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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

195 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-29

Study Completion Date

2026-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Persistent Spinal Pain Syndrome Type 2 Spinal Cord Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Both the outcome assessors as well as the investigator (statistician) will be blinded.

Study Groups

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No pain medication tapering (usual care)

Usual care

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type PROCEDURE

Usual care with respect to Spinal Cord Stimulation implantation

Standardized pain medication tapering

Group Type ACTIVE_COMPARATOR

Standardized pain medication tapering

Intervention Type PROCEDURE

A standardized pain medication tapering program before Spinal Cord Stimulator implantation.

Personalized pain medication tapering

Group Type ACTIVE_COMPARATOR

Personalized pain medication tapering

Intervention Type PROCEDURE

A personalized pain medication tapering program before Spinal Cord Stimulator implantation.

Interventions

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Usual care

Usual care with respect to Spinal Cord Stimulation implantation

Intervention Type PROCEDURE

Standardized pain medication tapering

A standardized pain medication tapering program before Spinal Cord Stimulator implantation.

Intervention Type PROCEDURE

Personalized pain medication tapering

A personalized pain medication tapering program before Spinal Cord Stimulator implantation.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No