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

NCT03702010 | Completed Results

• 2 other identifiers: EST-MED-2018-01E.C.P.S. 18/1398
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

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

Keywords

Spinal cord stimulation; Back surgery; Chronic pain

Outcome Measures

Primary Outcomes (1)

• Comparing Visual Analogue Scale (VAS)

  Visual analogue scale (VAS) at the end of each test phase (either with conventional spinal cord stimulation or with EVOLVE). VAS consists of a 10 centimeter (cm) line, whose ends are defined as the extreme limits of pain (left end corresponds with the absence of pain and the right end with the maximum amount of pain). The patient is asked to point out in the line the place that better correspond to his/her pain, ranging from 0 to 10.

  Baseline, After first stimulation (5days), after washout and second stimulation (12 days), After 30-day follow-up (42 days)

Secondary Outcomes (3)

• Change (%) in VAS Scale at the End of Treatment.

  After first stimulation (Five days after baseline), After second stimulation (12 days after baseline), at the end of follow-up (42 days after baseline)

• Evaluation Disability

  Baseline, After first stimulation (+5 days), After washout and second stimulation (+12 days), at the end of follow-up (+42days)

• Number of Participants With Adverse Events in Each Arm

  42 days from baseline

Study Arms (2)

CME branch

ACTIVE COMPARATOR

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

Device: spinal cord stimulation conventional

EME branch

EXPERIMENTAL

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

Device: spinal cord stimulation experimental

Interventions

spinal cord stimulation conventional 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.

Also known as: CME

CME branch

spinal cord stimulation experimental 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.

Also known as: EME

EME branch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León: lead
• Instituto de Investigación Biomédica de Salamanca: collaborator

Study Sites (2)

Hospital San Pedro de Logroño

Logroño, La Rioja, 26006, Spain

Location

Complejo Asistencial Universitario de Salamanca

Salamanca, 37007, Spain

Location

MeSH Terms

Conditions

post laminectomy syndrome; Spinal Cord Injuries; Failed Back Surgery Syndrome; Chronic Pain

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Dr. Francisco José Sánchez Montero
• Organization: Hospital Universitario de Salamanca

fjsmontero@saludcastillayleon.es

923291100

Study Officials

• Francisco J Sánchez-Montero, MD

  IBSAL-Instituto de Investigación Biomédica de Salamanca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-blind, multicenter, crossover

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: October 10, 2018
• Study Start: November 20, 2018
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: September 1, 2021
• Results First Posted: September 1, 2021

Record last verified: 2021-08

Locations

ES (2)