Pilot Study Of The Curative Effect Of Radiofrequency Thermocoagulation Combined With Ozone Injection For Herniated Lumbar Disc Evaluated By Far-infrared Thermography

[Background]The study of radiofrequency thermocoagulation combined with ozone injection for lumbar disc herniationLumbar disc herniation is the most common cause of low back pain. It is a syndrome which is characterized by nerve damage. A variety of inflammatory mediators and autoimmune components is produced by the prominent nucleus pulposus tissue stimulation, which resulting in secondary high sensitivity of nerve pressure. The main traditional treatment methods of LDH is conservative treatment and surgery. Conservative treatment including acupuncture、massage and traction can not solve the intervertebral disc lesions fundamentally. The surgery would destroy the normal physiological structure of the lumbar spine which could easily cause serious complications such as lumbar instability, nerve damage, ect.1981, Sluijter First used RF treat LDH.This method uses RF, accurately output Ultrahigh frequency current to make high temperatures in the local organizations through a specific needle. On the one hand, it can rupture the covalent bond which maintains the three-dimensional structure of the collagen, so that the collagen can be condensed, the volume and the pressure of lumbar disk can be reduced; On the other hand, it can ablate the nociceptor inside the annular fibrosus, prevent nerve grows in it, and reduce the stimulation of disc degeneration organization impact on the nerve.Meanwhile, it can damage sinus vertebral nerve endings around the electrode and mitigate the disc-derived pain directly, so as to achieve the purpose of treating diseases.The advantages of RF technology is temperature controlled, time controlled, and it can also find and locate the position of sensory nerves and motor nerves by detecting the impedance and the function of nerve stimulation. So that, it can effectively avoid the damage to the nerves, organs, etc. in July2000, RF was approved for the treatment of LDH by the FDA.Percutaneous with ozone ablation is a new minimally invasive surgery for the treatment of LDH, which is widely popular in European countries in recent years. The principle is injecting into ozone the intervertebral disc to the destroy of the proteoglycan in the nucleus pulposus and make the nucleus pulposus degenerate, necrose, atrophy. In this way it can relieve nerve root compression, and it also can relieve pain, eliminate aseptic inflammation of the nerve root, inhibit the immune response, ect.After radiofrequency ablation, the RF needle can be kept in place to inject the ozone treatment. Full using of the advantages of both can greatly enhance the curative effect.In recent years, Wangzhonghua, Shenbangli have did some clinical research on" radiofrequency thermocoagulation combined with ozone injection for herniated lumbar disc", and obtained good curative effect.About the aided diagnosis of LDH by far-infrared thermographyThe clinical application of F-IRT is not very long.1800, British astronomer F.W. Herschel found F-IRT technology. Until1956, R. Lawson started using it in diagnosing breast carcinoma which creating a new era in the diagnosis with F-IRT.In recent years, with the development of optoelectronic technology, computer multimedia technology, the resolution capability and definition of thermal imager become able to meet the clinical needs. F-IRT technology starts being received attention in the clinical diagnosis, and gradually being used in other clinical areas, such as in the diagnosis of breast tumors, bone tumors, peripheral vascular disease and the observing the condition of the replantation of severed limb. Chinese Medical Association also held F-IRT academic exchanges in2001.Medical F-IRT is a technology that combines medical technology, infrared imaging technology and multimedia technology. It is a kind of a modern physics detection technology that using the human body infrared radiation imaging principle to study the surface temperature of human.The human body is a natural biological heating unit. Because of the difference between anatomical structure, tissue metabolism, blood circulation and neurological status, making different temperatures and different thermal field around the body.Through filter gathering, modulating and photoelectric conversion by optical electronic systems, F-IRT turns the far-infrared from the human body into electrical signals and then converts it into digital by the A/D. Finally, the invisible surface temperature of human body is turned into visual and quantitative infrared imaging by multimedia image processing technology. The infrared imaging reveals the distribution and variation of body temperature, and thus to make the diagnosis of disease.In clinical practice, we found that the clinical symptoms and the imaging are inconsistent on the diagnosis of LDH:①False-negative:patients have the symptoms of significant low back pain and typical nerve root compression, but they CT/MRI examinations show the lumbar disc herniation is not obvious or only a slight bulging, and even the prominent direction is inconsistent with the site where thesymptoms show;②False positive:LDH can be found in healthy people, while they don’t have LDH symptom.This gives the doctors some difficulties in clinical diagnosis and treatment, so the F-IRT technology has its practical significance in the diagnosis of LDH as a functional diagnostic method.[Objective]This study is in order to compare the changes of infrared imaging of radiofrequency thermocoagulation combined with ozone injection for LDH and traditional conservative treatment for LDH through F-IRT technology, and then find an objective indicator to evaluate the curative effect for LDH.[Method]Select the eligible46patients who have LDH for this clinical study.The patients was Randomly allocated to RF treatment group(23cases) and conservative treatment group (23cases) by random number table. The two groups had good compliance, non-shedding phenomenon.RF treatment groups:15males and8females, age18-81years, mean age (50.3±18.1) years, duration0.5-198months, average (31.7±40.4) months. Conservative treatment group:12males and11females, age27-79years, mean age (50.0±16.7) years, duration0.3-120months, average (29.2±28.8) months.The two groups all did Lumbar CT examination. The general information of two group had no significant difference (P>0.05), suggesting that the two group are randomization balanced, comparable.The two groups were treated by radiofrequency thermocoagulation combined with ozone injection and conservative treatment respectively. Check the difference of temperature(Δ T) of the lower limbs of patients by F-IRT before and after treatment, and then analyzed with clinical improvement (VAS). F-IRT Inspection MethodPatients must expose the inspected parts for15minutes in a quiet examination room, and then stand still in front of the camera. The examination sites are the front of the thighs knee、 calf and ankle, and back of the thigh and calf, popliteal fossa and planta pedis of both limbs. Each site has to be measured the temperature.RF treatment group checked the F-IRT before treatment and after three days of treatment. Conservative treatment group also checked the F-IRT before treatment and after a course of treatment (10days), and recorded the difference of temperature changes of both lower extremities and analysed of the characteristics of thermal imaging changes.Treatment MethodRF group:complete preoperative inspection and read carefully the MRI and CT to locate the position of the herniated disc.The R-2000B of radiofrequency ablation equipment, needle and the corresponding electrode produced by North Qi Company, as well as ozone generator produced by Germany Herman MED are used in the operation, which is operating under the monitored of the C-arm X-ray.The patients are prone position. Routinely use of iodine and alcohol disinfecting lumbar surgery area and spreaded sterile surgical drapes.Under the vision of the tube lesions, centered by the diseased intervertebral disc and took the after roadside small medial edge as the puncture site, anchored the anteroposterior location and lateral location.After injecting 2ml2%lidocaine along the skin, subcutaneous and shallow muscle of the puncture path for local anesthesia, push the RF needle catheter into the diseased intervertebral disc in the lateral position under fluoroscopy, slow forward, until the tip get to the intervertebral disc in1/3and the fluoroscopy shows the tip is located in the disc in the anteroposterior and lateral position.Remove of the catheter needle, insert the RF electrode needle, connect the wire and operate the RF equipment according to the operating procedures. Test the resistance where the electrode needle is in, and then stimulate with1-2.5V,100Hz,1.0ms current. If the patient is not discomfortable, stimulate again with1-2.5V,2Hz,1.0ms current, and check whether the patients have muscle twitching and discomfort. If not, treat with RF according to continuous mode, followed by gradually warming up from70,80,90,95℃. Giving3cycles treatment under the maximum temperature patients are able to tolerate,60s each cycle.Finally, connect the10ml sterilized syringe filled with ozone, inject ozone slowly in a lateral position under fluoroscopy. Ask patients to lie supine without pillow postoperation for6hours, and avoid excessive activity with the waist.Conservative groups:①ie supine on the hard bed and wear the waistband;②Lumbar traction with weight about1/3of body weight,30minutes each time, once a day;③Manual therapy, relax the back muscle, press the pain points of lumbosacral portion;④Physical Therapy:Ultrashort wave therapy, electrodes are placed on the waist and abdomen corresponding position,15minutes each time, once a day; Low frequency therapy, place the electrodes on the pain points, tolerated dose,20minutes each time, once a day. All patients are given above treatments for a course (10days).[Curative Effect Evaluation Index]Analyze with Visual analogue scale(VAS).[Statistical Methods]Statistic with SPSS17.0. Use x2test method to analyze two groups’Significant efficiency and effective rate, and Two-sample T test method to analyze two groups’ data before treatment. While use Analysis of covariance method to analyze tow groups’ data after treatment and the difference between before and after treatment. While P<0.05, the difference has significant meaning.[Result]The remarkable effective rate of RF Group and Conservative Treatment Group were52.17%and17.39%, and the effective rate were95.65%and65.22%. There was statistical difference between the two groups’ curative effect (P<0.05); The difference in temperature of thermograph had remarkable decrease in RF Group after treatment compare to Conservative Treatment Group, the difference has significant meaning (P=0.00<0.01);The difference in temperature of thermograph had remarkable decrease in Conservative Treatment Group after treatment(ΔT后) compare to before treatment, the difference has significant meaning (P=0.00<0.01); The difference in temperature of thermograph had remarkable decrease in RF Group after treatment(ΔT后) compare to before treatment, the difference has significant meaning (P=0.00<0.01);The difference in temperature before and after treatment in RF Group(ΔT前-后) had remarkable increase compare to Conservative Treatment Group, the difference has significant meaning (P=0.00<0.01).[Conclusion](1) The decrease of temperature difference on the lower limbs (ΔT) before and after treatment is in proportion to the improvement of clinical.(2) F-IRT can be used as an objective indicator to evaluate the curative effect of radiofrequency thermocoagulation combined with ozone injection for herniated lumbar disc.