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An open-label, sequential, dose escalation study of the Pharmacokinetics, Safety, and Preliminary ...
“Chance favors the prepared mind.”
— Louis Pasteur
Interventional procedures are performed for establishing diagnosis and for treatment purpose. Indications of such interventions should be evidence based. At the Advanced Pain Treatment center only safe and effective procedures are recommended and performed. Most of the procedures are performed under mild sedation. Prior to performing any procedure, detailed informed consent is obtained which means patient is explained in details the indications, alternative options, risks and complications of the proposed procedure.
Before the procedure, an I.V. line is placed usually in the forearm for administration of medication as well as I.V. fluids. Interventional procedures are performed in a fully equipped procedure room with the state of the art equipment for monitoring heart rate, blood pressure and blood oxygen saturation.
Almost all procedures are performed under fluoroscopy guidance. State of the art fluoroscope machine is used at the center. At all the time, patient’s comfort and safety remains the top priority at this center.
Cervical Epidural Steroid Injection:
It is primarily indicated for treating neck pain associated with radiating arm pain. The commonest cause of this is herniated cervical disc. The herniated disc causes pinching of nerve. Pinched nerve causes neck pain but more importantly arm pain. It is also very effective for treating spondylosis and arthritis of small joint of cervical spine. At times the procedure is also indicated to for treating severe headache when all other measures have failed.
Procedure description: Patient is positioned prone or on their stomach. Neck is supported on a pillow so that slight neck flexion is achieved. Skin is prepared with antiseptic solution such as betadine and chloroprep. Skin is anesthetized with local anesthesia. A specialized needle called “Touhy needle” is advanced through the anesthetized skin. Using loss of resistance technique epidural space is accessed and the needle placement is confirmed by using iodine dye. At this stage, therapeutic medicine is administered for treating the problem.
Cervical Transforaminal injection:
This is also a way of administering steroid in the epidural space but the technique is more specialized and requires operator to have special skills, training and experience. This procedure is performed only after conventional epidural injection fails to resolve radicular or radiating arm pain resulting from pinched nerve. This is an excellent option for patients who have had persistent arm pain from either cervical disc herniation or neural foraminal (opening through which nerve roots exits spinal canal) stenosis or narrowing. Narrowing may be because of combination of arthritis of facet joints, calcified bulged disc or abnormal osteophyte formation. This procedure is very effective, but, it is not without risk. When this technique is used for diagnostic purpose, it is called as selective nerve root injection. Selective nerve root injection or block is performed to find the level of pinched nerve. This procedure may be used in addition to MRI, CT myelogram etc.
Cervical Facet joint injection:
This is indicated for treating cervical facet joint pain. About 53 – 54% of neck pain is because of facet joint disease. Usually the procedure is for making a diagnosis. Sometimes, facet joint injection is performed for therapeutic reasons, however scientific research does not support this treatment. For the diagnosis of facet joint mediated pain, a diagnostic nerve block is performed to make the affected or suspected joint numb. If the procedure relieves the pain completely then the procedure is repeated to rule out a placebo response. A placebo response is a false positive response which can be compared with “sugar pill” response. If both the time the response is positive means adequate pain relief then those nerves are destroyed using radiofrequency technology (see below) for long term pain relief.
Lumbar Epidural Steroid Injection:
This is performed for treating lumbar disco herniation or bulge causing leg and back pain. It is also tried in patients with symptoms of neurogenic claudication from spinal stenosis or narrowing of spinal canal or narrowing of neural foramen irritating nerve root.
Lumbar Tranforaminal Injection:
Lumbar transforaminal injection is another way of administering epidural steroid injection. Unlike straightforward epidural injection which is delivered in the posterior epidural space (behind the dural sac that contains spinal cord and spinal nerves), the transforaminal technique, if performed properly, would allow delivery of the medicine in to the anterior epidural space, which is in front of the dural sac and therefore behind the disc. The disc is the target for treatment purpose. When only a small volume is used, primarily for diagnostic purpose, the procedure is called selective nerve root block. This procedure, if performed properly should be painless and therefore it is better tolerated by the majority of the patients.
Lumbar Facet joint Injection or block:
This procedure is performed for diagnosis. Only 15% of back pain patients suffer from facet joint mediated pain. This causes mechanical back pain which means pain with movement: such as pain with rotation of spine or bending backwards. Each facet joint is supplied by two nerves called medial branch. They are branch of dorsal ramus of spinal nerve. The location of these nerves are fairly constant and therefore can be easily blocked or numbed using local anesthetics. Numbing of those nerves would numb the facet joint and therefore would reduce pain significantly and at time eliminates the pain. If this happens then ideally the procedure should be repeated to make sure that the first positive outcome was not false (placebo response or “sugar pill response”). Once the diagnosis is established beyond doubt, then those nerves are destroyed using radiofrequency generated heat (radiofrequency thermal neurotomy) for long term pain relief (therapeutic option). For further information please click here.
Radiofrequency Thermal Neurotomy of the nerves supplying the facet joints (RF denervation of Lumbar and Cervical facet joints):
The technology is used mainly to treat facet joint mediated pain in neck, thoracic area or lumbar area. The most effective outcome of the treatment is seen in patients with neck pain. It is also effective for back pain provided the diagnostic facet joint block confirmed the diagnosis of facet joint mediated pain. Once the diagnosis is confirmed ( as discussed in facet joint injections above), this procedure is considered for long term pain relief. A Teflon coated insulated cannula along with a thermistor or thermocouple inside the cannula is used to deliver heat to the nerve to destroy it. The active tip of the cannula ranges from 5mm to 10 mm. Probe inserted in the cannula is called thermistor. The thermistor delivers radiofrequency energy to the tissue as well as it registers the local temperature of the tissue. The radiofrequency waves generates motion in tissue molecules, which in turn generates heat. The heat is measured by the thermistor. Once the optimum temperature is achieved in the tissue, the temperature maintained for a desired period of time. This results in destruction of nerve. The procedure is performed under mild sedation and under fluoroscopy guidance. Complication rates are negligible. At our center we haven’t had any complication from this procedure so far. We have treated patients with severe headache from C2-C3 arthropathy with occipital nerve neuralgia successfully using this technique. We have also treated patient with C2-C3 stable anterolisthesis causing severe headache, successfully using the same technology. Patients with spondylolisthesis and spondylolysis with associated facet joint arthropathy also benefits from this procedure.
Diagnostic Discogram (Cervical, Thoracic and Lumbar):
This is a diagnostic procedure. Once all conventional diagnostic and therapeutic procedures have been performed, this procedure is considered to establish diagnosis. Low back pain with pain in the buttock and coccygeal or tail bone area usually is from discogenic cause. Intractable back pain is most of the time from discogenic cause ( up to 40% cases of all back pain). Repetitive minor trauma or a major trauma may produce intractable back pain, and most of the time the cause of such pain is internally disrupted disc (IDD). The only way of diagnosing this condition is by performing a diagnostic discogram. At our center, the lumbar discogram is performed using Intellisystem syringe to measure pressure at which patient experiences familiar pain. This is the most important part of the diagnosis. After pressure study is concluded, patient undergoes CAT scan of Lumbar spine which shows the architecture of the disc. This is not the mandatory part of the study.
Unlike lumbar spine, for cervical and thoracic discogram, only digital pressure using 5 mm syringe is used to find the painful disc. Unlike back pain, neck pain stems more from facet joint arthropathy. The architecture of cervical disc is also different than the lumbar disc. In the lumbar area the demarcation of the components of disc is much well defined (the disc is made up of nucleus and annulus and the junction of nucleus and annulus is well defined in lumbar area).
Percutaneous diskectomy with automated Per cutaneous diskectomy device (DEKOPRESSOR): This is an option for patients with herniated disc. Most often these patients suffer from back and leg pain. The outcome is excellent when the herniaiton is less than 8mm and the herniation of disc is contained.
Minimally Invasive Lumbar Decompression (mild): This is an ideal treatment for patients who are unable to walk more than 50 yards or stand for more than 5 minutes without sever leg pain, numbness, weakness or heaviness. The condition is called spinal stenosis. Spinal stenosis is a condition where the spinal canal diameter has gotten narrowed because of ligament thickening, arthritis of small joints (facet joints), disc bulge. This procedure allows us to debulk the thickness of ligament and increase the diameter of the canal slightly. Slight increase in diameter is enough to restore function and reduce pain. This procedure does not interfere with structural stability of the spine. However the procedure is not to replace the decompression surgery but to help those patients who would not qualify for surgery or does not fulfill the absolute indication of surgery. For further information please click here.
SPINAL CORD STIMULATION for back & leg pain, Neck and arm pain, abdominal pain, pelvic pain, severe neuropathic pain or neuralgia (occipital neuralgia). This is an excellent option for pain stemming from nerve damage. The procedure is performed in two stages. The first stage is called trial and the second stage is permanent implantation of the stimulator. This is an excellent option for patient suffering from failed back surgery with symptoms of back and leg pain (leg pain > back pain) and the leg pain is from nerve damage, shingle pain in thoracic area, legs etc, diabetic peripheral neuropathy, idiopathic peripheral neuropathy causing severe burning leg or feet pain, neck pain with arm pain from failed neck surgery or nerve damage from nerve injury from disc herniation, Phantom pain, etc. For more information please click here. Please visit the following links for more information. http://www.tamethepain.com and www.youtube.com/medtronicchronicpain .
Implantable intraspinal drug delivery system (morphine, dilaudid, baclofen, local anesthetics etc). This is indicated for controlling cancer pain, for treating severe muscle spasm, or to treat patients with end stage degenerative disc disease. It also offered to the patient who suffer uncontrolled side effects from oral opioid therapy. The procedure is performed in two stages. The first stage is the trial stage and the second stage is performed only after the trial has been successful. For details of the information please click here.
Vertebroplasty and Kyphoplasty (repair of deformed fractured vertebra) for osteoporotic fracture, traumatic or from spread of cancer. Vertebral fracture requires prompt treatment. It causes significant debility and disability. If remains untreated it causes progressive worsening of deformity of spine leading to difficulty with breathing and oxygenation. Pain becomes uncontrollable. Progressive deformity leads to multiple fall and further fracture not only from falls but also from the deformity. Vertebroplasty and Kyphoplasty are performed in our pain treatment center. Both the procedures are performed under mild sedation and fluoroscopy guidance. For further information please click the link for the Kyphoplasty brochure. We have successfully performed Kyphoplasty procedure in our office in a cost effective way.
Ramus Communicants Block: This procedure is performed for treating intractable back pain because of either vertebral body fracture or intractable discogenic pain where no other options are available for treatment. Usually a diagnostic block is performed first. If that is positive then a second block is performed to rule out placebo response. Once the block provides concordant pain relief then RF or radiofrequency thermal lesioning is performed to achieve long term pain relief. For further information please review below given reference. Please click for reference article.
BOTOX injection for Headache, Myofascial pain, Excessive sweating in armpit or hand (hyperhidrosis).
New Biologic Treatment Option for low back pain : Leading cause of low back pain is disruption of disc either from major trauma or from repetitive minor trauma. Currently there is no good treatment option for repairing disrupted disc (internally disrupted disc, commonly called – IDD). According to the outcome of the clinical trial NCT # 01011816, there may be hope for such patients in near future. The trial is looking at the effect of administration of fibrin sealant in to the painful disc. Preliminary reports are very encouraging. Please also visit the Spinal Restoration Inc, for updates about the progress of Biostat system and ongoing phase III study.
Discolysis for discogenic back pain with or with out leg pain (Minimally invasive procedure to reduce disc bulge for treating disc mediate radicular leg pain). The procedure is not FDA approved yet. However two studies are currently underway. The studies are #1 & #2.
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