- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03670147
Paresthesia Free Spinal Cord Stimulation (PF-SCS)
Effects of Paresthesia Free Spinal Cord Stimulation on Pain Intensity, Functional Improvement, Pain Thresholds and Sensory Perceptions in Chronic Pain Patients
Study Overview
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Karina de Sousa
- Phone Number: 617-724-6102
- Email: kdesousa1@mgh.harvard.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Recruiting
- MGH Center for Translational Pain Research
-
Contact:
- Karina de Sousa
- Phone Number: 617-724-6102
- Email: kdesousa1@mgh.harvard.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
Intervention / Treatment |
---|---|
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.
|
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.
|
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
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
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:
|
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):
|
from date of consent until end of study (14-28 days)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shihab Ahmed, M.D., Massachusetts General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018P-001645
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Chronic Pain
-
Pain ConcernThe Thistle Foundation; Health and Social Care Alliance Scotland (the ALLIANCE) and other collaboratorsCompletedChronic Pain | Chronic Pain Syndrome | Chronic Pain, Widespread | Chronic Pain Due to Trauma | Chronic Pain Due to Malignancy (Finding) | Chronic Pain Due to Injury | Chronic Pain Post-Procedural | Chronic Pain HipUnited Kingdom
-
Consorci Sanitari de l'Alt Penedès i GarrafRecruitingChronic Post Operative Pain | Chronic Post-surgical Pain | Chronic Knee PainSpain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
University of Alabama, TuscaloosaPatient-Centered Outcomes Research Institute; East Carolina University; Whatley...CompletedPain | Chronic Pain | Chronic Pain Syndrome | Widespread Chronic Pain | Chronic Pain Due to InjuryUnited States
-
University of UtahRecruitingChronic Pain | Chronic Pain Syndrome | Widespread Chronic PainUnited States
-
Evolve Restorative CenterFlowonix Medical; Celéri Health, Inc.; Advanced Infusion SolutionsCompletedPain, Chronic | Pain, Intractable | Chronic Nonmalignant PainUnited States
-
Assiut UniversityNot yet recruiting
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Istanbul UniversityCompletedLow Back Pain, Mechanical, Biofeedback, Pain, Chronic
-
Apurano Pharmaceuticals GmbHRecruitingPain | Lower Back Pain | Back Pain | Chronic Pain | Pain, Chronic | Chronic Pain Syndrome | Pain Syndrome | Lower Back Pain ChronicGermany
Clinical Trials on PF-SCS programming
-
Stimgenics LLCCompleted
-
SGX Nova LLCCompletedChronic Back PainUnited States
-
Boston Scientific CorporationTerminated
-
Boston Scientific CorporationCompleted
-
Hospital General Universitario de ValenciaNot yet recruitingFailed Back Surgery Syndrome | Spinal Cord Stimulation | Genetic ChangeSpain
-
Thomas KöglspergerUniversity Hospital Muenster; Heinrich-Heine University, Duesseldorf; University... and other collaboratorsRecruitingParkinson Disease | Telemedicine | Deep Brain StimulationGermany
-
Meshalkin Research Institute of Pathology of CirculationCompletedChronic Limb-Threatening IschemiaRussian Federation
-
University of MichiganNational Institute of Mental Health (NIMH)Completed
-
University Hospital TuebingenAbbottRecruitingSpinal Cord Stimulation (SCS) | Blood Glucose Metabolism | Euglycemic Hyperinsulinemic ClampGermany
-
University of MichiganNational Institutes of Health (NIH)RecruitingPain, Chronic | Failed Back Surgery SyndromeUnited States