To investigate nociceptive processing and possible underlying pathological pain processing mechanisms in ACNES patients.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
buikwand aandoening
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pressure pain and electrical pain thresholds as investigated by QST.
Secondary outcome
Secondary study parameters are Visual Analog Scale (VAS) scores and results of
Pain Anxiety Symptom Scale (PASS) and Pain Catastrophizing Scale (PCS)
questionnaires.
Background summary
Chronic abdominal pain is a frequently occurring condition. Although hardly
ever considered, the abdominal wall is the primary cause in 10-30% of cases.
Most often it is caused by entrapment of an intercostal nerve in the anterior
rectus sheath, the Anterior Cutaneous Nerve Entrapment Syndrome (ACNES).
Treatment consists of local anaesthetic injections combined with
methyl-prednisolon. When ineffective, a neurectomy at the site of penetration
out of the ventral rectus sheet should be considered. This neurectomy however
is effective in 73% of cases, leaving some 25% of patients in pain. Whether
these refractory ACNES patients suffer from underlying pathologic pain
disorders is subject to investigation, by using quantitative sensory testing
(QST).
Study objective
To investigate nociceptive processing and possible underlying pathological pain
processing mechanisms in ACNES patients.
Study design
An observational case-control study.
Study burden and risks
The patients participating will obtain no direct personal benefit. The results
from the study will provide new insight into pain mechanisms and future
treatment options for ACNES patients. There risks for the participants are
negligible.
Geert Groteplein-Zuid 10
Nijmegen 6525 GA
NL
Geert Groteplein-Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
1. Patient has been diagnosed with abdominal complaints, matching ACNES:
i) Patient had a constant site of tenderness that is superficially located with a small (<2cm2) area of maximal tenderness.
ii) The most intense pain could be localized with the tip of one finger.
iii) Tenderness increased by abdominal muscle tensing (Carnett*s test).
2. has been treated (successfully and unsuccessfully) for ACNES.
3. Patient is at least 18 years old on the day the informed consent form will be signed.
4. Patient is willing and able to comply with the trial protocol.
5. Patient is able to speak, read and understand the local language of the investigational site, is familiar with the procedures of the study, and agrees to participate in the study program by giving oral and written informed consent prior to screening evaluations.
Exclusion criteria
1. Abdominal complaints were due to a condition other than ACNES (e.g. pain related to scar tissue).
2. Patient has (a history of) another (chronic) pain syndrome that interferes with the interpretation of QST results.
3. Patient has (a history of) a medical disorder that interferes with the study measurements or may pose a risk for the patient.
4. Patient does not feel a pinprick test to the lower extremities, due to affected sensory input (e.g. neuropathy as a result of diabetes mellitus).
5. Female patient is pregnant during the course of the study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL43583.091.13 |