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

Completed

Conditions: 10034606
Failed Back Surgery Syndrome and Complex Regional Pain Syndrome

Registration Number: NL-OMON44147

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

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

- 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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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