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Chronic PainSTIM-RENASEDNCT05770700

Effectiveness and Safety of Implantable Neurostimulation Systems for Chronic Pain: A Spanish Multicenter Study (STIM-RENASED)

An observational study of Chronic Pain, run by Sociedad Espanola del Dolor at 16 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Chronic pain is a prevalent condition that negatively affects patients' quality of life. Implantable neurostimulation therapies have been proposed as a treatment option for chronic 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
Chronic Pain
How many people
504 participants
Where
16 sitesSpain
Study dates
1 Apr 2023to 1 Apr 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 chronic refractory pain who are candidates for treatment with a implantable neurostimulation 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

16 sites in 1 country.

Antonio Ojeda, MD contact

0034911729144

renased@sedolor.es

16 sites in 1 country

Spain16 sites, 16 recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036

    Antonio Ojeda, MD, ojeda@clinic.cat

    Antonio Ojeda, MD

    Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

    Miren Revuelta, MD, PhD

    Miren Revuelta

    Not yet recruiting

  • Hospital Universitario Vall d'Hebron

    Barcelona

    Anna Server, MD

    Not yet recruiting

  • Hospital Universitario Puerta del Mar

    Cadiz, 11009

    Jose Manuel Trinidad Martín-Arroyo, MD

    Jose Manuel Trinidad Martín-Arroyo, MD

    Not yet recruiting

  • Complejo Hospitalario Universitario de Cartagena

    Cartagena, Murcia, 30203

    María Luz Padilla del Rey, MD

    María Luz Padilla del Rey, MD

    Recruiting

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

    Angel Alonso, MD

    Angel Alonso, MD

    Not yet 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

    Agustin Mendiola, MD, PhD

    Agustin Mendiola, MD, PhD

    Recruiting

  • Hospital FREMAP Majadahonda

    Majadahonda, Madrid, 28221

    Rogelio Rosado, MD

    Recruiting

  • Hospital Regional Univeristario de Málaga

    Málaga, 29010

    Mariano Fernández Baena, MD

    Mariano Fernández Baena, MD

    Recruiting

  • Complexo Hospitalario Univeritario de Ourense

    Ourense, 32005

    Luz Cánovas Martínez, MD

    Luz Cánovas Martínez, MD

    Recruiting

  • Hospital Universitari Son Espases

    Palma de Mallorca, 07120

    Hermann Ribera Leclerc, MD

    Hermann Ribera Leclerc, MD

    Recruiting

  • Hospital Universitario de Navarra

    Pamplona, Navarre, 31008

    Laura Gómez Glia, MD

    Recruiting

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

    Isaac Peña, MD

    Recruiting

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026

    Maria Ángeles Canós Verdecho, MD

    Maria Ángeles Canós Verdecho, MD

    Not yet recruiting

  • Complejo Hospitalario Universitario de Vigo

    Vigo, 36204

    Alfonso Carrregal, MD

    Not yet recruiting

Other trials in Spain

About this study

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

Chronic pain is a prevalent condition that negatively affects patients' quality of life. Implantable neurostimulation therapies have been proposed as a treatment option for chronic 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 implantable stimulation systems for chronic pain treatment in Spain.

Read the detailed description

All Spanish hospitals that implant neurostimulation systems for pain treatment 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 six and twelve months after the procedure.

Conditions
Chronic Pain
Keywords
Spinal cord stimulation, Dorsal root ganglion stimulation, Peripheral nerve stimulation
Medical subject headings
Chronic Pain

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 % pain relief in the area of their predominant pain at one year.

    Percentage of patients who experience a reduction of at least 50% in the intensity of their predominant pain compared to the initial value, assessed twelve months after the implantation of the neurostimulation 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 % pain relief in the area of their predominant pain at six months.

    Percentage of patients who experience a reduction of at least 50% in the intensity of their predominant pain compared to the initial value, assessed six months after the implantation of the neurostimulation 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: Six months

  2. Percentage of patients with at least 50 % pain relief in the area of their non-predominant pain at one year.

    Percentage of patients who experience a reduction of at least 50% in the intensity of their non-predominant pain compared to the initial value, assessed six and twelve months after the implantation of the neurostimulation 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: Six and 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 six 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: Six and twelve months

  4. Patient Global Impression of Improvement

    Assessment of clinical global impression of improvement using the PGI-I scale at six and twelve months after implantation of the neurostimulation 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: Six and twelve months

  5. Patient Satisfaction

    Percentage of implanted subjects satisfied with the treatment at six and twelve months after the implantation of the neurostimulation 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: Six 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 six and twelve months after implantation of the neurostimulation system.

    Measured: Six 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 posted15 Mar 2023
  2. Study start1 Apr 2023
  3. Primary completion1 Apr 2025 (estimated)
  4. Study completion1 Apr 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
NCT05770700
Sponsor's protocol ID
PI 238/22
Acronym
STIM-RENASED
Status last verified
May 2024
First submitted
5 Mar 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 Chronic Pain, run by Sociedad Espanola del Dolor at 16 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 16 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 % 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 NCT05770700.

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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