The primary objective of this Randomised Controlled Trial (RCT) is to evaluate the efficacy of DRG stimulation with the Axium® SCS system as compared to CMM in terms of pain relief. Efficacy will be assessed by comparing the percentage of subjects…
ID
Source
Brief title
Condition
- Other condition
- Peripheral neuropathies
Synonym
Health condition
chronische liespijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The percentage of subjects with *50% pain relief between the two groups and the
difference between groups in the change in numerical pain rating scale (NPRS).
Secondary outcome
* Repeat of primary objective measured at 12 months
* As Treated and Number Needed To Treat analysis of Axium
group and TNS failures combined at 6 months.
* Primary objective analysis as a true Intention to Treat using combined data
from the DRG group and TNS trial failures at 6 months
* Safety assessed by monitoring occurrence of device related (S)AEs
* Quality of life improvements and intergroup comparison between at 6 months
(EQ-5D)
* Physical functioning improvements and intergroup comparison at 6 months (BPI)
* Changes in Sensory Disturbances and intergroup comparison at 6 months
(Bedside Quantitative Sensory Testing, QST)
* Changes in Neuropathic Pain Scale (NPRS) and intergroup comparisons at 6
months
* Subject satisfaction and intergroup comparison at all follow up visits (7
point Likert Scale)
* Changes in healthcare resource utilisation and intergroup comparison at 6
months (Health Practitioner Visits/Medication Usage)
* Changes in sleep quality and intergroup comparison at 6 months (Daily Sleep
Interference Scale)
* All above mentioned secondary outcomes will be repeated at 12 months
follow-up for the treated group and will be compared to baseline.
Background summary
Initial clinical studies have shown that Spinal Cord Stimulation (SCS) of the
Dorsal Root Ganglion (DRG) with the Spinal Modulation Axium® SCS system can
significantly reduce chronic intractable pain in a variety of pain conditions.
Successfully treated conditions include refractory, postoperative inguinal pain
following various operative procedures such as mesh hernia repair, Pfannenstiel
incision and femoral vein access. In the Netherlands it is not uncommon for
patients suffering from chronic pain following such procedures to undergo a
further surgery (neurectomy) to alleviate this pain. In clinical studies the
neurectomy procedure has shown itself to be effective in approximately 70% of
patients after one year. For those patients who are still in pain despite the
neurectomy procedure the Axium® SCS system offers a further opportunity for
patients to achieve pain relief and several such patients have been treated
successfully with this therapy recently in the Netherlands. This Trial sets out
to evaluate the efficacy of the Axium® SCS system as compared to conservative
medical management (CMM) in subjects with persistent, chronic pain following
open inguinal hernia repair or Pfannenstiel incision that had subsequently
undergone and failed to respond to a neurectomy procedure.
Study objective
The primary objective of this Randomised Controlled Trial (RCT) is to evaluate
the efficacy of DRG stimulation with the Axium® SCS system as compared to CMM
in terms of pain relief. Efficacy will be assessed by comparing the percentage
of subjects with *50% pain relief between the two groups and the difference
between groups in the change in numerical pain rating scale (NPRS). The trial
is powered to demonstrate superiority of the Axium SCS System over CMM at the
6-month follow up visit.
Study design
This is a prospective, multicenter, randomized (1.2:1 * DRG:CMM) controlled
trial (RCT) with optional crossover at 6 months designed to assess the efficacy
of the Spinal Modulation Axium® SCS System for the treatment of intractable
postsurgical pain in the Inguinal area, refractory to neurectomy.
Eligible subjects will be randomized to either DRG stimulation (Axium® SCS
system) or CMM and prospectively followed for 12 months following; inclusion
(CMM group) or implantation (Axium® group). Following data collection at the 6
month follow up visit subjects in the CMM group will be given the option to
cross over to the alternate arm of the trial. Subsequently subjects will be
followed prospectively for either a further 6 or 12 months dependent on the
outcome of their procedure
Intervention
The commercially available Spinal Modulation Axium® SCS System for the
management of chronic intractable pain (CE 567069).
Study burden and risks
There are no additional risks to the subjects participating in this trial. The
implantation of the system is a standard procedure in the designated
implantation centres, the device under Trial is being used within its approved
(CE Mark) indication and regular follow up visits are standard practice for
patients implanted with SCS devices such as and including the Axium® SCS
system. Data that will be collected consists of questionnaires and keeping a
diary seven days prior to follow-up visits concerned with; pain relief, quality
of life, physical functioning and subject satisfaction. Some simple bedside
sensory tests commonly utilised in pain management clinics will be done plus
extensive quantitative sensory testing at baseline and final visit. These tests
can be briefly uncomfortable and patients can refuse to undergo them without
this having consequences for participation in the trial.
Ds. Th. Fliednerstraat 1
Eindhoven 5631BM
NL
Ds. Th. Fliednerstraat 1
Eindhoven 5631BM
NL
Listed location countries
Age
Inclusion criteria
Subject is at least 18 years old.
Subject is able and willing to comply with the follow-up schedule and protocol.
Chronic inguinal pain following pfannenstiel incision or inguinal hernia repair or laparoscopic inguinal repair for at least 6 months.
Previously undergone neurectomy procedure as a treatment for chronic inguinal pain.
Minimum baseline pain rating of 6 out of 10 in the inguinal area on an 11-point NPRS.
Subject is able to provide written informed consent.
Meets the inclusion criteria for the implantation of a neurostimulation system as set out by the Dutch Neuromodulation Society.
Subject has been screened by a multi-disciplanary panel including the designated psychologist of the Máxima Medical Centre Eindhoven and deemed suitable for implantation.
Neuropathic Pain as described by a score of *4 on the DN4 questionnaire
Exclusion criteria
Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the trial.
Escalating or changing pain condition within the past month as evidenced by investigator examination.
Subject has had injection therapy or radiofrequency treatment of a target neural structure within the past 3 months
Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump.
Subject is unable to operate the device.
Subject currently has an active infection.
Subject has participated in another clinical investigation within 30 days.
Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation.
Subject has a current or ongoing condition, which will probably require MRI investigation sometime in the following 2 years
Subject has had a spinal surgical procedure at or between vertebral levels T10-L2.
Subject had been diagnosed with cancer in the past 2 years, except for skin malignancies
Subject has a significant progressive peripheral or central neurological disorder such as Diabetic Polyneuropathy or Multiple Sclerosis
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 |
|---|---|
| ClinicalTrials.gov | NCT02349659 |
| CCMO | NL50024.015.14 |