EndometriosisNCT05558540
Spinal Cord Stimulation for Intractable Chronic Lower Abdominal Neuropathic Pain Caused by Endometriosis
A study testing spinal cord stimulator in people with Endometriosis, run by Prof. Velja Mijatovic at 1 site in Netherlands.
Trial summary
Endometriosis is a chronic, inflammatory disease where endometrium-like tissue is present outside the uterus. Nerve cells in the proximity of this tissue express cytokine receptors causing a signaling cascade. This results in active cross-talk between endometriosis and nerves, causing pelvic pain. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- What is being tested?
- spinal cord stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2022to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Amsterdam UMC, location VUmc
Amsterdam, North Holland, 1081 HV
Annelotte A.P. van Haaps, Drs, 0204445277 ext. 020, a.vanhaaps@amsterdamumc.nl
Velja V Mijatovic, Prof. Dr., 0204445277, mijatovic@amsterdamumc.nl
About this study
Endometriosis is a chronic, inflammatory disease where endometrium-like tissue is present outside the uterus. Nerve cells in the proximity of this tissue express cytokine receptors causing a signaling cascade. This results in active cross-talk between endometriosis and nerves, causing pelvic pain. Other symptoms associated with endometriosis are cyclical such as dysmenorrhea and dysuria, and non-cyclical such as dyspareunia. Despite adequate disease management, women can still experience endometriosis-related pain. A recent development proven to be efficient in treatment of neuropathic pain, is Spinal Cord Stimulation (SCS). It is also thought to be effective in the treatment of visceral pain. Several studies found Spinal Cord Stimulation (SCS) to be effective in the reduction of endometriosis-related pelvic pain. However, scientific evidence on the efficacy of SCS in visceral pain is limited.
Read the 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
- Conditions
- Endometriosis
- Being tested
- spinal cord stimulator
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal cord stimulatorDevice
Also called neuromodulation
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).
| Study group | Role | What they receive |
|---|---|---|
| Implantation with spinal cord stimulator | Experimental | 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. Receives: Device: spinal cord stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain severity at 6 month follow-up
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.
Measured: 6 months
Secondary outcomes (9)
Change in Mean pain from baseline until 12 month follow-up
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.
Measured: 12 months
Patient's global impression of change
Measured using the PGIC questionnaire. Dichotomous (better or improved versus not better or improved) at baseline,3-6-and 12-months post implant.
Measured: 12 months
Change in quality of life
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.
Measured: 12 months
Change in quality of life
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.
Measured: 12 months
Change in fatigue
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.
Measured: 12 months
Change in Pain Catastrophizing Scale
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.
Measured: 12 months
Change in Central Sensitization Inventory
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.
Measured: 12 months
Change in pain medication use
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.
Measured: 12 months
Lost working days
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All women participating in the trial will receive a SCS. Women will first undergo a trial period of 14 days. If succesful (\>50% pain reduction), women will receive a permanently implanted SCS. The follow-up period will enclose 12 months. There is an aimed sample size of 15 participants. However, due to financial limitations, inclusion will stop after 10 women have been succesfully implanted with a permanent SCS.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Velja Mijatovic
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor-investigator, Prof. Velja Mijatovic, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558540
- Sponsor's protocol ID
- NL76287.018.21
- Status last verified
- Sep 2022
- First submitted
- 15 Sep 2022
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Bajaj P, Bajaj P, Madsen H, Arendt-Nielsen L. Endometriosis is associated with central sensitization: a psychophysical controlled study. J Pain. 2003 Sep;4(7):372-80. doi: 10.1016/s1526-5900(03)00720-x.
PubMed 14622679van Haaps AP, Kallewaard JW, Bieze M, Erwteman M, Nap A, Hollmann MW, Schreurs AMF, Mijatovic V. Spinal-Cord Stimulation for Intractable, Visceral Pain Associated With Endometriosis: Positive Results of a Feasibility Study. Neuromodulation. 2025 Dec 3:S1094-7159(25)01143-2. doi: 10.1016/j.neurom.2025.10.067. Online ahead of print.
PubMed 41335088
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Stimulation for Intractable Chronic Lower Abdominal Neuropathic Pain Caused by Endometriosis
- ClinicalTrials.gov ID
- NCT05558540
- Acronym / sponsor ID
- NL76287.018.21
- Conditions
- Endometriosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Prof. Velja MijatovicUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 28 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Endometriosis is a chronic, inflammatory disease where endometrium-like tissue is present outside the uterus. Nerve cells in the proximity of this tissue express cytokine receptors causing a signaling cascade. This results in active cross-talk between endometriosis and nerves, causing pelvic pain. Other symptoms associated with endometriosis are cyclical such as dysmenorrhea and dysuria, and non-cyclical such as dyspareunia. Despite adequate disease management, women can still experience endometriosis-related pain. A recent development proven to be efficient in treatment of neuropathic pain, is Spinal Cord Stimulation (SCS). It is also thought to be effective in the treatment of visceral pain. Several studies found Spinal Cord Stimulation (SCS) to be effective in the reduction of endometriosis-related pelvic pain. However, scientific evidence on the efficacy of SCS in visceral pain is limited.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All women participating in the trial will receive a SCS. Women will first undergo a trial period of 14 days. If succesful (>50% pain reduction), women will receive a permanently implanted SCS. The follow-up period will enclose 12 months. There is an aimed sample size of 15 participants. However, due to financial limitations, inclusion will stop after 10 women have been succesfully implanted with a permanent SCS.
| Arm | Type | Receives |
|---|---|---|
| Implantation with spinal cord stimulator | Experimental | Device: spinal cord stimulatorWomen 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spinal cord stimulatorAlso: neuromodulationBy 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). | Device | Implantation with spinal cord stimulator |
Primary outcome
Change in pain severity at 6 month follow-up
Time frame: 6 months
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.
9 secondary outcomes
Change in Mean pain from baseline until 12 month follow-up
Time frame: 12 months
Patient's global impression of change
Time frame: 12 months
Change in quality of life
Time frame: 12 months
Change in quality of life
Time frame: 12 months
Change in fatigue
Time frame: 12 months
Change in Pain Catastrophizing Scale
Time frame: 12 months
Change in Central Sensitization Inventory
Time frame: 12 months
Change in pain medication use
Time frame: 12 months
Lost working days
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Results publication: PubMed 14622679Bajaj P, Bajaj P, Madsen H, Arendt-Nielsen L. Endometriosis is associated with central sensitization: a psychophysical controlled study. J Pain. 2003 Sep;4(7):372-80. doi: 10.1016/s1526-5900(03)00720-x.
- Derived from this study: PubMed 41335088van Haaps AP, Kallewaard JW, Bieze M, Erwteman M, Nap A, Hollmann MW, Schreurs AMF, Mijatovic V. Spinal-Cord Stimulation for Intractable, Visceral Pain Associated With Endometriosis: Positive Results of a Feasibility Study. Neuromodulation. 2025 Dec 3:S1094-7159(25)01143-2. doi: 10.1016/j.neurom.2025.10.067. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spinal cord stimulator in people with Endometriosis, run by Prof. Velja Mijatovic at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain severity at 6 month follow-up (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05558540, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.