Spinal Cord Stimulation in Patients With Post-Laminectomy Syndrome in Testing Phase

NCT ID: NCT03702010

Last Updated: 2021-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-20
• Study Completion Date: 2020-07-01

Brief Summary

Traditionally, pain relief through spinal cord stimulation has been associated with the appearance of paresthesia in the affected area. Several parameters are set to maximize the overexposure zone, such as frequency,and pulse width. Although this technique has improved pain in many patients, paresthesia itself can be uncomfortable. Traditionally, the occurrence of paresthesias has been considered to be a predictor of success in pain elimination, while the non-occurrence of paresthesias would indicate failure. So far, few studies have reported pain relief below the threshold of onset of paresthesia. Some clinical trials for pathologies other than the one considered in this study have achieved relief below the threshold by reducing the amplitude of the stimulus. Recently, however, it has been observed in a pilot study that, by increasing the frequency of spinal cord stimulation to 1 kilohertz, it is possible to significantly improve pain relief compared to less frequent conventional stimulation based on the occurrence of paresthesias.

A recent review by the Cochrane Library concluded that conventional spinal cord stimulation for pain relief of Failed Back Surgery Syndrome (or FBSS) requires further clinical studies and better designs to demonstrate its superiority over other therapeutic options. Therefore, although spinal cord stimulation is accepted by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), new techniques are being introduced that offer better results in terms of pain relief. Among these techniques, there is the high frequency mode, which allows avoiding the annoying sensation of paresthesia that substitutes pain with the conventional technique. In order to provide greater rigour and scientific quality, the present study is proposed, in which the conventional spinal cord stimulation (CME) technique (control branch or CME) is compared with paresthesias and a standard frequency (60 hertz) with a high frequency (1000 hertz) EVOLVE system (Evolve workflow - standardized guidance to simplify the trial and implant experience and optimize patient outcomes) (experimental branch or EME) by means of a design with a high degree of scientific evidence, randomising the global sample of patients to each of the two branches of stimulation in the study (blind to the patient) and crossing the branches after a period of washing

Conditions

Laminectomy; Post-laminectomy Syndrome; Spinal Cord Syndrome; Failed Back Surgery Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

CME branch

In this study, the conventional spinal cord stimulation method (control Branch-CME branch)

Group Type: ACTIVE_COMPARATOR

spinal cord stimulation conventional

Intervention Type: DEVICE

If the patient has been assigned to the branch of the CME control group, after mapping the search for the pain zone, the neurostimulator is programmed to conventional stimulation.

EME branch

In this study, the experimental spinal cord stimulation method are used in the same patient with the EVOLVE programming guide (EME branch)

Group Type: EXPERIMENTAL

spinal cord stimulation experimental

Intervention Type: DEVICE

If the patient has been randomized to the branch of the EME experimental group, after a mapping of the search for the pain zone, a 90% subthreshold stimulation is programmed.

Interventions

spinal cord stimulation conventional

If the patient has been assigned to the branch of the CME control group, after mapping the search for the pain zone, the neurostimulator is programmed to conventional stimulation.

Intervention Type: DEVICE

spinal cord stimulation experimental

If the patient has been randomized to the branch of the EME experimental group, after a mapping of the search for the pain zone, a 90% subthreshold stimulation is programmed.

Intervention Type: DEVICE

Other Intervention Names

CME; EME

Eligibility Criteria

Inclusion Criteria

• Patients over 18 years of age.
• Patients with FBSS syndrome with leg pain or leg and back pain.
• Get a score on the visual analogue scale (VAS) ≥ 7.
• Have received medical pharmacological treatment for at least 6 months after back surgery.
• The patient has signed the informed consent form.

Exclusion Criteria

• Patients under 18 years of age.
• Patients who require a diathermic energy source (microwave, ultrasound or short wave).
• Patients with a pacemaker.
• Patients carrying a defibrillator.
• Patient with a cochlear implant.
• Patients with other active implanted devices.
• Patients who are scheduled to have any of the following procedures during the study period: an MRI, defibrillation or cardioversion, electrocautery, lithotripsy, radiofrequency or microwave ablation, and any other high-frequency ultrasound procedure,
• Women of childbearing age who do not use adequate contraception.
• Pregnant or breastfeeding.
• Participation in another trial.
• Patients who have expressed a desire not to participate in the study and have not formed informed consent.
• Patients with a failed spinal cord stimulation implant previously

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Investigación Biomédica de Salamanca

OTHER

Sponsor Role: collaborator

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francisco J Sánchez-Montero, MD

Role: STUDY_DIRECTOR

IBSAL-Instituto de Investigación Biomédica de Salamanca

Locations

Hospital San Pedro de Logroño

Logroño, La Rioja, Spain

Complejo Asistencial Universitario de Salamanca

Salamanca, , Spain

Countries

Spain

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

E.C.P.S. 18/1398

Identifier Type: OTHER

Identifier Source: secondary_id

EST-MED-2018-01

Identifier Type: -

Identifier Source: org_study_id