Health TrialsbyHealthPanel

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

ConditionsPersistent Spinal Pain Syndrome Type 2Spinal Cord Stimulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMoens Maarten

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Usual care

    Procedure/Surgery

    Usual care with respect to Spinal Cord Stimulation implantation

  • Standardized pain medication tapering

    Procedure/Surgery

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

  • Personalized pain medication tapering

    Procedure/Surgery

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

Treatment groups

195 Participants
are divided into 3 treatment groups
Group A: No pain medication tapering (usual care)Active comparator 1 intervention
Group B: Standardized pain medication taperingActive comparator 1 intervention
Group C: Personalized pain medication taperingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Disability

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 outcomes

1

Pain intensity

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.
2

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.

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.
3

Participation

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.
4

Drug related patient characteristics and problems

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Moens Maarten

Lead sponsor

Universitair Ziekenhuis Brussel

Sponsor institution

Vrije Universiteit Brussel

Collaborator

Source ClinicalTrials.gov
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