- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05558540
Spinal Cord Stimulation for Intractable Chronic Lower Abdominal Neuropathic Pain Caused by Endometriosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Endometriosis is an estrogen-dependent gynaecologicalcondition characterized by the presence and growth of ectopic endometrial tissue. This tissue stimulates the infiltration of immune cells such as macrophages andmast cells into the peritoneal cavity. Both the immune cells and the endometriotic tissue secrete cytokines which create an inflammatory microenvironment. Nerve cells located in the proximity of endometriosis lesions express cytokine receptors which stimulate a cascade of signalling kinases within the nerve. This results in an active cross-talk between endometriosis and nerves causing endometriosis associated pain.
Because of the chronic nature of endometriosis, treatment can be challenging difficult. It consists of three pillars: hormonal therapy, surgery and conventional pain management. Despite adequate disease management, women with endometriosis can still experience endometriosis-associated chronic pelvic pain. This might suggest that the pathology was either an incidental finding, or that other mechanisms continue to generate pain without the need for a peripheral input. One study proposed that central sensitization may be involved mechanistically in the development and maintenance of endometriosis-related pain. The hypothesis was that persistent nociceptive input from endometriotic tissues might result in increased responsiveness among dorsal horn neurons processing input from the affected viscera and pelvic tissues [1].
When standard endometriosis treatment is insufficient in the suppression of endometriosis-related pelvic pain, spinal cord stimulation (SCS), an accepted treatment option for neuropathic pain, could be a potential treatment.This hypothesis was substantiated by several (case) studies. However, they stated that studies on SCS for treatment of visceral pain is limited and made a call for action to broaden this knowledge
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Noord Holland
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Amsterdam, Noord Holland, Netherlands, 1081 HV
- Amsterdam UMC, location VUmc
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Contact:
- Annelotte A.P. van Haaps, Drs
- Phone Number: 020 0204445277
- Email: a.vanhaaps@amsterdamumc.nl
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Contact:
- Velja V Mijatovic, Prof. Dr.
- Phone Number: 0204445277
- Email: mijatovic@amsterdamumc.nl
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Sub-Investigator:
- Annelotte van Haaps, Drs
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Principal Investigator:
- Velja Mijatovic, Prof. Dr.
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Sub-Investigator:
- Jan Willem Kallewaard, Dr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Premenopausal woman aged ≥ 18 years
- Patients with endometriosis/ adenomyosis confirmed at surgery macroscopically and without options for further surgical treatment.
- Patients with at least one of the endometriosis related pain symptoms: dysmenorrhea, pelvic pain or dyspareunia. With a mean pain NRS of at least 5 (scale 0-10).
- The pain complaints are therapy resistant (including hormonal, medical and/or surgical options).
- Refractory pain; before neuromodulation patient has tried: Paracetamol, NSAIDs, Anti neuropathic pain therapy, TENS.
- The patient meets all the inclusion criteria for the implantation of a neurostimulation system as typically utilized in the study center.
- Neurologic exam without marked motor deficit.
- Subject has been screened by a multi-disciplinary panel including a psychologist and deemed suitable for implantation
- Subject is able and willing to comply with the follow-up schedule and protocol
- Subject is able to provide written informed consent
Exclusion Criteria:
- Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study.
- The presence of malignancy
- Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump
- Subject is unable to operate the device
- Previous Neurostimulation therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Implantation with spinal cord stimulator
Women participating in the trial will receive a spinal cord stimulator (SCS).
Women will first undergo a trial implantation period of 14 days.
When the trial period is considered successfull (at least 50 percent reported pain reduction) women will receive definitive placement of the SCS.
Normal lead placement( bilateral TH8-12) and different stimulation types will be used (FAST, subthresholdand/orCombination).
When participating in the trial, women will be asked to complete a set of questionnaires on several occasions, i.e. at baseline, 3 months after implantation, 6 months after implantation and 12 months after implantation.
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By continuous electrical stimulation of the nerve causing endometriosis-related pain, painful inputs to the spinal cord and brain can be reduced or even eliminated.
The electrical stimulation is performed by the spinal cord stimulator (SCS).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in pain severity at 6 month follow-up
Time Frame: 6 months
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An aimed pain reduction of at least 30% or 2 points reduction in mean NRS pain score (0-10).
This is measured using a pain diary.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Mean pain from baseline until 12 month follow-up
Time Frame: 12 months
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Measured using a pain diary, women report their pain score expressed with the Numeric rating scale (NRS) pain scores) 3 times a day for 3 days at baseline, 3-and 12-months post implant.
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12 months
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Patient's global impression of change
Time Frame: 12 months
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Measured using the PGIC questionnaire.
Dichotomous (better or improved versus not better or improved) at baseline,3-6-and 12-months post implant.
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12 months
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Change in quality of life
Time Frame: 12 months
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Measured using the EHP-30 questionnaire at baseline, 3-6-and 12-months post implant.
Each scale was transformed on a range from 0 to 100.
A score of "0" stands for best possible health status.
A score of "100" stands for worst possible health status.
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12 months
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Change in quality of life
Time Frame: 12 months
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Measured using the SF-36 questionnaire at baseline, 3-6-and 12-months post implant.
Scores are divided between 8 domains and calculated.
They range from 0 to 100, and are compiled as a percentage.
The higher the score, the more favorable the health state.
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12 months
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Change in fatigue
Time Frame: 12 months
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Measured using the shortened fatigue questionnaire (SFQ) at baseline, 3-6-and 12-months post implant.
Scores can range between 4 and 28.
The higher the score, the more severe the fatique.
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12 months
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Change in Pain Catastrophizing Scale
Time Frame: 12 months
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Measured using the PCS questionnaire.
Measured at baseline, 3-6-and 12-months post implant.
A score between 0 and 52 can be calculated.
The higher the score, the more severe the patient catastrophizes her pain.
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12 months
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Change in Central Sensitization Inventory
Time Frame: 12 months
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Measured using the CSI questionnaire.
Measured at baseline, 3-6-and 12-months post implant.
A score between 0 and 100 can be calculated.
A score between 0-29 stands for subclinical central sensitization syndrome (CSS).
A score between 30 and 39 for mild SCC.
A score between 40 and 49 for moderate SCC.
A score between 50 and 59 for severe SCC.
A score between 60-100 for extreme SCC.
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12 months
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Change in pain medication use
Time Frame: 12 months
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Assessed using a questionnaire.
Women are asked on their possible use of pain medication at baseline, 3-month, 6-month and 12-month follow up.
Use of pain medication is compared between the follow-up moments.
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12 months
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Lost working days
Time Frame: 6 months
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Measured using the EHP-30 at baseline and at 6 months post implant.
Asked using part A of the modular questionnaire.
A score between 0 and 100 can be calculated.
The higher the score, the higher the impact of endometriosis on working life.
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6 months
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL76287.018.21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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