The purpose of this prospective post market observational pilot study is to evaluate the effect of DRG stimulation in the management of chronic discogenic pain in subjects who are refractory to other available treatments. Selected subjects will not…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Chronic discogenic low back pain
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the number (percentage) of subjects who achieve a sustained and
clinically meaningful reduction in the intensity of LBP of >=30% or 2 points on
a numerical pain rating scale (NPRS)22 in the implanted subjects at 6 and 12
month follow up visits as compared to baseline.
Secondary outcome
• Subject Satisfaction with treatment will be assessed using the Patient Global
Impression of Change (PGIC), a 7 point Likert scale
• Number (percentage) of subjects who achieve a >=50% reduction in the intensity
of the LBP at 6 and 12 months FU
• Pain relief (>=30% and >=50%) in other painful anatomy related to the back pain
(e.g. Leg, buttock or foot)
• Functional improvements will be assessed using the Oswestry Disability Index
(ODI) at the 6 and 12 month follow up as compared to baseline
• Reduction in analgesia intake will be assessed by a comprehensive inventory
of medication used at the 6 and 12 month FU as compared to baseline.
• Quality of Life (QOL) improvements will be assessed at all visits using the
EQ-5D as compared to baseline values
• Change in psychological disposition assessed using the Profile of Mood States
(POMS) at 6 and 12 month FU visits as compared to baseline
• Characterisation of LBP will be assessed at baseline; then at the 6 month and
12 month FU visits using the painDETECT® questionnaire which is designed to
differentiate neuropathic and non-neuropathic pain states. This may provide
interesting data in post hoc analysis of responders and non-responders to the
therapy
• Safety will be monitored by the collection and reporting (as required) of
device related adverse events (AE*s), device related serious adverse events
(SAE*s) and any unanticipated SAE*s (regardless of device relatedness)
Background summary
Initial clinical studies have shown that Dorsal Root Ganglion (DRG) can
significantly reduce chronic intractable pain in a variety of chronic pain
conditions including Chronic Low Back Pain (CLBP). CLBP as a diagnosis
represents a heterogeneous patient population, for which there are few
treatments with proven long-term efficacy other than lumbar spinal surgery.
This study sets out to evaluate the effectiveness of DRG stimulation in a
homogenous sub population of CLBP, that being Discogenic Low Back Pain or
Discogenic Pain which is chiefly driven by disruption or deterioration of the
lower lumbar intervertebral discs and is believed to represent around 40% of
CLBP generally.
Study objective
The purpose of this prospective post market observational pilot study is to
evaluate the effect of DRG stimulation in the management of chronic discogenic
pain in subjects who are refractory to other available treatments. Selected
subjects will not be suitable candidates for lumbar spinal surgery and will
meet the standard selection process for DRG stimulation as routinely utilised
in the study centre. Results from this pilot study will inform current clinical
practice and future comparative studies in this specific population.
Study design
This is a prospective, single-arm, multi-centre, post market, observational
pilot study to collect data on pain relief, subject satisfaction, quality of
life, physical functioning and safety.
Intervention
Subjects enrolled will be asked to complete several questionnaires prior to
their procedure and at routine follow up visits for 12 months.
Study burden and risks
During the investigation there is no additional burden for the patients as they
will receive the standard treatment with neurostimulation. They are only asked
to fill in a few extra questionnaires. Completing these questionnaires takes
about 30 minutes.
Since this study is only about the completion and analysis of standard
questionnaires, we expect no risks or side effects as a result of participation
in this study.
Cicerostraat 7
Sittard 6135HT
NL
Cicerostraat 7
Sittard 6135HT
NL
Listed location countries
Age
Inclusion criteria
1. Subject of either gender between 18 and 65 years of age
2. Subject is able and willing to comply with the follow-up schedule and protocol
3. Subject is able to provide written informed consent
4. Chronic low back pain of at least 6 months
5. History consistent with discogenic low back pain (e.g. Pain produced on lumbar motion, significant functional limitation in sitting duration and tolerance)
6. Neurologic exam without marked motor deficit.
7. Definite/Highly Probable/Discogenic Pain as confirmed by provocative discography according to IASP/ISIS guidelines*
8. Low Back Pain intensity should be 6 or higher measured on a NPRS at baseline
9. Meets all the inclusion criteria for the implantation of a neurostimulation system as typically utilised in the study centre
10. Subject has been screened by a multi-disciplinary panel including a psychologist and deemed suitable for implantation
Exclusion criteria
1. Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study
2. Escalating or changing pain condition within the past month as evidenced by investigator examination
3. BMI >=35
4. Subject has had injection therapy or radiofrequency treatment for their low back pain 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 is unable to operate the device
7. Severe disc degeneration at the affected level as evidenced by >50% disc height loss on plain anteroposterior and lateral lumbar radiographs or CT/MRI.
8. Extruded or sequestered herniated nucleus pulposus at the affected level(s).
9. Previous lumbar back surgery (e.g. Laminectomy, discectomy or fusion) at the affected level(s)
10. Moderate to severe spinal stenosis due to osteophyte and/or ligamentous overgrowth as evidenced by MRI or CT in the previous 6 months
11. Moderate to severe endplate degenerative changes at the affected levels
12. Grade 1-2 spondylolisthesis
13. 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 |
|---|---|
| Other | ClinicalTrials.gov; Number not yet assigned |
| CCMO | NL54405.091.15 |