Refractory Pain
Conditions
Keywords
Intrathecal Drug Delivery, Implantable Infusion Pump, Refractory Pain
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Sociedad Espanola del Dolor
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic refractory pain patients candidates for treatment with an implantable neurostimulation system. * Accept to participate in the study and sign informed consent.
Exclusion criteria
* Patients in whom it would be difficult to complete follow-up. * Insufficient understanding of the Spanish language. * Pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with at least 50 percent pain relief in the area of their predominant pain at one year | Twelve 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 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with at least 50 percent pain relief in the area of their non-predominant pain at one year | Twelve months | 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) |
| Compared change from baseline on health-related quality of life scores (EQ Index) | Three and twelve months | 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. |
| Percentage of patients with at least 50 percent pain relief in the area of their predominant pain at three months | 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) |
| Patient Satisfaction | Three and twelve months | 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 |
| Number of Adverse Events as a Measure of Safety | Three and twelve months | Number and percentage of patients with adverse effects related to therapy at three and twelve months after implantation of the intrathecal drug delivery system. |
| Patient Global Impression of Improvement (PGI-I) | Three and twelve months | 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. |
Countries
Spain
Contacts
Primary ContactAntonio Ojeda, MD
Outcome results
None listed