Prospective Validation Study of an E-health Tool for Patient Selection for SCS

NCT06853795 | Not Yet Recruiting

• 1 other identifier: SCS e-health tool
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Pain, Chronic

Keywords

SCS; e-health tool; patient selection

Outcome Measures

Primary Outcomes (1)

• 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).

  12 months

Secondary Outcomes (2)

• Relationship between panel recommendations with centre decisions

  1 week

• Trial results

  1 week

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic pain being eligible for spinal cord stimulation and receiving a direct implant or SCS screening trial

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Herman Stoevelaar, PhD

  Ismar Healthcare

  STUDY DIRECTOR

Central Study Contacts

Herman Stoevelaar, PhD

CONTACT

+3134856072; herman.stoevelaar@ismar.com

Frank Huygen, MD, PhD

CONTACT

+31107034906; f.huygen@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: March 3, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share