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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.



- candidate number15284
- NTR NumberNTR4141
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-aug-2013
- Secondary IDsABR NUMBER NL 41980.015.12
- Public TitleACNES 3.0
Single-blind gerandomiseerde trial voor het Anterior Cutaneous Nerve Entrapment Syndrome.
Resultaten van een injectieregime met of zonder corticosteroïden.
- Scientific TitleACNES 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.
- ACRONYMACNES-CORTICO
- hypothesisACNES 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.
- Healt Condition(s) or Problem(s) studiedAnterior (of Abdominal) Cutaneous Nerve Entrapment Syndrome (ACNES), Nerve entrapment, Abdominal wall pain
- Inclusion criteriaInclusion 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 criteriaExclusion 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2013
- planned closingdate1-sep-2015
- Target number of participants136
- InterventionsGroep 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.
- Primary outcomeDifference 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 outcomePain levels 3 months after diagnosis and the necessity of other treatment for ACNES during this period
- TimepointsTime 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
- Trial web sitewww.buikpijn.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. R.M.H. Roumen
- CONTACT for SCIENTIFIC QUERIESDr. R.M.H. Roumen
- Sponsor/Initiator Máxima Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Self Funding
- PublicationsN/A
- Brief summarySummary 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.
- Main changes (audit trail)
- RECORD18-aug-2013 - 22-sep-2013


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