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Pulsed Radiofrequency in comparison to neurectomy in ACNES patiŽnts


- candidate number21955
- NTR NumberNTR5131
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-apr-2015
- Secondary IDsNL53171.015.15 CCMO
- Public TitlePulsed Radiofrequency in comparison to neurectomy in ACNES patiŽnts
- Scientific TitleA Randomised Controlled Trial to Evaluate the Efficacy of Pulsed Radiofrequency as a Treatment for Anterior Cutaneous Nerve Entrapment Syndrome in comparison to Anterior Neurectomy
- ACRONYMPULSE Trial
- hypothesisPrimary 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
- Healt Condition(s) or Problem(s) studiedAnterior (of Abdominal) Cutaneous Nerve Entrapment Syndrome (ACNES), Abdominal wall pain, Chronic abdominal pain
- Inclusion criteria1) 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 criteria1) 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2015
- planned closingdate1-sep-2016
- Target number of participants65
- InterventionsSubjects 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.
- Primary outcomePrimary 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 outcomeFollowing 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) .
- TimepointsBaseline
8 weeks FU
6 months FU
12 months FU
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Robbert Maatman
- CONTACT for SCIENTIFIC QUERIESDr. R.M.H. Roumen
- Sponsor/Initiator MŠxima Medical Center
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD15-apr-2015 - 17-okt-2015


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