A new study, published in the journal Neuromodulation, has found that patients show a preference for a one-stage spinal cord stimulation (SCS) screening trial, both before and after implantation. This was regardless of whether patients had undergone a one-stage or two-stage procedure.
According to the authors of this study, Raymond Chadwick (James Cook University Hospital, Middlesbrough, UK) et al, temporary SCS is often used to determine the suitability for a permanent implant in a patient. The authors state that in Europe, North America and many other countries, patients are required to undergo a SCS screening trial to be eligible to receive a SCS implant, provided that a patient’s screening trial is successful. It is reported by the authors that a successful trial is defined as the patient reporting a ≥50% pain relief with stable or reduced pain medication.
The authors report some benefits to SCS screening, initially that it gives patients a taste of what living with SCS therapy is like. Additionally, it allows physicians to measure a baseline evaluation of the pain relief experienced, and the electrical current consumed by the device, which may impact the choice of pulse generator implanted. However, they also note some disadvantages, stating that these screening trials require duplication of procedures, consuming more healthcare resources. Furthermore, a two-stage trial may expose patients to a higher risk of infection.
TRIAL-STIM, a randomised controlled trial at three centres across the UK, found no evidence that an SCS screening trial strategy either provides superior patient outcomes or cost effectiveness as compared with a no trial approach. As part of this study, the authors also undertook a nested qualitative study of patients’ preferences for undergoing a screening trial or not.
Thirty one of the participants of the TRIAL-STIM study were invited to take part in this nested study. For the preimplant interviews, 16 subjects were to undergo a one-stage procedure and 15 were to undergo a two-stage procedure. Eight patients did not participate in the follow-up stage, four who had undergone a one-stage procedure, and four who had undergone a two-stage procedure.
Participants were interviewed using a semi-structured guide. The majority of interviews were audio-recorded and transcribed for analysis, nine were conducted with contemporaneous notes. These interviews were performed on the phone and recorded, and the transcripts were then analysed for themes. Additionally, patients were asked to give an overall preference between a one-stage and a two-stage procedure, on a five-point Likert scale, before and after implantation.
Overall, the study found that common reasons for patient preference for one-stage trial were saving time, avoiding worries about ‘loose wires’ in the two-stage procedures, having only one recovery period, and saving NHS resources. While all of those interviewed showed a preference for a one-stage trial, they were all asked of any benefits which could be seen for a two-stage trial. The main benefit identified by patients was the ease of removing a wire compared with removing an implanted battery pack.
Correction: An earlier version of this article incorrectly stated this study found a preference for two-stage screening trial among patients.