The discontinuation of pain medication in patients with failed back surgery, treated with spinal cord stimulation.

Pain medication tapering for patients with Persistent Spinal Pain Syndrome Type II, treated with Spinal Cord Stimulation. - PIANISSIMO

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-003925-23-BE

Enrollment

195

Registered

2023-01-17

Start date

2023-04-12

Completion date

Unknown

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent spinal pain syndrome type 2

Interventions

Trade Name: Catapressan 150µg tablets Pharmaceutical Form: Tablet INN or Proposed INN: Clonidine hydrochloride CAS Number: 4205-91-8 Other descriptive name: Clonidine hydrochloride Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients being diagnosed with persistent spinal cord stimulation type 2, 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 - 18 years and older - Speaking and reading Dutch or French Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 156 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 39

Exclusion criteria

Exclusion criteria: - Being actively treated for cancer, - Having a life expectancy below 6 months, - Receiving intrathecal drug delivery, - Having contraindications for Clonidine (e.g., known hypotension which requires medication) or for Buprenorphine/Naloxone (e.g., severe respiratory insufficiency, hepatic insufficiency) - Having epilepsy currently treated by Pregabalin, - Currently using benzodiazepines at doses more than 40 mg diazepam-equivalents per day.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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 persistent spinal cord stimulation type 2 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. ;Secondary Objective: The secondary objective of the study is to examine whether there is a difference after 12 months of spinal cord stimulation (SCS) in persistent spinal cord stimulation type 2 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. ;Primary end point(s): The primary endpoint is to observe whether there is a difference in the Oswestry Disability Index score in persistent spinal cord stimulation type 2 patients 12 months after definitive spinal cord stimulation implantation between the three arms. ;Timepoint(s) of evaluation of this end point: A longitudinal mixed models analysis will be used with timepoints defined at baseline, 1 month, 3 months, 6 months and 12 months after definitive spinal cord stimulation implantation.	—

Measure

Time frame

Main Objective: 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 persistent spinal cord stimulation type 2 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. ;Secondary Objective: The secondary objective of the study is to examine whether there is a difference after 12 months of spinal cord stimulation (SCS) in persistent spinal cord stimulation type 2 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. ;Primary end point(s): The primary endpoint is to observe whether there is a difference in the Oswestry Disability Index score in persistent spinal cord stimulation type 2 patients 12 months after definitive spinal cord stimulation implantation between the three arms. ;Timepoint(s) of evaluation of this end point: A longitudinal mixed models analysis will be used with timepoints defined at baseline, 1 month, 3 months, 6 months and 12 months after definitive spinal cord stimulation implantation.

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Secondary

Measure	Time frame
Secondary end point(s): The secondary endpoint is whether the three arms differ on the Visual Analogue Scale, Euro Quality of Life with five dimensions and five levels, Impact on Participation and Autonomy Questionnaire, Measurements in the Addictions for Triage and Evaluation, Hospital Anxiety and Depression Scale, Opioid Craving Visual Analogue Scale, Current Opioid Misuse Measure, Medication Quantification Scale III, General Self-Efficacy Scale, Pain Catastrophizing Scale, Multidimensional Pain Inventory, Pittsburg Sleep Quality Index, Central Sensitization Inventory and Health Expenditure after definitive spinal cord stimulation implantation. ;Timepoint(s) of evaluation of this end point: Longitudinal mixed models analyses will be used with timepoints defined at baseline, 1 month, 3 months, 6 months, and 12 months after definitive spinal cord stimulation implantation.	—

Measure

Time frame

Secondary end point(s): The secondary endpoint is whether the three arms differ on the Visual Analogue Scale, Euro Quality of Life with five dimensions and five levels, Impact on Participation and Autonomy Questionnaire, Measurements in the Addictions for Triage and Evaluation, Hospital Anxiety and Depression Scale, Opioid Craving Visual Analogue Scale, Current Opioid Misuse Measure, Medication Quantification Scale III, General Self-Efficacy Scale, Pain Catastrophizing Scale, Multidimensional Pain Inventory, Pittsburg Sleep Quality Index, Central Sensitization Inventory and Health Expenditure after definitive spinal cord stimulation implantation. ;Timepoint(s) of evaluation of this end point: Longitudinal mixed models analyses will be used with timepoints defined at baseline, 1 month, 3 months, 6 months, and 12 months after definitive spinal cord stimulation implantation.

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Countries

Belgium

Contacts

Public ContactMaarten Moens

Vrije Universiteit Brussel

maarten.ta.moens@vub.be

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 6, 2026