TerminatedNot Applicable

Paresthesia Free Spinal Cord Stimulation (PF-SCS)

Stopped: Unable to recruit subjects due to Covid pandemic

United States10 participantsStarted 2018-12-01

Plain-language summary

The goal is to document efficacy of PF-SCS therapy in a blinded fashion and better understand how SCS therapy works in the clinical setting. Overall the investigators hope to improve patient care and selection of candidates who have the best potential for effective pain relief from an expensive and invasive therapy.

Who can participate

Age range18 Years – 80 Years

SexALL

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

Inclusion Criteria: * Subject will be 18-80 years old * Subject who is currently treated with PF-SCS (HF-10 or Burst-mode capable SCS system) for chronic pain Exclusion Criteria: * Subject has neurological disease or a condition causing chronic persistent sensory deficit to the painful area * Those receiving remuneration for their pain treatment (pending litigation or ongoing litigation). * Those unable to read English and complete the assessment instruments.

What they're measuring

20% increase of NRS (numerical rating scale) pain scale

Timeframe: from date of consent until end of study (14-28 days)

Trial details

NCT IDNCT03670147

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-01

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