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

Spinal Cord Stimulation Clinical Trial

— PIANISSIMO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05861609
• Other study ID #: PIANISSIMO
• Status: Recruiting
• Phase: N/A
• Start date: September 29, 2023
• Est. completion date: September 2026

Study information

• Verified date: October 2023
• Source: Universitair Ziekenhuis Brussel
• Contact: Maarten Moens, Prof, Dr.
• Phone: +3224775514
• Email: stimulusresearchgroup[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 195
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Somatoform Disorders
• Spinal Cord Stimulation
• Syndrome

Intervention

Procedure:
• Usual care
Usual care with respect to Spinal Cord Stimulation implantation
• Standardized pain medication tapering
A standardized pain medication tapering program before Spinal Cord Stimulator implantation.
• Personalized pain medication tapering
A personalized pain medication tapering program before Spinal Cord Stimulator implantation.

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Jette
Belgium	Heilig Hart Ziekenhuis Lier	Lier
Belgium	AZ Delta	Roeselare

Sponsors (2)

Lead Sponsor	Collaborator
Moens Maarten	Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.