Quantitative Sensory Testing in Failed Back Surgery Syndrome and Complex Regional Pain Syndrome Patients during Dorsal Root Ganglion stimulation

Quantitative Sensory Testing in Failed Back Surgery Syndrome and Complex Regional Pain Syndrome Patients during Dorsal Root Ganglion stimulation - FBSS study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44147

Enrollment

Registered

2015-12-11

Start date

2016-01-06

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Failed Back Surgery Syndrome and Complex Regional Pain Syndrome

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients aged 18-55years - Patients diagnosed with the Failed Back Surgery Syndrome or Complex Regional Pain Syndrome - Unilateral leg pain - A spinal cord stimulator was implanted recently ( at least 1 month ago)

Exclusion criteria

Exclusion criteria: - Patient refusal - Diabetes - Pre-existing neurological- of psychiatric disease - Alcohol- of drug abuse - Difficulties in communication - Recent therapies that influence QST measurements, i.e. neuroablative procedures within 2 months

Design outcomes

Primary

Measure	Time frame
Quantitative Sensory Testing: * pQST o Pressure Pain Detection Threshold (PPDT) (N) * eQST o Electrical Pain Detection Threshold (EPDT) [mA] o Electrical Pain Tolerance Threshold (EPTT) [mA] * Nociceptive Perception thresholds (NPT) o Stimulus amplitude [mA] o Responses to stimuli (perceived / not perceived) o Stimulation time [s]	—

Secondary

Measure	Time frame
Pain intensity * Initial pain intensity (NRS; (total population as mean ± SD) SCS-OFF * Pain intensity (NRS; total population as mean ± SD) SCS-ON * Mean (% ± SD) pain reduction during SCS * Questionnaires o Brief Pain Inventory Subjects characteristics * Age, sex, BMI, ASA classification, smoking habits o Pain history (duration, intensity etc) o Medication (i.e. acetaminophen, NSAIDs, opioids) o Area of paresthesia Neurological examination	—

Measure

Time frame

Pain intensity * Initial pain intensity (NRS; (total population as mean ± SD) *SCS-OFF* * Pain intensity (NRS; total population as mean ± SD) *SCS-ON* * Mean (% ± SD) pain reduction during SCS * Questionnaires o Brief Pain Inventory Subjects characteristics * Age, sex, BMI, ASA classification, smoking habits o Pain history (duration, intensity etc) o Medication (i.e. acetaminophen, NSAID*s, opioids) o Area of paresthesia * Neurological examination

—

Countries

Netherlands

Outcome results