臨床研究等提出・公開システム

Exploratory Arial of Systemic Steroid Administration for Refractory Anterior Cutaneous Nerve Entrapment Syndrome (ACNES)

Systemic Steroid Administration for Refractory ACNES

Otsuka Yuki

Okayama University Hospital

2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama

otsuka@s.okayama-u.ac.jp

Otsuka Yuki

Okayama University Hospital

2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama

+81-86-235-7342

otsuka@s.okayama-u.ac.jp

Not Recruiting

Dec. 25, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Persons who meet all of the following criteria will be included in this study
(1) Patients who are 18 years of age or older at the time of obtaining consent.
(2) Patients who have received a thorough explanation of their participation in this study, and who have given written consent of their own free will based on sufficient understanding.
(iii) Patients diagnosed with ACNES based on the criteria specified in the research protocol.
4) Patients who have been judged by several physicians familiar with the treatment of ACNES to be difficult to treat with standard treatments such as internal medicine therapy, nerve blocks, surgery, and pulsed radiofrequency therapy.

Patients who meet any of the following criteria will not be included in the study
(1) Patients with contraindications to corticosteroid administration
(2) Patients who are already using or have used systemic corticosteroids within 1 year due to other diseases
(3) Patients for whom follow-up after administration is difficult.
(4) Patients who have difficulty in assessing quality of life and pain due to their cognitive dysfunction, etc.
(5) Patients who are judged not to be candidates for steroid administration based on the results of screening tests.
(6) Other patients deemed inappropriate as research subjects by the principal investigator and subinvestigators.

Both

Anterior Cutaneous Nerve Entrapment Syndrome (ACNES)

once daily by intravenous infusion. This is administered for 3 consecutive days.

Any adverse events related to the administration of Sol Medrol and how they were treated

1) Severity of symptoms: pain scale (patient reported VAS and physician reported VAS), quality of life (EuroQOL: EQ-5D-5L)
2) Area of pain (vertebral level, size)
3) Prescribed dose of analgesics
4) Existence of unscheduled medical visits
5) Vital signs

+81-86-235-6503

Dec. 17, 2024

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