The main question is: results addition of 40mg of corticosteroids to 10 cc lidocaine 2% for local trigger point injection in a significant pain reduction compared to 10 cc lidocaine 2% alone. Pain reduction is defined as more than 50% decrease on a…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
buikwandpijnsyndroom
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference of number of patients with a more than 50% pain reduction on VAS
and/or a 2 point reduction on the 5-point VRS 2-3 weeks after the second
injection.
Secondary outcome
Pain levels 3 months after diagnosis and the necessity of other treatment for
ACNES during this period
Background summary
ACNES is the anterior cutaneous nerve entrapment syndrome, characterized by
(chronic) abdominal wall pain caused by entrapment of the end branches of these
intercostal nerves at the level of the rectus abdominis fascia.
One of the therapies is local injections with anesthetics sometimes combined
with corticosteroids like 40 mg methylprednisolonacetate. From our own
retrospective data it seems advantageous to inject the combination. However, no
randomized data exist on this subject and literature on other pain syndromes is
controversial with reference to the use of corticosteroids locally.
Therefore we conduct this randomized trial
Study objective
The main question is: results addition of 40mg of corticosteroids to 10 cc
lidocaine 2% for local trigger point injection in a significant pain reduction
compared to 10 cc lidocaine 2% alone. Pain reduction is defined as more than
50% decrease on a VAS scale and/or 2 points reduction on a 5 points VRS
(McGill) pain questionnaire.
Study design
Single blind randomized controlled two center study (Maxima MC Veldhoven and
Maas Hospital Boxmeer)
Intervention
Group A: trigger point injection with10 cc lidocaine 2% combined with 40mg of
corticosteroids 2-3 weeks after diagnosis and repeated once more 2-3 weeks
later.
Group B (control): trigger point injection with 10 cc lidocaine 2% only 2-3
weeks after diagnosis and repeated once more 2-3 weeks later.
Study burden and risks
Since trigger point injection is normal standard treatment, there is no extra
burden for these patients.
de run 4600
veldhoven 5500MB
NL
de run 4600
veldhoven 5500MB
NL
Listed location countries
Age
Inclusion criteria
-abdominal wall pain (ACNES)
-unilateral
-trigger point in musculus rectus
-worse with Carnett's test
-more than 50% pain reduction by local infiltration
-informed consent
-age over 18
Exclusion criteria
-recent abdominal pathology
-previous treatment for ACNES
-allergic to lidocaine or methylprednisolonacetaat
-no adequate follow up possible
-blood analysis abnormalities not compatible with ACNES
Design
Recruitment
Medical products/devices used
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 |
---|---|
EudraCT | EUCTR2013-002426-24-NL |
Other | Nederlands trial register NTR2016 |
CCMO | NL41980.015.13 |