1. 2020;23;495-506The Efficacy of Scrambler Therapy for the Management of Head, Neck and Thoracic Cancer Pain: A Randomized Controlled Trial
   Randomized Trial
   Sada Nand Dwivedi, PhD, Seema Mishra, MD, Komal Kashyap, PhD, Vishwajeet Singh, MSc, PhD, and Sushma Bhatnagar, MD.

BACKGROUND: Pain is still a common feature in all types of cancers including head and neck and thoracic cancer. Neuromodulatory techniques have gained popularity over opioids in recent times because of the risks associated with chronic opioid therapy. There are no clinical trials evaluating the efficacy of scrambler therapy (ST) for the management of pain due to head and neck and thoracic cancer.

OBJECTIVE: This trial was undertaken to evaluate the efficacy of scrambler therapy (ST) for pain relief and to assess the possible effect of ST on the dosage of opioids in patients suffering from cancer pain.

STUDY DESIGN: A randomized control trial (RCT) was performed.

SETTING: The trial was conducted at the Pain and Palliative Care Unit of the Dr. B.R. Ambedkar Institute Rotary Cancer Hospital of All India Institute of Medical Sciences, New Delhi, India.

METHOD: Forty patients were included in each of the 2 arms, control and Intervention. In both arms, patients were given pain management drugs. In the intervention group, patients additionally received 10 consecutive sessions of ST with one follow-up after 7 days. A numeric rating scale (NRS-11) was used to measure pain. Drug dosage was also recorded.

RESULTS: Overall, pain decreased in both arms. However, pain decreased more in the intervention arm as compared to the control arm. The total change in the mean score of the NRS-11 from baseline to follow-up was 3.1 and 6.19 in the control and ST arms, respectively. Differences between pain scores in both arms became significant from day 3 onwards. Mean morphine dose was significantly lower in the intervention arm from day 7 onwards.

LIMITATIONS: The study followed the patients until one week after the last treatment session and encouraged patients to return for treatment if their pain returned to previous levels within 10 days. Moreover, patients in the control arm received the standard of care in the form of pharmacological treatment but did not receive either transcutaneous electrical nerve stimulation (TENS) or a sham (placebo) procedure.

CONCLUSIONS: The trial showed that ST is an effective treatment for the management of pain due to head and neck and thoracic cancer. On the basis of this study, the use of ST for the management of refractory cancer pain in head and neck and thoracic cancer is recommended.

KEY WORDS: Calmare Therapy, cancer pain, noninvasive pain treatment, numerical rating scale, opioids, RCT, scrambler therapy, TENS