A Guide To Minimally Invasive Treatment Options for Chronic Back Pain

interventional radiology

What’s in this Guide?

What is chronic back pain?

Back pain, and most other forms of pain, can be divided into three categories:

Acute pain is defined as pain that has been present for less than 6 weeks. The reason 6 weeks is an important number is because approximately 80% of back pain will resolve on its own. Almost always, acute back pain does not require minimally invasive or surgical treatment and patients and physicians should focus on controlling one’s symptoms,i.e., controlling pain while the body heals.

Subacute pain is defined as pain that has been present for 6 to 12 weeks. The subacute pain period represents a transition phase. While most patients will experience resolution of their pain before the end of the subacute period, some patients will go on to develop chronic pain. Just as with acute pain, minimally invasive and/or surgical therapy is usually not necessary for subacute pain, and treatment should focus on pain management while the body heals.

Chronic pain is defined as pain that has been present for longer than 12 weeks. It is abnormal for pain to last longer than 12 weeks; therefore, once pain has become chronic, further evaluation is necessary to understand why the body is still sending pain signals. Chronic pain is unlikely to resolve on its own and usually requires treatment. Contrary to popular belief, back surgery is usually not required to alleviate chronic pain as minimally invasive treatments (discussed in detail in the next section) have dramatically improved over the last 20 years and now provide superior pain relief with fewer risks when compared to back surgery. However, there are special cases (discussed below) where back surgery still remains the gold standard treatment option.

When to see a doctor for chronic pain

If you’re experiencing severe back pain that is limiting your ability to function (you can’t go to work or you can’t get out of bed) or you’re experiencing any of the following red flag symptoms, then you need to see a doctor.

  • New muscle weakness in arms or legs
  • Severe back pain following trauma (car accident or fall)
  • New loss of bowel or bladder control
  • You’re currently being treated for cancer
  • New or progressive numbness in arms or legs

Any of the above findings could indicate a severe underlying spinal abnormality like cancer, infection,  a severely pinched nerve from a herniated disc (that could eventually lead to permanent paralysis), or a compression fracture. Just remember…severe pain, especially if it comes on quickly, is usually a warning sign from your body to your brain that something may be seriously damaged. If you’re unable to see your primary care doctor or go to an urgent care, a PainTheory patient coordinator can provide you with a free consultation.

Treatment options for chronic pain

Treatment options for chronic pain largely fall into 7 buckets. This article will mainly discuss “minimally invasive” treatment options for chronic pain, but you can see the categories of treatment options listed below.

  • Conservative Home Therapy: Rest, ice, over-the-counter medications, CBD, etc.
  • Non-Invasive Alternative Therapies: Acupuncture, massage therapy, cupping, chiropractic manipulation, etc.
  • Mental Health Therapies: Cognitive behavioral therapy (CBT), Pain neuroscience education (PNE), etc.
  • Traditional Minimally Invasive Therapies: Injections, nerve ablations, certain implants, etc.
  • Emerging Minimally Invasive Therapies: Platelet rich plasma (PRP), stem cell therapy, etc.
  • Surgery: Laminectomy, spinal fusion, etc.
  • Prescription Medication Management: Oral opioids, muscle relaxers, etc.

Determining the right treatment option varies from patient to patient and depends on numerous other factors such as duration and severity of the pain, degree to which pain is limiting the patient’s life, success of other treatment options, the patient’s work and lifestyle constraints, and willingness to try other therapies.

However–barring certain red flag symptoms–a basic rule of thumb that should be followed when determining the correct treatment option is to start with conservative, non-invasive therapies, and reserve surgery and oral opioid therapies as options of last resort.

We will write additional articles on the 7 buckets of treatment for chronic pain, but the remainder of this articles will cover “minimally invasive” treatments for chronic pain.

What are minimally invasive treatments?

Minimally invasive treatments use techniques to significantly decrease the size of surgical incisions. Often, minimally invasive treatments are performed through a needle (no incision required) and use only local anesthesia or moderate sedation (twilight anesthesia). The purpose of minimally invasive treatments (examples include epidural steroid injection (ESI) and radiofrequency nerve ablation) are to decrease pain and reduce, if not eliminate, recovery times after the procedure. Minimally invasive procedures are typically performed in-office and patients usually go home 1 hour after their procedure.

epidural steroid injection back pain

Epidural Steroid Injection (ESI): Mixture of long acting local anesthetic and anti-inflammatory steroid are injected into the epidural space. Inflamed spinal nerve roots which cause pain syndromes such as sciatica are coated with the anti-inflammatory cocktail leading to significant pain relief in appropriately selected patients. The physician uses real-time [wiki]fluoroscopy[/wiki] to ensure appropriate positioning of the needle within the epidural space. Epidural steroid injections are used to treat patients who are diagnosed with a [wiki]radiculopathy[/wiki] (back pain that radiates or shoots into the arms or legs).

Although there are minimally invasive treatments for acute and subacute pain, the majority of minimally invasive treatments aim to treat chronic pain, i.e., pain that has been present for longer than 12 weeks and is therefore unlikely to resolve on its own. When performed on the right patient by a skilled physician, patients with chronic pain usually achieve greater than 50% pain relief. Not uncommonly do patients experience complete resolution of their painful symptoms. Before we review each of the minimally invasive treatments for chronic pain  (spinal cord stimulation, etc.),  first we must discuss an equally, if not more, important topic: which patients are unlikely to benefit from minimally invasive treatment?

When is minimally invasive treatment less helpful?

Acute or Subacute Pain

Over 80% of american’s will experience back pain at some point during their life. If we were able to freeze time right now and assess every person experiencing back pain, only 1 person out of 100 would be experiencing pain due to a serious underlying medical condition like cancer. Put another way, the vast majority of back pain is not life threatening, although it can be highly life limiting. Let’s go back to our time freeze scenario for one additional important point. Of all the people experiencing back pain right now, 80% will experience resolution of their symptoms within 1 month.

As the above statistics show, the majority of patients will experience relief with conservative therapies alone (exercise, physical therapy, and OTC pain medication) which are discussed in a separate article. Here are the scenarios where your back pain will almost certainly resolve on its own; therefore, minimally invasive treatment is usually unnecessary:

  • Back pain has only been present for 1-2 weeks;
  • You haven’t tried conservative therapy; or
  • The pain is not severely impacting your daily activities.

MEDICAL INSIGHT

There is one major exception to the above rule…no matter how long your back pain has been present (it could be less than 1 day), if the pain is so severe that you can’t do activities that you’d be able to do any other day like walk, get out of the car, or transition from standing to lying, then seek medical help. Severe debilitating pain, especially if bedridden, can lead to serious downstream medical problems such as blood clots (deep vein thrombosis), lung collapse (atelectasis), and pneumonia. Sometimes severe pain, especially when it comes on quickly, can be related to a spinal compression fracture or insufficiency fracture.

When surgery is required

First and foremost, surgery should be thought of as a last ditch effort to solve back pain. Back surgery is different than minimally invasive treatment in that surgery often requires large surgical incisions that take months to heal. Spinal fusion is an example of a back surgery that requires significant recovery prior to returning to full function.

In fact, surgery is only used when a patient is experiencing both pain and muscle weakness. Back pain alone (in the absence of true muscle weakness) is rarely an indication for back surgery.

Muscle weakness is defined as a lack of muscle strength within a muscle and is a red flag symptom that requires immediate medical attention as the weakness  can become permanent (paralysis) if left untreated. Muscle weakness is often related to severe pinching of a spinal nerve which must be fixed surgically with a decompression procedure (laminectomy, discectomy, fusion).

Unfortunately, severe pain during muscle contraction leading to decreased range of motion is often misinterpreted as muscle weakness. Remember, pain alone (in the absence of muscle weakness) rarely if ever requires surgical intervention as it can almost always be treated with a minimally invasive procedure that not only alleviates pain but carries far fewer risks.  For this reason, it is very important to distinguish true muscle weakness (related to severe nerve damage) from false muscle weakness (caused by severe pain during muscle contraction).

True muscle weakness is not, in and of itself, a painful process…one simply cannot activate a particular muscle group regardless of whether they experience pain during the action. For example, with foot drop (video below), the ankle muscles do not activate; therefore, one foot flops or appears to drag behind the other as the patient walks. In contrast, when pain is limiting motion, the muscle activates normally; however, the action (for example, lifting your arm above your head) cannot be completed due to extreme pain during the motion. In essence, the pain becomes so unbearable the action is stopped.

In some cases, patients can experience both true muscle weakness and pain that limits motion at the same time. If you are at all uncertain whether you are experiencing muscle weakness, consultation with a physician is recommended. If you don’t have a primary care physician or you simply want answers as soon as possible, you can talk to a patient coordinator now. 

Video: This video shows a patient experiencing right sided foot drop. Notice how his right foot is floppy and how it appears as though his right foot would not clear uneven pavement. If you were to ask this patient to “stand on his heels”, his right foot would stay flat on the ground while his left foot would make a “V” shape.

Additional red flag symptoms, which require immediate medical attention (similar to true muscle weakness) because surgery could be required are:

RED FLAG SYMPTOMS

  • Inability to control your bowl/bladder or numbness along both inner thighs (cauda equina syndrome)
  • Pain that started after trauma such as a fall or car accident (compression fracture)
  • Pain associated with a throbbing sensation in your abdomen (abdominal aortic aneurysm)
  • Back pain associated with a new fever, night sweats, or chills (discitis)
  • New or progressive weakness in the arms or legs (myelopathy)

If any of the previous scenarios describe you, it could be case that you have a severe underlying medical condition causing your pain, and prompt evaluation by a medical doctor is recommended.

However, if you’re not experiencing red flag symptoms and you’re not someone whose pain is likely to resolve with conservative treatment alone (discussed above), then read on, because you’re someone who’s likely to benefit from minimally invasive treatment strategies.

When is minimally invasive treatment more helpful?

If you’ve read through the above sections and determined that you don’t have red flag symptoms and your pain is unlikely to resolve on its own (scenarios where pain is likely to resolve on its own are detailed above), then you may stand to benefit from a minimally invasive treatment. In bullet format, here are the scenarios where your back pain is much less likely to resolve on it’s own:

  • When you’ve tried conservative therapy and are still in pain; or
  • Have been in pain for longer than 3 months; or
  • Have severe pain that is limiting your life.

If you fall into one of the three buckets above or you’ve been diagnosed with one of the following medical conditions then you are likely to be a candidate for a minimally invasive therapy. I have:

  • Failed back syndrome
  • Chronic sciatica unresponsive to other treatments
  • Chronic pain related to [wiki]degenerative disc disease
  • Chronic pain related to spinal stenosis
  • Chronic pain related to facet syndrome
  • Pain related to metastatic cancer (bone metastasis)
  • Intolerable side effects from oral opioid medications

Let’s now discuss some of the innovative, minimally invasive treatment options that exist for patients struggling with chronic pain. These treatment options have given hope and a sense of normalcy to those patients who previously had one option only…constant suffering.

Spinal Cord Stimulation

What is spinal cord stimulation (SCS)?

A spinal cord stimulator (SCS) is a small medical device, similar to a pacemaker, that uses electrical impulses to mask pain signals before reaching the brain.

Medical Insight
Spinal cord stimulation (SCS) results in meaningful pain relief for 50-70% percent of well-selected patients and has minor rates of complication (1).

Who is spinal cord stimulation good for?

Spinal cord stimulation is best for patients who suffer from:

  • Chronic pain after back surgery termed “failed back surgery syndrome.”
    Chronic pain after surgery is defined as pain that has not resolved 6 months after surgery.
  • Chronic pain that has not responded to other treatments.
    Chronic pain is defined as pain that has been present for longer than 4 to 6 months and has failed to resolve with other treatments like medication management, injections, and physical therapy.
  • Patients who suffer from chronic pain that radiates from the back into one or both of the legs.
    Patients that have radiating pain–or “radicular pain,” commonly known as “sciatica”–have a particularly high chance for treatment success

Other conditions that can be successfully treated with spinal cord stimulation are:

  • Arachnoiditis
  • Chronic Sciatica or Arm Pain
  • Complex Regional Pain Syndrome (CRPS)
  • Failed Back Surgery Syndrome (FBSS)
  • Multiple Sclerosis

Find out if spinal cord stimulation is a good fit for you with our quiz.

What is the process for getting a spinal cord stimulator?

Step 1: Evaluation by a medical doctor

If you have have chronic back pain that has failed multiple therapies or have persistent back pain after spine surgery (failed back surgery syndrome), discuss spinal cord stimulation with your interventional pain doctor. An interventional pain doctor specializes in using non surgical, minimally invasive procedures to reduce pain. If you are unsure if you’re a candidate for spinal cord stimulation or you don’t have an interventional pain doctor, you’re eligible for a free digital pain consultation today on PainTheory.

Step 2: Stimulator trial

Before a permanent spinal cord stimulator is inserted, a trial is performed to ensure adequate pain relief. At your physician’s office or surgery center, temporary leads are placed into the back (image 1). Unlike the long-term implant, the temporary leads have an external stimulator device that can be easily disconnected (image 2). Over the next 3 to 7 days you will be able to see if the SCS works for managing your pain.

Image 1

Thin wires are inserted under image guidance into the space near the spinal nerves (intrathecal space)

Graphic of the intrathecal space where a spinal cord stimulator is inserted

Image 2

The temporary wires are hooked to a temporary pulse generator that very closely resembles the implanted device

Graphic of temporary pulse generator

What defines SCS trial success?

  • Your pain is reduced by at least 50%.
  • You’re able to return to activities that matter to you.
  • Your need for pain medication is reduced.
  • You’re able to relax and sleep better.

Step 3: Implantation

If the trial run is successful, a minimally invasive procedure is performed to place a permanent stimulator. During the procedure, the lead wires along the back of the vertebrae are then connected to a pulse generator positioned just below the skin near the waistline (image). Most patients leave the day of or the morning after their procedure.

Graphic of where permanent spinal cord stimulator is placed

Image: pulse generator is positioned just beneath the skin near the waistline. The pulse generator is not visible to others but can be easily removed by an interventional pain doctor

Step 4: Recovery

The spinal cord stimulator is programmed before leaving the surgery center. Approximately 10 days after the procedure, the incision is checked to ensure adequate wound healing. Fine tuning of the device also occurs to ensure maximum pain relief.

Top 6 patient questions about SCS

Q: Will the implant be visible?

No. You will not be able to see the device under your skin. Unless you tell someone you have it, they’d never know. Your doctor can position it in the most comfortable and convenient location for you. Some patients report that they can feel the unit by pressing on their skin. In many cases, it is not visible to others.

Q: When can I resume activity?

For several weeks after the implant procedure, you will be asked to restrict your physical activity. The reason for this is to give your body time to heal around the battery pack and leads which keeps the system in an appropriate position.

Q: Is SCS reversible?

Yes. Even though your leads and battery pack are surgically implanted, they can be disengaged or removed by your physician, if ever needed.

Q: Is SCS safe?

Yes. SCS delivers stimulation that doesn’t interfere with normal sensory perception, cognitive abilities, or motor functions. It doesn’t interact with pain medications or requires major surgery, and it is completely reversible.

Q: What are the risks of SCS?

Occasionally patients experience device complications, such as a displaced lead, internally fractured electrode, or device malfunction. Major complications, however, are rare. Complication rates should generally be lower in the hands of an experienced practitioner. The medical problems most often seen are bleeding at the site of the implant, or infection. In such instances, removal of the device and antibiotic treatment are generally required. Infection rates can be as low as 1%, but may rise to 4% in some centers.

Q: What’s the difference between a family practitioner and a pain specialist?

Pain Management Specialists are physicians who specialize in treating chronic pain. These physicians receive years of advanced, specialized training in pain management and focus on treating patients with severe pain. If you do not currently have a pain management specialist or are interested in spinal cord stimulation, you’re eligible for a free digital consultation at PainTheory today.

Intrathecal Pain Pump

What is an intrathecal pain pump?

An intrathecal pain pump is a small medical device that delivers pain medications directly to the spinal cord. The pain pump consists of two parts: 1) the pump (reservoir) that holds pain medication, and 2) the medication tubing ([wiki]catheter[/wiki]) that carries pain medication to the spinal cord nerves.

MEDICAL INSIGHT

Because medication is targeted to areas of pain signaling – as opposed to oral medications that are distributed throughout the entire body – pain pumps can alleviate pain with less than 1% of the amount of oral medication.

Who are intrathecal pain pumps good for?

Pain pumps have been proven most successful for patients with:

  • Chronic pain (pain that has been present for years)
  • Failed back surgery syndrome
  • Cancer related pain
  • Complex regional pain syndrome
  • Chronic pancreatitis
  • Causalgia (burning pain related to peripheral neuropathy)
  • Arachnoiditis

Pain pumps can also help lessen [wiki]spasticity[/wiki] (muscle rigidity and spasms) caused by:

  • Cerebral palsy
  • Multiple sclerosis
  • Stroke
  • Traumatic brain injury
  • Spinal cord injury

What is the process for getting a pain pump?

Step 1: Evaluation by a medical doctor

If you have any of the medical conditions above and you’re interested in learning more, the first step is to discuss pain pumps with your interventional pain doctor. An interventional pain doctor specializes in non-surgical, minimally invasive procedures to reduce pain. If you’re unsure if you’re a candidate for a pain pump or you don’t have an interventional pain doctor, you can have a patient coordinator evaluate you for candidacy now.

Step 2: Pain pump trial

Before a permanent pain pump is inserted, a trial run is performed. The purpose of the trial is to evaluate the degree of pain relief and side effects of having a pain pump without having to actually implant the full device. There are two trial methods, both of which work well and are determined by you and your pain doctor.

Injection method

In this method, a needle filled with pain medication (usually morphine or baclofen) is injected into the space surrounding the spinal cord (the same location where the implanted pain pump delivers medication). Over the day, your degree of pain relief and comfort is assessed by you and your doctor.

Continuous infusion method

In this method, an easily removable temporary system that closely resembles an actual pain pump is inserted. Over the next day, your degree of pain relief and comfort is assessed by you and your doctor.

Anatomy of the cross-section of lower spine with labels

Image: Illustration of the space surrounding the spinal cord nerves (intrathecal space). This is where a pain pump delivers medications such as morphine and baclofen.

After the trial, you and your physician have three tasks:

  • Assess if the trial led to pain relief that helped you throughout the trial.​
  • Discuss if the trial led to any unwanted side effects.
  • Decide if you’re ready to go ahead with pump implantation.

Step 3: Implantation

If the trial run is successful, a minimally invasive procedure is performed to place a more permanent pain pump. First, a small tube (catheter) is placed into the fluid surrounding the spinal cord. During this portion of the procedure, the doctor uses real-time fluoroscopy to guide the catheter into the appropriate location. Next, through a small incision near the waistline, the reservoir/pump (similar in size to a pacemaker) is placed just beneath the skin. Most patients leave the day of or the morning after their procedure.

spinal cord stimulator implantation procedure

Image: pump/reservoir is positioned just beneath the skin near the waistline. The pump is not visible to others but can be easily accessed by an interventional pain doctor

Step 4: Recovery

Full recovery usually takes 6–8 weeks. You may experience some initial discomfort and limits on movements; however, this usually resolves quickly. After a few weeks, you should be able to start getting back to many of the activities you enjoy, such as going for a walk, riding your bike, or going to a movie.

Step 5: Refill

During refill appointments, your physician will assess your symptoms, check that your drug delivery system is working properly, and confirm you are receiving appropriate therapy. The pump will be emptied with a small needle that is inserted under local sedation (numbing medication). The pump will then be refilled with medication. Refill appointments usually take 10 to 15 minutes. How often your pump needs to be refilled depends on your individual dosing schedule and the size of your drug pump.

Top 3 patient questions about pain pumps

Q: Will the pump be visible?

No. Before the procedure, you and your physician will decide where in your abdominal soft tissue to position the pain pump for your comfort.

Q: Will I be awake during the procedure?

No. Typically, the implant is performed under general anesthesia.

Q: What are the risks of the procedure?

Surgical complications are rare but, just as with any procedure, do occur. The most common risks are bleeding or infection.

Regenerative Medicine

What is regenerative medicine?

Regenerative medicine is defined as the process of replacing or “regenerating” human tissue in order to restore normal biologic function. It turns out that the gradual breakdown of normal tissue due to factors like human aging and prior injury are some of the most common causes of pain (National Institute of Neurological Disorder and Stroke).

The major cells used in regenerative medicine are the mesenchymal stem cell and [platelet-rich plasma (PRP). Unlike the fields of heart or liver regeneration, which are years to decades from mainstream clinical use, regenerative techniques to reverse musculoskeletal damage (arthritis, ligament injury, degenerative disc disease) are being used now.

Effectiveness

Clinical trials supporting the use of regenerative medicine in humans have been reported since 2011. Studies as recent as 2017 (Akeda et al.) on platelet rich plasma injection for back pain found that 71% of study participants showed a 50% or greater reduction in their back pain, and 79% of patients showed reductions in their physical disability scores. Similar levels of effectiveness were observed when using stem cells to treat back pain. However, just as with most large health topics (effective dieting strategies, risks/benefits of aspirin for heart disease, or hormone therapy for menopause) results vary between studies.

effectiveness of stem cell therapy and platelet rich plasma (PRP) for the treatment of osteoarthritis

Who is regenerative therapy good for?

Below are the five best times to consider regenerative medicine as a treatment for pain.

Spine arthritis

Numerous scientific articles support the use of stem cell therapy and platelet rich plasma (PRP) for the treatment of spine arthritis, also called degenerative disc disease. Additional studies support the use of regenerative medicine in other joints such as the knees, hips, and shoulders.

From 2015 to 2017, three large scale review articles demonstrated a noticeable benefit when using regenerative therapies like platelet rich plasma for arthritis related to aging. The study conclusions are bulleted below:

  • Platelet-rich plasma improved function and pain scores for knee arthritis.
  • Platelet-rich plasma improved pain scores for knee arthritis at 3, 6, and 12 months.

MEDICAL INSIGHT

Although there is growing evidence supporting regenerative medicine in patients with severe arthritis, patients with mild to moderate arthritis, i.e., patients who are treated during the earlier phases of arthritis have better outcomes. A 2016 meta-analysis published in the Journal of Orthopedic Surgery and Research evaluated 60 individual studies and found the following variables to correspond to best treatment outcomes: earlier stages arthritis, low body mass index, and younger age (defined as treatment in a patient under the age of 60).

Getting back to work

Usually, six weeks to five months of recovery is required to return to work after large back surgeries such as spinal fusion, laminectomy, and discectomy. For people whose jobs require physical activity, recovery can be even longer, ranging from five months to six months. Large surgical incisions that involve the skin and the underlying musculature can take up to 8 weeks to heal. For many patients, not working for this long may mean the difference between financial solvency and bankruptcy. Stem cell and platelet-rich plasma injections require minimal post-procedure recovery as no surgical incision is made. Patients go home the same day as their procedure and can return to their previous level of activity the following day. Truly noticeable improvement in function and pain scores usually begin after a few months and reaches maximum effectiveness after one year.

Getting back to exercise

Exercise is a major outlet of stress reduction and social activity. For surgeries with large surgical incisions that cause significant tissue damage, it can take weeks to months to return to baseline function which can cause stress and a sense of isolation, particularly in those who are athletically driven. Minimally invasive procedures such as stem cell and platelet-rich plasma injections do not require surgical incisions; therefore, almost no damage occurs to the soft tissues. Baseline function usually returns the day after the procedure.Improvements above baseline usually begin within weeks and reach maximum effectiveness after one year.

MEDICAL INSIGHT

If you think about large surgical incisions, often the skin (dermis) and underlying muscle belly are cut. Unfortunately, damage to musculature is often unavoidable based on the procedure and patient’s unique anatomy, leading to x, y, z.

Looking to avoid surgery

Complications are a known risk of surgical procedures and do occasionally occur. The risk of a surgical complication is dependent on the skill of the surgeon, the hospital or surgery center where the operation is performed, the type of surgery performed, and the health of the patient before surgery.

MEDICAL INSIGHT

A 2015 study evaluated 95 patients undergoing spine surgery and found the major complication rate (complications requiring additional surgery) to be approximately 7% (5).

Minimally invasive procedures pose very small procedural risks. For example, the procedural complication rate for image-guided stem cell (SC) or platelet-rich plasma (PRP) injections are estimated to occur in less than 1% of patients. However, it is important to verify the quality of any regenerative medicine clinic as wide quality differences exist between facilities.

Non-surgical candidates

Many times, surgery is considered unsafe in patients with co-existing medical problems such as chronic obstructive pulmonary disease or congestive heart failure. In these instances, the increased risk of surgery is often unrelated to the surgery itself but instead is related to the risk of general anesthesia, i.e., requiring mechanical ventilation or a breathing tube. Because image-guided injections are significantly less painful and stressful to the body, almost always, general anesthesia is not required. For this reason, image-guided injections are safe in many patients who are too sick for surgery.

 

The information included in this document in no way substitutes for medical advice.

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