Photonic Needle and Sleeve Study
Condition: Puncture; Instrument; Pain
Study type: Observational

Summary: 
      Rationale: evaluate the potential of the photonic needle (photonic needle technology) to
      discriminate tissues that are relevant to recognize during intraforaminal (transforaminal)
      epidural injection on lumbar level.

      Objective: The primary objective of this study is to investigate the potential of the
      photonic needle to discriminate between correct and incorrect placement of the needle tip in
      the target area of the procedure (M4 - tissue), as confirmed by contrast-enhanced
      fluoroscopy. The secondary objectives are to investigate the differences in the optical
      signals obtained with the photonic needle at a set of different pre-defined positions (M1, M2
      and M3) encountered along the needle trajectory during above-mentioned procedures, and to
      detect potential intravascular positioning of the needle-tip at the target point (M4 -
      blood), Study design: this is a single blind observational study. Study population: Patients
      who have radicular pain on lumbar level, for example caused by disc herniation, and/or
      lateral recessus stenosis and/or radiculopathy eci.

      Main study parameters/endpoints: The main study parameters are: 1) successfully acquired
      diffuse reflectance spectra obtained at measurement point M4: midforaminal, halfway the
      foramen (the target treatment location) as encountered during image-guided intraforaminal
      injections on lumbar level, 2) confirmation of target area with fluoroscopy and injection of
      contrast fluid (gold standard), 3) "Certainty score" on a 3-point scale (1 = uncertain, 2 =
      certain, 3 = very certain) will be provided by the physician. The type of tissue present at
      the needle tip will be based on the information available from imaging .

      The secondary study parameters are: 1) successfully acquired diffuse reflectance spectra
      obtained at measurement points M1-M3: M1 in muscle, M2 extra-foraminal, M3 foraminal at a
      distance 1/3 of the diameter of the foramen from the entrance of the foramen, as encountered
      during image-guided intraforaminal injections on lumbar level, 2) successfully acquired
      diffuse reflectance spectra obtained at measurement point M4, in case of a vascular puncture
      (M4-blood), 3) confirmation images by ultrasound imaging at location M1 as described above,
      4) confirmation images by fluoroscopy at locations M2 and M3, 5) digital subtraction
      angiography images after contrast injection at location M4, confirming vascular penetration
      (gold standard for vessel puncture), 6) "Certainty score" on a 3-point scale (1 = uncertain,
      2 = certain, 3 = very certain) provided by the physician for assignment of the type of tissue
      present at the needle tip, based on the information available from imaging at M1 and at M4.
    


Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who have radicular pain on lumbar level, caused by disc herniation, and/or lateral
        recessus stenosis and/or radiculopathy eci.
      
Keywords: Puncture; Instrument; Optics and Photonics; Pain