Persistent Spinal Pain Syndrome Type 2PIANISSIMONCT05861609
Pain Medication Tapering for Patients With Persistent Spinal Pain Syndrome Type 2, Treated With Spinal Cord Stimulation.
A study testing Standardized pain medication tapering and Personalized pain medication tapering in people with Persistent Spinal Pain Syndrome Type 2 and Spinal Cord Stimulation, run by Moens Maarten at 3 sites in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Spinal Pain Syndrome Type 2, Spinal Cord Stimulation
- What is being tested?
- Standardized pain medication tapering and Personalized pain medication tapering
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 3 sitesBelgium
- Study dates
- 29 Sep 2023to Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites, 3 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Jette, 1090
Maarten Moens, Prof, Dr., +3224775514, stimulusresearchgroup@gmail.com
- Not yet recruiting
Heilig Hart Ziekenhuis Lier
Lier, 2500
Sofie Denkens, Dr.
- Recruiting
AZ Delta
Roeselare, 8800
Bart Billet, Dr.
About this study
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.
Read the 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.
- Being tested
- Usual care, Standardized pain medication tapering, Personalized pain medication tapering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careProcedure or surgery
Usual care with respect to Spinal Cord Stimulation implantation
Standardized pain medication taperingProcedure or surgery
A standardized pain medication tapering program before Spinal Cord Stimulator implantation.
Personalized pain medication taperingProcedure or surgery
A personalized pain medication tapering program before Spinal Cord Stimulator implantation.
| Study group | Role | What they receive |
|---|---|---|
| No pain medication tapering (usual care) | Active comparator | Usual care Receives: Procedure: Usual care |
| Standardized pain medication tapering | Active comparator | Standardized pain medication tapering Receives: Procedure: Standardized pain medication tapering |
| Personalized pain medication tapering | Active comparator | Personalized pain medication tapering Receives: Procedure: Personalized pain medication tapering |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability
Disability, evaluated with the Oswestry Disability Index
Measured: 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 (14)
Pain intensity
Pain intensity will be evaluated using a Visual Analogue Scale (100 mm).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start29 Sep 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Persistent Spinal Pain Syndrome Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moens Maarten
- Sponsor type
- University, hospital or other
- Collaborators
- Vrije Universiteit Brussel
- Responsible party
- Sponsor-investigator, Moens Maarten, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861609
- Sponsor's protocol ID
- PIANISSIMO
- Acronym
- PIANISSIMO
- Status last verified
- Oct 2023
- First submitted
- 6 May 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moens M, Crunelle CL, Putman K, Wuyts E, Bultinck F, Van Puyenbroeck H; PIANISSIMO consortium; Goudman L. Pain medication tapering for patients with Persistent Spinal Pain Syndrome Type II, treated with Spinal Cord Stimulation: A RCT-study protocol of the PIANISSIMO study. PLoS One. 2024 Aug 12;19(8):e0302842. doi: 10.1371/journal.pone.0302842. eCollection 2024.
PubMed 39133680
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Medication Tapering for Patients With Persistent Spinal Pain Syndrome Type 2, Treated With Spinal Cord Stimulation.
- ClinicalTrials.gov ID
- NCT05861609
- Acronym / sponsor ID
- PIANISSIMO / PIANISSIMO
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- Moens MaartenUniversity, hospital or other
- Collaborators
- Vrije Universiteit Brussel
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No pain medication tapering (usual care) | Active comparator | Procedure: Usual careUsual care |
| Standardized pain medication tapering | Active comparator | Procedure: Standardized pain medication taperingStandardized pain medication tapering |
| Personalized pain medication tapering | Active comparator | Procedure: Personalized pain medication taperingPersonalized pain medication tapering |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual careUsual care with respect to Spinal Cord Stimulation implantation | Procedure or surgery | No pain medication tapering (usual care) |
| Standardized pain medication taperingA standardized pain medication tapering program before Spinal Cord Stimulator implantation. | Procedure or surgery | Standardized pain medication tapering |
| Personalized pain medication taperingA personalized pain medication tapering program before Spinal Cord Stimulator implantation. | Procedure or surgery | Personalized pain medication tapering |
Primary outcome
Disability
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
Disability, evaluated with the Oswestry Disability Index
14 secondary outcomes
Pain intensity
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.
Health-related Quality of Life
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.
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.
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.
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.
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.
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.
Healthcare utilization
Time frame: The change in healthcare utilization starting from the baseline screening up to 12 months after the intervention.
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.
General Self-Efficacy
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.
Pain Catastrophizing
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.
Coping
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.
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.
Symptoms of Central Sensitization
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Derived from this study: PubMed 39133680Moens M, Crunelle CL, Putman K, Wuyts E, Bultinck F, Van Puyenbroeck H; PIANISSIMO consortium; Goudman L. Pain medication tapering for patients with Persistent Spinal Pain Syndrome Type II, treated with Spinal Cord Stimulation: A RCT-study protocol of the PIANISSIMO study. PLoS One. 2024 Aug 12;19(8):e0302842. doi: 10.1371/journal.pone.0302842. eCollection 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized pain medication tapering and Personalized pain medication tapering in people with Persistent Spinal Pain Syndrome Type 2 and Spinal Cord Stimulation, run by Moens Maarten at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maarten Moens, Prof, Dr. (+3224775514, stimulusresearchgroup@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05861609, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.