Caring Medical - Where the world comes for ProlotherapyWhen Spinal Cord Stimulators are not helping

Ross Hauser, MD, Caring Medical Regenerative Medicine Clinics, Fort Myers, Florida
David N. Woznica, MD, Caring Medical Regenerative Medicine Clinics, Oak Park, Illinois
Danielle R. Steilen-Matias, MMS, PA-C, Caring Medical Regenerative Medicine Clinics, Oak Park, Illinois

When Spinal Cord Stimulators are not helping

In our many years of helping people with spinal pain, we have seen many patients with Spinal Cord Stimulation systems (SCS) implanted in their spines. We have also seen many patients who had these systems explanted or removed and expressed a degree of regret for having them implanted in the first place. For some people, Spinal Cord Stimulation systems are a successful treatment and provide these people with a way to manage their pain. These, however, are not the people we usually see in our practice. We see the people who have had their Spinal Cord Stimulation systems removed because they were not successful.

Spinal cord stimulators are usually reserved as THE last-chance effort at controlling spinal pain. Specifically, Spinal Cord Stimulation systems are used for people who have pain after spinal surgery or spinal issues in which an additional surgery would be risky or come with a high expectation of surgical failure. The Spinal Cord Stimulation system involves implanting a small pulse generator into the stomach and running coated wires to the spine to deliver electrical impulses to the spinal cord. These electrical impulses block pain signals traveling to the brain.

If you are reading this page, it is likely you have been recommended to a Spinal Cord Stimulation system instead of a traditional spinal surgery or you have had your system removed after a failed back surgery and you are seeking options. This article will offer an introduction to the possible use of Prolotherapy injections to assist in managing your back pain after Spinal Cord Stimulation failure. Prolotherapy is a treatment that seeks to rebuild weakened spinal ligaments that can help stabilize the spine.

“My Spinal Cord Stimulator did not help”

We want to stress again that Spinal Cord Stimulation system (SCS) does help people, they did not help the people we see in our office.

When a patient comes in with a history of Spinal Cord Stimulation or SCS implant, they will usually tell us a similar story to other patients we have seen:

  • I had an SCS in for a little more than a year. It did not help. I was back on heavy doses of opioids and painkillers and antidepressants. I am not even looking for total pain relief anymore, I just want to reduce my painkiller usage.
  • I had an SCS implanted for cervical radiculopathy pain. After a few weeks, I had to have the electrodes adjusted because I was not getting any benefit. After a few more weeks I decided to have it taken out so I could explore other options.
  • I never seemed to get out of the recovery period from the Spinal Cord Stimulation system surgery. I had to have it removed, I do not think I have recovered from the removal surgery either. Everything is worse.

“I got the Spinal Cord Stimulator because another surgery was not going to help me.”

What we found in many people, is that they went with the SCS device implantation because they did not want to go through an extensive spinal or cervical surgery with no guarantees that it would help.

In the July 2017 issue of the medical journal Spine, (1) doctors explained that spinal cord stimulators should be explored as the best option against further exposing patients to more failed procedures: “Clinical evidence suggests that for patients with Failed Back Surgery Syndrome, repeated surgery will not likely offer relief. Additionally, evidence suggests long-term use of opioid pain medications is not effective in this population, likely presents additional complications, and requires strict management.”

“I got the Spinal Cord Stimulator because I needed to do something, try anything.”

A study from June 2019 from the University of California at San Francisco published in the journal Translational perioperative and pain medicine, (2) gave recommendations to doctors on who SCS would be best suggested to, but even then, evidence suggests that Spinal cord stimulation devices may work only in the short-term and what makes it work maybe a placebo effect in some patients. Note anything that gives pain relief, placebo included is, is a blessing to the pain sufferer.

“Spinal cord stimulation (SCS) and its recent technical advances have opened the door to a promising treatment option for FBSS. However, critical appraisal of supporting and refuting data is necessary to identify the best patient population for this treatment modality.

Evidence for the efficacy of SCS in Failed Back Surgery Syndrome is accumulating, with most studies demonstrating its efficacy especially for those patients with leg pain as the predominant symptom. . . Additionally, it is clear that SCS provides short-term benefit, yet there is no solid evidence that SCS provides any benefit beyond two years of implantation.

Another major concern is the significant placebo effect, which makes the true therapeutic response difficult to judge.”

Why the spinal cord stimulations had to be removed 

In an August 2017 study, (3) seventeen pain centers across the United States took part in a research program to see why spinal cord stimulations had to be removed from patients. These pain centers found that clinically, spinal cord stimulation devices are cost-effective and improve function as well as the quality of life in some patients with back pain. However, despite the demonstrated benefits of spinal cord stimulation, some patients have the device removed. The researchers in this study wanted to know why.

The most common reason for device removal was:

  • lack or loss of pain relief, (43.9%)
  • followed by complications (20.2%)

“Better Safe Than Sorry.”

A January 2020 study (4) from leading Italian university neurological surgery researchers is titled: “Surgical Back Risk Syndrome and Spinal Cord Stimulation: Better Safe Than Sorry.” The paper was published in the journal, World neurosurgery. Here is what the researchers wrote:

The surgery may be riskier than the disease.

“Recurrent and chronic low back pain, caused by degenerative lumbar spondylosis, commonly affects elderly patients, even those with no previous low back surgery. These patients, like those affected by failed back surgery syndrome (FBSS), may become unresponsive to medical conservative treatment and their quality of life could be easily compromised. Moreover, general comorbidities (accompanying symptoms), obesity, and other typical conditions of the elderly may make surgery under general anesthesia riskier than the natural history of the disease. These patients could be considered affected by surgical back risk syndrome (SBRS).”

In this study, the researchers suggested that for some people “in whom back surgery under general anesthesia may be challenging and overcome the potential benefit of the surgery itself,” surgeons should instead consider the implantation of a Spinal Cord Stimulator. A device surgically placed in the spine to send electrical pulses to kill the pain.

Spinal Cord Stimulators are a surgical procedure to prevent spinal surgery

When someone is in significant and chronic pain, anything that helps them is a good treatment. For some people, Spinal Cord Stimulators are very helpful. For others, Spinal Cord Stimulators are not helpful and can possibly make someone’s situation worse. As risky as Spinal Cord Stimulators can be, in the above study from neurosurgeons, they are still seen as a better option to more complicated spinal surgery for many people. Let’s also point out that Spinal Cord Stimulators suppress pain symptoms, they are a surgically implanted form of painkillers. They do not repair spinal damage. Many patients that we see with Spinal Cord Stimulation systems continue to need narcotic pain medications. They are visiting us because pain medications are not their choice of treatment and are looking for options.

Spinal cord stimulation failure: evaluation of factors underlying hardware explantation (removal)”

In October 2019, doctors from the Department of Neurosurgery, University of Cincinnati College of Medicine lead a study published in the Journal of neurosurgery. Spine. (5) The title of this paper is: “Spinal cord stimulation failure: evaluation of factors underlying hardware explantation.”

“Spinal cord stimulation has been shown to improve pain relief and reduce narcotic analgesic use in cases of complex refractory (difficult to treat) pain syndromes. However, a subset of patients ultimately undergoes removal of the spinal cord stimulator (SCS) system, presumably because of surgical complications or poor efficacy.”

In this study, the researchers looked at 129 patients who had the spinal cord stimulator hardware removed in surgery. Here is a little bit about these patient stories

  • More than half of the patients were legally disabled.
  • Initial postoperative reduction in pain was reported in 81% of patients, and 37.8% returned to work.

Why the Spinal cord stimulation had to be removed:

  • Among 15 patients with acute post-surgical complications (12 infections, 2 hemorrhages, 1 immediate paraplegia), the average time to removal was 2 months.
  • Primary reasons for hardware removal were:
    • lack of stimulation efficacy (81%),
    • electrode failure due to migration (14%),
    • and allergic reactions to implanted hardware in 2 patients.
  • Other risk factors center on psychiatric evaluation
    • The 72 patients who underwent formal psychiatric evaluation before implantation were affected by:
      • high rates of major depression (64%),
      • anxiety (34%),
      • posttraumatic stress disorder (PTSD) (12%),
      • drug or alcohol abuse (12%),
      • and physical or sexual abuse (22%).

After spinal cord stimulation failure – targeted drug delivery

Some patients, having failed spinal cord stimulation are recommended targeted drug delivery. A January 2020 study in the journal Regional Anesthesia & Pain Medicine (5) discusses these patient’s problems:

  • “(Current treatment options begin with) conservative non-invasive (non-surgical) strategies, later progressing from minimally invasive (surgical) interventions to invasive (surgery) techniques or implantable devices (following failed surgery). The most commonly used implantable devices are spinal cord stimulation systems or targeted drug delivery (TDD) devices.”

The researchers noted that spinal cord stimulators are generally offered to patients first and then when they fail, targeted drug delivery devices are then recommended.

The researchers in this study examined patients who succeeded with SCS and those who failed SCS and consequently proceeded to targeted drug delivery. Here are some patient characteristics they noted:

  • 945 patients were included in the study of which 119 (12.6%) subjects achieved adequate pain relief with targeted drug delivery after failure of SCS.
    • Males were 52% less likely to experience pain relief with SCS.
    • The odds of SCS success decreased as age increased by 6% per year.
    • Patients with comorbid depression, interestingly, were 63% more likely to succeed with SCS.
    • Older male patients diagnosed with spine-related pain were more likely to benefit from targeted drug delivery than SCS. These findings lead the researchers to suggest that in this group targeted drug delivery should be recommended ahead of spinal cord stimulation.

Causes of Chronic Post-Surgical Spinal Pain

In this video, Ross Hauser, MD describes the 5 main reasons that back surgery failed to help the patient’s condition. It is these patients that implantable devices – spinal cord stimulation systems or targeted drug delivery (TDD) devices are usually recommended.

  1. The surgery did not address the actual cause of the patient’s pain. The diagnosis is wrong.  A primary cause of “missed” low back pain is an injury to the Sacroiliac Joint. If your MRI showed disc degenerative disease and you had the discs operated on but the Sacroiliac Joint was not addressed, the pain will continue after the surgery.
  2. The surgery made the lower back MORE unstable. Foraminotomy, Laminectomy, Microdiscectomy, disc surgery, all have to remove parts of the bone in the spine.
  3.  The “missed secondary problem.” The surgery may have successfully addressed what was considered your primary problem, but, you really had two problems. This could be a multi-segmental problem that was not discovered until after the first surgery.
  4. Too much sitting after surgery, possibly too much bed rest.
  5. Rarer, scar tissue pinches on the nerves. This is discussed at length below.

Comprehensive Prolotherapy for failed disc surgery: the realistic goals

Comprehensive Prolotherapy is a treatment designed to strengthen weakened soft tissue in the spine and bring stability to the area through injections, not surgery. In the case of spinal stimulators, we ask patients to bring in their X-rays showing exactly where the spinal cord stimulator is placed. As long as we can see where the stimulator electrodes are located we can safely do Prolotherapy injections.

The treatment is not a painkiller or pain suppression treatment although pain relief is a noted benefit. The treatment strengthens the spine by way of tightening the spinal ligaments that hold the vertebrae in place.

The Spinal ligament repair injection treatment option Prolotherapy

In this video Danielle R. Steilen-Matias, MMS, PA-C ., explains and demonstrates a Prolotherapy treatment into the lumbar spine.

Video Summary and Learning Points

  • Prolotherapy is multiple injections of simple dextrose into the damaged spinal area.
  • Each injection goes down to the bone, where the ligaments meet the bone at the fibro osseous junction. It is at this junction we want to stimulate repair of the ligament attachment to the bone.
  • We treat the whole low back area to include the sacroiliac or SI joint. In this video, the patient’s  sacroiliac area in being treated to make sure that we get the ligament insertions and attachments of the SI joint in the low back.
  • I’ve marked with a black crayon all down the midline of this patient’s back  and then I have a horizontal line drawn where her pain stops. This patient has a curvature of her spine, scoliosis, so it is important to understand where the midpoint (center) of her spine is. In this patient we are going to go up to the horizontal line into the thoracic area which is usually not typical of all treatments.
  • It’s important to note that this particular patient is actually not sedated in any way so even though it is a lot of shots and a lot of injections through the skin which can be painful, patients tend to tolerate it really well the whole procedure goes relatively quickly
  • At 2:20 I’m just making sure that I get the sacroiliac or SI ligaments as well as the iliolumbar ligament to help strengthen the low back.
  • After treatment we want the patient to take it easy for about 4 days.
  • Depending on severity of the low back pain condition, we may need to offer 3 to 10 treatments every 4 to 6 weeks.

What does Prolotherapy address?

In research from Harold Wilkinson MD, published in the medical journal Pain Physician, (6) Dr. Wilkinson looked at difficult back pain cases, “Of the patients studied, 86% of patients had undergone prior lumbar spine surgery and all were referred for neurosurgical evaluation for possible surgery,” to see is simple dextrose Prolotherapy would be of benefit.

Here are some learning points:

  • Thirty of the 35 patients in this study had been referred to a neurosurgeon because of persistent pain and disability despite prior low back surgery and were referred for consideration for possible additional surgery.
  • After inclusion in this study, only four patients subsequently underwent additional surgery, though 29 patients requested repeat injections.
  • This suggests that painful enthesopathies can be major pain generators for some patients and that diagnosing their condition as being due to a focal problem and treating those sites with prolotherapy can be an effective and “minimally invasive” treatment alternative. (The enthesis is the point at which the connective tissue structures, such as a joint capsule, fascia, ligament, tendon, or muscle attach to the bone.)

Please refer to for more discussion Cervical pain Adjacent segment disease following neck surgery for a discussion of the cervical spine.

Platelet Rich Plasma Therapy in combination with Prolotherapy

Some doctors may recommend the use of Platelet Rich Plasma to help patients with failed back surgery syndrome. Platelet Rich Plasma is an injection of your concentrated blood platelets into the area of pain. The concentrated blood platelets bring healing and regenerating growth factors to the areas possibly damaged or affected by surgery.

Recent research says that  Platelet-rich plasma (PRP) represents an additional approach, as it has shown some promise in bone regeneration, and should be explored  for its potential role in limiting spinal fusion surgery failures.(7)

In our practice, PRP is used in conjunction with dextrose Prolotherapy to stimulate healing of the ligament and tendon attachments of the spine that cause pain, muscle spasms, and degenerative disc and other conditions.

Can these treatments help you?

If this article has helped you understand problems of Failed back surgery syndrome treatment options and you would like to explore Prolotherapy as a possible remedy, ask for help and information from our specialists


1 Kapural L, Peterson E, Provenzano DA, Staats P. Clinical Evidence for Spinal Cord Stimulation for Failed Back Surgery Syndrome (FBSS). Spine. 2017 Jul 15;42(1):S61-6. [Google Scholar]
2 Palmer N, Guan Z, Chai NC. Spinal Cord Stimulation for Failed Back Surgery Syndrome–Patient Selection Considerations. Translational perioperative and pain medicine. 2019;6(3):81. [Google Scholar]
3 Pope JE, Deer TR, Falowski S, Provenzano D, Hanes M, Hayek SM, Amrani J, Carlson J, Skaribas I, Parchuri K, McRoberts WP. Multicenter retrospective study of neurostimulation with exit of therapy by explant. Neuromodulation: Technology at the Neural Interface. 2017 Aug;20(6):543-52. [Google Scholar]
4 Graziano F, Gerardi RM, Bue EL, Basile L, Brunasso L, Somma T, Maugeri R, Nicoletti G, Giacopino D. Surgical Back Risk Syndrome and Spinal Cord Stimulation: Better Safe Than Sorry. World Neurosurgery. 2020 Jan 1;133:e658-65.
5 Patel SK, Gozal YM, Saleh MS, Gibson JL, Karsy M, Mandybur GT. Spinal cord stimulation failure: evaluation of factors underlying hardware explantation. Journal of Neurosurgery: Spine. 2019 Oct 4;1(aop):1-6.
6. Wilkinson HA. Injection therapy for enthesopathies causing axial spine pain and the “failed back syndrome”: a single blinded, randomized and cross-over study. Pain Physician. 2005 Apr;8(2):167-73. [Google Scholar]
7. Hussein M, Hussein T. Effect of autologous platelet leukocyte rich plasma injections on atrophied lumbar multifidus muscle in low back pain patients with monosegmental degenerative disc disease. SICOT-J. 2016;2:12. doi:10.1051/sicotj/2016002. [Google Scholar]

 

 

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