TerminatedNot Applicable

A Randomised Pilot Study to Assess Differences in Stimulation Induced Paresthesia Between 2 Spinal Cord Stimulation Systems

Netherlands5 participantsStarted 2014-09

Plain-language summary

12-SMI-2014 is a post-market, randomised, pilot study to identify and rate differences in patient experiences with two different types of Spinal Cord Stimulator devices which are routinely used to treat chronic pain.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subject is appropriate for SCS implantation according to standard criteria
✓. Subject is \>18 to \<75 years old
✓. Subject is able and willing to comply with the follow-up schedule and protocol
✓. Subject has chronic (\> 6 months) uni/bi-lateral neuropathic pain in the lower limb(s) (below the knee) with predominant foot pain
✓. Minimum baseline pain rating of 50 mm on the VAS in the primary region of pain
✓. Subject is able to provide written informed consent

Exclusion criteria

✕. Subject has no other exclusion criteria for SCS implantation according to standard criteria
✕. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
✕. Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
✕. Subject has participated in another clinical study within 30 days
✕. Subject has been previously treated with and failed to respond to an implantable neuromodulation therapy

What they're measuring

Specificity of Stimulation Induced Paresthesia

Timeframe: 3 Months post implantation

Stability of Stimulation Induced Paresthesia

Timeframe: 3 Months post implantation

Patient Interactions with System

Timeframe: 3 Months post implantation

Trial details

NCT IDNCT02250469

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-12

View on ClinicalTrials.gov More Chronic Pain trials

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subject is appropriate for SCS implantation according to standard criteria
✓. Subject is \>18 to \<75 years old
✓. Subject is able and willing to comply with the follow-up schedule and protocol
✓. Subject has chronic (\> 6 months) uni/bi-lateral neuropathic pain in the lower limb(s) (below the knee) with predominant foot pain
✓. Minimum baseline pain rating of 50 mm on the VAS in the primary region of pain
✓. Subject is able to provide written informed consent

Exclusion criteria

✕. Subject has no other exclusion criteria for SCS implantation according to standard criteria
✕. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
✕. Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
✕. Subject has participated in another clinical study within 30 days
✕. Subject has been previously treated with and failed to respond to an implantable neuromodulation therapy