Subcutaneous stimulation as add on therapy to spinal cord stimulaion to treat low back pain in FBSS.

Phase 3

Conditions: chronische neuropathische pijn als gevolg van Failed Back Surgery Syndrome
Low Back Pain after low back sugery
10005944

Registration Number: NL-OMON34144

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

• Male/female >= 18 and <= 75 years
• Chronic neuropathic pain secondary to FBSS
• Pain radiating in lumbar segments L4 and/or L5 and/or S1 for at least 6 months
• Pain intensity assessed by VAS >= 5 scored separately for leg and back
. Insufficient pain reduction after medication, invasive pain therapy, TENS, etc.
• Willing to provide informed consent

Exclusion Criteria

• Presence of any other clinically significant or disabling chronic pain condition
• Expected inability of patients to properly operate the neurostimulation system
• History of coagulation disorders, lupus erythematosus, diabetes mellitus, rheumatoid arthritis or morbus Bechterew
• Active malignancy
• Current use of medicines affecting coagulation which cannot be temporarily stopped
• Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by the investigator
• Life expectancy of less than 1 year
• Existing or planned pregnancy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The proportion of patients with SCS plus SubQ and SCS alone having 50% or more<br /><br>pain relief (responder rate) in back after 3 months of stimulation, assessed<br /><br>with the VAS.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Effect of SCS plus SubQ or SCS alone after 3, 6 and 12 months on:<br /><br>• Mean reduction in pain intensity for leg and back pain separately, assessed<br /><br>by the VAS<br /><br>• Responder rate of SCS on leg pain assessed by the VAS<br /><br>• Responder rate of SubQ on back pain assessed by the VAS (after 6 and 12<br /><br>months)<br /><br>• Quality of life assessed by Short Form 36 (SF-36)<br /><br>• Quality of life as assessed by EuroQuol (EQ-5D)<br /><br>• Function assessed by the Oswestry disability index<br /><br>• Patient satisfaction assessed by the Global Impression of Change (GPIC)<br /><br>• Pain assessed by the McGill questionnaire<br /><br>• Concomitant drug treatment for relief of pain<br /><br>• Concomitant need for physical therapy or other non-drug treatment.<br /><br>• Employment status<br /><br>• Frequency and nature of adverse events<br /><br><br /><br>And in addition after 12 months of stimulation, on:<br /><br>• Cost-utility<br /><br>• Preferred stimulation settings</p><br>