Patient Reported Outcome Measurements Registration in Spinal Pathologies and Neuromodulation

NCT07552519 | Recruiting

• 1 other identifier: 2025/049
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

Longitudinal prospective observational data collection with questionnaires and categorical diagnostic and therapeutic registration and follow-up in spinal pathologies and neuromodulation

Conditions

Spinal Pathologies; Pain; Cervical Pain; Lumbar Pain Syndrome; Neurostimulation; Disc Degenerative Disease

Keywords

neuromodulation; pain; spinal pathologies

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale (VAS) PAIN

  Visual analogue scale of pain

  baseline (T0), post treatment ( 6 weeks +/- 2 weeks), 6 months (+/- 1 month) and yearly (+/- 2 months)

Secondary Outcomes (7)

• Work Status

  baseline (T0), post treatment ( 6 weeks +/- 2 weeks), 6 months (+/- 1 month) and yearly (+/- 2 months)

• Patiënt global impression of change (PGIC)

  baseline (T0), post treatment ( 6 weeks +/- 2 weeks), 6 months (+/- 1 month) and yearly (+/- 2 months)

• Pain vigilance and awareness questionnaire (PVAQ)

  baseline (T0), post treatment ( 6 weeks +/- 2 weeks), 6 months (+/- 1 month) and yearly (+/- 2 months)

• Pain Catastrophizing Scale (PCS)

  baseline (T0), post treatment ( 6 weeks +/- 2 weeks), 6 months (+/- 1 month) and yearly (+/- 2 months)

• Oswestry Disability index (neck or back, ODI)

  baseline (T0), post treatment ( 6 weeks +/- 2 weeks), 6 months (+/- 1 month) and yearly (+/- 2 months)

Study Arms (1)

patients suffering from spinal pathologies

patients who enter the hospital at a spine department for treatment / advice for spinal pathologies

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 suffering from spinal pathology visiting a spine department for advice and treatment

You may qualify if:

• Clinical diagnosis of spinal disease
• Clinical indication to perform treatment of this disease
• willing and capable to provide informed consent
• Age ≥18 y

You may not qualify if:

• not able to provide consent

Sponsors & Collaborators

• Jessa Hospital: lead

Study Sites (1)

JEssa Ziekenhuis

Hasselt, Limburg, 3500, Belgium

RECRUITING

MeSH Terms

Conditions

Pain; Neck Pain; Somatoform Disorders; Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Mark Plazier, M.D. PhD.

CONTACT

+3211309071; mark.plazier@jessazh.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator, clinical professor

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: April 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)