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ID
Source
Brief title
Health condition
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, treatment includes sub-fascial injections of an local anesthetic (whether or not combined with an long acting corticosteroid). If pain is recurrent, the entrapped nerve is surgically removed. A neurectomy procedure is effective in approximately 70% of patients after one year.
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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) .
Study objective
Primary objective is to evaluate the effect of PRF treatment in comparison with neurectomy in
terms of pain relief. This outcome will be measured using Numeric Pain Rating Scale 0-10 (0
= no pain and 10 = excruciating).
Hypothesis:
PRF as treatment for ACNES is equally effective (or better) than neurectomy
Study design
Baseline
8 weeks FU
6 months FU
12 months FU
Intervention
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 weeks follow up visit, the PRF group will be given the option to cross over to the
alternate arm of the trial. All patients who do not cross over will be prospectively followed to
12 months evaluation time point.
Robbert Maatman
Maastricht 6211PW
The Netherlands
0643690767
rc.maatman@student.maastrichtuniversity.nl
Robbert Maatman
Maastricht 6211PW
The Netherlands
0643690767
rc.maatman@student.maastrichtuniversity.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4985 |
| NTR-old | NTR5131 |
| CCMO | NL53171.015.15 |
| OMON | NL-OMON42800 |