Primary objective is to study the number of patients gaining at least 50% pain reduction within 8 weeks following PRF as compared to following a neurectomy. Pain intensity will be measured using numeric pain rating score (NPRS, 0-10) and Verbal…
ID
Source
Brief title
Condition
- Peripheral neuropathies
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary objective is to study the number of patients gaining at least 50% pain
reduction within 8 weeks following PRF as compared to following a neurectomy.
Pain intensity will be measured using numeric pain rating score (NPRS, 0-10)
and Verbal Rating Scales (VRS) methodology. Double measurement enables wider
comparison of outcome to available literature. An Intention to Treat (ITT)
principle is used.
Secondary outcome
A Number Needed to Treat (NNT) analysis at the 12-month time point for >=30% and
>=50% pain relief using ITT principle.
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)
• There is a high concordance between pain and anxiety. State of anxiety
improvements and intergroup comparison will be measured using the State-Trait
Anxiety Inventory (STAI) .
Background summary
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 anestheticum (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. However, research on less invasive alternative treatment forms
of ACNES is scarce.
Pulsed Radiofrequency (PRF) treatment is a relatively new form of treatment for
chronic pain syndromes(1). Initial clinical studies were promising i.e.
significantly reduced levels of chronic pain in a variety of pain syndromes.
Therefore, it may be worthwhile to study PRF as an alternative approach for the
treatment of ACNES.
This trial is aimed to evaluate the efficacy of PRF treatment and a neurectomy
in subjects suffering from ACNES. If comparable, PRF may standard be included
in the treatment plan as a less invasive alternative to the surgical procedure.
Study objective
Primary objective is to study the number of patients gaining at least 50% pain
reduction within 8 weeks following PRF as compared to following a neurectomy.
Pain intensity will be measured using numeric pain rating score (NPRS, 0-10)
and Verbal Rating Scales (VRS) methodology. Double measurement enables wider
comparison of outcome to available literature. An Intention to Treat (ITT)
principle is used.
Secondary Objectives
A Number Needed to Treat (NNT) analysis at the 12-month time point for >=30% and
>=50% pain relief using ITT principle.
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)
• There is a high concordance between pain and anxiety. State of anxiety
improvements and intergroup comparison will be measured using the State-Trait
Anxiety Inventory (STAI) .
Study design
The trial will be a multicentre, randomized (1:1 - PRF : neurectomy) controlled
trial (RCT) with a one way optional crossover at 8 weeks to assess the efficacy
of PRF as a form of treatment for ACNES in comparison with neurectomy.
Subjects will be randomized to either arm of treatment, one arm being PRF and
the other arm neurectomy treatment. Subjects will be followed for 6 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.
Either way, all are prospectively followed to 6 months evaluation time point,
whether they have crossed over or not.
Intervention
Group 1 will recieve the Pulsed radiofrequency treatment, after which follow-up
moments take place at 8 weeks, 6 and 12 months.
Group 2 will recieve the neurectomy surgery, after which follow-up moments take
place at 8 weeks, 6 and 12 months.
In-Depth information about the Pulsed Radio Frequency can be found in the
research protocol on page 19.
Study burden and risks
There are no additional risks to the subjects participating in this trial. When
applied by ultrasound guidance, PRF treatment is a safe and standard treatment
modality that is already being used at the Máxima Medical Centre for several
other pain syndromes. It is already used in the Maasziekenhuis Pantein for
treating patients with refractory ACNES following surgery.
Ds. Th. Fliednerstraat 1
Eindhoven 5631 BM
NL
Ds. Th. Fliednerstraat 1
Eindhoven 5631 BM
NL
Listed location countries
Age
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) Subject has surgical scar-related pain syndromes
2) Subject has recent intra-abdominal pathology.
3) Patient has other chronic pain syndromes (such as fibromyalgia, dystrophy, chronic low back pain)
4) Subject has other neuropathic diseases
5) Subject has impaired communication
6) Subject has participated in another clinical investigation within 30 days
7) Subject has had a spinal surgical procedure at or between vertebral levels T7-L1
8) Subject has been diagnosed with cancer in the past 2 years, except for skin malignancies
9) Female subject 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 is not able to stop coagulantia
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL53171.015.15 |
| OMON | NL-OMON20554 |