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Pain Medication Tapering for Patients With Persistent Spinal Pain Syndrome Type 2, Treated With Spinal Cord Stimulation. (PIANISSIMO)

Primary Purpose

Persistent Spinal Pain Syndrome Type 2, Spinal Cord Stimulation

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Usual care
Standardized pain medication tapering
Personalized pain medication tapering
Sponsored by
Moens Maarten
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Spinal Pain Syndrome Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 18 years and older Speaking and reading Dutch or French Exclusion Criteria: 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.

Sites / Locations

  • Universitair Ziekenhuis BrusselRecruiting
  • Heilig Hart Ziekenhuis Lier
  • AZ DeltaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

No pain medication tapering (usual care)

Standardized pain medication tapering

Personalized pain medication tapering

Arm Description

Usual care

Standardized pain medication tapering

Personalized pain medication tapering

Outcomes

Primary Outcome Measures

Disability
Disability, evaluated with the Oswestry Disability Index

Secondary Outcome Measures

Pain intensity
Pain intensity will be evaluated using a Visual Analogue Scale (100 mm).
Health-related Quality of Life
Health-related quality of life will be assessed using the Euro Quality of Life with five dimensions and five levels.
Participation
The Impact on Participation and Autonomy Questionnaire is used to evaluate participation.
Drug related patient characteristics and problems
The Measurements in the Addictions for Triage and Evaluation is used assess drug related patient characteristics and problems.
Opioid craving
Opioid craving will be assessed with the Visual Analogue Scale for Opioid Craving.
Risk for aberrant medication-related behaviour
The Current Opioid Misuse Measure is used to evaluate the risk for aberrant medication-related behaviour.
Medication use
The Medication Quantification Scale III is used to quantify pain medication use.
Healthcare utilization
Healthcare utilization is investigated by two means: expenditures associated with in-hospital care are inventoried using the hospital claims data whereas other costs are collected through self-reported (diaries and questionnaires).
Anxiety and depression
The Hospital Anxiety and Depression Scale is used to assess feelings of anxiety and depression.
General Self-Efficacy
Perceived self-efficacy is evaluated using the General Self-Efficacy Scale.
Pain Catastrophizing
With the Pain Catastrophizing Scale, catastrophizing thoughts or feelings accompanying the previously experienced pain are evaluated.
Coping
The Multidimensional Pain Inventory is used to assess the participants coping strategy profile.
Sleep quality
The Pittsburgh Sleep Quality Index is used to assess sleep quality.
Symptoms of Central Sensitization
To assess symptoms associated with central sensitization, the Central Sensitization Inventory is used.

Full Information

First Posted
May 6, 2023
Last Updated
October 17, 2023
Sponsor
Moens Maarten
Collaborators
Vrije Universiteit Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT05861609
Brief Title
Pain Medication Tapering for Patients With Persistent Spinal Pain Syndrome Type 2, Treated With Spinal Cord Stimulation.
Acronym
PIANISSIMO
Official Title
Pain Medication Tapering for Patients With Persistent Spinal Pain Syndrome Type 2, Treated With Spinal Cord Stimulation.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 29, 2023 (Actual)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Moens Maarten
Collaborators
Vrije Universiteit Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
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. One way to help patients to alleviate their pain, is with Spinal Cord Stimulation (SCS). SCS is able to provide pain relief and a decrease in disability but also to decrease the amount of pain medication and more specifically opioid intake. Nevertheless, the number of patients that can eventually totally omit the use of opioids is rather limited. In this trial, we will investigate the effect of a pain medication 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 pain medication 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 there is a difference in disability (primary outcome) 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. Two different pain medication tapering programs (standardized versus personalized tapering) will be evaluated in this project. Pain medication tapering will be provided to 130 patients during a hospital stay, compared to 65 patients who do not undergo pain medication tapering before SCS implantation. Besides disability as primary outcome measure, several secondary outcome measurements will be collected namely pain intensity, health-related quality of life, participation, domains affected by substance use, anxiety and depression, medication use, psychological constructs, sleep, central sensitization and health expenditure. Outcome measurements will be collected at baseline, and after 1 month, 3, 6 and 12 months of SCS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Spinal Pain Syndrome Type 2, Spinal Cord Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Both the outcome assessors as well as the investigator (statistician) will be blinded.
Allocation
Randomized
Enrollment
195 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No pain medication tapering (usual care)
Arm Type
Active Comparator
Arm Description
Usual care
Arm Title
Standardized pain medication tapering
Arm Type
Active Comparator
Arm Description
Standardized pain medication tapering
Arm Title
Personalized pain medication tapering
Arm Type
Active Comparator
Arm Description
Personalized pain medication tapering
Intervention Type
Procedure
Intervention Name(s)
Usual care
Intervention Description
Usual care with respect to Spinal Cord Stimulation implantation
Intervention Type
Procedure
Intervention Name(s)
Standardized pain medication tapering
Intervention Description
A standardized pain medication tapering program before Spinal Cord Stimulator implantation.
Intervention Type
Procedure
Intervention Name(s)
Personalized pain medication tapering
Intervention Description
A personalized pain medication tapering program before Spinal Cord Stimulator implantation.
Primary Outcome Measure Information:
Title
Disability
Description
Disability, evaluated with the Oswestry Disability Index
Time Frame
The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation
Secondary Outcome Measure Information:
Title
Pain intensity
Description
Pain intensity will be evaluated using a Visual Analogue Scale (100 mm).
Time Frame
The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.
Title
Health-related Quality of Life
Description
Health-related quality of life will be assessed using the Euro Quality of Life with five dimensions and five levels.
Time Frame
The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.
Title
Participation
Description
The Impact on Participation and Autonomy Questionnaire is used to evaluate participation.
Time Frame
The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.
Title
Drug related patient characteristics and problems
Description
The Measurements in the Addictions for Triage and Evaluation is used assess drug related patient characteristics and problems.
Time Frame
The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.
Title
Opioid craving
Description
Opioid craving will be assessed with the Visual Analogue Scale for Opioid Craving.
Time Frame
The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.
Title
Risk for aberrant medication-related behaviour
Description
The Current Opioid Misuse Measure is used to evaluate the risk for aberrant medication-related behaviour.
Time Frame
The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.
Title
Medication use
Description
The Medication Quantification Scale III is used to quantify pain medication use.
Time Frame
The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.
Title
Healthcare utilization
Description
Healthcare utilization is investigated by two means: expenditures associated with in-hospital care are inventoried using the hospital claims data whereas other costs are collected through self-reported (diaries and questionnaires).
Time Frame
The change in healthcare utilization starting from the baseline screening up to 12 months after the intervention.
Title
Anxiety and depression
Description
The Hospital Anxiety and Depression Scale is used to assess feelings of anxiety and depression.
Time Frame
The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.
Title
General Self-Efficacy
Description
Perceived self-efficacy is evaluated using the General Self-Efficacy Scale.
Time Frame
The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.
Title
Pain Catastrophizing
Description
With the Pain Catastrophizing Scale, catastrophizing thoughts or feelings accompanying the previously experienced pain are evaluated.
Time Frame
The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.
Title
Coping
Description
The Multidimensional Pain Inventory is used to assess the participants coping strategy profile.
Time Frame
The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.
Title
Sleep quality
Description
The Pittsburgh Sleep Quality Index is used to assess sleep quality.
Time Frame
The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.
Title
Symptoms of Central Sensitization
Description
To assess symptoms associated with central sensitization, the Central Sensitization Inventory is used.
Time Frame
The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 18 years and older Speaking and reading Dutch or French Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maarten Moens, Prof, Dr.
Phone
+3224775514
Email
stimulusresearchgroup@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Goudman, Prof, Dr.
Phone
+3224775514
Email
stimulusresearchgroup@gmail.com
Facility Information:
Facility Name
Universitair Ziekenhuis Brussel
City
Jette
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maarten Moens, Prof, Dr.
Phone
+3224775514
Email
stimulusresearchgroup@gmail.com
Facility Name
Heilig Hart Ziekenhuis Lier
City
Lier
ZIP/Postal Code
2500
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sofie Denkens, Dr.
Facility Name
AZ Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bart Billet, Dr.

12. IPD Sharing Statement

Learn more about this trial

Pain Medication Tapering for Patients With Persistent Spinal Pain Syndrome Type 2, Treated With Spinal Cord Stimulation.

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