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New treatment option for CRPS (Complex Regional Pain Syndromes)
Official title Intermittent Dosing of Dorsal Root Ganglion Stimulation as an Alternate Paradigm to Continuous Low-Frequency Therapy
ClinicalTrials.gov ID: NCT04909138
What this study is testing
- What it's testing
- This study seeks to evaluate the use of intermittent dosing as an alternative paradigm for patients with DRG stimulation in place for at least 1 year and minimum 50% pain relief in the targeted area. Patients will be prospectively randomized to one of two stimulation paradigms both of which involve intermittent dosing at 30 seconds ON and 90 seconds OFF.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- Age between 18 and 99
- 1-year or more use of continuous DRG therapy as delivered a permanently implanted Abbott PROCLAIM XR Dorsal Root Ganglion Neurostimulator System for...
- Endorse at least 50% pain relief in the targeted area over the last year
- Must have been seen for routine follow-up within last 4 months
- Must have been reprogrammed in standard fashion at least once prior to randomization
You likely can't join if
- Significant lead migration, as determined by clinician
- Other concurrent neuromodulation system in place
- Corticosteroid injection in previous 30 days prior to enrollment
- Intermittent dosing and/or failure within last 6m
- Changing or unstable pain medications within 30 days
See the full eligibility criteria
- Age between 18 and 99
- 1-year or more use of continuous DRG therapy as delivered a permanently implanted Abbott PROCLAIM XR Dorsal Root Ganglion Neurostimulator System for chronic back and/or leg pain
- Endorse at least 50% pain relief in the targeted area over the last year
- Must have been seen for routine follow-up within last 4 months
- Must have been reprogrammed in standard fashion at least once prior to randomization
- Willing and able to complete protocol requirements, including:
- Complete health questionnaires and pain scales as specified in the protocol
- Sign the study-specific informed consent form
- Complete follow-ups at the designated time periods
- Significant lead migration, as determined by clinician
- Other concurrent neuromodulation system in place
- Corticosteroid injection in previous 30 days prior to enrollment
- Intermittent dosing and/or failure within last 6m
- Changing or unstable pain medications within 30 days
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, 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, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, 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.