|- candidate number||6538|
|- NTR Number||NTR2016|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-sep-2009|
|- Secondary IDs||0818/NL23189.015.08 METC/CCMO |
|- Public Title||The Anterior Cutaneus Nerve Entrapment Syndrome (ACNES). A Randomized double blind controlled trial for the diagnosis and treatment of entrapment of the anterior cutaneus nerve through the rectus muscle. |
|- Scientific Title||The Anterior Cutaneus Nerve Entrapment Syndrome (ACNES). A Randomized double blind controlled trial for the diagnosis and treatment of entrapment of the anterior cutaneus nerve through the rectus muscle. |
|- ACRONYM||ACNES diagnosis and treatment trial|
|- hypothesis||1. Lidocaine is a powerful tool in diagnosis; |
2. Lidocaine with corticosteroids are beneficial in conservative treatment;
3. An anterior neurectomy is contributes to a substancial relief of pain in patients with failure of conservative treatment.
|- Healt Condition(s) or Problem(s) studied||Abdominal wall pain, Anterior cutaneus nerve entrapment syndrome (ACNES)|
|- Inclusion criteria||1. Unilateral abdominal triggerpoint in rectus muscle; |
2. More than 1 month continues pain;
3. Complaints worsen on fysiacal activity;
4. Positive Carnett's sign.
|- Exclusion criteria||1. Age below 18 years;|
2. Recent intra-abdominal pathology;
3. Proven lidocaine allergy;
6. No follow-up possible: mental retardation, dementia, impaired communicatio due to language.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2009|
|- planned closingdate||1-dec-2011|
|- Target number of participants||44|
|- Interventions||Fase 1, diagnosis: Patients will be randomized into two groups. One group will be infiltrated with 10 cc lidocaine at the triggerpoint, the control group will be infiltrated with 10cc of saline. Evaluation will follow at 15 minutes and at 1 week by short questionnaire and VAS.|
Fase 2, conservative treatment: Following Fase 1 all patients from both groups will receive an injection with 40 mg of corticosteroids in 10cc of lidocaine in case the primary injection was not succesfull or only temporarily succesfull. Evaluation will follow at 15 minutes and 2 weeks by short questionnaire and VAS.
Fase 3, treatment: Patients are selected that had a positive result on one or more of the injections but only a temporary effect was achieved. These patients will be randomized into two groups. In one group an anterior neurectomy at the level of the ventral fascia of the rectus abdominal muscle will be performed via a small, 3-5 cm, transverse incision at the triggerpoint. In the control group a sham operation will be performed. Both procedures will be performed in daycare under general anesthesia. Evaluation will be performed at 1 week and 6 weeks. Incase no effect is achieved in the sham group a neurectomy is suggested and performed at patient's wishes. This will be decided on at least 6 weeks of follow-up
|- Primary outcome||Fase 1: The difference in number of patients with a clinically relevant reduction of pain measured on VAS of at least 50 %, 15 minutes after infiltration of Lidocaine vs Saline.|
Fase 3: The difference in number of patients with a clinically relevant reduction of pain measured on VAS of at least 50 %, 6 weeks after neurectomy vs sham.
|- Secondary outcome||Fase 1: Difference in the number of patients with longterm painfree result after diagnostic injection (VAS<10); absolute and relative difference on VAS; Difference on Verbal Rating Scale.|
Fase 2: the number of patients with a painfree result after infiltration with lidocain and corticosteroids at follow-up of hree months.
Fase 3: Longterm evaluation: frequncy of patients developing a recurrent pain at the site of surgery after a painfree period of at least 6 weeks.
Difference on Verbal Rating Scale.
Improvement on FS-36.
|- Timepoints||Fase 1: 15 minutes, 1 week;|
Fase 2: 2 weeks;
Fase 3: 1 week, 6 weeks.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| O.B.A. Boelens|
|- CONTACT for SCIENTIFIC QUERIES|| O.B.A. Boelens|
|- Sponsor/Initiator ||Máxima Medical Center|
(Source(s) of Monetary or Material Support)
|Máxima Medical Center|
|- Brief summary||Entrapment of one or more nerve branches in the rectus abdominis muscle, known as the anterior cutaneus nerve entrapment syndrome(ACNES), can cause adominal pain and discomfort. It is often overseen as a cause of abdominal pain. Once diagnosed several therapeutic options are available. Our study group propagates neurectomy, dissection of the nerve branches perforating the anterior fascia of the rectus abdomins muscle. In our experience this leads to succesfull improving complaints in patients of at least 75% of the cases. Pain specialists and non-believers remain critical and doubt the surgical intervention to be usefull for various reasons. This study will provide evidence on diagnostic and therapeutic options.|
|- Main changes (audit trail)|
|- RECORD||30-sep-2009 - 29-okt-2009|