Endometriosis-related visceral pain Lower abdominal pain due to endometriosis
Conditions
Interventions
Patients will be randomized into either the SCS or the CMM group. The SCS group will be implanted with the Boston Specra WaveWriter Alpha 
system, providing both tonic and subthreshold stimulation forms. The CMM group will receive comprehensive treatment with analgesics, transcutaneous electrical nerve stimulation (TENS), or minimal inva
until the end of the study. 
Sponsors
Rijnstate
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Women diagnosed with endometriosis (by surgery and/or imaging).Women between 18-60 years of age.Average endometriosis-related pain (i.e., dysmenorrhea, dyspareunia and/or chronic pelvic pain) intensity of > 5 measured with the validated 11-box NRS (0 no pain, 10 worst imaginable pain).Refractory to conservative treatments provided by the gynecologist (i.e., hormonal therapy, surgery, laparoscopy) and fist line pain treatments (i.e., paracetamol, NSAIDs, tramadol, anti-neuropathics, physiotherapy, TENS)Screened by a multi-disciplinary panel including a psychologist and deemed suitable for SCS treatment according to the inclusion criteria of the Dutch “Standpunt Neuromodulatie bij chronische pijn”.Be willing and capable of giving informed consent.
Exclusion criteria
Exclusion criteria: Subject is unable to understand or operate the SCS device.Subject currently has an active implantable device including pacemakers, spinal cord stimulator or intrathecal drug delivery system. Ongoing coagulation disorder / Use of anticoagulation therapy which cannot be stopped temporarilyOngoing abuse of alcohol, drugs, or prescription opioids.Active debilitating psychiatric illness.Active malignancy.Condition with increased general infection sensitivity, such as known immunodeficiency.Expected lifespan <1 year.Ongoing local infection or other skin disease where the IPG is planned to be placed.Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is pain intensity at 6 months post-randomization, measured using the Numeric Rating Scale (NRS, 0–10), in patients with endometriosis-related CVP receiving either SCS or CMM. | — |
Secondary
| Measure | Time frame |
|---|---|
| Healthcare costs, measured with the Medical consumption questionnaire (iMCQ) and the productivity cost questionnaire (iPCQ) [Time Frame: The change between the baseline screening and the evaluation at 3, 6, 12 and 24 months post-randomization]Health related quality of life, measured with the Endometriosis Health Profile 30 (EHP-30) and PROMIS Global Health (PROMIS-GH) [Time Frame: The change between the baseline screening and the evaluation at 3, 6, 12 and 24 months post-randomization]Physical functioning , measured with the PROMIS 29+2 Profile v2.1 (Domains Physical Function, Pain Interference, and Pain Intensity) [Time Frame: The change between the baseline screening and the evaluation at 3, 6, 12 and 24 months post-randomization]Emotional functioning , measured with the PROMIS 29+2 Profile v2.1 (Domains Pain Interference, Anxiety and Depression) [Time Frame: The change between the baseline screening and the evaluation at 3, 6, 12 and 24 months post-randomization]Sleep quality , measured with the PROMIS 29+2 Profile v2.1 (Domain Sleep Disturbance) [Time Frame: The change between the baseline screening and the evaluation at 3, 6, 12 and 24 months post-randomization]Patient rating of global improvement, measured using the Patient Global Impression of Change (PGIC) [Time Frame: The change between the baseline screening and the evaluation at 3, 6, 12 and 24 months post-randomization]Medication use [Time Frame: The change between the baseline screening and the evaluation at 3, 6, 12 and 24 months post-randomization]Return to work, measured using the iPCQ [Time Frame: The change between the baseline screening and the evaluation at 3, 6, 12 and 24 months post-randomization]Adverse events [Time Frame: At the evaluation at 3, 6, 12 and 24 months post-randomization] | — |
Countries
Netherlands
Contacts
Public ContactJ.W. Kallewaard
Rijnstate
Outcome results
None listed