Pain Medication Tapering for Patients With Persistent Spinal Pain Syndrome Type 2, Treated With Spinal Cord Stimulation.
PIANISSIMO
1 other identifier
interventional
195
1 country
3
Brief Summary
The primary objective of the study is to examine whether there is a difference in disability after 12 months of Spinal Cord Stimulation (SCS) in patients with Persistent Spinal Pain Syndrome Type 2 (PSPS T2) after receiving a standardized pain medication tapering protocol before SCS implantation, a personalized pain medication tapering protocol before SCS implantation, or no tapering protocol before SCS implantation. The secondary objective of the study is to examine whether there is a difference after 12 months of SCS in PSPS T2 patients after receiving a standardized pain medication tapering protocol before SCS implantation, a personalized pain medication tapering protocol before SCS implantation, or no tapering protocol before SCS implantation on pain intensity, health-related quality of life, participation, domains affected by substance use, anxiety and depression, medication use, psychological constructs, sleep, central sensitization, and healthcare expenditure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2023
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2023
CompletedFirst Posted
Study publicly available on registry
May 17, 2023
CompletedStudy Start
First participant enrolled
September 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
October 18, 2023
October 1, 2023
2.9 years
May 6, 2023
October 17, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Disability
Disability, evaluated with the Oswestry Disability Index
The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation
Secondary Outcomes (14)
Pain intensity
The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.
Health-related Quality of Life
The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.
Participation
The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.
Drug related patient characteristics and problems
The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.
Opioid craving
The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.
- +9 more secondary outcomes
Study Arms (3)
No pain medication tapering (usual care)
ACTIVE COMPARATORUsual care
Standardized pain medication tapering
ACTIVE COMPARATORStandardized pain medication tapering
Personalized pain medication tapering
ACTIVE COMPARATORPersonalized pain medication tapering
Interventions
Usual care with respect to Spinal Cord Stimulation implantation
A standardized pain medication tapering program before Spinal Cord Stimulator implantation.
A personalized pain medication tapering program before Spinal Cord Stimulator implantation.
Eligibility Criteria
You may qualify if:
- Patients with PSPS T2, defined as patients suffering from neuropathic pain of radicular origin with pain in the lower back and/or leg(s), of an intensity of at least 4/10 on the Numeric Rating Scale, for a period of at least 6 months after a minimum of one anatomically successful spinal surgery and being refractory to conservative treatment (according to Belgian reimbursement rules from January 1st, 2018)
- Patients need to be scheduled for SCS to be eligible for participation in the study
- Currently taking opioids
- years and older
- Speaking and reading Dutch or French
You may not qualify if:
- Being actively treated for cancer.
- Having a life expectancy below 6 months.
- Receiving intrathecal drug delivery.
- Patients with contraindications for Clonidine (e.g., known hypotension which requires medication) or for Buprenorphine/Naloxone (e.g., severe respiratory insufficiency, hepatic insufficiency).
- Epilepsy treated by Pregabalin.
- Currently using benzodiazepines at more than 40 mg diazepam-equivalents per day.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Moens Maartenlead
- Vrije Universiteit Brusselcollaborator
Study Sites (3)
Universitair Ziekenhuis Brussel
Jette, 1090, Belgium
Heilig Hart Ziekenhuis Lier
Lier, 2500, Belgium
AZ Delta
Roeselare, 8800, Belgium
Related Publications (1)
Moens M, Crunelle CL, Putman K, Wuyts E, Bultinck F, Van Puyenbroeck H; PIANISSIMO consortium; Goudman L. Pain medication tapering for patients with Persistent Spinal Pain Syndrome Type II, treated with Spinal Cord Stimulation: A RCT-study protocol of the PIANISSIMO study. PLoS One. 2024 Aug 12;19(8):e0302842. doi: 10.1371/journal.pone.0302842. eCollection 2024.
PMID: 39133680DERIVED
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Both the outcome assessors as well as the investigator (statistician) will be blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 6, 2023
First Posted
May 17, 2023
Study Start
September 29, 2023
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
October 18, 2023
Record last verified: 2023-10