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NCT Number: NCT03702010

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

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

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Key information

Conditions

Laminectomy Back Pain Central Nervous System Diseases Chronic Pain Failed Back Surgery Syndrome Nervous System Diseases Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Post-Laminectomy Syndrome Postoperative Complications Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Syndrome Trauma, Nervous System Wounds and Injuries post laminectomy syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital San Pedro de Logroño, Logroño, La Rioja, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: CME

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.

Other names: EME

Primary outcomes

  1. Comparing Visual Analogue Scale (VAS)

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

    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.

Secondary outcomes

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

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

    Change (%) in Visual Analogue Scale (VAS) at the end of treatment.

    • Δ = [(VAS Initial Visit - VAS Final Visit) / VAS initial visit] *100

    Please note that positive values indicate a decrease in the VAS scale, which would indicate pain relief, as it was calculated as the value at the earlier time point minus the value at the later time point.

  2. Evaluation Disability

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

    Oswestry Disability Index of the patients: it is a questionnaire consisting of 10 questions with 6 possible answers each. Every answer gives a punctuation from 0 (less disability) to 5 (more disability).

    This scale is expressed in percentage in which 0 percentage (%) would the least disability and 100 percentage (%) would represent the maximum disability.

  3. Number of Participants With Adverse Events in Each Arm

    Time frame: 42 days from baseline

    Considering as an adverse event those that result in death, or in severe harm to patient's health (lesion that threatens life, permanent harm on an organ or corporal function, or process that needs a medical or surgical intervention to avoid permanent harm)

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Instituto de Investigación Biomédica de Salamanca

Registry information

Official study title

Randomized, Single-blind, Multicenter, Crossover, Controlled Clinical Trial to Compare Difference on the Visual Analogue Scale With Two Modes of Spinal Cord Stimulation in Patients With Post-Laminectomy Syndrome in Testing Phase

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 10, 2018
Registry last updated
Sep 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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