The objective of this study is to assess the feasibility of SCS using the Wavewriter Alpha for control of treatment resistant endometriosis-related pain symptoms
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Chronische neuropathische pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mean pain intensity and patients global impression of change at 6 months
Secondary outcome
• Mean pain: NRS pain score (3 times a day for 3 days) at baseline and 3-6 and
12 months post implant.
• The number (percentage) of subjects who achieve a reduction in the pain
intensity of at least 50%(substantial change) or 30% (moderately important
change) at 6 months compared to baseline.(12)
• Patient*s global impression of change(PGIC): dichotomous (better or improved
versus not better or improved) at 3-6- and 12-months post implant.
• Change in quality of life: EHP 30 & SF36 at baseline and at 6- and 12-months
post implant.
• Change in fatigue: EHP 30 at baseline and 6- and 12-months post implant
• Pain Catastrophizing assessed with the PCS at baseline, 6- and 12-months post
implant.
• Central Sensitization Inventory at baseline and 6- and 12-months post implant.
• Pain medication use at baseline 3- 6- and 12-months post implant
• Lost working days: iPCQ Productivity Cost Questionnaire at baseline and at 6
months post implant
• Number of patients with a failed trial SCS
• Complications and side effects: 3, 6, and 12 months post implant.
Background summary
Endometriosis is a condition characterised by the presence and growth of
ectopic endometrial tissue. Definitive diagnosis of endometriosis is by
visualization and/or confirmed by histologic examination of excised lesions via
laparoscopy. With a prevalence of 6-10%, endometriosis isn't rare. Besides
complaints like dysmenorrhea, dyspareunia and infertility, a substantial
percentage of these patients complain of chronic pelvic pain. This pain that
should be seen as a form of centralised pain is notoriously hard to treat and
results in a substantial loss in quality of life and impairment of professional
and social functioning.
Spinal cord stimulation is a well accepted treatment for neuropathic pain.
There is some evidence that patients with visceral pain can benefit from
treatment with spinal cord stimulation. The question this study seeks to answer
is wether spinal cord stimulation is a feasible treatment modality for patients
suffering from chronic pelvic pain caused by endometriosis.
Study objective
The objective of this study is to assess the feasibility of SCS using the
Wavewriter Alpha for control of treatment resistant endometriosis-related pain
symptoms
Study design
This is a prospective, multicenter, unblinded feasibility study (pilot study)
to assess the hypothesis that the chronic intractable severe pain from patients
with endometriosis could be treated with SCS. Patients who failed all treatment
options (hormonal, medical and surgical), and fulfil the inclusion criteria,
and have signed the approved informed consent form will be enrolled in the
study.
For this study 15 patients will receive an implant SCS. After implantation of
the system the patients will be followed up for 1 year.
After the test period of 5 patients an interim analysis will be performed to
assess if the study should continue, at least 2 patients should benefit from
the treatment with at least 50% pain relief for the study to continue.
Intervention
Implantation of a spinal cord stimulator with accompanying epidural leads
(Boston Spectra Wavewriter System).
Study burden and risks
The risks patients are undergoing during implantation in this study are the
same as the risks any patient faces undergoing neuromodulation. There is a very
small risk of epidural hemorrhage (not higher than any form of regional
anesthesia) and a risk of infection of the system. Routinely patients will
receive pre operative prophylactic antibiotics and patients are made aware of
the symptoms of the infection (pain, redness, fever, stiff neck).
Besides implantation of the neuromodulator the additional burden for the
patients comprises of extra hospital visits.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Patients with endometriosis/ adenomyosis confirmed at surgery and without
options for further surgical treatment.
- Premenopausal woman aged >= 18 years
- Patients with at least one of the endometriosis related pain symptoms:
dysmenorrhea, pelvic pain or dyspareunia.
- 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
- Neurologic exam without marked motor deficit.
- Meets all the inclusion criteria for the implantation of a neurostimulation
system as typically utilized in the study center.
- 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 any malignancy
- BMI >=35
- 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76287.018.21 |