PIANISSIMO consortium
- Prof. Dr. Maarten Moens (VUB/UZB, Principal Investigator)
- Prof. Dr. Lisa Goudman (VUB/UZB)
- Prof. Dr. Koen Putman (VUB)
- Prof. Dr. Cleo Crunelle (VUB/UZB)
- Dr. Bert Van Puyenbroeck (VUB, project coordinator)
- Dra. Elke Wuyts (PhD researcher VUB)
- Dra. Frenn Bultinck (PhD researcher VUB)
Study flowchart
PIANISSIMO consists of a three-arm RCT, whereby two groups will undergo a tapering protocol and one group of patients will receive usual care. In order to make the comparison between patients in the three arms, five assessments will take place: before SCS implantation, after SCS implantation and at 3, 6 and 12 months after SCS implantation.
Study status
This study has received funding from the Research Foundation Flanders (FWO), Belgium. PIANISSIMO has officially started in October 2022. The study is approved by the Ethics Committees and recruitment will start shortly.
Contact
Please contact pianissimo@vub.be for more information about this trial.
This study received funding from the Research Foundation Flanders through the FWO-TBM call.
Project overview
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Persistent Spinal Pain Syndrome Type II (PSPS T2) is a condition in which patients are suffering from persistent low back pain, despite previously performed surgical interventions. Patients with PSPS T2 experience chronic pain with an enormous impact on the functioning, quality of life, general well-being and medication use. One way to help patients to alleviate their pain, is with Spinal Cord Stimulation (SCS). SCS provides pain relief and a decrease in disability. SCS also decreases the amount of pain medication, more specifically opioid intake. Nevertheless, the number of patients that can eventually totally omit the use of opioids is rather limited. In this project, we propose to start with an opioid tapering program before starting the SCS trajectory as the new treatment strategy for patients implanted with SCS. This allows us to tackle the high burden of patients that are taking a lot of opioids by proceeding towards a more logical treatment plan for a costly and debilitating condition. A three-arm multicenter randomized controlled trial will be conducted to evaluate whether an opioid tapering program before SCS implantation (Intervention) is more effective in reducing disability (Outcome) after 12 months in PSPS T2 patients scheduled for SCS implantation (Patient) compared with usual care (Comparison). Two different tapering programs will be evaluated in this project. Opioid tapering will be provided during a hospital stay, compared to a group of patients who do not undergo opioid tapering before SCS implantation. Besides disability as primary outcome measure, several secondary outcome measurements will be collected namely pain intensity, quality of life, participation, domains affected by substance use, anxiety and depression, medication use and health expenditure. Outcome measurements will be collected at baseline, and after 1 month, 3, 6 and 12 months of SCS. |
Study interventions
Usual care
Patients allocated to the usual care (no opioid tapering protocol before SCS) will follow the usual care as it is implemented in Belgian hospitals, before and after SCS implantation. Before implantation, patients will undergo the trial SCS procedure (as prescribed by the reimbursement rules), whereafter a definitive SCS implantation will be performed. After implantation, patients are seen by the treating physician and delegates of the companies to program the SCS parameters and have a fixed 6 month follow up to re-evaluate the therapy. Each hospital can continue the usual care as normally provided to patients after SCS implantation. Nevertheless, all interventions will be documented in the diaries for healthcare utilization.
Standardized tapering protocol
For each patient who is randomized to the standardized opioid tapering protocol, a standardized program will be delivered to wean off opioids before neuromodulation. Patients are to be hospitalised. At admission, all opioids are stopped and normal saline and clonidine are provided until the end of the hospitalization. Additionally, paracetamol and diclofenac will be provided.
Personalized tapering protocol
For each patient who is randomized to the personalized opioid tapering protocol, a combination of opioid substitution with opioid rotation will be used to wean off opioids before neuromodulation. Patients are to be hospitalised. First, if long-acting opioids are used, these will be substituted for short-acting opioids. Second, short-acting opioids will be rotated to the partial agonist BuNa (buprenorphine combined with naloxone) under continuous measurement of opioid withdrawal severity and pain monitoring using a VAS. Withdrawal symptoms will be determined using a subjective and objective withdrawal scale, based on the subjective opioid withdrawal scale and clinical opioid withdrawal scale, respectively .
Study status
