Paresthesia Free Spinal Cord Stimulation (PF-SCS)

January 29, 2026 updated by: Shihab Ahmed, MD, Massachusetts General Hospital

Effects of Paresthesia Free Spinal Cord Stimulation on Pain Intensity, Functional Improvement, Pain Thresholds and Sensory Perceptions in Chronic Pain Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The PF-SCS has 3 programs (P1, P2, P3) that can be used. At Visit 1, the study physician will review the PF-SCS program that the participant has been using. This program is known as the optimal program (OPP) and will be known as P1. The study physician will then designate the other two programs (P2 and P3); one of them will be identical to the OPP (P1) and the other program will be the LAP. The participant will be unaware if the LAP is assigned to P2 or P3. At the end of Visit 1, the study physician will have the participant switch from P1 to the LAP (P2 or P3). The participant will be reassured that if their pain returns after they switch programs, they can immediately call the study physician and will be switched back to the previous OPP (P1) without delay. The participants whose pain returns will be categorized as Group 1. The physician will document the time that had elapsed before their pain returned. This time will be considered as "carry over time" (COT) from PF-SCS. Only the study physicians will be aware of the programming parameters for P2 and P3. The rest of the study staff and participants will be blinded and will not be aware of the programming parameters for P2 and P3.

The participants whose pain remains stable while on the LAP will be categorized as Group 2. All participants will keep a daily diary for pain intensity, sleep and any other concerns that may arise related to the change of program.

At the end of Visit 1, a member of the study team will schedule Visit 2, between 14 to 28 days from Visit 1.

Phone call: A study physician will call subjects between 7-14 days after Visit 1. Group 1 participants will be asked to switch to the LAP (P2 or P3) before Visit 2. To minimize the duration of the LAP, Visit 2 will be scheduled within six hours from the end of COT. The Group 2 participants will attend Visit 2 without changing their LAP.

At Visit 2, participants will fill out questionnaires on pain intensity, sleep, activities and global impression. A blinded study staff will perform QST on the subject. At the end of Visit 2, Group 1 participants will be instructed to go back to the OPP (P1). At the end of Visit 2, Group 2 will be allowed to switch back to the OPP (P1).

The investigators will use quantitative sensory testing (QST) as a tool to objectively quantify the impact of SCS on heat pain threshold, heat pain tolerance and wind-up over the painful area and compare this with a non-painful area in each subject. QST will be performed at Visit 1 and Visit 2.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • MGH Center for Translational Pain Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pain Returns
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
In a blinded fashion, the study physician will ask subjects to switch their PF-SCS to the LAP.
Experimental: No Pain
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
In a blinded fashion, the study physician will ask subjects to switch their PF-SCS to the LAP.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
20% increase of NRS (numerical rating scale) pain scale
Time Frame: from date of consent until end of study (14-28 days)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quantitative Sensory Testing (QST) Results
Time Frame: from date of consent until end of study (14-28 days)

Compare sensory perception on both the area of pain and the non-painful area on the opposite side while on the OPP (optimal program) and the LAP (lowest amplitude program). The following tests will be analyzed:

  • warm sensation (degrees Celsius)
  • heat pain threshold (degrees Celsius)
  • heat pain tolerance (degrees Celsius)
  • wind-up (NRS pain scale)
from date of consent until end of study (14-28 days)
Daily diary results
Time Frame: from date of consent until end of study (14-28 days)

Subject reported responses regarding their pain while using the OPP (optimal program):

  • global impression of change in pain (0=no pain, 10=worst pain)
  • impact on sleep and mood (0= does not interfere, 10= interferes completely)
  • daily living (0= does not interfere, 10= interferes completely)
  • enjoyment and general activity (0= does not interfere, 10= interferes completely)
from date of consent until end of study (14-28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shihab Ahmed, M.D., Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018P-001645

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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