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Refractory PainNCT05970081

Effectiveness and Safety of Implantable Intrathecal Systems for Refractory Pain in Spain (INTRATHECAL-RENASED)

An observational study of Refractory Pain, run by Sociedad Espanola del Dolor at 9 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Refractory Pain
How many people
504 participants
Where
9 sitesSpain
Study dates
1 Aug 2023to 1 Aug 2025
How long will I take part?
1 Year
Phase
Observational
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

Study population: Patients with refractory pain who are candidates for treatment with an implantable intrathecal infusion system.

Who may be able to join

  • Chronic refractory pain patients candidates for treatment with an implantable neurostimulation system.
  • Accept to participate in the study and sign informed consent.

Who cannot join

  • Patients in whom it would be difficult to complete follow-up.
  • Insufficient understanding of the Spanish language.
  • Pregnancy.

Trial locations and contacts

9 sites in 1 country.

Antonio Ojeda, MD contact

0034911729144

renased@sedolor.es

9 sites in 1 country

Spain9 sites, 9 recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036

    Antonio Ojeda, MD

    Recruiting

  • Hospital Universitario de La Princesa

    Madrid, 28028

    Concepción Pérez, MD, PhD

    Concepción Pérez, Md, PhD

    Not yet recruiting

  • Hospital Universitario Puerta de Hierro Majadahonda

    Madrid, 28222

    Agustín Mendiola, MD, PhD

    Agustin Mendiola, MD, PhD

    Not yet recruiting

  • Hospital Regional Univeristario de Málaga

    Málaga, Andalusia, 29010

    Mariano Fernández Baena, MD

    Mariano Fernández Baena, MD

    Recruiting

  • Complejo Hospitalario Universitario de Cartagena

    Murcia, 30203

    Maria Luz Padilla del Rey, MD

    Maria Luz Padilla del Rey, MD

    Recruiting

  • Complexo Hospitalario Univeritario de Ourense

    Ourense, 32005

    Luz Cánovas Martínez, MD

    Luz Cánovas Martínez, MD

    Not yet recruiting

  • Hospital Universitari Son Espases

    Palma de Mallorca, Balearic Island, 07120

    Hermann Ribera Leclerc, MD

    Hermann Ribera Leclerc

    Not yet recruiting

  • Hospital Universitario de Navarra

    Pamplona, Navarre, 31008

    Laura Gómez Glia, MD

    Laura Gómez Glia

    Not yet recruiting

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026

    Maria Ángeles Canós Verdecho, MD

    Maria Ángeles Canós Verdecho, MD

    Recruiting

Other trials in Spain

About this study

Official title: Effectiveness and Safety of Implantable Intrathecal Systems for the Treatment of Chronic Refractory Pain in Spain: Prospective Multicenter Study From the Spanish Pain Society Registry (INTRATHECAL-RENASED)

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.

Read the 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.

Conditions
Refractory Pain
Keywords
Intrathecal Drug Delivery, Implantable Infusion Pump, Refractory Pain
Medical subject headings
Pain, Intractable

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Twelve months

Secondary outcomes (6)

  1. 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)

    Measured: Three months

  2. 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)

    Measured: Twelve months

  3. 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.

    Measured: Three and twelve months

  4. 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.

    Measured: Three and twelve months

  5. 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

    Measured: Three and twelve months

  6. 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.

    Measured: Three and twelve months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2023
  2. Study start1 Aug 2023
  3. Primary completion1 Aug 2025 (estimated)
  4. Study completion1 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
504 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT05970081
Sponsor's protocol ID
5215
Status last verified
Sep 2023
First submitted
24 Jul 2023
Last updated
22 May 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Refractory Pain, run by Sociedad Espanola del Dolor at 9 sites in Spain.

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 2 inclusion and 3 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 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Spain. 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 Antonio Ojeda, MD (0034911729144, renased@sedolor.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients with at least 50 percent pain relief in the area of their predominant pain at one year (time frame: Twelve months). 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 NCT05970081.

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 22 May 2024.

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