Caregiver Burden and Correlation With Clinical Outcome in Spinal Cord Stimulation for Chronic Neuropathic Pain

NCT04737746 | Completed

• 2 other identifiers: B1172020000048CME AZ Delta
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

Prospective multicentric observational trial on caregiver burden, caregiver satisfaction and clinical outcome in spinal cord stimulation for chronic neuropathic pain.

Conditions

Pain, Chronic; Pain, Neuropathic; Failed Back Surgery Syndrome

Outcome Measures

Primary Outcomes (3)

• Zarit Burden index

  Zarit Burden index measures the burden of a caregiver in 12 questions

  baseline to 12 months

• relation quality index caregiver

  baseline to 12 months

• caregiver strain index

  baseline to 12 months

Secondary Outcomes (5)

• NRS pain leg and back

  baseline to 12 months

• Oswestry Disability Index

  baseline to 12 months

• EuroQol five dimensions EQ-5D

  baseline to 12 months

• relation quality index patient

  baseline to 12 months

• analgetics dose

  baseline to 12 months

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

All patients who are considered to be treated with spinal cord stimulation in AZ Delta hospital and Jan Yperman hospital between 1/1/2021 and 31/12/2021 are potentially eligible for inclusion. The inclusion is not limited to a specific device and all different types of routinely used spinal cord stimulation systems and neurostimulation modalities are included: percutaneous of surgical lead placement in both thoracic or cervical location. All patients follow the standard flow for screening and reimbursement (neuro pain platform and MAO)

You may qualify if:

• Patients Age \> 18 years
• Patients with an identified spousal or offspring caregiver
• Patients receiving neurostimulator for the first time
• Patient complies to reimbursement criteria for spinal cord stimulation in Belgium

You may not qualify if:

• Non-spinal cord type of neuromodulation (DRG, occipital, peripheral nerve, )
• Revision cases, previous neuromodulation
• Patients unable to consent for this study
• Patients without identified spousal or offspring caregiver

Sponsors & Collaborators

• AZ Delta: lead

Study Sites (2)

Jan Ypermanziekenhuis

Ieper, 8900, Belgium

Location

AZ Delta

Roeselare, 8800, Belgium

Location

MeSH Terms

Conditions

Chronic Pain; Neuralgia; Failed Back Surgery Syndrome

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Back Pain

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 13 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: neurosurgeon

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 4, 2021
• Study Start: January 18, 2021
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)