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Trial record 20 of 20 for:    Recruiting, Not yet recruiting, Available Studies | Pain | Neurostimulation

Study Comparing Conventional, Burst and High Frequency (HF) Spinal Cord Stimulation (SCS) in Refractory Failed Back Surgery Syndrome (FBSS) Patients After a 32-contact Surgical Lead Implantation (MULTIWAVE)

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ClinicalTrials.gov Identifier: NCT03014583
Recruitment Status : Recruiting
First Posted : January 9, 2017
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

Brief Summary:

Chronic Back and/or Leg Pain (CBLP) after spinal surgical procedures, a condition commonly labelled Failed Back Surgery Syndrome (FBSS), affects between 15% and 40% of patients after a spine surgery. Treatment of this chronic condition by further operation or medical management has a heavy financial impact on health care systems.

Many studies have demonstrated the efficacy and economic value of Spinal Cord Stimulation (SCS) for chronic neuropathic pain, and randomized controlled trials (RCTs) have shown SCS to be a clinically effective adjunct to medical management. SCS has the advantages of being reversible and less invasive than surgery and may cause fewer issues over time than long-term pharmacological treatments.

Despite variable levels of success in the literature, approximately 30-55% of the patients treated with traditional SCS for neuropathic pain disorders will not receive adequate long term pain relief. Therefore, technical SCS system refinements, as well as new techniques have emerged.

Two new stimulation waveforms based on traditional SCS technology have appeared to further optimize the outcome for specific painful conditions;

  • Burst stimulation mode: which generates constant-current stimuli with 5 spikes at 500 Hz per burst and pulse width and interspike intervals of 1 ms.
  • High-frequency stimulation (from 1 to 10 kHz) mode.

Several studies have demonstrated the potential interest of these 2 new waveforms to treat FBSS patients compared to traditional SCS.

The Precision Spectra™ system allows MultiWave Technology by offering a broad spectrum of waveform options (from Tonic Conventional Stimulation (TCS), BURST stimulation to High Frequency stimulation (HF)).

To date, literature data comparing these 3 stimulation patterns is lacking but it is suggested the pain relief in some of non-responsive patients can be "recaptured" by increasing the SCS frequency to 500 Hz by BURST stimulation or beyond by HF stimulation. It seems important to conduct RCT in crossover, thanks to the new Precision SCS Stimulator, to compare the effects of these 3 different SCS modalities in FBSS patients and to determine which concept is the most effective in terms of pain reduction and energy consumption.


Condition or disease Intervention/treatment Phase
Failed Back Surgery Syndrome Device: Precision Spectra™ system Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Randomized Study Comparing Conventional, Burst And High Frequency (HF) Spinal Cord Stimulation (SCS) in Refractory Failed Back Surgery Syndrome (FBSS) Patients After a 32-contact Surgical Lead Implantation
Actual Study Start Date : January 19, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020

Arm Intervention/treatment
Experimental: HF/TCS/BURST Device: Precision Spectra™ system
Neurostimulation procedures

Experimental: HF/BURST/TCS Device: Precision Spectra™ system
Neurostimulation procedures

Experimental: BURST/HF/TCS Device: Precision Spectra™ system
Neurostimulation procedures

Experimental: BURST/TCS/HF Device: Precision Spectra™ system
Neurostimulation procedures

Experimental: TCS/BURST/HF Device: Precision Spectra™ system
Neurostimulation procedures

Experimental: TCS/HF/BURST Device: Precision Spectra™ system
Neurostimulation procedures




Primary Outcome Measures :
  1. Change from baseline global Pain Visual Analogic Scale (VAS) to 1 month after each waveform stimulation [ Time Frame: 1 month after stimulation ]

Secondary Outcome Measures :
  1. Leg and back Pain Visual Analogic Scale (VAS) [ Time Frame: Through study completion, an average of 1 year ]
  2. Oswestry Disability Index (ODI) [ Time Frame: Through study completion, an average of 1 year ]
  3. EQ-5D [ Time Frame: Through study completion, an average of 1 year ]
  4. Paraesthesia perception VAS [ Time Frame: Through study completion, an average of 1 year ]
  5. Adverse Events/Serious Adverse Events [ Time Frame: Through study completion, an average of 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years or ≤ 80 years.
  • Subject has FBSS and does not require further surgery. For the purposes of this study, FBSS is defined as persistent or recurrent low back and leg pain of at least 6 months duration following at least one decompression and/or fusion procedure.
  • Subject has persistent low back and leg pain despite other treatment modalities (pharmacological, surgical, physical, or psychological therapies) that have been tried and did not prove satisfactory or are unsuitable or contraindicated for the subject.
  • Average global pain is ≥ 50 mm as assessed by the baseline VAS.
  • With significant back, with mean intensity on a back pain VAS ≥ 50 mm (mean daily VAS score calculated on 5 consecutive days).
  • Meeting the criteria for spinal cord stimulation test according to HAS guidelines (multidisciplinary consultation, psychological assessment, etc.).
  • Subject is a candidate for SCS.
  • Absence of active psychosis or history of serious psychotic illness requiring hospitalisation.
  • Understands and accepts the constraints of the study.
  • Free subject, not under temporary or permanent guardianship and not subject to subordination.
  • Patients covered by French national health insurance.
  • Patients who have given their written consent to the study after having received clear information.

Exclusion Criteria:

  • Age < 18 years or > 80 years
  • Subject is or has been treated with SCS, subcutaneous or peripheral nerve stimulation, an intrathecal drug delivery system, requires back surgery at the location related to his/her original back pain complaint or experimental therapies.
  • Cause of low back pain accessible to etiological "mechanical" surgical treatment (discogenic low back pain, vertebral instability, spinal deformity, etc.).
  • Subject had most recent back surgery less than 6 months ago.
  • Presenting a surgical, anaesthetic or psychiatric contraindication to implantation of a spinal cord stimulation system.
  • Based on the opinion of the principal or sub-investigator, the subject is unable to operate the SCS equipment.
  • Subject has a life expectancy of less than 24 months beyond study enrolment.
  • Absence of signature of the informed consent form.
  • Patients not covered by French national health insurance.
  • Subjects requiring closer protection, i.e. minors, pregnant women, nursing mothers, subjects deprived of their freedom by a court or administrative decision, subjects admitted to a health or social welfare establishment, major subjects under legal protection, and finally patients in an emergency setting.
  • Pregnant women, nursing mothers, women of childbearing potential not using effective contraception (hormonal/barrier: oral, parenteral, percutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014583


Contacts
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Contact: Philippe RIGOARD, MD,PhD +33 5 49 44 30 40 philippe.rigoard@chu-poitiers.fr

Locations
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France
Poitiers University Hospital Recruiting
Poitiers, France
Contact: Véronique FERRAND-RIGALLAUD       Veronique.FERRAND-RIGALLAUD@chu-poitiers.fr   
Principal Investigator: Philippe RIGOARD         
Sponsors and Collaborators
Poitiers University Hospital

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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT03014583     History of Changes
Other Study ID Numbers: 2016-A01145-46
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Syndrome
Failed Back Surgery Syndrome
Disease
Pathologic Processes
Postoperative Complications
Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms