When Spinal Cord Stimulators are not helping

Ross A. Hauser, MD., Danielle R. Steilen-Matias, MMS, PA-C.

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 very successful treatments and provide many 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 and you are seeking other options beyond increasing pain medications and learning behavioral or coping skills. This article will offer an introduction to the possible use of Prolotherapy injections to assist in managing your back pain after Spinal cord stimulator 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 the Spinal Cord Stimulation system (SCS) does help people, it 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 am not a candidate for more surgery. I guess the damage is done.

I had an SCS in for a little more than a year. I don’t think it has worked for me, as I expected. I am heavy doses of opioids and painkillers and antidepressants. The same drugs that I was on before the implant. I have had two back surgeries, the last in 2016. I am not a candidate for more surgery. I guess the damage is done.

Radiculopathy pain

I had an SCS implanted for 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.

It just didn’t help

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 Spinal Cord Stimulation device implantation because they did not want to go through an extensive spinal or cervical surgery with no guarantees that it would help. Their doctors agreed. There was good research and understanding that a Spinal Cord Stimulation recommendation would be considered a good option for many of their patients.

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.”

“The Spinal Cord Stimulator was my best chance to avoid surgery.”

The decision to go ahead with Spinal Cord Stimulation is a challenging one, but as it is considered much less risky than another surgery, there is a degree of hope and reassurance that this will help.

Benefits for overweight and older adults

A February 2021 study in the medical journal Neuromodulation (2) suggests that “In overweight, older adults for whom the risks of corrective surgery must be carefully considered, neuromodulation (Spinal Cord Stimulation) can significantly reduce low back pain as well as regional pain in the first six months following implantation. These findings may provide a reasonable alternative in patients not willing or eligible to undergo extensive corrective surgery.”

It was however pointed out that in these patients “Loss of thoracic kyphosis and increased pelvic incidence was associated with worse (pain relief scores) to Spinal Cord Stimulation stimulation at six months follow-up.”

As you may be aware from your own medical history:

This is something we will discuss below. It shows that in some people it is not the Spinal Cord Stimulation that is failing, it is the whole of the spine that is collapsing. Spinal instability is creating more pain and more problems that than the Spinal Cord Stimulation device can handle. Below we will discuss how we may approach this situation.

“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, (3) gave recommendations to doctors on who Spinal Cord Stimulation 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 technological 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 benefits, 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.”

“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.

Spinal Cord Stimulators are a surgical procedure to prevent spinal surgery

When someone is suffering from 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 for 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.

Why the spinal cord stimulations have to be removed 

Above we briefly mentioned that a possibility of Spinal Cord Stimulation failure is not the system itself but the continued collapse of the spine at segments above and blow previous surgeries. This is a complication of surgery, spinal instability. However, there are other types of complications associated with the SCS device itself.

In an August 2017 study, (5) 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:

Higher-frequency dose Spinal Cord Stimulation

A November 2020 study published in the Journal of Pain Research (6) suggested better results in managing Spinal Cord Stimulation failure if the patient received a higher-frequency SCS.

As you are likely aware there is a discussion in the medical community about the superiority of using higher-frequency dose Spinal Cord Stimulation as opposed to a lower-frequency dose Spinal Cord Stimulation

Here are the learning points of this research:

What were the results? Here is the study conclusion:

Many of you reading this article may have had this option explained to you and you are reading this article because the higher-frequency SCS may not be an option for you.

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. (7) 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

Why the Spinal cord stimulation had to be removed:

After spinal cord stimulation failure – targeted drug delivery

Some patients, having failed spinal cord stimulation are recommended for targeted drug delivery. A January 2020 study in the journal Regional Anesthesia & Pain Medicine (8) discusses these patient’s problems:

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:

Limitations of Spinal Cord Stimulators – People still take opioids

A February 2021 study in the Journal of Clinical Neuroscience (9) examined the effectiveness of Spinal cord stimulation as a treatment to reduce opioids (pain medication needs). Here are the suggestions and learning points of this study:

“Spinal cord stimulation has been considered as an alternative therapy to reduce opioid requirements in certain chronic pain disorders. However, information on long-term opioid consumption patterns and their impact on Spinal cord stimulation device explantation is lacking. We conducted a retrospective study of 45 patients to characterize long-term patterns of opioid usage after Spinal cord stimulation implantation.

Opioid usage

Spinal cord stimulation device explanation

Daily opioid consumption does not decrease

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 in 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.

New evidence that spinal cord stimulation is helpful

In this article, we discussed the failure of spinal cord stimulators. We would like to again state that spinal cord stimulators do offer people relief.

A July 2021 study (10) from the Department of Neuroscience and Experimental Therapeutics, Albany Medical College in New York examined the effectiveness of spinal cord stimulation in older patients by comparing their outcomes to middle-aged patients. The researchers noted that spinal cord stimulation is an effective chronic pain treatment most commonly used in middle-aged patients and that difficult to treat older patients with pain after spinal surgery should have results just as good. The cutoff line as being defined as older compared to middle-age was 65 years old. The researchers found and were able to provide evidence that This study represents the largest study where age was correlated to specific pain, depression, and disability outcomes following SCS. We provide evidence that spinal cord stimulation outcomes are equivalent, or better, in older patients following spinal cord stimulation. Based on these findings, spinal cord stimulation is a viable option for the treatment of chronic pain in elderly patient populations.

A June 2021 paper from the Departments of Anesthesiology, Amsterdam University Medical Centers, and published in the journal Pain and Therapy (11). The purpose of this study was to compare low and high-frequency devices and to assess their outcomes in helping patients.

After examining 32 patients (age differences 18-70 years old) the researchers found pain suppression and improved quality of life were sustained at 12 months; both were statistically significant and clinically relevant. Fifty percent of patients had greater than 80% pain suppression. They concluded: “that our hypothesis regarding the effect of 1000 Hz and 30 Hz stimulation strategies on pain suppression was confirmed. Both stimulation strategies led to a large, sustainable, clinically relevant pain suppression and improvement in quality of life.”

Prolotherapy injections as an option

When someone contacts our center with a history of an SCS implant or explant, we need to explore with them the realistic option that Prolotherapy can offer them.

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 the pain relief is a noted benefit. The treatment strengthens the spine by way of tightening the spinal ligaments that hold the vertebrae in place.

What are we seeing in this image?

It is a pelvic x-ray showing a patient’s spinal cord stimulator and the spinal fusion screws. This is a graphic display of the complication and challenges of a failed back surgery. The patient to whom this x-ray belongs had a history of multiple spinal surgeries, cortisone injections, and the implantation of a spinal cord stimulator. The patient came in to see us because she was not getting pain relief. Following Prolotherapy treatments she had the SCS removed. Her story may not be typical of patient success with treatment. It is her story.

What does Prolotherapy address?

In research from Harold Wilkinson MD, published in the medical journal Pain Physician, (12) 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:

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

The Spinal ligament repair injection treatment option Prolotherapy

Summary and Learning Points of Prolotherapy to the low back

Kyphosis and increased pelvic incidence

What are we seeing in this image immediately below?

In the third or C image, we see the development of Kyphosis or the “hunchback” condition.

Also notice a change in the pelvic tile or pelvic incidence:

spine curves

For many patients we see, who have issues of chronic back pain and neurological or radiculopathy issues causing pain to move into the legs or arms, they come into the first visit us with an understanding that something is wrong with the curve of their spine. They also have an understanding that it is this curve problem, whether their spines curve inwards too much or that they lost the natural curvature of the spine that is a cause of their problems. But the curvature of the spine is a complex problem and many of our patients who come in have reduced their understanding of this problem, and rightfully so, to how it impacts their daily lives.

Above we mentioned that patients with a hunchback or kyphosis condition may not respond well to spinal cord stimulators. A state of hunchback clearly is a state of spinal abnormality. To help people with failed back surgery syndrome, the state of their kyphosis should be addressed and treated as optimally as realistically possible.

For many years we have had good success treating patients who were suffering from post spinal surgery pain.  In some patients, though, symptoms would return. Through extensive research and patient data analysis, it became clear that in order for patients to obtain long-term relief (approximately 90% relief of symptoms) the re-establishment of some lordosis (normal spinal; curvature) is necessary. Once spinal stabilization was achieved with Prolotherapy and the normalization of spinal forces by restoring some lordosis, lasting relief of symptoms was highly probable.

This is achieved through our various spinal curve correction programs and Prolotherapy.

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. (13)

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.

Summary and contact us. Can we help you?

Prolotherapy can help many people who have failed back surgery and failed spinal cord stimulation by addressing spinal instability and repairing loose, lax, damaged ligaments. The key to successful treatment is identifying the right candidates. These treatments will not help everyone.

We hope you found this article informative and it helped answer many of the questions you may have surrounding your back problems and spinal instability.  If you would like to get more information specific to your challenges please email us: Get help and information from our Caring Medical staff

This is a picture of Ross Hauser, MD, Danielle Steilen-Matias, PA-C, Brian Hutcheson, DC. They treat people with non-surgical regenerative medicine injections.

Brian Hutcheson, DC | Ross Hauser, MD | Danielle Steilen-Matias, PA-C

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References

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 Lucia K, Nulis S, Tkatschenko D, Kuckuck A, Vajkoczy P, Bayerl S. Spinal Cord Stimulation: A Reasonable Alternative Treatment in Patients With Symptomatic Adult Scoliosis for Whom Surgical Therapy Is Not Suitable? A Pilot Study. Neuromodulation: Technology at the Neural Interface. 2021 Feb 9. [Google Scholar]
3 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]
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. [Google Scholar]
5 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]
6 Kapural L, Sayed D, Kim B, Harstroem C, Deering J. Retrospective Assessment of Salvage to 10 kHz Spinal Cord Stimulation (SCS) in Patients Who Failed Traditional SCS Therapy: RESCUE Study. Journal of Pain Research. 2020;13:2861. [Google Scholar]
7 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. [Google Scholar]
8 Mekhail N, Mehanny DS, Armanyous S, Costandi S, Saweris Y, Azer G, Bolash R. Choice of spinal cord stimulation versus targeted drug delivery in the management of chronic pain: a predictive formula for outcomes. Reg Anesth Pain Med. 2020 Jan 12:rapm-2019-100859. doi: 10.1136/rapm-2019-100859. Epub ahead of print. PMID: 31932490.
9 Hwang BY, Negoita S, Duy PQ, Tesay Y, Anderson WS. Opioid use and spinal cord stimulation therapy: The long game. Journal of Clinical Neuroscience. 2021 Feb 1;84:50-2.  [Google Scholar]
10 Bondoc M, Hancu M, DiMarzio M, Sheldon BL, Shao MM, Khazen O, Pilitsis JG. Age as an Independent Predictor of Adult Spinal Cord Stimulation Pain Outcomes. Stereotactic and Functional Neurosurgery.:1-7. [Google Scholar]
11 Breel J, Wille F, Wensing AG, Kallewaard JW, Pelleboer H, Zuidema X, Bürger K, de Graaf S, Hollmann MW. A Comparison of 1000 Hz to 30 Hz Spinal Cord Stimulation Strategies in Patients with Unilateral Neuropathic Leg Pain Due to Failed Back Surgery Syndrome: A Multicenter, Randomized, Double-Blinded, Crossover Clinical Study (HALO). Pain and Therapy. 2021 Jun 6:1-4. [Google Scholar]
12 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]
13 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]

This page was updated July 28, 2021

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