Pain, ChronicNCT06853795
Prospective Validation Study of an E-health Tool for Patient Selection for SCS
An observational study of Pain, Chronic, run by Erasmus Medical Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic pain being eligible for spinal cord stimulation and receiving a direct implant or SCS screening trial
Who may be able to join
- Age ≥18 years
- Chronic pain with a duration of least 6 months
- One of the following primary indications: Persistent Spinal Pain Syndrome (PSPS) (type 1 and type 2), Complex Regional Pain Syndrome, Neuropathic Pain Syndrome, Ischaemic Pain Syndrome
- Pain severity at least moderate (VAS ≥ 5, on average over the last month) having a substantial impact on daily functioning and quality of life at the discretion of the attending physician
- Insufficiently responding to appropriate trials of medication, conservative management (e.g. physiotherapy) and/or minimally invasive treatments (such as local anaesthetic nerve blocks), and/or experiencing intolerable side effects of these treatments
- No clear benefits of surgery expected
Who cannot join
- Unwilling to have an implant
- Unable to manage the device
- Absolute contra-indications for active treatment (e.g. unfit for undergoing SCS, pregnancy, spine- or skin-related infections, coagulation disorder)
- Uncontrolled disruptive psychological or psychiatric disorder at the discretion of the attending physician
- Ongoing alcohol and drug misuse
- Widespread pain
- Lack of reimbursement of SCS
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: European E-health Tool for the Appropriate (pre)selection for Spinal Cord Stimulation in Patients with Chronic Pain
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.
Read the detailed description
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:
- General baseline data
- e-Health tool variables
- Centre decision on SCS (direct implant or trial)
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.
- Conditions
- Pain, Chronic
- Keywords
- SCS, e-health tool, patient selection
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic pain patients eligible for spinal cord stimulation | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (2)
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).
Measured: 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).
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Frank Huygen, Erasmus Medical Center
- Investigators
- Herman Stoevelaar, PhD, Study director, Ismar Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853795
- Sponsor's protocol ID
- SCS e-health tool
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data will be shared with researchers not part of the study
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European E-health Tool for the Appropriate (pre)selection for Spinal Cord Stimulation in Patients with Chronic Pain
- ClinicalTrials.gov ID
- NCT06853795
- Acronym / sponsor ID
- SCS e-health tool
- Conditions
- Pain, Chronic
- Keywords
- SCS, e-health tool, patient selection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- General baseline data
- e-Health tool variables
- Centre decision on SCS (direct implant or trial)
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic pain patients eligible for spinal cord stimulation | – | –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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic pain being eligible for spinal cord stimulation and receiving a direct implant or SCS screening trial
Key inclusion criteria (6 listed)
- Age ≥18 years
- Chronic pain with a duration of least 6 months
- One of the following primary indications: Persistent Spinal Pain Syndrome (PSPS) (type 1 and type 2), Complex Regional Pain Syndrome, Neuropathic Pain Syndrome, Ischaemic Pain Syndrome
- Pain severity at least moderate (VAS ≥ 5, on average over the last month) having a substantial impact on daily functioning and quality of life at the discretion of the attending physician
- Insufficiently responding to appropriate trials of medication, conservative management (e.g. physiotherapy) and/or minimally invasive treatments (such as local anaesthetic nerve blocks), and/or experiencing intolerable side effects of these treatments
Key exclusion criteria (7 listed)
- Unwilling to have an implant
- Unable to manage the device
- Absolute contra-indications for active treatment (e.g. unfit for undergoing SCS, pregnancy, spine- or skin-related infections, coagulation disorder)
- Uncontrolled disruptive psychological or psychiatric disorder at the discretion of the attending physician
- Ongoing alcohol and drug misuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
e-health tool predictive value
Time frame: 12 months
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).
2 secondary outcomes
Relationship between panel recommendations with centre decisions
Time frame: 1 week
Trial results
Time frame: 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: No. No data will be shared with researchers not part of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Herman Stoevelaar, PhD study director
Ismar Healthcare
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Chronic, run by Erasmus Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Herman Stoevelaar, PhD (+3134856072, herman.stoevelaar@ismar.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
e-health tool predictive value (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.