1. Pulsed radiofrequency or anterior neurectomy for anterior cutaneous nerve entrapment syndrome (ACNES) (the PULSE trial): study protocol of a randomized controlled trial.
- Author
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Maatman RC, Steegers MAH, Boelens OBA, Lim TC, van den Berg HJ, van den Heuvel SAS, Scheltinga MRM, and Roumen RMH
- Subjects
- Abdominal Pain diagnosis, Abdominal Pain physiopathology, Analgesics therapeutic use, Chronic Pain diagnosis, Chronic Pain physiopathology, Clinical Protocols, Denervation adverse effects, Humans, Intercostal Nerves physiopathology, Nerve Compression Syndromes diagnosis, Nerve Compression Syndromes physiopathology, Netherlands, Pain Measurement, Pain, Postoperative etiology, Patient Satisfaction, Proof of Concept Study, Prospective Studies, Quality of Life, Research Design, Surveys and Questionnaires, Time Factors, Treatment Outcome, Abdominal Pain surgery, Abdominal Wall innervation, Catheter Ablation adverse effects, Chronic Pain surgery, Denervation methods, Intercostal Nerves surgery, Nerve Compression Syndromes surgery, Skin innervation
- Abstract
Background: Some patients with chronic abdominal pain suffer from an anterior cutaneous nerve entrapment syndrome (ACNES). This somewhat illusive syndrome is thought to be caused by the entrapment of end branches of the intercostal nerves residing in the abdominal wall. If ACNES is suspected, a local injection of an anesthetic agent may offer relief. If pain is recurrent following multiple-injection therapy, an anterior neurectomy entailing removal of the entrapped nerve endings may be considered. After 1 year, a 70% success rate has been reported. Research on minimally invasive alternative treatments is scarce. Pulsed radiofrequency (PRF) treatment is a relatively new treatment for chronic pain syndromes. An electromagnetic field is applied around the nerve in the hope of leading to pain relief. This randomized controlled trial compares the effect of PRF treatment and neurectomy in patients with ACNES., Methods: Adult ACNES patients having short-lived success following injections are randomized to PRF or neurectomy. At the 8-week follow-up visit, unsuccessful PRF patients are allowed to cross over to a neurectomy. Primary outcome is pain relief after either therapy. Secondary outcomes include patient satisfaction, quality of life, use of analgesics and unanticipated adverse events. The study is terminated 6 months after receiving the final procedure., Discussion: Since academic literature on minimally invasive techniques is lacking, well-designed trials are needed to optimize results of treatment for ACNES. This is the first large, randomized controlled, proof-of-concept trial comparing two therapy techniques in ACNES patients. The first patient was included in October 2015. The expected trial deadline is December 2017. If effective, PRF may be incorporated into the ACNES treatment algorithm, thus minimizing the number of patients requiring surgery., Trial Registration: Nederlands Trial Register (Dutch Trial Register), NTR5131 ( http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5131 ). Registered on 15 April 2015.
- Published
- 2017
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