The purpose of this Post Market Cohort is to evaluate the commercially available Spinal Modulation Neurostimulator system in the management of intractable chronic pain in patients that are routinely scheduled to receive a Spinal Modulation…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Chronic intractable pain
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Pain relief measured using a Visual Analogue Scale (VAS).
2. Device safety by monitoring occurrence of (S)AEs
3. Quality of life (EQ-5D)
4. Physical functioning (BPI, ODI)
5. Oswestry low back pain disability questionairy
6. Pain distribution
7. Paresthesia distribution
8.Subject satisfaction
Secondary outcome
NA
Background summary
Initial clinical studies have shown that stimulation of the dorsal root
ganglion can significantly reduce chronic intractable pain. These results have
supported the CE marking of the Spinal Modulation Neurostimulator system in the
management of chronic pain. Following the requirements of the AIMDD, Spinal
Modulation will also collect clinical data on the commercially available
Neurostimulator Systems.
Study objective
The purpose of this Post Market Cohort is to evaluate the commercially
available Spinal Modulation Neurostimulator system in the management of
intractable chronic pain in patients that are routinely scheduled to receive a
Spinal Modulation Neurostimulator system.
Study design
This is a prospective, multi center, post market cohort to collect data on
quality of life, physical functioning, subject safety, and subject
satisfaction.
Study burden and risks
There are no additional risks for the patients by participating in this post
market cohort. The implantation of the system is a standard procedure in the
hospital and the additional data that will be collected consists of
questionnaires on pain relief, quality of life and subject satisfaction.
Cicerostraat 7
Sittard 6135HT
NL
Cicerostraat 7
Sittard 6135HT
NL
Listed location countries
Age
Inclusion criteria
1.Subject is at least 18 years old
2.Subject is able and willing to comply with the follow-up schedule and protocol
3.Chronic, intractable pain in the thoracic, lumbar, and/or sacral distribution(s) for at least 6 months
4.Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain
5.Minimum baseline pain rating of 60 mm on the VAS in the primary region of pain
6.In the opinion of the investigator, the subject is psychologically appropriate for the implantation for an active implantable medical device
7.Subject is able to provide written informed consent
8.Subject speaks Dutch or English
Exclusion criteria
1.Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control
2.Escalating or changing pain condition within the past month as evidenced by investigator examination
3.Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
4.Subject has had radiofrequency treatment of an intended target DRG(s) within the past 3 months
5.Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump
6.Subject has pain only or primarily within a cervical dermatomal distribution
7.Subject is unable to operate the device
8.Subjects with indwelling devices that may pose an increased risk of infection
9.Subjects currently has an active infection
10.Subject has, in the opinion of the investigator, a medical comorbidity that contraindicates placement of an active medical device
11.Subject has participated in another clinical investigation within 30 days
12.Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
13.Subject has been diagnosed with cancer in the past 2 years
Design
Recruitment
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 | NL39022.100.12 |