Background & Aims
From 2015 to 2020, there were 7.8 million women diagnosed with Breast Cancer (BC), making it one of the world’s most prevalent cancers. It causes pain and has a negative impact on quality of life (QOL). Till date, opioids have proven to be effective but have significant side effects that negatively impact QOL in patients, including BC patients. Neuromodulation techniques (NTs) could be an alternate treatment option. In clinical trials, multiple NTs, particularly transcutaneous electrical nerve stimulation and scrambler therapy (ST), have shown promising results in the context of both nociceptive and neuropathic pain. Studies have shown that ST reduces pain and improves QOL. However, for BC pain there is no study available on ST that studies the interaction between ST, pain, QOL, and opioid intake. This study assesses the efficacy of ST for the management of pain in BC patients by comparing the effectiveness of ST with a sham procedure and studying its effect on QOL and opioid intake.
Methods
This is a randomized sham-controlled trial in the Palliative Care Department of AIIMS, Delhi. Patients aged 18-70 years, having BC, and pain >4 on a ten-point numerical rating scale (NRS), and taking opioids, were included in the study. 100 patients were randomized equally into two arms using a computer-generated random sequence. Written consent was obtained from each patient before enrolment. NRS score was the primary outcome measure. QOL was assessed through FACT-B. In the intervention arm, in addition to the standard treatment, patients received ST sessions of 40 minutes each for 10 days. Patients in the control arm received a sham procedure instead of ST. The sham procedure included correct placement of electrodes, but the intensity of the treatment was not increased beyond the device’s starting level, so no real stimulus was applied. The data were analysed using the software package STATA version 17.
Results
At baseline, no significant differences were found between both arms. By day 10, NRS mean score was significantly lower in the ST arm (arm 2) compared to the control (arm 1) (1.02 (0.66) vs. 3.92 (0.95); p<0.001). The difference from baseline to day 10 (post intervention) of mean NRS score was 5.98 in arm 2, but it was only 2.96 in arm 1. FACT-B domain scores were higher for all domains in arm 2 in comparison to arm 1 on day 10. The difference was statistically significant for all domains (p<0.001). Opioid consumption in arm 1 increased from 36.78mg at baseline to 37.00mg on day 10. However, in arm 2, opioid consumption decreased from 34.8mg to 21.16mg. The difference in opioid consumption between the arms was statistically significant (p<0.001).
Conclusions
The results look promising as ST significantly reduces pain in BC patients who had received the therapy in comparison to BC patient who received a placebo. Moreover, these findings suggest that the intervention in arm 2 may have contributed to a reduction in opioid consumption compared to arm 1. ST may be an effective technique to improve QOL through reduction of pain, thus lessening the need for opioids, which have substantial side-effects. By reducing opioid consumption, ST leads to improved QOL.
References
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Presenting Author
Komal Kashyap
Poster Authors
Komal Kashyap
Lead Author
Topics
- Specific Pain Conditions/Pain in Specific Populations: Cancer Pain & Palliative Care