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Refractory pain is a prevalent condition that negatively affects patients' quality of life. Intrathecal implantable systems have been proposed as a treatment option for refractory pain. However, real-world data on the effectiveness and safety of these therapies in Spain are scarce. This study aims to obtain real-world data on the effectiveness and safety of intrathecal implantable systems for refractory pain treatment in Spain.
All Spanish hospitals that implant intrathecal systems for refractory pain will be invited to participate in the study. Patients will be recruited before the procedure, and before providing data to the registry, the study will be explained to them, and they will sign an informed consent form. Demographic data related to the pathology and procedure will be collected. Follow-up will be conducted at three and twelve months after the procedure.
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with at least 50 percent pain relief in the area of their predominant pain at one year | Percentage of patients who experience a reduction of at least 50 percent in the intensity of their predominant pain compared to the initial value, assessed twelve months after the implantation of the intrathecal drug delivery system. Pain intensity will be measured using an 11-point Numeric Pain Rating Scale (NPRS), with a range from 0 (no pain) to 10 (maximum pain possible) | Twelve months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with at least 50 percent pain relief in the area of their predominant pain at three months | Percentage of patients who experience a reduction of at least 50 percent in the intensity of their predominant pain compared to the initial value, assessed three months after the implantation of the implantable intrathecal system. Pain intensity will be measured using an 11-point Numeric Pain Rating Scale (NPRS), with a range from 0 (no pain) to 10 (maximum pain possible) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with refractory pain who are candidates for treatment with an implantable intrathecal infusion system.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Ojeda, MD | Contact | 0034911729144 | renased@sedolor.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Regional Univeristario de Málaga | Recruiting | Málaga | Andalusia | 29010 | Spain |
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| ID | Term |
|---|---|
| D010148 | Pain, Intractable |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Three months |
| Percentage of patients with at least 50 percent pain relief in the area of their non-predominant pain at one year | Percentage of patients who experience a reduction of at least 50 percent in the intensity of their non-predominant pain compared to the initial value, assessed twelve months after the implantation of the intrathecal drug delivery system. Pain intensity will be measured using an 11-point Numeric Pain Rating Scale (NPRS), with a range from 0 (no pain) to 10 (maximum pain possible) | Twelve months |
| Compared change from baseline on health-related quality of life scores (EQ Index) | The impact of the treatment on the patient's health-related quality of life will be evaluated using the EQ-5D-5L questionnaire at three and twelve months after implantation. The EQ-5D-5L assesses quality of life across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain is scored on a scale of 1 (no problems) to 5 (extreme problems), generating a 5-digit code that corresponds to the patient's health status. | Three and twelve months |
| Patient Global Impression of Improvement (PGI-I) | Assessment of clinical global impression of improvement using the PGI-I scale at three and twelve months after implantation of the intrathecal drug delivery system. The PGI-I score ranges from 1 (Very much better) through to 7 (Very much worse). The lower the score, the better the improvement. | Three and twelve months |
| Patient Satisfaction | Percentage of implanted subjects satisfied with the treatment at three and twelve months after the implantation of the intrathecal drug delivery system. Defined as indicating: "since the start of the therapy has the pain improved? yes/no", "Are you satisfied with the treatment?" yes/no or "would you agree to the treatment again?" yes/no | Three and twelve months |
| Number of Adverse Events as a Measure of Safety | Number and percentage of patients with adverse effects related to therapy at three and twelve months after implantation of the intrathecal drug delivery system. | Three and twelve months |
| Hospital Universitari Son Espases | Not yet recruiting | Palma de Mallorca | Balearic Island | 07120 | Spain |
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| Hospital Universitario de Navarra | Not yet recruiting | Pamplona | Navarre | 31008 | Spain |
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| Hospital Clinic de Barcelona | Recruiting | Barcelona | 08036 | Spain |
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| Hospital Universitario de La Princesa | Not yet recruiting | Madrid | 28028 | Spain |
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| Hospital Universitario Puerta de Hierro Majadahonda | Not yet recruiting | Madrid | 28222 | Spain |
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| Complejo Hospitalario Universitario de Cartagena | Recruiting | Murcia | 30203 | Spain |
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| Complexo Hospitalario Univeritario de Ourense | Not yet recruiting | Ourense | 32005 | Spain |
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| Hospital Universitari i Politècnic La Fe | Recruiting | Valencia | 46026 | Spain |
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