Trial document




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  DRKS00018929

Trial Description

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Title

Investigation of efficacy of different spinal cord stimulation paradigms for the treatment of chronic neuropathic pain

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Trial Acronym

PARS

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URL of the Trial

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Brief Summary in Lay Language

Spinal cord stimulation is a treatment option for patients suffering from severe, chronic pain. This type of pain may arise after repeated spine surgery, certain viral infections or in the context of inflammatory diseases of the joints. With spinal cord stimulation, the different pain causes are not treated, but the pain is superimposed by a kind of interference current and thereby reduced. The interference current can be used in different stimulation variants, meaning that it can be applied in different frequencies or in different intensities.

This trial recruits patients implanted with a so-called wireless spinal cord stimulator. There is no standard specifying which variant of stimulation current (intensity and frequency) is most suitable for the treatment of neuropathic pain. Usually, the treating physician determines the type of stimulation current and decides for one of the three most common stimulation variants, called "burst", "1KHz" and "10KHz”, taking into account the current medical knowledge and the physician’s personal experience. Currently it is not known which of these different stimulation variants is most effective. The purpose of this study is to compare the efficacy of the three most common modes of stimulation.

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Brief Summary in Scientific Language

Spinal cord stimulation (SCS) is an effective method to treat neuropathic pain. An electric current is applied over an electrode placed on the outer layer of the spinal cord. This current interferes with neuronal activity and can lead to pain relieve in patients suffering from neuropathic pain. A pacemaker is typically implanted subcutaneously and can be operated by the patient via remote control.
SCS devices have been implanted for five decades, however, it is largely unknown which of the many available types of electric currents (so-called SCS paradigms) is most effective. This is mainly due to the fact that, in practice, it is extremely challenging to compare all the different stimulation modalities in an individual patient. Specifically, electrodes leading out though the skin would have to be consecutively connected to different, incompatible SCS devices and be tested over a time period of several weeks. Wound infection risks of such a study would be unacceptably high and blinding of the trial difficult.
This study proposal seizes the capacity of a new type of wireless SCS stimulation device (Stimwave®), which has been approved for SCS and is routinely implanted at the department of neurosurgery at Heidelberg University Hospital. This device enables a blinded and systematic intra-patient comparison of different SCS modalities over extended time periods and without increasing wound infection rates.
The PARS trial is a double-blinded, randomized and controlled study. It aims to compare the clinical effectiveness of the three most relevant SCS paradigms in individual patients. The trial will recruit 60 patients suffering from intractable neuropathic pain, who have been considered for SCS therapy and, prior to the study, were already implanted with a wireless SCS device (Stimwave®). Over a time period of 34 days, patients will be treated consecutively with three different SCS paradigms („burst“, „1kHz“ and „10kHz“) as well as placebo stimulation. The primary endpoint of the study is the level of pain measured on the visual analogue scale.
Secondary, exploratory endpoints will be neuropathic pain quality, anxiety, disability and quality of life.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00018929
  •   2020/01/14
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  •   yes
  •   Approved
  •   S-738/2019, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   M54.4 -  Lumbago with sciatica
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Interventions/Observational Groups

  •   SCS device with SCS paradigm "burst"
  •   SCS device with SCS paradigm 1 kHz
  •   SCS device with SCS paradigm 10 kHz
  •   SCS device with SCS paradigm placebo-stimulation
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, assessor, data analyst
  •   Other
  •   Treatment
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

Self-assessment of pain perception measured on the Visual Analogue Scale (VAS)

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Secondary Outcome

Self-assessment of pain quality (as determined by Pain Detect Questionnaire), quality of life (as determined by Quality of Life EQ-5D-5L Questionnaire), anxiety perception (as determined by the Hospital Anxiety and Depression Scale) and physical restriction (as determined by the Oswestry Disability Index)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Planned
  •   2020/02/16
  •   60
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

• Patients suffering from intractable neuropathic pain, who have been considered for SCS therapy according to current German treatment guidelines and, within 48 of study enrolment, were already implanted with a wireless SCS device (Stimwave®)
• Placement of the distal tip of the electrode between upper level of Th8 and lower level of Th12
• leg pain > back pain
• age of patient ≥ 18 Jahre
• Written consent
• Duration of pain history >6 months and < 5 years

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Exclusion Criteria

• Covering of the pain area with the SCS stimulation device (Stimwave®) <90%
• Ischemic pain (i.e. Peripheral artery disease, angioma)
• Chronic primary pain
• Implantation of several SCS electrodes
• Coagulopathy
• Any planned changes in existing pain medication for the duration of trial participation (period of 34 days)
• Pregnancy
• Neurodegenerative disease
• Lack of understanding of the trial and the individual consequences of participating in the trial
• Expected lack of compliance (i.e. patient is not able to complete the trial questionnaires)

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Addresses

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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    • Neurochirurgische UniversitätsklinikUniversitätsklinikum Heidelberg
    • Ms.  PD Dr. med.  Rezvan  Ahmadi 
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
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    • Neurochirurgische UniversitätsklinikUniversitätsklinikum Heidelberg
    • Ms.  PD Dr. med.  Rezvan  Ahmadi 
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Stimwave LLC
    • 1310 Park Central Blvd S
    • 33064-2217  FL, Pompano Beach
    • United States
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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