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Study of PM Modulation Therapy in Trial Phase

CompletedNot applicableNCT03110601
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

Trialing of PM modulation therapy in patients with chronic intractable low back pain

Study details

Official title
Trialing of PM Modulation Therapy in Patients With Chronic Intractable Low Back Pain With or Without Leg Pain
Conditions
Interventions
  • Device: Control - Conventional SCS
  • Device: Test - Stimgenics SCS
Sponsor
Stimgenics LLC
Start date
2017-05-05
Primary completion
2017-10-12
Sex
All
Age range
from 19 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Capable of giving written informed consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the patient's participation is provided to them. 2. Chronic intractable pain of the lower back equal to or greater than pain in lower limbs, and that has been refractory to conservative therapy for ≥ 3 months. 3. Must be older than 18 years old. 4. Average back pain intensity of ≥ 5 out of 10 on the numerical pain rating scale (NPRS). 5. Appropriate candidate for spinal cord stimulation trial. 6. Subjects must be on a stable dose of pain medication regimen for at least 1 month. 7. Female patients who are not pregnant and do not plan to become pregnant during the study. Females of child bearing potential must provide a negative pregnancy test and must be using reliable contraception and must continue to use reliable contraception until study completion. Non-childbearing potential is defined as postmenopausal for at least 2 years or surgical sterilization or hysterectomy at least 3 months before study start. Patients who become pregnant or who have a spouse/significant other that becomes pregnant during the course of this study agree to report pregnancy to the study physician/staff. 8. Must be able to comply with the requirement of study visits and follow-up and phone visits. 9. Have cognitive ability of operate the remote control and follow therapy instructions and directions by clinicians. Exclusion Criteria: 1. Systemic infection. 2. Any active implanted device. 3. Previous experience with SCS therapy either during a trial or fully implanted 4. Evidence of serious neurological, psychological or psychiatric disorders. 5. Mechanical spinal instability. 6. Patients with uncorrected coagulation disorders or who are on anticoagulation therapy and cannot interrupt the therapy. 7. Patient who are pregnant, breast-feeding or women of childbearing potential with positive pregnancy tests. 8. Human immunodeficiency virus (HIV) infection or a clinically significant infection. 9. Patients who are undergoing or will undergo therapies or diagnostics that involve electromagnetic fields such as: diathermy based therapies, electrocautery, magnetic resonance imaging (MRI), radiofrequency (RF) or microwave ablation, bone growth stimulators, electrolysis, therapeutic ultrasound, ultrasound, lithotripsy, psychotherapeutic procedures, radiation therapy, and transcutaneous electrical nerve stimulation. 10. A clinical…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03110601