Sham-Controlled, Randomized Trial: Three-Month Results
Diab Fuad Hetta, MD1, Ali Mohammed Mahran, MD2, and Emad Eldien Kamal, MD2
Pain Physician 2018; 21:199-205 • ISSN 1533-3159
Background: Chronic post-surgical pain in the groin region represents a challenge for the
managing physician and is a burden on the quality of life of the patient. None of the existing
interventions or medical treatment is satisfactory.
Objectives: We aim to evaluate the analgesic efficacy of pulsed radiofrequency (PRF) applied to the ilioinguinal nerve and the genital branch of the genitofemoral nerve for patients suffering from chronic post-surgical orchialgia.
Study Design: A prospective randomized, controlled clinical trial.
Settings: An interventional pain unit in a tertiary center at a university hospital in Egypt.
Methods: Seventy patients complaining of chronic post-surgical orchialgia were randomized into
2 groups: PRF group (n = 35), received pulsed radiofrequency on the ilioinguinal nerve and genital branch of the genitofemoral nerve, or sham group (n = 35). The percentage of patients that showed > 50 % reduction of their visual analog scale (VAS) pain score as well as the percentage of patients that did not require additional analgesic drugs was assessed. The VAS pain score and the global perceived effect (GPE) were reported during the 3-month follow-up period.
Results: The percentage of patients that showed > 50% reduction of their VAS pain score was
80% (24/30) in the PRF group versus 23.33% (7/30) in the sham group. The percentage of patients
that did not require analgesic drugs was 50% (15/30) in the PRF group versus 3.3% (1/30) in the sham group. There was a significant reduction of the mean post-procedural VAS pain score at 2,4, 6, 8, and 12 weeks (P = 0.001) in the PRF group in comparison to the sham group. Likewise,
there was a significant improvement of the GPE in the PRF group in comparison to the sham group
(P = 0.00).
Limitations: The study’s follow-up period was limited to 3 months only.
Conclusions: For patients suffering from chronic post-surgical orchialgia, PRF applied to the
ilioinguinal nerve and the genital branch of the genitofemoral nerve is an effective treatment
modality. It provides long-lasting pain relief and decreases the demand for pain medications.
Key words: Orchialgia, groin pain, radiofrequency, ilioinguinal nerve, genitofemoral nerve
Trial Registry: www.anzctr.org.au, ACTRN12616000649415.
Pain Physician 2018; 21:199-205