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ACNES 3.0 Single-blind gerandomiseerde trial voor het Anterior Cutaneous Nerve Entrapment Syndrome. Resultaten van een injectieregime met of zonder corticosteroïden.

ACNES 3.0 The Anterior Cutaneous Nerve Entrapment Syndrome (ACNES). Randomized single-blind controlled trial of conservative treatment by local injection therapy (with or without corticosteroids) for entrapment of the anterior intercostal cutaneous nerve through the rectus abdominis muscle.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24284
Enrollment
136
Registered
2013-08-18
Start date
2013-09-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Abdominal wall pain caused by entrapment of intercostal nerve branches at the level of the rectus abdominus muscle. = ACNES

Interventions

Groep A: trigger point injection with 10 cc lidocaine 2% plus 40 mg methylprednisolonacetate 2-3 weeks after diagnosis and repeated after 2-3 weeks. Groep B (controle): trigger point injection with o

Sponsors

none
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria: • abdominal wall pain consistent with signs of ACNES • Localisation unilateral • one single pain trigger point within the borders of musculus rectus abdominis • pain worse by Carnett sign • good (temporary) effect of local anesthetic (more than 50% pain reduction) after one single injection with local anesthetic into or around triggerpoint • Informed consent • age above 18 years

Exclusion criteria

Exclusion criteria: Exclusion criteria: • recent other intra-abdominal pathology • allergic to local anesthetic (lidocaïne) of corticosteroïds • Previous treatment for ACNES, like by corticosteroïds, Pulsed-Radio-Frequency, epidural injections, etc. • No adequate follow-up possible • abnormal laboratory results possibly compatible with other i.a. pathology • Patiënts with a (relative) contra-indication for the use of corticosteroïds: besides allergy, known with ulcus duodeni of ventriculi, with viral or fungal infections, tropical worm infections, recently vaccinated. • Pregnancy

Design outcomes

Primary

MeasureTime frame
Difference of number of patients with a more than 50% pain reduction on VAS and/or a 2 point reduction on the 5-point VRS 2-3 weeks after the second injection.

Secondary

MeasureTime frame
Pain levels 3 months after diagnosis and the necessity of other treatment for ACNES during this period

Contacts

Public ContactR.M.H. Roumen

Maxima Medical Center, Department of Surgery, P.O. Box 7777

R.Roumen@mmc.nl+31 (0)40 8888000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)