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Optical Tissue Stylet - observational study in humans

Optical Tissue Stylet - observational study in humans - OTS OS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON34816
Enrollment
35
Registered
2010-04-19
Start date
2010-06-11
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nerve pain

Interventions

None listed

Sponsors

Philips
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients that fall into one of the following classes: A. Neuralgia paraesthetica patients for whom the indication of a blockade of the nervus cutaneus femoris lateralis has been made. B. Patients experiencing pain in the groin area, for whom the indication of a blockade of the nervus ilioinguinalis, nervus iliohypogastricus, or nervus genitofemoralis, nervus femoralis, nervus ischiadicus, nervus peroneus, nervus tibialis anterior, nervus saphenus, nervus suralis, nervus pudendus and has been made. C. Patients experiencing pain in the arm and neck area, for whom the indication of a blockade of the nervus auricularis magnus and plexus brachialis (nn radialis, ulnaris, medianus) has been made. D. Patients experiencing discogenic lower back pain, which have been indicated for a blockade of the communicating ramus. E. Patients who have been indicated for a sympathetic blockade either because of a complex regional pain syndrome, or because of a peripheral vascular disease.

Exclusion criteria

Exclusion criteria: - patients that undergo photodynamic therapy - pregnancy

Design outcomes

Primary

MeasureTime frame
The primary objective of the trial is to explore differences in the optical signals obtained in tissues encountered along the needle trajectory during image-guided interventional pain procedures. Therefore, successful acquisition of optical spectra at well-defined points during the image-guided interventional pain procedures is the primary study parameter. The primary objective of the trial is to explore differences in the optical signals obtained in tissues encountered along the needle trajectory during image-guided interventional pain procedures. Therefore, the primary study parameters are: 1. Successfully acquired diffuse reflectance spectra obtained in subcutaneous fat, muscle, fascia, and the adipose tissue surrounding the target nerve. 2. Confirmation images by ultrasound, fluoroscopy, and the electrical stimulation threshold levels obtained at the locations where the diffuse reflectance spectra have been collected 3. the *certainty score* on a 3-point scale provided by the physician for assignment of the type of tissue present at the needle tip, based on the information available from imaging and/or electrical stimulation

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)