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New treatment option for Persistent Spinal Pain Syndrome Type 2
Official title Pain Medication Tapering for Patients With Persistent Spinal Pain Syndrome Type 2, Treated With Spinal Cord Stimulation.
ClinicalTrials.gov ID: NCT05861609
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Patients need to be scheduled for SCS to be eligible for participation in the study
- Currently taking opioids
- 18 years and older
- Speaking and reading Dutch or French
You likely can't join 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...
- Epilepsy treated by Pregabalin.
- Currently using benzodiazepines at more than 40 mg diazepam-equivalents per day.
The study team makes the final eligibility decision.
Where it's taking place
- Jette, Belgium
- Lier, Belgium
- Roeselare, Belgium
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jette, Belgium; Lier, Belgium; Roeselare, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.