SCSNCT03670147
Paresthesia Free Spinal Cord Stimulation (PF-SCS)
A study testing PF-SCS programming in people with SCS and Chronic Pain, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- SCS, Chronic Pain
- What is being tested?
- PF-SCS programming
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2018to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
MGH Center for Translational Pain Research
Boston, Massachusetts, 02114
About this study
Official title: 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.
Read the 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.
- Conditions
- SCS, Chronic Pain
- Being tested
- PF-SCS programming
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-SCS programmingDevice
In a blinded fashion, the study physician will ask subjects to switch their PF-SCS to the LAP.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: PF-SCS programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: from date of consent until end of study (14-28 days)
Secondary outcomes (2)
Quantitative Sensory Testing (QST) Results
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)
Measured: from date of consent until end of study (14-28 days)
Daily diary results
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)
Measured: from date of consent until end of study (14-28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start1 Dec 2018
- Primary completion1 Sep 2022
- Study completion15 Dec 2022
Why it stopped: Unable to recruit subjects due to Covid pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCSStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shihab Ahmed, MD, Massachusetts General Hospital
- Investigators
- Shihab Ahmed, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670147
- Sponsor's protocol ID
- 2018P-001645
- Status last verified
- Jan 2026
- First submitted
- 1 Aug 2018
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Paresthesia Free Spinal Cord Stimulation on Pain Intensity, Functional Improvement, Pain Thresholds and Sensory Perceptions in Chronic Pain Patients
- ClinicalTrials.gov ID
- NCT03670147
- Acronym / sponsor ID
- 2018P-001645
- Conditions
- SCS, Chronic Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit subjects due to Covid pandemic
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain Returns | Experimental | Device: PF-SCS programmingPF-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. |
| No Pain | Experimental | Device: PF-SCS programmingPF-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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-SCS programmingIn a blinded fashion, the study physician will ask subjects to switch their PF-SCS to the LAP. | Device | No Pain, Pain Returns |
Primary outcome
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).
2 secondary outcomes
Quantitative Sensory Testing (QST) Results
Time frame: 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)
Results and safety
The study was stopped early (reason given: Unable to recruit subjects due to Covid pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shihab Ahmed, M.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PF-SCS programming in people with SCS and Chronic Pain, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit subjects due to Covid pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
20% increase of NRS (numerical rating scale) pain scale (time frame: from date of consent until end of study (14-28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026; AzTrials last refreshed its copy on 31 Oct 2026.