A Prospective Clinical Study to Assess the Spinal Cord Stimulation System in the Treatment of Chronic Pelvic Pain

NCT05373667 | Unknown

• 1 other identifier: NSM 1-129/2021
• Study Type: observational
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

Prospective observational assessment of the efficacy of Spinal Cord Stimulation (SCS) treatment in patients with neuropathic pelvic pain.

Conditions

Pelvic Pain

Keywords

Spinal cord Stimulation, Pelvic Pain

Outcome Measures

Primary Outcomes (25)

• Visual analog scale

  1 month follow-up

• Visual analog scale

  3 month follow-up

• Visual analog scale

  6 month follow-up

• Visual analog scale

  9 month follow-up

• Visual analog scale

  12 month follow-up

• Pain Disability Index

  1 month follow-up

• Pain Disability Index

  3 month follow-up

• Pain Disability Index

  6 month follow-up

• Pain Disability Index

  9 month follow-up

• Pain Disability Index

  12 month follow-up

• McGill Pain questionnaire (SF-MPQ-2)

  1 month follow-up

• McGill Pain questionnaire (SF-MPQ-2)

  3 month follow-up

• McGill Pain questionnaire (SF-MPQ-2)

  6 month follow-up

• McGill Pain questionnaire (SF-MPQ-2)

  9 month follow-up

• McGill Pain questionnaire (SF-MPQ-2)

  12 month follow-up

• European Quality of Life-5 Dimensions (EQ-5D-5L)

  1 month follow-up

• European Quality of Life-5 Dimensions (EQ-5D-5L)

  3 month follow-up

• European Quality of Life-5 Dimensions (EQ-5D-5L)

  6 month follow-up

• European Quality of Life-5 Dimensions (EQ-5D-5L)

  9 month follow-up

• European Quality of Life-5 Dimensions (EQ-5D-5L)

  12 month follow-up

• Short Form 12-Item Survey on Health (SF-12)

  1 month follow-up

• Short Form 12-Item Survey on Health (SF-12)

  3 month follow-up

• Short Form 12-Item Survey on Health (SF-12)

  6 month follow-up

• Short Form 12-Item Survey on Health (SF-12)

  9 month follow-up

• Short Form 12-Item Survey on Health (SF-12)

  12 month follow-up

Secondary Outcomes (5)

• Neurologic status

  6 month follow-up

• Neurologic status

  12 month follow-up

• Hospitalizations

  12 month follow-up

• Adverse events

  12 month follow-up

• Medication usage

  12 month follow-up

Interventions

Spinal Cord Stimulation (SCS) PROCEDURE

Spinal Cord Stimulation (SCS) - High Frequency at 10 kHz

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic pelvic pain

You may qualify if:

• \. Have a clinical diagnosis of chronic predominant pelvic pain as determined by a multidisciplinary study team.
• \. Score 13 or greater in PainDETECT questionnaire 3. 4. Have been refractory to conservative therapy for a minimum of 3 months, including assessment of at least 2 different classes of medications.
• \. Average pain intensity (over the last 7 days) of ≥ 5 out 10 cm on the Visual Analog Scale (VAS) in the primary area of pain at enrollment (in accordance with the NICE guidelines).
• \. Have stable neurological status measured by motor, sensory and reflex function as determined by the investigator.
• \. Be 18 years of age or older at the time of enrollment. 9. Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician.
• \. Be capable of subjective evaluation, able to read and understand written questionnaires, and are able to read, understand and sign the written inform consent.
• \. Be willing and capable of giving informed consent. 12. Be willing and able to comply with study-related requirements, procedures, and visits.
• \. Have adequate cognitive ability to use a patient programmer and recharger as determined by the Investigator

You may not qualify if:

• Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the investigator (such as primary headache diagnosis or fibromyalgia).
• Have a current diagnosis of a progressive neurological disease such a multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, central deafferentation syndrome, Complex regional Pain Syndrome, acute herniating disc, severe spinal stenosis and brachial plexus injury as determined by the investigator.
• Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure as determined clinically by the investigator.
• Significant stenosis, objective evidence of epidural scarring and/or any signs or symptoms of myelopathy as determined by MRI conducted within the past 12 months.
• Be benefitting within from an interventional procedure and/or surgery to treat chronic pelvic pain (Subjects should be enrolled at least 30 days from last benefit).
• Have an existing drug pump and/or another active implantable device such as a pacemaker.
• Have failed other neuromodulation therapies including traditional SCS, peripheral nerve stimulation or dorsal root ganglion stimulation.
• Have metastatic malignant disease or active local malignant disease.
• Have a life expectancy of less than 1 year.
• Have an active systemic or local infection at the anticipated needle entry site.
• Be pregnant or plan to become pregnant during the study (participants of child-bearing potential that are sexually active must use a reliable form of birth control).
• Are currently nursing (if female).
• Have been immunocompromised.
• Have been known to be allergic or have shown hypersensitivity to any materials of the neurostimulation system which come in contact with the body.
• Have within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including opioids, benzodiazepines, alcohol and illicit drugs).

Sponsors & Collaborators

• Europainclinics z.ú.: lead
• National Hospital for Neurology and Neurosurgery, London: collaborator

MeSH Terms

Conditions

Pelvic Pain

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Róbert Rapcan, MD, PhD, MBA, FIPP

  Europainclinics z.ú.

  STUDY DIRECTOR

• Ladislav Kočan, MD, PhD

  Europainclinics z.ú.

  STUDY CHAIR

Central Study Contacts

Ashish Shetty, MD, FRCA, FFPMRCA

CONTACT

+447723309217; drashshetty@gmail.com

Nicolas Varela, MD, DESA

CONTACT

+447723309217

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 13, 2022
• Study Start: August 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: May 1, 2025
• Last Updated: May 13, 2022

Record last verified: 2022-05