Paresthesia Free Spinal Cord Stimulation (PF-SCS)

NCT03670147 | Terminated

• 1 other identifier: 2018P-001645
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SCS; Chronic Pain

Outcome Measures

Primary Outcomes (1)

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

  20% increase on low back pain NRS pain scale (0 = no pain and 10= maximum pain imaginable) while on LAP (lowest amplitude program) compared to OPP (optimal program).

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

Secondary Outcomes (2)

• Quantitative Sensory Testing (QST) Results

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

• Daily diary results

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

Study Arms (2)

Pain Returns

EXPERIMENTAL

PF-SCS programming: in a blinded fashion, subjects will be asked to switch to the lowest amplitude program (LAP). Subjects whose pain returns after switching to the LAP will be considered Group 1.

Device: PF-SCS programming

No Pain

EXPERIMENTAL

PF-SCS programming: in a blinded fashion, subjects will be asked to switch to the lowest amplitude program (LAP). Subjects whose pain does not return after switching to the LAP will be considered Group 2.

Device: PF-SCS programming

Interventions

PF-SCS programming DEVICE

In a blinded fashion, the study physician will ask subjects to switch their PF-SCS to the LAP.

No Pain; Pain Returns

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

MGH Center for Translational Pain Research

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shihab Ahmed, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant and study staff will be blinded. The study physicians will not be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: September 13, 2018
• Study Start: December 1, 2018
• Primary Completion: September 1, 2022
• Study Completion: December 15, 2022
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)