28)

Control group

3% (1/30)

P-value

p=0.13

Pfirrmann ІV

total

Intradiscal prolapse

Contained Disc < 5 mm

Concentric disc bulging

Hot T2 spot

18% (5/28)

18% (5/28)

7% (2/28)

11% (3/28)

18% (5/28)

100 % 28

27% (8/30)

7% (2/30)

20% (6/30)

3% (1/30)

27% (8/30)

13% (4/30)

100% 30

p=0.24

p=0.19

p=0.83

p=0.51

p=0.12

p=0.6

58

Table 2: Сcomparison between patient’s subgroups in terms of the degree of the disc degeneration and selected neuro-radiologic characteristics. Baseline

1-st week

1-st month

3-rd month

6-th month

Disc-FX n=28

37.4 SD ± 10.2

31.2 SD ±8.8

24.2 SD ±6.4

12.2 SD ±5.7

8.6 SD ±7.1

Control group n=30

38.7 SD ± 15.3

37.7 SD ±14.8

31.6 SD ± 11.1

17.4 SD ±9.2

9.4 SD ±8.2

P value

P=0.707

P=0.049

P=0.003

P=0.013

P=0.694

Table 3: Comparative results in terms of Oswestry Low Back Pain Disability Index.

functional capacity of the patients on the sixth month after beginning of the study. The best results concerning the functional capacity of patients after the Disc-FX intervention were observed on the third month in following subgroups: in the patients with Phirrmann ІІ disc degeneration accompanied with an intradiscal prolapse; Phirrmann ІІІ disc degeneration and disc prolapse or contained disc