Neuromodulation in Treating Pelvic Pain.
Corey W Hunter, Steven Falowski
https://pubmed.ncbi.nlm.nih.gov/33534006Actively Recruiting
Age: 18Years +
All Genders
ID06413277
Targeting the Conus Medullaris With ECAP-Controlled Closed-Loop SCS for the Treatment of Chronic Pelvic Pain: HOPE Trial
Led by Ainsworth Institute of Pain Management · Updated on 2024-05-14
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
A
Ainsworth Institute of Pain Management
Lead Sponsor
S
Saluda Medical Pty Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of using ECAP-controlled closed-loop spinal cord stimulation (CL-SCS) to treat chronic pelvic pain by targeting the conus medullaris, the lowermost part of the spinal cord. This observational, prospective study focuses on patients with chronic, intractable pelvic pain who have not responded to other treatments. The study also assesses impacts on daily living, pain quality, quality of life, sleep, anxiety, depression, urinary symptoms, and device safety. Participants will undergo surgical implantation of the Saluda Evoke Smart SCS System to stimulate the conus medullaris. The study includes a trial phase followed by possible permanent implantation. Data will be collected at baseline, during the trial, at implant, and at 3, 6, and 12 months after permanent implantation. Up to 20 subjects will be enrolled, with 15 expected to receive permanent implants. During the study, participants will be monitored through regular visits involving assessments of pain relief, quality of life changes, and device performance. Researchers will measure the proportion of patients achieving significant pain relief and improvements in related symptoms over 12 months. Safety will be evaluated by tracking adverse events and device settings. Statistical analyses will summarize outcomes and safety data to better understand this treatment's potential.
CONDITIONS
Brief Title
Targeting the Conus Medullaris With ECAP-Controlled Closed-Loop SCS for Treatment of Chronic Pelvic Pain: HOPE Trial
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Subject is 18 years of age or older at the time of enrollment.
- Subject has a minimum Visual Analog Scale (VAS) score of 60 mm or higher at baseline.
- Subject has chronic intractable pelvic or related pain lasting at least 6 months that has not improved with conservative therapy.
- Subject has pain resulting from a known injury such as surgery or trauma.
- Subject has been diagnosed with chronic pelvic pain including conditions like complex regional pain syndrome, postsurgical pain, interstitial cystitis, vulvodynia, chronic ovarian pain, or pudendal neuralgia.
- Subject is considered appropriate for surgical implantation by the implanting physician.
- Subject is willing and able to give informed consent.
- Subject is willing and able to follow study procedures and visits.
You will not qualify if you...
- Subject is pregnant or nursing.
- Subject has ongoing litigation or worker's compensation claims related to malignancy or injury.
- Subject's pain cause is unknown.
- The suspected cause and onset of pain are more than 30 days apart.
- Subject has history of small fiber neuropathy, mitochondrial disease, fibromyalgia, addiction, or atypical facial pain.
- Subject has ongoing inflammatory bowel disease such as Crohn's Disease or ulcerous colitis.
- Subject has medical conditions or pain outside the treatment area that could interfere with the study.
- Subject has history of sexual abuse or trauma.
- Subject has unmanaged depression or anxiety before symptom onset.
- Subject is using more than 100 morphine milligram equivalents of opioids at baseline.
- Subject has active psychological or psychiatric disorders affecting pain perception or study compliance.
- Subject has prior neuromodulation experience including spinal cord or dorsal root ganglion stimulation.
- Subject has existing implantable devices such as pacemakers or drug pumps.
- Subject is currently in another clinical study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Trial Procedure
Duration - Up to 1 week
Participants undergo a trial procedure involving temporary use of the device to assess suitability for permanent implantation.
1 visit for trial procedure
Device Implant
Duration - 1 day
Participants who respond positively to the trial procedure receive a permanent implant of the Saluda Evoke Smart SCS System targeting the conus medullaris.
1 implant procedure visit
Post-implant Follow-up
Duration - 12 months
Participants are followed up to assess efficacy, safety, and device performance after permanent implantation.
3 visits at 3, 6, and 12 months post-implant
Trial Site Locations
Total: 1 location
1
Ainsworth Institute of Pain Management
New York, New York, United States, 10022
Actively Recruiting
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Research Team
Z
Zoey Smith
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Anatomy, Pathophysiology and Interventional Therapies for Chronic Pelvic Pain: A Review.
Corey W Hunter, Brad Stovall, Grant Chen...
https://pubmed.ncbi.nlm.nih.gov/29565946The economic costs of pain in the United States.
Darrell J Gaskin, Patrick Richard
https://pubmed.ncbi.nlm.nih.gov/22607834Prevalence of chronic pain in the UK: a systematic review and meta-analysis of population studies.
A Fayaz, P Croft, R M Langford...
https://pubmed.ncbi.nlm.nih.gov/27324708Ambulatory care visits to physician offices, hospital outpatient departments, and emergency departments: United States, 2001-02.
Susan M Schappert, Catharine W Burt
https://pubmed.ncbi.nlm.nih.gov/16471269Chronic pain as a symptom or a disease: the IASP Classification of Chronic Pain for the International Classification of Diseases (ICD-11).
Rolf-Detlef Treede, Winfried Rief, Antonia Barke...
https://pubmed.ncbi.nlm.nih.gov/30586067Chronic pelvic pain.
Sharon L Stein
https://pubmed.ncbi.nlm.nih.gov/24280400Male chronic pelvic pain: An update.
Christopher P Smith
https://pubmed.ncbi.nlm.nih.gov/26941492Chronic pelvic pain: prevalence, health-related quality of life, and economic correlates.
S D Mathias, M Kuppermann, R F Liberman...
https://pubmed.ncbi.nlm.nih.gov/8598948The 2013 EAU guidelines on chronic pelvic pain: is management of chronic pelvic pain a habit, a philosophy, or a science? 10 years of development.
Daniel S Engeler, Andrew P Baranowski, Paulo Dinis-Oliveira...
https://pubmed.ncbi.nlm.nih.gov/23684447