Failed Back Surgery Syndrome, Persistent Spinal Pain Syndrome Type 2
Conditions
Brief summary
Spinal cord stimulation (SCS) has shown to be an effective treatment for patients with persistent spinal pain syndrome Type 2 (PSPS Type 2). The method used to deliver electrical charge in SCS is important. One such method is burst stimulation. Two variations of burst waveforms are currently in use: one that employs active recharge and one that uses passive recharge. It is still unknown if there are clinical differences between active recharge and passive recharge burst SCS. To date, no clinical studies have been performed that directly compared these two burst stimulation waveforms. The objective of this Randomized Clinical Trial (RCT) is to assess and compare effect of passive recharge burst SCS with active recharge burst SCS on pain relief and motivational-emotional facets of pain
Detailed description
This multicenter randomized clinical trial will take place in 6 Dutch hospitals: the Rijnstate Hospital (Arnhem), Bravis Hospital (Roosendaal), Elizabeth TweeSteden Hospital (Tilburg), Diakonessen Hospital (Utrecht), Alrijne Hospital (Leiden) and the Amsterdam University Medical Hospitals A-UMC). PSPS Type II2 patients (n=96) will be randomized into a group receiving either active or passive recharge burst. Following a successful trial period, patients are permanently implanted. Patients complete the pain catastrophizing score (PCS) (primary outcome at 6 months), numeric pain rating scale (NRS), patient vigilance and awareness questionnaire (PVAQ), hospital anxiety and depression scale (HADS), quality of life (EQ-5D), Oswestery disability index (ODI), patient global impression of change (PGIC) and painDETECT questionnaires (secondary outcomes) at baseline, after trial, 1, 3, 6 and 12 months following implantation.
Interventions
DEVICESpinal cord stimulation using passive recharge burst stimulation
Passive recharge burst is marked by a recharge pattern that passively compensates for charge differences.
DEVICESpinal cord stimulation using active recharge burst stimulation
Active recharge burst is characterized by negative pulses that directly compensate for charge differences.
Sponsors
Rijnstate Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Subjects between 18 and 70 years of age * At least moderate level of catastrophizing as measured with the Pain catastrophizing scale (PCS) of at least 20 at first visit of the pain clinic. * Chronic pain diagnoses as PSPS Type 2 of at least 6 months * Neurologic exam without marked motor deficit. * LBP and/or leg pain intensity should be 5 or higher measured with the 11-box NRS 0-10 * Meets all the inclusion criteria for the implantation of a neurostimulation system as typically utilized in the study center. PM: depression is not an
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain catastrophizing score | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient vigilance and awareness questionnaire | 3, 6, 12 months | — |
| Hospital anxiety and depression scale | 3, 6, 12 months | — |
| EQ-5D questionnaire | 3, 6, 12 months | Quality of life questionnaire |
| Oswestery disability index | 3, 6, 12 months | — |
| Numeric pain rating scale | 3, 6, 12 months | — |
| PainDETECT questionnaire | 3, 6, 12 months | Characterisation of neuropathic pain components |
| Mean charge per second used | 3, 6, 12 months | Measures the amount of electrical charge used |
| Mean charge per hour used | 3, 6, 12 months | Measures the amount of electrical charge used |
| Patient global impression of change | 3, 6, 12 months | — |
Countries
Netherlands
Contacts
Primary ContactMartijn Mons, Msc.
Backup ContactJan-Willem Kallewaard, PhD
Outcome results
None listed