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

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Stimulation; Persistent Spinal Pain Syndrome Type 2
• Intervention / Treatment: Procedure: Usual care; Procedure: Standardized pain medication tapering; Procedure: Personalized pain medication tapering

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.

• Study Type: Interventional
• Enrollment (Estimated): 195
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maarten Moens, Prof, Dr.; Phone Number: +3224775514; Email: stimulusresearchgroup@gmail.com
• Study Contact Backup: Name: Lisa Goudman, Prof, Dr.; Phone Number: +3224775514; Email: stimulusresearchgroup@gmail.com

Study Locations

• Belgium
  • Jette, Belgium, 1090
    • Recruiting
    • Universitair Ziekenhuis Brussel
    • Contact: Maarten Moens, Prof, Dr.; Phone Number: +3224775514; Email: stimulusresearchgroup@gmail.com
  • Lier, Belgium, 2500
    • Not yet recruiting
    • Heilig Hart Ziekenhuis Lier
    • Contact: Sofie Denkens, Dr.
  • Roeselare, Belgium, 8800
    • Recruiting
    • AZ Delta
    • Contact: Bart Billet, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: No pain medication tapering (usual care); Usual care	Procedure: Usual care; Usual care with respect to Spinal Cord Stimulation implantation
Active Comparator: Standardized pain medication tapering	Procedure: Standardized pain medication tapering; A standardized pain medication tapering program before Spinal Cord Stimulator implantation.
Active Comparator: Personalized pain medication tapering	Procedure: Personalized pain medication tapering; A personalized pain medication tapering program before Spinal Cord Stimulator implantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Pain intensity will be evaluated using a Visual Analogue Scale (100 mm).	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	Health-related quality of life will be assessed using the Euro Quality of Life with five dimensions and five levels.	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 Impact on Participation and Autonomy Questionnaire is used to evaluate 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 Measurements in the Addictions for Triage and Evaluation is used assess 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	Opioid craving will be assessed with the Visual Analogue Scale for 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.
Risk for aberrant medication-related behaviour	The Current Opioid Misuse Measure is used to evaluate the risk for aberrant medication-related behaviour.	The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.
Medication use	The Medication Quantification Scale III is used to quantify pain medication use.	The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.
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).	The change in healthcare utilization starting from the baseline screening up to 12 months after the intervention.
Anxiety and depression	The Hospital Anxiety and Depression Scale is used to assess feelings of anxiety and depression.	The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.
General Self-Efficacy	Perceived self-efficacy is evaluated using the General Self-Efficacy Scale.	The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.
Pain Catastrophizing	With the Pain Catastrophizing Scale, catastrophizing thoughts or feelings accompanying the previously experienced pain are evaluated.	The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.
Coping	The Multidimensional Pain Inventory is used to assess the participants coping strategy profile.	The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.
Sleep quality	The Pittsburgh Sleep Quality Index is used to assess sleep quality.	The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.
Symptoms of Central Sensitization	To assess symptoms associated with central sensitization, the Central Sensitization Inventory is used.	The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.

Collaborators and Investigators

• Sponsor: Moens Maarten
• Collaborators: Vrije Universiteit Brussel

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: May 6, 2023
• First Submitted That Met QC Criteria: May 6, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Syndrome; Somatoform Disorders; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Analgesics
• Other Study ID Numbers: PIANISSIMO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No