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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.

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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26786
Enrollment
44
Registered
2009-09-30
Start date
2009-09-01
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 Anterior Cutaneus Nerve Entrapment

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. Evalu

Sponsors

Performer: drs. O.B.A. Boelens
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Age below 18 years; 2. Recent intra-abdominal pathology; 3. Proven lidocaine allergy; 4. Anticoagulants; 5. Coagulopathy; 6. No follow-up possible: mental retardation, dementia, impaired communicatio due to language.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Contacts

Public ContactO.B.A. Boelens

Surgical Department Maxima Medisch Centrum Veldhoven P.O.Box 7777

o.boelens@chir.umcn.nl+31 (0)88 88000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)