ACNES, anterior cutaneous nerve entrapment syndrome, abdominal wall pain, chronic abdominal pain ACNES, buikwandpijn, chronische buikpijn Anterior Cutaneous Nerve Entrapment Syndrome (ACNES) is caused by entrapment of end branches of intercostal nerves that are residing in the abdominal wall. Patients suffer from severe abdominal pain that is often not recognized as most doctors are focused, when confronted with abdominal pain, on a visceral source of the pain. If ACNES is diagnosed, treatme
Conditions
Interventions
Subjects will be randomized to either arm of treatment, one arm being PRF and the other arm
neurectomy treatment. Subjects will be followed for 12 months after receiving the procedure.
At the 8 we
Sponsors
Maxima Medisch Centrum Veldhoven
Eligibility
Inclusion criteria
Inclusion criteria: 1) Subject is diagnosed with unilateral ACNES 2) Eligible for neurectomy 3) Subject > 18 years old 4) Subject is able to provide written informed consent 5) Subject is willing to participate in the follow-up schedule and protocol
Exclusion criteria
Exclusion criteria: 1) Patient has surgical scar-related pain syndromes 2) Patient has recent intra-abdominal pathology. 3) Patient has other chronic pain syndromes (such as fibromyalgia, dystrophy, chronic low back pain) 4) Patient has other neuropathic diseases 5) Patient has impaired communication 6) Patient has participated in another clinical investigation within 30 days 7) Patient has had a spinal surgical procedure at or between vertebral levels T7-L1 8) Patient has been diagnosed with cancer in the past 2 years, except for skin malignancies 9) Female patient of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the Trial 10) Significant anatomic deformity (either congenital or acquired) 11) Language barrier 12) Allergy to local anesthetics 13) Patient should be able to stop their anticoagulants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective is to evaluate the effect of PRF treatment in comparison with neurectomy in terms of pain relief at 8 weeks follow up. This outcome will be measured using Numeric Pain Rating Scale 0-10 (0 = no pain and 10 = excruciating). Primary outcome will be the percentage of decrease on the NPRS scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Following secondary outcomes will be assessed at baseline, 8 weeks, 6 and 12 months: - Evaluation characteristics of pain using The Douleur Neuropathique (DN4) questionnaire. - Health related Quality of life improvements using Short Form-12 (SF-12) questionnaire. - Pain disability improvements using Pain Disability Index (PDI). - Patient satisfaction using Patient Global Impression of Change (PGIC) questionnaire. - Overall improvement measured using multidimensional Brief Pain Inventory (BPI) questionnaire. - Analgesic usage (Medication Usage of patients) - State of anxiety improvements and intergroup comparison will be measured using the State- Trait Anxiety Inventory (STAI) . | — |
Contacts
Public ContactRobbert Maatman
Herdenkingsplein 8B11
Outcome results
None listed