CompletedNot Applicable

Study of PM Modulation Therapy in Trial Phase

United States25 participantsStarted 2017-05-05

Plain-language summary

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

Age range19 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. 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.
✓. Must be older than 18 years old.
✓. Average back pain intensity of ≥ 5 out of 10 on the numerical pain rating scale (NPRS).
✓. Appropriate candidate for spinal cord stimulation trial.
✓. Subjects must be on a stable dose of pain medication regimen for at least 1 month.
✓. 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.
✓. Must be able to comply with the requirement of study visits and follow-up and phone visits.

✕. Systemic infection.
✕. Any active implanted device.
✕. Previous experience with SCS therapy either during a trial or fully implanted
✕. Evidence of serious neurological, psychological or psychiatric disorders.
✕. Mechanical spinal instability.
✕. Patients with uncorrected coagulation disorders or who are on anticoagulation therapy and cannot interrupt the therapy.
✕. Patient who are pregnant, breast-feeding or women of childbearing potential with positive pregnancy tests.
✕. Human immunodeficiency virus (HIV) infection or a clinically significant infection.

Change in Pain Relative to Baseline and After a Trial Period

Timeframe: Baseline and 4 days plus or minus 1 days

NCT IDNCT03110601

SponsorStimgenics LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-10-12

Results submitted2018-10-12

Who can participate

Age range19 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. 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.
✓. Must be older than 18 years old.
✓. Average back pain intensity of ≥ 5 out of 10 on the numerical pain rating scale (NPRS).
✓. Appropriate candidate for spinal cord stimulation trial.
✓. Subjects must be on a stable dose of pain medication regimen for at least 1 month.
✓. 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.
✓. Must be able to comply with the requirement of study visits and follow-up and phone visits.

✕. Systemic infection.
✕. Any active implanted device.
✕. Previous experience with SCS therapy either during a trial or fully implanted
✕. Evidence of serious neurological, psychological or psychiatric disorders.
✕. Mechanical spinal instability.
✕. Patients with uncorrected coagulation disorders or who are on anticoagulation therapy and cannot interrupt the therapy.
✕. Patient who are pregnant, breast-feeding or women of childbearing potential with positive pregnancy tests.
✕. Human immunodeficiency virus (HIV) infection or a clinically significant infection.