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Given the substantial socioeconomic impact of Spinal Cord Stimulation (SCS) implantations and given that currently no direct high-quality evidence with a relevant outcome measurement is available to guide the treatment choice between subthreshold SCS versus best medical treatment in patients with Persistent Spinal Pain Syndrome Type 2 (PSPS-T2), we here propose a scientifically well-constructed randomized controlled trial to answer this question.
The primary scientific objective is to examine whether subthreshold SCS, compared to best medical treatment, provided to patients with PSPS-T2 results in a higher percentage of clinical holistic responders at 6 months. The secondary objective of the study is to examine if subthreshold SCS compared with BMT is having more efficacy in improving patients' individual competencies for self-management, increasing the likelihood to return to work, work status and healthcare expenditure, improving pain relief, obtaining pain medication reduction, decreasing anxiety and depression, increasing quality of life and decreasing disability.
After filling in the questionnaires at the 6 months follow-up visit, patients could change treatment groups (in both directions). This decision will be a shared decisions between patient and treating physician in case the randomized intervention did not provided enough pain relief.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Best Medical Treatment | Active Comparator |
| |
| Subthreshold Spinal Cord Stimulation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Medical Treatment | Other | For each patient who is randomized to BMT, an optimal individual treatment plan will be developed by the treating physician. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical holistic responder status | The clinical holistic responder status as a composite measure represents the global effect of a treatment, based on a combination of questionnaires. | The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall pain intensity with Visual Analogue Scale (VAS) | Overall pain, defined as a combination of back and leg pain, but not pain from other body parts, measured with the VAS (100mm) | The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months. |
| Pain medication use |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jessa Ziekenhuis | Hasselt | Belgium | ||||
| Universitair Ziekenhuis Brussel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36803412 | Derived | Goudman L, Putman K, Van Doorslaer L, Billot M, Roulaud M, Rigoard P; TRADITION consortium; Moens M. Proportion of clinical holistic responders in patients with persistent spinal pain syndrome type II treated by subthreshold spinal cord stimulation compared to best medical treatment: a study protocol for a multicentric randomised controlled trial (TRADITION). Trials. 2023 Feb 20;24(1):120. doi: 10.1186/s13063-023-07140-3. |
| Label | URL |
|---|---|
| Study protocol | View source |
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| ID | Term |
|---|---|
| D055111 | Failed Back Surgery Syndrome |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
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| Subthreshold Spinal Cord Stimulation | Other | SCS will be programmed at subthreshold stimulation. |
|
Open question regarding the dosage, frequency and type of pain medication |
| The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months. |
| Functional disability | The functional disabilities will be assessed with the Oswestry Disability Index (ODI) | The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months. |
| Health related quality of life | Health related quality of life, evaluated with the EuroQol with five dimensions and 5 levels | The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months. |
| Patient global impression of change | Patients will be asked to quantify the impression of change after treatment using the Patient Global Impression of Change scale (PGIC). | Evaluated at 1 month, 6 months and 12 months. |
| Work status | Work status is evaluated with a self-designed questionnaire | The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months. |
| Patients' individual competencies for self-management | Patient activation measure-13 (PAM) is a 13-item instrument which assesses self-reported behaviour, knowledge, and confidence for self-management of one's health. | The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months. |
| Healthcare utilisation. | Healthcare expenditure will be investigated by self-reporting methods. | The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months. |
| Anxiety and Depression. | The hospital Anxiety and Depression Scale (HADS) will measure symptoms of anxiety and depression | The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months. |
| Jette |
| 1090 |
| Belgium |
| Emmaüs, AZ Sint-Maarten | Mechelen | Belgium |
| AZ Delta | Roeselare | Belgium |
| AZ Turnhout | Turnhout | Belgium |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |