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Tests treatment safety and results for Chronic Pain
Official title Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation
ClinicalTrials.gov ID: NCT05968664
What this study is testing
- What it's testing
- The goal of this study is to compare pain outcomes achieved by spinal cord stimulation (SCS) using time varying stimulation patterns with pain outcomes achieved by current standard of care SCS.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- Ability to provide informed consent
- Age ≥ 22
- Chronic pain of the trunk and/or limbs for at least 6 months
- Baseline average daily overall pain score of \>60 (on a scale of 0-100mm) on the Visual Analog Scale related to pain of the back and/or limbs
- Failed ≥3 medically supervised treatments (i.e. pain medications, physical therapy, facet joint/medial branch nerve blocks, acupuncture), and...
You likely can't join if
- Patient exhibits catastrophization based on physician evaluation (e.g., average overall daily pain intensity of 100 on a 0-100mm visual analog scale...
- Pain originating from peripheral vascular disease
- Active treatment for cancer in past 6 months
- Involved in disability litigation
- High surgical risk including documented history of allergic response to titanium or silicone, current systemic infection, or local infection in close...
- Body mass index ≥ 45 at Screening
See the full eligibility criteria
- Ability to provide informed consent
- Age ≥ 22
- Chronic pain of the trunk and/or limbs for at least 6 months
- Baseline average daily overall pain score of \>60 (on a scale of 0-100mm) on the Visual Analog Scale related to pain of the back and/or limbs
- Failed ≥3 medically supervised treatments (i.e. pain medications, physical therapy, facet joint/medial branch nerve blocks, acupuncture), and treatment with \>2 classes of medications
- Stable pain-related medication regimen 4 weeks prior to the trial. Patients will be asked to not increase or add pain-related medication during the study period
- No back surgery within 6 months prior to Screening
- Consumed an average total daily morphine equivalent of ≤200 mg during the 30 days prior to Screening.
- Baseline Oswestry Disability Index score ≥40 and ≤80
- Eligible candidate for SCS from a psychological and psychiatric standpoint as determined within 180 days prior to Baseline Visit, per site's routine screening process
- Able to independently read and complete all questionnaires and assessments provided in English
- Female candidates of child-bearing potential agree to use contraception during the study period
- Deemed to be a good candidate for spinal cord stimulation by the PI, and a board certified pain management physician
- Willing to cooperate with study requirements
- Patient exhibits catastrophization based on physician evaluation (e.g., average overall daily pain intensity of 100 on a 0-100mm visual analog scale, every day during the 7 days prior to Screening, based on patient...
- Pain originating from peripheral vascular disease
- Active treatment for cancer in past 6 months
- Involved in disability litigation
- High surgical risk including documented history of allergic response to titanium or silicone, current systemic infection, or local infection in close proximity to anticipated surgical field
- Body mass index ≥ 45 at Screening
- Terminal illness with anticipated survival \< 12 months
- Participant is immunocompromised
- Significant cognitive impairment at Screening that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study
- Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study
- Previous spinal cord stimulation trial/implant or is already implanted with an active implantable device(s) (e.g. drug pump, implantable pulse generator)
- A pregnant female or a female of childbearing potential planning to get pregnant during the course of the study
- Plan to receive any massage or manipulation directly over the leads or by the anticipated location of the IPG or treatments that involve sudden jerking motions of the torso at any
- Existing medical condition that is likely to require the use of diathermy
- Any injury or medical/psychological condition that might be significantly exacerbated by the implant surgery or the presence of an implantable stimulator or otherwise compromise subject safety
- Unable to operate the study devices including wrist-worn biosensor and mobile app
- Documented history of substance abuse or dependency in the 6 months prior to baseline
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.