Patient Reported Outcome Measurements Registration in Spinal Pathologies and Neuromodulation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJessa Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical diagnosis of spinal disease

Clinical indication to perform treatment of this disease

willing and capable to provide informed consent

Age ≥18 y

Disqualifiers

None

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

5,000 Participants
are grouped into 1 trial group
Group A: patients suffering from spinal pathologies

Trial outcomes

Primary outcomes

1

Visual analogue scale (VAS) PAIN

Visual analogue scale of pain

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

Secondary outcomes

1

Work Status

Work status: work yes/no, profession, duration not working

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

Patiënt global impression of change (PGIC)

Patient Global Impression of Change (PGIC)

Time frame
baseline (T0), post treatment ( 6 weeks +/- 2 weeks), 6 months (+/- 1 month) and yearly (+/- 2 months)
3

Pain vigilance and awareness questionnaire (PVAQ)

Pain vigilance and awareness questionnaire (PVAQ)

Time frame
baseline (T0), post treatment ( 6 weeks +/- 2 weeks), 6 months (+/- 1 month) and yearly (+/- 2 months)
4

Pain Catastrophizing Scale (PCS)

Pain Catastrophizing Scale (PCS)

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

Other outcomes

Sponsors and contacts

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