Pulsed radiofrequency or surgery for anterior cutaneous nerve entrapment syndrome: Long-term results of a randomized controlled trial.

PURPOSE: Patients with anterior cutaneous nerve entrapment syndrome (ACNES) often require a step-up treatment strategy including abdominal wall injections, pulsed radiofrequency (PRF) or a neurectomy. Long-term success rates of PRF and surgery are largely unknown. The aim of the current study was to report on the long-term efficacy of PRF and neurectomy in ACNES patients who earlier participated in the randomized controlled PULSE trial. METHODS: Patients who completed the PULSE trial were contacted about pain status and additional treatments in the following years. Treatment success was based on numerical rating scale (NRS) following IMMPACT recommendations and Patient Global Impression of Change (PGIC) scores. RESULTS: A total of 44 of the original 60 patients were eligible for analysis (73.3%). Median follow-up was 71.5 months. One patient (4.3%) was still free of pain after a single PRF session, and five additional patients (21.7%) were free of pain by repetitive PRF treatments. By contrast, 13 patients (61.9%) in the neurectomy group were still free of pain without additional treatments. All pain recurrences and therefore primary re-interventions occurred in the first 2 years after the initial treatment. CONCLUSION: Approximately one in five ACNES patients undergoing PRF treatment reports long-term success obviating the need of surgical intervention. Surgery for ACNES is long-term effective in approximately two of three operated patients. Recurrent ACNES beyond 2 years after either intervention is rare.

A Randomized Controlled Trial to Evaluate the Effect of Pulsed Radiofrequency as a Treatment for Anterior Cutaneous Nerve Entrapment Syndrome in Comparison to Anterior Neurectomy.

BACKGROUND: Chronic abdominal pain can be due to entrapped intercostal nerves (anterior cutaneous nerve entrapment syndrome [ACNES]). If abdominal wall infiltration using an anesthetic agent is unsuccessful, a neurectomy may be considered. Pulsed radiofrequency (PRF) applies an electric field around the tip of the cannula near the affected nerve to induce pain relief. Only limited retrospective evidence suggests that PRF is effective in ACNES. METHODS: A multicenter, randomized, nonblinded, controlled proof-of-concept trial was performed in 66 patients. All patients were scheduled for a neurectomy procedure. Thirty-three patients were randomized to first receive a 6-minute cycle of PRF treatment, while the other 33 were allocated to an immediate neurectomy procedure. Pain was recorded using a numeric rating scale (NRS, 0 [no pain] to 10 [worst pain possible]). Successful treatment was defined as >50% pain reduction. Patients in the PRF group were allowed to cross over to a neurectomy after 8 weeks. RESULTS: The neurectomy group showed greater pain reduction at 8-week follow-up (mean change from baseline -2.8 (95% confidence interval [CI] -3.9 to -1.7) vs. -1.5 (95% CI -2.3 to -0.6); P = 0.045) than the PRF group. Treatment success was reached in 12 of 32 (38%, 95% CI 23 to 55) of the PRF group and 17 of 28 (61%, 95% CI 42 to 72) of the neurectomy group (P = 0.073). Thirteen patients were withdrawn from their scheduled surgery. Adverse events were comparable between treatments. CONCLUSIONS: PRF appears to be an effective and minimally invasive treatment option and may therefore be considered in patients who failed conservative treatment options before proceeding to a neurectomy procedure. Anterior neurectomy may possibly lead to a greater pain relief compared with PRF in patients with ACNES, but potential complications associated with surgery should be discussed.

HER2, chromosome 17 polysomy and DNA ploidy status in breast cancer; a translational study.

Breast cancer treatment depends on human epidermal growth factor receptor-2 (HER2) status, which is often determined using dual probe fluorescence in situ hybridisation (FISH). Hereby, also loss and gain of the centromere of chromosome 17 (CEP17) can be observed (HER2 is located on chromosome 17). CEP17 gain can lead to difficulty in interpretation of HER2 status, since this might represent true polysomy. With this study we investigated whether isolated polysomy is present and how this effects HER2 status in six breast cancer cell lines and 97 breast cancer cases, using HER2 FISH and immunohistochemistry, DNA ploidy assessment and multiplex ligation dependent probe amplification. We observed no isolated polysomy of chromosome 17 in any cell line. However, FISH analysis did show CEP17 gain in five of six cell lines, which reflected gains of the whole chromosome in metaphase spreads and aneuploidy with gain of multiple chromosomes in all these cases. In patients' samples, gain of CEP17 indeed correlated with aneuploidy of the tumour (91.1%; p < 0.001). Our results indicate that CEP17 gain is not due to isolated polysomy, but rather due to widespread aneuploidy with gain of multiple chromosomes. As aneuploidy is associated with poor clinical outcome, irrespective of tumour grade, this could improve future therapeutic decision making.

Pulsed radiofrequency or anterior neurectomy for anterior cutaneous nerve entrapment syndrome (ACNES) (the PULSE trial): study protocol of a randomized controlled trial.

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.

Pain after anterior mesh hernia repair.

BACKGROUND: The results of a randomized clinical trial comparing the Lichtenstein procedure, mesh plug repair, and the Prolene Hernia System provided a database for analyzing chronic pain after anterior mesh hernia repair to determine the characteristics and identify risk factors. STUDY DESIGN: A total of 334 patients with primary inguinal hernia were randomly allocated to receive one of the three meshes. Data on patient characteristics, hernia, and procedure were collected. Longterm followup was completed for 319 of 333 (95.8 %) patients with a postal questionnaire that included a Visual Analog Scale pain score, pain descriptions, and questions about numbness and prosthesis awareness. Chronic pain was analyzed irrespective of the technique used. RESULTS: With increasing age, significantly less intense chronic pain was reported (R = -0.267, p < 0.001) and pain descriptors were used less frequently (p < 0.001). This indirectly reflected the significance of employment (p = 0.019) and body mass index (R = -0.166, p = 0.005) in a univariate analysis because the elderly were, for the most part, unemployed and had a higher body mass index. Longterm Visual Analog Scale pain score correlated significantly with pain directly after an operation (R = 0.253, p = < 0.001). Reported pain increased with the presence of numbness (p < 0.001) and the number of descriptions used (R = 0.389, p < 0.001). Patients using only neuropathic descriptions (n = 56) suffered significantly more intense pain (Visual Analog Scale 26.5 versus 16.6, p = 0.014) than those using only words indicating nociceptive pain (n = 47). CONCLUSIONS: Chronic pain after anterior mesh hernia repair is determined by younger age and stronger pain directly after the operation. Especially in patients with chronic neuropathic pain, its intensity is aggravated when numbness is present and the number of words to describe pain increases.