An observational study in Spinal; Nerve Root, Pain, Pelvic Pain and Regional Pain Syndrome, sponsored by KM Clinical Research Group. Terminated at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-03-19.
Sponsored by KM Clinical Research Group · Observational
Among 151 studies in Pelvic Pain with a site in United States — 36 open to participants now, 39 under way, 1 of them phase 3. Pelvic Pain · United States.
Among the 151 studies in Pelvic Pain with a site in United States, this one is the 20th largest by enrollment of the 28 observational ones, is one of 6 that started in 2017, is one of 28 observational ones, and was the 79th registered.
375 studies on the registry are indexed under Pelvic Pain; 89 are open to participants now.
This study's enrollment of 55 is below the median of 100 across 83 observational studies indexed under Pelvic Pain.
Browse Pelvic Pain studies →36 of the 151 studies in Pelvic Pain with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 59 Pelvic Pain studies recruiting now, 21 (36%) set no upper age limit and 36 (61%) stop at 75 or younger; 5 take children under 18; 10 take healthy volunteers.
This study: 18 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →151 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 6 started in 2017.
Median enrollment 50 across the 123 interventional studies, 104 across the 28 observational. Of the 96 that completed or were terminated, 35 (36%) have results posted.
18 of 151 have an industry lead sponsor. The 10 most frequent:
KM Clinical Research Group is the lead sponsor of 3 studies on the registry; none are open to participants now.
KM Clinical Research Group has 1 study filed under Pelvic Pain — fewer than ten, so there is no comparison to draw.
15 of the studies in Pelvic Pain with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06110065University of ArizonaCT-guided Pudendal Nerve Cryoneurolysis for Palliation of Malignancy-induced Pelvic Pain | 2026-11 |
| NCT05354869University of California, Los AngelesTransvaginal Electrical Stimulation for Myofascial Pelvic Pain | 2026-12 |
| NCT03794466University of Kansas Medical CenterQuantify the Degree of Pain Relief of Pelvic Congestion Syndrome Following Gonadal Vein Embolization | 2026-12-31 |
| NCT06083597Weill Medical College of Cornell UniversityDevelopment of a Patient-reported Outcome Measure for Women With Chronic Pelvic Pain | 2026-12-31 |
| NCT06611501Boston Children's HospitalGlycemic Regulation as Endometriosis Adjunct Treatment | 2027-01 |
Among the 151 studies in Pelvic Pain with a site in United States, from their registry updates:
ACTIVE study- a prospective observational clinical study examining the changes in quality of life and pain following dorsal root ganglion stimulation for the treatment of chronic intractable pelvic and lower limb pain.
Objectives The primary objective is changes in pelvis and/or lower limb pain following dorsal root ganglion (DRG) stimulation. Pain levels will be determined using a 10-point Visual Analog Scale (VAS) with 10= Extreme Pain and 0= No Pain.
The null hypothesis is there will be no change in the subjects' self-reported pain levels from baseline to 52 weeks post-stimulator implantation. The alternate hypothesis is a significant change in pain levels.
Secondary objectives include changes in physical health, quality of life, and pain-related prescription medication usage. Each subject's overall quality of life will be measured with the National Institute of Health's PROMIS Global Health survey v1.2. Physical activity changes will be assessed using the NIH PROMIS Pain Interference 6a SF v1.0 and Pain Intensity 3a scale v1.0. Finally, patients will be asked the name, dosage, and frequency of use of any pelvic and/or lower limb pain-related prescription medications they are currently using.
Design and Outcomes This is a prospective observational single-arm study to access the primary outcome variable of pelvic and/or lower limb pain Intervention and Duration There will be no study intervention. Subjects will only be monitored and evaluated for pre and post-operative pain, physical activity levels, quality of life, and medication use. Subjects will be followed for 12 months following their DRG stimulation implant surgery.
Sample Size and Population This study will last for 4 years starting July 1, 2017. There will be no maximum subject population size. We aim for a minimum population size of 500 in order to give statistical significance with results. Subjects will be stratified by area of chronic pain.
375 studies on the registry are indexed under Pelvic Pain; 89 are open to participants now.
This study's enrollment of 55 is below the median of 100 across 83 observational studies indexed under Pelvic Pain.
Browse Pelvic Pain studies →KM Clinical Research Group is the lead sponsor of 3 studies on the registry; none are open to participants now.
Compared within Pelvic Pain, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pain. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patients medically indicated to receive DRG stimulator for treatment of chronic lower limb and/or pelvic pain.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic regional pain of lower limb(s) patients medically indicated to have dorsal root ganglion (DRG) stimulation for control of pain. DRG stimulator will be implanted for trial of 3-4 days and then permanently, if patient find acceptable levels of pain control with trial.
Device: dorsal root ganglion neuromodulation
Chronic pelvic or urological pain patients medically indicated to have dorsal root ganglion (DRG) stimulation for control of pain. DRG stimulator will be implanted for trial of 3-4 days and then permanently, if patient find acceptable levels of pain control with trial.
Device: dorsal root ganglion neuromodulation
stimulation for neuromodulation of the dorsal root ganglion
Change in pain
change in visual analogue scale rating
Time frame: 12 months post-permanent dorsal root ganglion stimulator implantation
Change in quality of life
change in NIH PROMIS Global health v2 score
Time frame: 12 months post-permanent dorsal root ganglion stimulator implantation
Change in physical health
Change in Pain Behavior and Pain Interference measures
Time frame: 12 months post-permanent dorsal root ganglion stimulator implantation
Change in pain-related prescription medication use
change in self-reported medication usage and types of medications needed to control pain
Time frame: 12 months post-permanent dorsal root ganglion stimulator implantation
Plan to share: No — Other researchers will only see participation data for the subjects they recruit and enroll in the study.
No publications or documents are linked to this record.
Ran from Aug 2017 to primary completion in Feb 2019, 18 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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KM Clinical Research Group