BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN) is a debilitating disturbance among patients who received chemotherapy, with no effective treatment available. Scrambler therapy (ST) is a noninvasive treatment capable of improving multiple quality-of-life symptoms beyond pain. We aimed to evaluate the efficacy of ST for pain and nonpain symptoms related to CIPN.
METHODS: Ten patients with moderate to severe CIPN symptoms for >3 months were enrolled in a single-arm trial of ST for 10 daily sessions. CIPN-related symptoms were measured throughout the treatment period and up to 6 months thereafter.
RESULTS: The worst pain was reduced by 6 months (p = 0.0039). QST demonstrated the greatest improvement in pressure of 60 g (p = 0.308, Cohen\'s d = 0.42) and cold temperature threshold of 2.5°C (p = 0.9375, Cohen\'s d = 0.51) in the gastrocnemius area. Symptoms of numbness, tingling, trouble walking, and disturbed sleep had significant improvements at 6 months. Pain medication use decreased by 70% at the end of treatment and by 42% at 6 months. Patient satisfaction was high (82%) and no adverse events with ST treatment were reported.
CONCLUSIONS: The results of this pilot trial support the use of ST by demonstrating improvement in multiple domains of quality of life for CIPN patients during an extended follow-up of 6 months. However, further large-scale studies are needed to confirm our findings.

UNASSIGNED: Given the known side effects of opioids and the negative impact of these side effects on quality of life (QOL), there is a need for therapies that can reduce opioid intake and improve QOL in patients suffering from cancer pain. Scrambler therapy (ST) is a neuromodulatory therapy that has been shown to reduce cancer pain, but its effect on QOL is not well understood. This study intended to evaluate the efficacy of ST for enhancing QOL in cancer patients through minimising pain and opioid intake.
UNASSIGNED: This was a randomised controlled trial including 80 patients with head, neck and thoracic cancer. In both arms, patients were given pain management drugs following the WHO analgesic ladder for ten consecutive days. In the intervention arm each day ST was given. Pain, morphine intake, and QOL (WHOQOL-BREF) were assessed.
UNASSIGNED: All domains of QOL improved significantly in the intervention arm in comparison to the control arm. In comparison to baseline, pain improved in both the intervention and the control arm on day 10 and at follow-up. However, QOL significantly improved in the intervention arm, while morphine intake decreased. In the control arm, QOL deteriorated, while morphine intake increased.
UNASSIGNED: ST significantly improved QOL. Since the increase in QOL took place along with a significantly lower morphine intake, the improvement in QOL may not only be explained by lower pain scores but, also, by a reduced intake of morphine, because the lower dosages of morphine will decrease the likelihood of side effects associated with the drug.

Chronic pain is common after burn injuries, and post-burn neuropathic pain is the most important complication that is difficult to treat. Scrambler therapy (ST) is a non-invasive modality that uses patient-specific electrocutaneous nerve stimulation and is an effective treatment for many chronic pain disorders. This study used magnetic resonance imaging (MRI) to evaluate the pain network-related mechanisms that underlie the clinical effect of ST in patients with chronic burn-related pain. This prospective, double-blinded, randomized controlled trial (ClinicalTrials.gov: NCT03865693) enrolled 43 patients who were experiencing chronic neuropathic pain after unilateral burn injuries. The patients had moderate or greater chronic pain (a visual analogue scale (VAS) score of ≥5), despite treatment using gabapentin and other physical modalities, and were randomized 1:1 to receive real or sham ST sessions. The ST was performed using the MC5-A Calmare device for ten 45 min sessions (Monday to Friday for 2 weeks). Baseline and post-treatment parameters were evaluated subjectively using the VAS score for pain and the Hamilton Depression Rating Scale; MRI was performed to identify objective central nervous system changes by measuring the cerebral blood volume (CBV). After 10 ST sessions (two weeks), the treatment group exhibited a significant reduction in pain relative to the sham group. Furthermore, relative to the pre-ST findings, the post-ST MRI evaluations revealed significantly decreased CBV in the orbito-frontal gyrus, middle frontal gyrus, superior frontal gyrus, and gyrus rectus. In addition, the CBV was increased in the precentral gyrus and postcentral gyrus of the hemisphere associated with the burned limb in the ST group, as compared with the CBV of the sham group. Thus, a clinical effect from ST on burn pain was observed after 2 weeks, and a potential mechanism for the treatment effect was identified. These findings suggest that ST may be an alternative strategy for managing chronic pain in burn patients.

Preliminary trials report that Scrambler Therapy, a form of electroanalgesia, may improve discomfort from chemotherapy-induced peripheral neuropathy (CIPN).
The objective of this phase II, randomized controlled trial was to evaluate the efficacy of Scrambler therapy vs. transcutaneous electrical nerve stimulation (TENS) in treating CIPN.
Fifty patients were accrued for the first half of this two-part, crossover trial consisting of a 2-week treatment period with either Scrambler or TENS, followed by an 8-week observation period, and then crossover treatment. Twenty-two patients proceeded to the crossover phase. The primary means of assessment was patient-reported outcomes, including symptom severity scales and Global Impression of Change questionnaires. Symptoms were assessed daily during the treatment period and weekly during an 8-week observation period.
A 50% or greater reduction in primary symptom (pain or tingling) score on the last day of treatment was achieved by 6 of 10 Scrambler-treated patients (60%) and 3 of 12 TENS-treated patients (25%) after crossover (P = 0.11). By day 4 of treatment, the two arms diverged with respect to mean change in primary symptom score; this effect was largely carried through to the end of the two-week treatment period. Similarly, Scrambler therapy appeared better than TENS when assessed by Global Impression of Change for neuropathy, pain, and overall quality of life.
Similar findings from the initial randomization and crossover phases of this study support further evaluation of the efficacy of Scrambler therapy in alleviating CIPN symptoms. Evaluation in a larger, randomized controlled trial with standardized treatment is warranted.

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.
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.
A randomized control trial (RCT) was performed.
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.
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.
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.
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.
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.

BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN) affects 30% to 40% of patients with cancer with long-lasting disability. Scrambler therapy (ST) appeared to benefit patients in uncontrolled trials, so we performed a randomized sham-controlled Phase II trial of ST.
METHODS: The primary end point was \"average pain\" after 28 days on the Numeric Rating Scale. Each received ten 30-minute sessions of ST on the dermatomes above the painful areas, or sham treatment on the back, typically at L3-5 where the nerve roots would enter the spinal cord. Outcomes included the Brief Pain Inventory (BPI)-CIPN and the EORTC CIPN-20 scale. Patients were evaluated before treatment (day 0), day 10, and days 28, 60, and 90.
RESULTS: Data regarding pain as a primary outcome were collected for 33 of the 35 patients. There were no significant differences between the sham and the \"real\" ST group at day 10, 28, 60, or 90, for average pain, the BPI, or EORTC CIPN-20. Individual responses were noted during the ST treatment on the real arm, but most dissipated by day 30. There was improvement in the sensory subscale of the CIPN-20 at 2 months in the \"real\" group (P = .14). All \"real\" patients wanted to continue treatment if available.
CONCLUSIONS: We observed no difference between sham and real ST CIPN treatment. Potential reasons include at least the following: ST does not work; the sham treatment had some effect; small sample size with heterogeneous patients; misplaced electrodes on an area of nonpainful but damaged nerves; or a combination of these factors.

[Purpose] This study was designed to investigate the effect of scrambler therapy on the pain and depression of patients with chronic low back pain. [Subject and Methods] Applied scrambler therapy to a 52 year-old man who was diagnosed with chronic low back pain, for 40 minutes once a day during the 10-day execution. Pain and depression were measured using the visual analogue scale and the Beck Depression Inventory. [Results] According to the measurement results, pain and depression decreased after ten sessions of scramble therapy. [Conclusion] Scrambler therapy shows positive effects on pain and depression of patients with chronic low back pain.

Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of chemotherapy, in need of effective treatment. Preliminary data support the efficacy of scrambler therapy (ST), a noninvasive cutaneous electrostimulation device, in adults with CIPN. We test the efficacy, safety, and durability of ST for neuropathic pain in adolescents with CIPN.
We studied nine pediatric patients with cancer and CIPN who received ST for pain control. Each patient received 45-min daily sessions for 10 consecutive days as a first step, but some of them required additional treatment.
Pain significantly improved comparing Numeric Rate Scale after 10 days of ST (9.22 ± 0.83 vs. 2.33 ± 2.34; P < 0.001) and at the end of the optimized cycle (EOC) (9.22 ± 0.83 vs. 0.11 ± 0.33, P < 0.001). The improvement in quality of life was significantly reached on pain interference with general activity (8.67 ± 1.66 vs. 3.33 ± 2.12, P < 0.0001), mood (8.33 ± 3.32 vs. 2.78 ± 2.82, P < 0.0005), walking ability (10.00 vs. 2.78 ± 1.22, P < 0.0001), sleep (7.56 ± 2.24 vs. 2.67 ± 1.41, P < 0.001), and relations with people (7.89 ± 2.03 vs. 2.11 ± 2.03, P < 0.0002; Lansky score 26.7 ± 13.2 vs. 10 days of ST 57.8 ± 13.9, P < 0.001; 26.7 ± 13.2 vs. EOC 71.1 ± 16.2, P < 0.001).
Based on these preliminary data, ST could be a good choice for adolescents with CIPN for whom pain control is difficult. ST caused total relief or dramatic reduction in CIPN pain and an improvement in quality of life, durable in follow-up. It caused no detected side effects, and can be retrained successfully. Further larger studies should be performed to confirm our promising preliminary data in pediatric patients with cancer.

OBJECTIVE: To study the effect of scrambler therapy on patients with chronic cancer pain.
METHODS: This is a prospective, observational study conducted on patients with chronic pain due to malignancy which is not responding to oral analgesics. A total of twenty patients were included in the study (ten males, ten females) with a visual analog scale score of >4 on oral analgesics. Patients aged 18-70 years with a life expectancy of >3 months having bony, neuropathic, or mixed type of pain were included in the study. A total of 12 sessions of scrambler therapy were planned, ten sessions on consecutive days and one session each on two follow-up visits after 1 week each. Each session lasted for 40 min. Pain relief and quality of life according to the World Health Organization Quality of Life were recorded as primary outcome variables.
RESULTS: All patients had good pain relief and improvement in all four domains of quality of life. Pain scores decreased significantly (P < 0.01) after each session and at each follow-up. Patients showed significant improvement in physical, psychological, social, and environmental health (P < 0.01) after the therapy.
CONCLUSIONS: Scrambler therapy offers a promising role in the pain physician\'s armamentarium as an adjunct to pharmacological therapy for the treatment of chronic drug-resistant cancer pain; it may bring down analgesic drug requirements significantly and improve quality of life in cancer patients. Larger prospective, randomized multicenter studies are needed to validate the findings of the small pilot studies published in literature so far.

OBJECTIVE: Pain Scrambler therapy is a patient-specific electrocutaneous nerve stimulation device. Burn pruritus is a common form of chronic and disabling neuropathic pain that is often difficult to treat effectively. Pruritus is mediated by histamines, which are effector molecules stored in mast cells and released locally during injury or inflammation. Burn pruritus may be accompanied by peripheral neuropathic pain, which may result from injury to sensory nerves that hampers conductance of neuronal messages along the large A and small C afferent fibers to the spinal cord. In this study, we investigated the effect of pain Scrambler therapy on burn scar pruritus.
METHODS: Sixteen subjects were recruited to participate in this study. The subjects complained of severe pruritus that was rated at least 5 on the visual analogue scale (VAS), despite treatments with antihistamines, gabapentin medication, and other physical modalities. Each Scrambler Therapy with the MC-5A Pain Scrambler Therapy® technology device was performed for 40min daily (Monday through Friday) for 10 consecutive days. The stimulus was increased to the maximum intensity bearable by the individual patient without causing any additional pain or discomfort. The numerical rating scale (NRS), 5-D Itch Scale, and Leuven Itch Scale were administered and evaluated immediately before Scrambler therapy, and then immediately after 5 and 10 therapy sessions.
RESULTS: For all 16 patients, NRS showed mean values of 6.75±1.13 before therapy, 5.06±1.53 after 5 sessions, and 4.13±1.45 after 10 sessions. The NRS values before therapy and after 10 sessions were significantly different (p<0.05). Pruritus frequency, severity, and consequences scores on the Leuven Itch Scale after Scrambler therapy were also significantly different (p<0.05). Duration, degree, direction, and disability scores on the 5-D Itch Scale were also significantly different (p<0.05).
CONCLUSIONS: Scrambler therapy is a non-invasive, non-medicinal modality that significantly reduced burn-associated pruritus. Scrambler therapy should be considered as a treatment option for burn survivors with severe pruritus.