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

Summary andBackground:

Entrapment of one or more of the branches of the cutaneous intercostal nerves Th8 – Th12, while they passage through the sheath of the musculus rectus abdominis may lead to an abdominal wall pain syndrome

This clinical entity is known as the Anterior Cutaneus Nerve Entrapment Syndrome (ACNES).

Our department has gained a lot of experience in diagnosing and treating patients with this: SolviMáx, Center of Excellence for Abdominal Wall and Groin Pain.

One of the therapies is local injections with anesthetics sometimes combined with corticosteroids like 40 mg methylprednisolonacetate. From our own retrospective data it seems advantageous to inject the combination. However, no randomized data exist on this subject and literature on other pain syndromes is controversial with reference to the use of corticosteroids locally.
Therefore we conduct this randomized trial.

Objective of the study:

The main question is: results addition of 40mg of corticosteroids to 10 cc lidocaine 2% for local trigger point injection in a significant pain reduction compared to 10 cc lidocaine 2% alone. Pain reduction is defined as more than 50% decrease on a VAS scale and/or 2 points reduction on a 5 points VRS (McGill) pain questionnaire.
Endpoint of the study will be reached after 12 weeks.

ACNES is the anterior cutaneous nerve entrapment syndrome, characterized by (chronic) abdominal wall pain caused by entrapment of the end branches of these intercostal nerves at the level of the rectus abdominis fascia.

One of the therapies is local injections with anesthetics sometimes combined with corticosteroids like 40 mg methylprednisolonacetate. From our own retrospective data it seems advantageous to inject the combination. However, no randomized data exist on this subject and literature on other pain syndromes is controversial with reference to the use of corticosteroids locally.

The main question is: results addition of 40mg of corticosteroids to 10 cc lidocaine 2% for local trigger point injection in a significant pain reduction compared to 10 cc lidocaine 2% alone. Pain reduction is defined as more than 50% decrease on a VAS scale and/or 2 points reduction on a 5 points VRS (McGill) pain questionnaire.

Time path
Week
1 2-3 4-5 6-7 12
x-----x----------x----------x---------------------------------x
a b c d e

a = moment of diagnosis and diagnostic injection
b = 1ste therapeutic trial injection
c = 2de therapeutic trial injection
d = primary end point evaluation
e = secundary end point evaluation and deblinding

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 only 10 cc lidocaine 2% weeks after diagnosis and repeated after 2-3 weeks.