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.
Study Type
OBSERVATIONAL
Enrollment
504
Hospital Regional Univeristario de Málaga
Málaga, Andalusia, Spain
RECRUITINGHospital Universitari Son Espases
Palma de Mallorca, Balearic Island, Spain
NOT_YET_RECRUITINGHospital Universitario de Navarra
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)
Time frame: Twelve months
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)
Time frame: 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)
Time frame: 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.
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Pamplona, Navarre, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
RECRUITINGHospital Universitario de La Princesa
Madrid, Spain
NOT_YET_RECRUITINGHospital Universitario Puerta de Hierro Majadahonda
Madrid, Spain
NOT_YET_RECRUITINGComplejo Hospitalario Universitario de Cartagena
Murcia, Spain
RECRUITINGComplexo Hospitalario Univeritario de Ourense
Ourense, Spain
NOT_YET_RECRUITINGHospital Universitari i Politècnic La Fe
Valencia, Spain
RECRUITINGTime frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Three and twelve months