Systemic Steroid Administration for Refractory ACNES

JRCT ID: jRCTs061240098

Registered date:25/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Anterior Cutaneous Nerve Entrapment Syndrome (ACNES)
• Date of first enrollment: 25/12/2024
• Target sample size: 5
• Study type: Interventional
• Intervention(s): once daily by intravenous infusion. This is administered for 3 consecutive days.

Outcome(s)

• Primary Outcome: Any adverse events related to the administration of Sol Medrol and how they were treated

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Otsuka Yuki