An observational study in Pain, Chronic, sponsored by Erasmus Medical Center. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-03.
Sponsored by Erasmus Medical Center · Observational
The goal of this observational study is to learn more about the selection of patients with chronic pain for spinal cord stimulation. The main question it aims to answer is to assess the predictive value of an e-health tool for patient outcomes.
Participants will be treated as normal and will be asked to complete patient questionnaires to evaluate their pain relief after receiving spinal cord stimulation. The e-health tool will not be used during the conduct of the study, as patient outcomes will only at the end of the study be compared with the recommendations made by the e-health tool.
This is a multicentre study within Europe, prospectively collecting data from patients with a positive decision on SCS, receiving either a direct implant or an SCS screening trial. Data will be collected by implant centres who have not previously used the e-health tool for SCS patient selection (i.e. tool-naïve). Furthermore, participating centres should declare neither to use the tool during the conduct of study nor on patients included in the study population. In addition, participating implant centres should have previous experience in conducting prospective clinical trials.
Baseline data should be collected at the moment of the final decision on SCS (i.e., after multidisciplinary team consultation if applicable) using an online data capture program:
Only for patients receiving SCS (direct implant or positive trial), follow-up data at 6 and 12 months will be collected.
Afterwards, the prospectively collected data will be applied to the e-health tool and its recommendations compared with the centre decisions, trial results and patient outcomes.
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's planned enrollment of 100 is below the median of 126 across 688 observational studies indexed under Chronic Pain.
Browse Chronic Pain studies →Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with chronic pain being eligible for spinal cord stimulation and receiving a direct implant or SCS screening trial
Exclusion criteria
Patients with chronic pain with a positive decision on SCS. Those receiving either a direct implant or a positive screening trial will be followed at 6 and 12 months after receiving SCS
e-health tool predictive value
Assessment of the predictive value of the panel recommendations (i.e., not recommended, recommended, highly recommended) embedded in the SCS e-health tool for patient outcomes (a). trial outcome: positive/negative, based on Numeric Pain Rating Scale, range 0-10; b).pain-related outcomes after SCS implant: EQ-5D-5L (range 5-25), Brief Pain Inventory (range 0-10), Global Perceived Effect (range 1-7).
Time frame: 12 months
Relationship between panel recommendations with centre decisions
Assessment of the relationship between the panel recommendations (i.e., not recommended, recommended, highly recommended) embedded in the SCS e-health tool with the centre decisions (positive=proceed with SCS; negative=no SCS; defer=reassess in a later phase).
Time frame: 1 week
Trial results
Assessment of the predictive value of the panel recommendations (i.e., not recommended, recommended, highly recommended) embedded in the e-health tool for trial results (% pain reduction on Numeric Pain Rating Scale; range 0-10).
Time frame: 1 week
No study locations are listed for this record.
Plan to share: No — No data will be shared with researchers not part of the study
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Erasmus Medical Center