Atypical Facial Pain Clinical Trial
— GLOA-MRTOfficial title:
MRI Observation After Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius
Verified date | October 2023 |
Source | Klinikum Klagenfurt am Wörthersee |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The blockade of the superior cervical ganglion (GCS) of the sympathetic trunk is a very special form of therapy. The transoral blocking technique, also known as GLOA (ganglionic local opioid analgesia), is very suitable for achieving GCS. A total of 5 μg of sufentanil in 2 ml of sodium chlorid are applied. Since no imaging evidence of the injected substances has been published for a GLOA in a living person, it is planned to carry out an MRI examination immediately after the ganglionic local opioid analgesia in order to show the spread and distribution pattern of the injected substance. It is also planed to show a correlation of the spread of the injected substance with the efficacy of the intervention. To determine the interrater reliability, the GLOA is carried out alternately by 2 different examiners and the existing MRI images of the GLOA are assessed by an radiologist and anatomist in a blinded manner. In a follow-up after 1 and 3 months, the questionnaires and pain scores are evaluated again.
Status | Completed |
Enrollment | 3 |
Est. completion date | October 1, 2023 |
Est. primary completion date | August 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Trigeminal neuralgia - Postherpetic neuralgia - Glossopharyngeal neuralgia - Atypical facial pain Exclusion Criteria: - psychosis - language barrier - Pregnant and breastfeeding women - Seizure disorders (epilepsy) - Increased risk of bleeding |
Country | Name | City | State |
---|---|---|---|
Austria | Klinikum Klagenfurt am Wörthersee | Klagenfurt |
Lead Sponsor | Collaborator |
---|---|
Klinikum Klagenfurt am Wörthersee | University of Klagenfurt |
Austria,
Feigl G, Rosmarin W, Likar R. [Block of the superior cervical ganglion of the Truncus sympathicus. Why it often is not possible!]. Schmerz. 2006 Aug;20(4):277-80, 282-4. doi: 10.1007/s00482-005-0435-6. German. — View Citation
Spacek A, Bohm D, Kress HG. Ganglionic local opioid analgesia for refractory trigeminal neuralgia. Lancet. 1997 May 24;349(9064):1521. doi: 10.1016/S0140-6736(05)62101-0. No abstract available. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Distribution of the injected fluid in the area of the superior cervical ganglion | MRI verified distribution of the injected fluid in the area of the superior cervical ganglion | immediately after the intervention | |
Secondary | Quality of life questionnaire | The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state (https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/) | Before first and after last GLOA. After 1 and 3 month (follow up) | |
Secondary | Pain assessed by NRS | Present pain intensity on a 0-10 Numerical Rating Scale (NRS) with 0 corresponding to "no pain" and 10 to "the worst pain imaginable | baseline, immediately after intervention, After 1 and 3 month (follow up) | |
Secondary | Patient satisfaction assessed by satisfaction questionaire | ZUF-8 is a measuring instrument for the global, one-dimensional recording of patient satisfaction. It is the German-language adaptation of the American CSQ-8 by Attkisson & Zwick (1982). General satisfaction ("general satisfaction") with aspects of the clinic or the treatment received is recorded using eight items. ZUF-8 is particularly suitable for an economical screening of patient satisfaction. | Before first and after last GLOA. After 1 and 3 month (follow up) | |
Secondary | Sleep quality assessed by sleep quality questionnaire | To record the sleep quality the questionnaire on sleep quality is carried out (PSQI) | Before first and after last GLOA. After 1 and 3 month (follow up) | |
Secondary | Efficacy prediction based on MRI verified fluid spread | Efficacy prediction based on the MRI verified fluid spread in millimeter in the area of the superior cervical ganglion | immediately after the intervention |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04158752 -
Anti-CGRP for Inflamation and Pain Modulation in Small Fiber Neuropathy/Fibromyalgia
|
Phase 4 | |
Terminated |
NCT02321566 -
Motor Cortex Stimulation for the Treatment of Chronic Facial, Upper Extremity, and Throat Pain.
|
Phase 1 |