Offering FBSS/FNSS patients the opportunity to participate in their own rehabilitation trajectory

The question

The incidence of developing failed back surgery syndrome (FBSS) after spinal surgery is estimated in the range of 10% to 40%, depending on the type of surgery.

(Chan CW, Peng P. Failed back surgery syndrome. Pain Med. 2011;12:577–606. Sebaaly A, Lahoud MJ, Rizkallah M, Kreichati G, Kharrat K. Etiology, evaluation, and treatment of failed back surgery syndrome. Asian Spine J. 2018;12:574–585.) 

Patients with FBSS are suffering from persistent or recurring low back pain, sometimes associated with referred or radiating leg pain, despite having undergone lumbosacral spine surgery. This heterogeneous group of patients is often difficult to treat, as they experience a wide variety of complaints. Spinal cord stimulation (SCS) is considered an effective treatment option for patients with FBSS and failed neck surgery syndrome (FNSS) to improve back and/or leg pain as well as the functional status of a patient.

Our client wanted to bring an upgraded neurostimulator with innovative features to the market. Before doing that, it was important for them to understand what the most common patient outcome goals are. The question behind this: will applying goal setting, as a form of patient empowerment, further improve the outcome of SCS?

The end goal 

The goal of our research was to understand what the most common patient outcome goals would be if he/she were to use this new and upgraded neurostimulator. With this information, the client can set up new endpoints in clinical trials: now they don’t only have information about the expectations regarding pain relief, but on top of that the research will provide them with new insights regarding the expected improvements in activity and quality of life.

In other words: the client wanted to gain better understanding of the personal patient goals and how to measure them in terms of activities – and ultimately translate them into measurable actions.  

Our approach

Product value drivers

Phase 1 

We organised 15 in-depth phone interviews with Belgian FBSS/FNSS patients that were already scheduled and waitlisted for Spinal Cord Stimulation. We asked them various questions, focusing on improvement of quality of life rather than the reduction of pain:

  • What are the goals you’d like to achieve?
  • Which activities would you like to undertake, both socially as in the area of sports?
  • Which practical activities are difficult for you now, but would you like to be able to do again on your own? (go to the grocery store, go to work, family visits, …

Phase 2

We analysed the answers coming out of this open discussion and distilled new questions based on the results. With this information we set up a new online survey that was sent to 200 participants across Europe. In this survey we put 50+ objectives that were to be rated on measurability and feasibility, such as:

  • If you’d like to run again: how many times a week would you like to run? How far and how long would you like to run?
  • If you’d like to be able to sit again: how long would you like to be able to sit comfortably? What are realistic goals according to the period you can stay seated now? 
  • If you’d like to return to work, how many days a week would you want to be able to? What are the main reasons for returning? (being part of society, getting out of the house, financial reasons)

With these results we came up with a quantification of the different goals and how the new stimulator would be able to measure them.

Our outcomes

In the first place, this research provided us with better understanding of the position/activity goals that chronic back patients have. But even more importantly: this study demonstrated that patients are not only focusing on pain relief as a treatment goal, but also on improving activities, participation and personal factors

How they will help the customer

Together with the Vrije Universiteit Brussel and patient organisation ‘Pain Association’, SUAZIO conducted this research in order to collect more and new input for establishing new clinical studies considering chronic pain patients. 

The interviews revealed a broad spectrum of individual patients’ goals, highlighting the need of individually targeted rehabilitation trajectories in the field of neuromodulation. Goal identification could entail the first step towards personalised medicine in the SCS trajectory.


Economic value proposition

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