Scrambler Therapy Research Articles

Scrambler Therapy Enhances Quality of Life in Cancer Patients in a Palliative Care Setting: A Randomised Controlled Trial.

Objectives: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.Material and Methods: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.Results: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.Conclusion: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.

Looking beyond the obvious: Role of non-invasive electroanalgesia in management of cancer pain.

Pain is considered as one of the most debilitating symptoms of cancer and its treatment. Owing to the limited efficacy of traditional pharmacological interventions to address cancer pain in its entirety, an avenue exists for exploration into nonpharmacological therapies. Analgesia using non-invasive electrotherapeutic modalities such as transcutaneous electrical nerve stimulation (TENS) and scrambler therapy emerges as a viable option to address cancer pain. The inability of these modalities to find a place within the recommended clinical guidelines has possibly resulted in the paucity of application of the same within the clinical setup. This perspective article aims at stimulating a discussion surrounding the inclusion of non-invasive neuromodulatory treatment techniques such as TENS and scrambler therapy to combat cancer pain and explore the benefits and pitfalls of using these techniques as an adjunct to the pre-existing treatment strategies. It is envisioned that this opinion piece will open a dialogue about a possible home for non-invasive electroanalgesia within the clinical treatment pathway for cancer pain.

Scrambler therapy for noncancer neuropathic pain: a focused review.

Therapeutic methods for neuropathic are limited; available drugs can be inadequate or have adverse effects that compromise quality of life. Interest has grown in alternatives to pharmacologic therapy for neuropathic pain. We present a focused review of the literature about the relatively novel noninvasive, nonpharmacologic electrocutaneous nerve stimulation technique called scrambler therapy for treating noncancer neuropathic pain. Neuromodulation techniques targeting peripheral sites have changed rapidly in recent years. Several clinical studies have demonstrated the analgesic effect of scrambler therapy after 10 sessions of treatment for various types of pain. Although scrambler therapy was originally used for cancer pain, its indications have broadened to postoperative pain, chemotherapy-induced peripheral neuropathy, postherpetic neuralgia, low back pain, diabetic neuropathy, complex regional pain syndrome and central pain syndrome. That said, some of the studies are controversial owing to their small sample size, lack of appropriate scrambler therapy protocol and possible lack of experience of the operators. We present the historical perspective, mechanism of action and trial outcomes of scrambler therapy, representing an avenue for managing neuropathic pain without drugs. Well designed phase II/III clinical trials must be conducted to confirm the positive findings reported using scrambler therapy technology. If validated, scrambler therapy could be a game changer.

Supportive Care: Low Cost, High Value.

Supportive care aims to prevent and manage adverse effects of cancer and its treatment across the entire disease continuum. Research and clinical experience in dedicated centers have demonstrated that early appropriate supportive care interventions improve symptoms, quality of life, and overall survival in a cost-effective manner. The challenge is to assess symptoms and needs with validated tools regularly and, ideally, between clinic appointments; electronic patient-reported outcome measures and dedicated easily accessible supportive care units can help. As management of certain problems improves, others come to the fore. Cancer-related fatigue and malnutrition are very frequent and need regular screening, assessment of treatable causes, and early intervention to improve. Pharmacologic agents and phytopharmaceuticals are of little use, but other interventions are valuable: physical exercise, counseling on fatigue, and cognitive behavioral therapy/mind-body interventions (e.g., for fatigue). Nutrition should be oral, rich in proteins, and accompanied by muscle training adapted to the patient's condition. Psychological and societal counseling is often useful; nausea or other problems such as gastrointestinal dysmotility or metabolic derangements must be tackled. Chemotherapy-induced peripheral neuropathy frequently worsens quality of life and has no established prevention strategy (notwithstanding current interest in cryotherapy and compression therapy) and thus requires careful assessment of patient predisposition to develop it with the consideration of feasible dose and treatment alternatives. When painful, duloxetine helps. Nonpharmacologic strategies, including acupuncture, physical exercise, cryotherapy/compression, and scrambler therapy, are promising but require large phase III trials to become the accepted standard. Personalization of chemotherapy, dependent on realistic goals, is key.

Differential response to scrambler therapy by neuropathic pain phenotypes

Scrambler therapy is a noninvasive electroanalgesia technique designed to remodulate the pain system. Despite growing evidence of its efficacy in patients with neuropathic pain, little is known about the clinical factors associated with treatment outcome. We conducted a prospective, open-label, single-arm trial to assess the efficacy and safety of scrambler therapy in patients with chronic neuropathic pain of various etiologies. A post-hoc analysis was performed to investigate whether cluster analysis of the Neuropathic Pain Symptom Inventory (NPSI) profiles could identify a subgroup of patients regarding neuropathic pain phenotype and treatment outcome. Scrambler therapy resulted in a significant decrease in the pain numerical rating scale (NRS) score over 2 weeks of treatment (least squares mean of percentage change from baseline, − 15%; 95% CI − 28% to − 2.4%; p < 0.001). The mean score of Brief Pain Inventory (BPI) interference subdimension was also significantly improved (p = 0.022), while the BPI pain composite score was not. Hierarchical clustering based on the NPSI profiles partitioned the patients into 3 clusters with distinct neuropathic pain phenotypes. Linear mixed-effects model analyses revealed differential response to scrambler therapy across clusters (p = 0.003, pain NRS; p = 0.072, BPI interference subdimension). Treatment response to scrambler therapy appears different depending on the neuropathic pain phenotypes, with more favorable outcomes in patients with preferentially paroxysmal pain rather than persistent pain. Further studies are warranted to confirm that capturing neuropathic pain phenotypes can optimize the use of scrambler therapy.

Randomized Trial of Scrambler Therapy for Chemotherapy-Induced Peripheral Neuropathy: Crossover Analysis

ContextPreliminary trials report that Scrambler Therapy, a form of electroanalgesia, may improve discomfort from chemotherapy-induced peripheral neuropathy (CIPN). ObjectiveThe 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. MethodsFifty 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. ResultsA 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. ConclusionsSimilar 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.

QOLP-16. EFFICACY OF SCRAMBLER THERAPY (CALMARE®) FOR THE TREATMENT OF CHRONIC CHEMOTHERAPY-INDUCED PERIPHERAL NEUROPATHY

Abstract BACKGROUND Chemotherapy-induced peripheral neuropathy (CIPN) is a common and serious consequence of cancer treatment that, for up to 30% of patients, persists beyond six months of completing chemotherapy. Scrambler therapy (ST) is a therapeutic modality with emerging evidence supporting its ability to diminish CIPN symptoms. METHODS Data was from a convenience sample of 24 CIPN patients (with symptoms between 1-240 months after platinum-based, taxane, or combination chemotherapy) completing 10 sessions of ST using the Calmare® device in the City of Hope Outpatient Physical Therapy Department. Patients were treated for ~45 minutes per session over 10 sessions. Patients received a standardized assessment pre- and post ST that included: EORTC chemotherapy-induced peripheral neuropathy questionnaire (QLQ-CIPN20), mono-filament testing, pain intensity numerical rating scale, numbness scale, extensor hallicus longus strength, Timed Up and Go, Romberg, and single leg balance. RESULTS Regardless of length of symptoms, significant changes were seen in post-treatment assessment of quality of life as measured by the QLQ-CIPN-20 and numbness scale. Post-treatment QLQ-CIPN-20 total scores decreased by an average of 7.1 points (n= 24, p&amp;lt; .01). Numbness in the left lower extremity decreased by an average of 1 point of the 0-4 point scale (n=24, p=.0007) and 1.09 points on the right lower extremity (n=24, p &amp;lt; .0004). There was a trend towards improvements in pain, monofilament testing, single leg balance, and Romberg test, though they did not reach a level of significance. Surprisingly, only 3 of 24 patients reported pain related to their CIPN at the start of treatment. CONCLUSION For patients with CIPN, scrambler therapy improves numbness and improves quality of life measures. This suggests an important role for this treatment modality in cancer patients suffering from this debilitating condition.

The Efficacy of Scrambler Therapy for the Management of Head, Neck and Thoracic Cancer Pain: A Randomized Controlled Trial

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

Electrical Stimulation via the Scrambler Device as a Treatment for Refractory Restless Legs Syndrome/Willis Ekbom Disease

Study objectives: To evaluate, in a pilot fashion, efficacy and tolerability of electrical counter-stimulation using the Scrambler device in alleviating discomfort and urge to move in patients with medically refractory restless legs syndrome/Willis Ekbom Disease (RLS/WED). Methods: Eligible patients had moderate to very severe RLS/WED symptoms for ≥ 3 months, based on the International Restless Legs Syndrome Study Group (IRLS) Rating Scale. Subjects were treated with Scrambler Therapy for up to ten daily 1-2 hour sessions. Symptoms were monitored using the IRLS as well as questionnaires regarding daily symptoms and global impression of change. Questionnaires were administered at baseline, during therapy, and one-week after the last Scrambler session. Subjects were also queried regarding any adverse effects. Results: Eight subjects were enrolled (M=F). Subjects were on an average of 3 RLS drugs at time of enrollment. Two patients were asked to taper off of gabapentin or pregabalin prior to starting treatments with Scrambler. The IRLS score decreased from a baseline of 27.6 ± 6.2 (mean ± SD) to 19.5 ± 8.0 (p=0.03) following therapy, and to 20.3 ± 10.8 (p=0.07) one week after the last Scrambler treatment. No adverse effects were noted by subjects. Conclusions: Scrambler therapy may be associated with symptom improvements in patients with severe, medically refractory RLS/WED. No adverse effects were associated with therapy. Further work is necessary to characterize this possible treatment option. This study is registered in Clinicaltrials.gov as “Treatment of RLS/WED Symptoms through Sensory Counterstimulation.” ClinicalTrials.gov identifier: NCT03249779.

Evidence for the Efficacy of Scrambler Therapy for Cancer Pain: A Systematic Review

Certain types of cancer pain have remained hard to control even by highly skilled pain experts. Uncontrolled cancer pain can have severe effects on quality of life, physical functioning, and leads to psychological distress. From this perspective, nonpharmacologic modalities of treatment are important. Neuromodulatory techniques, such as transcutaneous electrical nerve stimulation and scrambler therapy (ST), have gained popularity in recent times. ST is a relatively new therapy that has been used for the management of cancer pain resistant to pharmacologic management. Several studies have shown that ST is an effective therapy for this type of pain. The aim of this study was to detect possible gaps in the literature regarding the efficacy of ST for cancer pain and formulate recommendations for research through a systematic review of the literature. A systematic review of the literature was performed following the recommendations of the PRISMA Statement. PubMed and EMBASE were searched for studies that met the inclusion criteria using a predetermined search strategy. Reference list of retrieved studies and Google Scholar were used to verify that no relevant studies had been omitted. Data were extracted from the studies with a data extraction sheet. A qualitative analyses of the extracted data was undertaken. Twenty-seven studies were retrieved. Ten were articles that were categorized as literature reviews, including 7 general literature reviews not following a specific review methodology, 1 editorial, and 2 systematic reviews. Seventeen were original studies, including 2 single-arm trials, 1 randomized controlled trial, 4 pilot trials, 4 case reports, 2 retrospective studies, and 4 prospective studies. By and large, the available literature supports the use of ST as an effective therapy for the management of refractory cancer pain. However, the level of evidence for its application to cancer pain is not particularly strong, and improvement in pain with ST may even be owing to a placebo effect. This study was not a meta-review. Because of the limited number of clinical trials on ST in cancer pain, such a meta-review could not meaningfully be performed. Methodologically sound, large randomized control trials are needed in this area. However at this stage, ST may be considered a good option for cancer patients suffering from pain that does not respond to pharmacologic treatment. Scrambler therapy, cancer, cancer pain, neuropathic pain, Calmare therapy, evidence, noninvasive pain treatment, chronic pain.

Effects of Scrambler Therapy in Patients with Failed Back Surgery Syndromes and Factors Associated with Depression Affecting Pain before and after the Therapy.

Objectives To report the effects of scrambler therapy in patients diagnosed with failed back surgery syndromes and to analyze the factors affecting pain before and after the therapy. Methods This study included 26 patients (12 males and 14 females). The Oswestry Disability Index (ODI) and Brief Pain Inventory (BPI) before and after scrambler therapy, Beck Depression Inventory (BDI) score before therapy, and residual pain after therapy were assessed. The changes in the ODI, BPI, and residual pain before and after the therapy were analyzed using the Wilcoxon signed rank test. Spearman correlation analysis and Fisher's exact test were used to confirm the correlation between BDI and other factors. Multiple regression analysis was used to identify independent factors predicting residual pain, posttherapy ODI, and posttherapy BPI. Results The ODI changed from 25.69 ± 7.98 to 21.80 ± 9.41 (p < 0.05), and the BPI changed from 68.96 ± 18.00 to 61.62 ± 20.27 after scrambler therapy (p < 0.05). In addition, residual pain changed from 100 to 76.15 (p < 0.05). The BDI was negatively correlated with the duration of scrambler therapy and positively correlated with the initial OPD and BPI. In multiple regression analysis, residual pain was significantly correlated with the BDI (p < 0.05). Conclusion Scrambler therapy can be used to change the total scores of the ODI and BPI after 5 sessions of treatment. Also, residual pain was significantly related to the BDI. Clinical significance of depression severity on pain should be further investigated via prospective studies.

Inaccuracy in the Article “Scrambler Therapy Treatment: The Importance of Examining Clinically Meaningful Improvements in Chronic Pain and Quality of Life”

Inaccuracy in the Article “Scrambler Therapy Treatment: The Importance of Examining Clinically Meaningful Improvements in Chronic Pain and Quality of Life”

Treatment of Déjerine–Roussy Syndrome Pain with Scrambler Therapy

Aim: Déjerine-Roussy syndrome or central thalamic pain can be devastating, and treatment with drugs and even deep brain stimulation can be unsatisfactory. Scrambler therapyis a form of neuromodulation that uses external skin electrodes to send a 'non-pain'signal to the brain, with some success in difficult-to-treat syndromes such as neuromyelitis optica spectrum disorder. We used scrambler therapy to treat a patient with 6years of disabling Déjerine-Roussy syndrome pain. Methods: A 56-year-old man received multiple daily then monthly treatments with electrode pairs placed just above the area of distal pain. Each treatment was for 40min. Results: His allodynia and hyperalgesia resolved within 10min, and his pain score fell to almost zero after 30min. Months later, he resumed normal activity and is off all his pain medications. No side effects were noted. Conclusion: Scrambler therapy appeared to reverse 6years of disabling pain safely and economically, and continues to be effective. Further multi-institutional trials are warranted for this rare syndrome.

Scrambler therapy improves pain in neuromyelitis optica: A randomized controlled trial.

To determine whether Scrambler therapy is an effective, acceptable, and feasible treatment of persistent central neuropathic pain in patients with neuromyelitis optica spectrum disorder (NMOSD) and to explore the effect of Scrambler therapy on co-occurring symptoms. We conducted a randomized single-blind, sham-controlled trial in patients with NMOSD who have central neuropathic pain using Scrambler therapy for 10 consecutive weekdays. Pain severity, pain interference, anxiety, depression, and sleep disturbance were assessed at baseline, at the end of treatment, and at the 30- and 60-day follow-up. Twenty-two patients (11 per arm) were enrolled in and completed this trial. The median baseline numeric rating scale (NRS) pain score decreased from 5.0 to 1.5 after 10 days of treatment with Scrambler therapy, whereas the median NRS score did not significantly decrease in the sham arm. Depression was also reduced in the treatment arm, and anxiety was decreased in a subset of patients who responded to treatment. These symptoms were not affected in the sham arm. The safety profiles were similar between groups. Scrambler therapy is an effective, feasible, and safe intervention for central neuropathic pain in patients with NMOSD. Decreasing pain with Scrambler therapy may additionally improve depression and anxiety. NCT03452176. This study provides Class II evidence that Scrambler therapy significantly reduces pain in patients with NMOSD and persistent central neuropathic pain.

Scrambler Therapy for the Reduction of Chemotherapy-Induced Neuropathic Pain

Scrambler Therapy for the Reduction of Chemotherapy-Induced Neuropathic Pain

Scrambler Therapy Treatment: The Importance of Examining Clinically Meaningful Improvements in Chronic Pain and Quality of Life.

Calmare Scrambler Therapy (ST) interferes with pain signal transmission by using nerve fibers to convey a message of normality to the central nervous system. This prospective, double-blinded, randomized trial had three aims. First, we tried to determine ST's effectiveness in reducing chronic neuropathic pain symptoms and analgesic medication use in military service members, when compared to sham treatment. Next, we examined its effect on reported mental and physical health-related quality of life. Finally, we sought to describe participant perceptions of treatment effectiveness. Forty-seven subjects were randomized to receive ten 30-minute active ST or sham treatments. Data were collected at baseline, posttreatment, and 1-month follow-up. The groups showed no statistically significant differences in pain scores, medication use, or mental or physical health-related quality of life with active versus sham treatment. However, both produced clinically meaningful reductions in pain and improvements in physical health-related quality posttreatment that was sustained at 1-month follow-up. Ninety percent of the blinded sample described the treatment intervention as a partial or complete success. ST is no better than sham treatment in decreasing pain. Yet, patient perceptions of treatment effectiveness are equally important in chronic pain treatment.

Scrambler therapy - A novel treatment approach for chronic postoperative pain.

Scrambler therapy - A novel treatment approach for chronic postoperative pain.

Treatment of central and spinal cord neuropathic pain with Scrambler Therapy.

127 Background: Central pain caused by spinal cord or brain injury tends to be severe and refractory despite aggressive treatment, such as in thalamic pain syndrome, neuromyelitis optica spectrum disorder (NMOSD) and other forms of transverse myelitis, and spinal cord gliomas. Methods: We reviewed our experience with treatment of these relatively rare maladies with Scrambler Therapy, a noninvasive form of neuromodulation. Results: One transverse myelitis patient got substantial relief lasting months (Mealy M, Int J MS Care. 201), leading to the NMOSD trial. In a small, sham-controlled randomized trial, NMOSD patient pain scores were reduced in the ST arm from 5 to 1.5 at 30 days, P&lt; 0.01, while the sham treatment gave no relief. (Neurology, resubmitted) Of three patients with pain due to thalamic strokes, surgery and/or radiation, treatment gave over 50% relief long-term in 2 of 3 (D’Amato S, A A Pract. 2018). In the one spinal cord glioma patient, pain in her index finger was reduced from 8-10/10 to 1-2/10 and treatment is ongoing. All successfully treated patients reported marked relief of allodynia and hyperalgesia, in addition to pain relief as reported previously (Marineo G, JPSM 2012). Conclusions: Scrambler therapy is a promising treatment modality for patients with these individually rare but collectively common forms of central pain. It has allowed return to more normal function in most patients, with reductions in pain medication use. Pictures of electrode placement and treatment plans will be shown, allowing others to do this safe and often effective treatment. Clinical trial information: NCT03452176.

Phase II Randomized Controlled Trial Evaluating Scrambler Therapy for Central Neuropathic Pain Treatment in Patients with Neuromyelitis Optica Spectrum Disorder (S43.007)

Phase II Randomized Controlled Trial Evaluating Scrambler Therapy for Central Neuropathic Pain Treatment in Patients with Neuromyelitis Optica Spectrum Disorder (S43.007)

Effects of Pain Scrambler Therapy for the Alterations of Cerebral Blood

Effects of Pain Scrambler Therapy for the Alterations of Cerebral Blood