ABSTRACT
BACKGROUND: Spinal cord stimulation (SCS) has emerged as a treatment option for patients with chronic pancreatitis (CP) who experience pain that does not respond to standard interventions. However, there is a lack of sham-controlled trials to support its efficacy. METHODS: This randomized, double-blinded, sham-controlled, cross-over trial enrolled 16 CP patients with insufficient pain relief from standard therapies. Patients underwent high-frequency (1000 Hz) paraesthesia-free SCS or sham for two 10-day stimulation periods, separated by a 3-day washout period. The primary outcome was daily pain intensity registered in a pain diary based on a numeric rating scale (NRS). Secondary outcomes included various questionnaires. Quantitative sensory testing was used to probe the pain system before and after interventions. RESULTS: The average daily pain score on the NRS at baseline was 5.2 ± 1.9. After SCS, the pain score was 4.2 ± 2.1 compared to 4.3 ± 2.1 in the sham group (mean difference -0.1, 95% CI [-1.4 to 1.1]; P = 0.81). Similarly, no differences were observed between groups for the maximal daily pain score, secondary outcomes or quantitative sensory testing parameters. During an open-label, non-sham-controlled and non-blinded extension of the study, the average daily NRS was 5.2 ± 1.7 at baseline, 3.2 ± 1.8 at 3 months, 2.9 ± 1.9 at 6 months and 3.4 ± 2.2 at 12 months of follow-up (P = 0.001). CONCLUSION: In this first sham-controlled trial of SCS in painful CP, we did not find evidence of short-term pain relief with paraesthesia-free high-frequency (1000 Hz) stimulation. However, evaluation of the long-term effect by larger sham-controlled trials with long-term follow-up is warranted. SIGNIFICANCE STATEMENT: In this first sham-controlled trial to apply high-frequency (1000 Hz) spinal cord stimulation in patients with visceral pain due to chronic pancreatitis, we did not find evidence for clinically relevant pain relief. Taken together with potential procedure-related complications, adverse effects and costs associated with spinal cord stimulation, our findings question its use for management of visceral pain.
ABSTRACT
PURPOSE: The purpose of this article is to highlight some new findings from a qualitative study that have not been previously considered. METHOD: The research was based on a qualitative phenomenological method. Data were collected by semi-structured individual interviews. A purposeful sample was recruited from West Norway of 14 women with a possible risk of developing breast and ovarian cancer. Data collection took place at least one year after prophylactic removal of the ovaries. Data from the study was analyzed according to the phenomenological method of Amedeo Giorgi. KEY FINDINGS: Two themes were revealed as essential factors of the interviewed women's experiences: "the loss of a mother" and "dealing with genetic cancer risk." For the most part, these two themes also appeared to be interrelated. When a mother died of ovarian cancer while her daughter was a child or a young woman, this often led to her daughter's strong desire to find an explanation for her mother's death, as well as to her efforts to undergo genetic testing and surgery to prevent cancer in her family in the future. CONCLUSION: The study indicates that women's experiences in families at risk of hereditary cancer are closely related to an understanding of their life stories, particularly their "loss of a mother," and how this influences how they deal with genetic cancer risk. Health care workers can thus help patients identify connections and establish coherence through the act of storytelling, by listening to their illness experiences as part of their life stories.
