Cutaneous stimulation involves stimulation of nerves via skin contact in an effort to reduce pain impulses to the brain, based on the "gate control" theory of pain. A device used to provide electrocutaneous nerve stimulation was studied for its effect on symptoms of peripheral neuropathy.
Effectiveness Not Established
Research Evidence Summaries
Coyne, P.J., Wan, W., Dodson, P., Swainey, C., & Smith, T.J. (2013). A trial of Scrambler therapy in the treatment of cancer pain syndromes and chronic chemotherapy-induced peripheral neuropathy. Journal of Pain and Palliative Care Pharmacotherapy, 27, 359–364.doi: 10.3109/15360288.2013.847519
To evaluate the effectiveness of Scrambler therapy on cancer pain, chemotherapy-induced peripheral neuropathy, neuropathic pain, and quality of life
Intervention Characteristics/Basic Study Process:
Scrambler therapy is cutaneous electrostimulation that blocks the effect of pain information on the cutaneous nerves. In this study, all participants received the intervention to the affected area for 45 minutes daily for 10 consecutive days (Monday–Friday). Pain was measured before and after each intervention session.
- N = 39
- MEAN AGE = 56.5 years
- MALES: 41%, FEMALES: 59%
- KEY DISEASE CHARACTERISTICS: The majority of the study participants had chemotherapy-induced peripheral neuropathy (n = 33), followed by post-mastectomy pain (n = 3), postherpetic neuralgia (n = 2), and radiation-related pain (n = 1).
- OTHER KEY SAMPLE CHARACTERISTICS: Participants had to have pain or symptoms of peripheral neuropathy for longer than one month with an average daily pain rating of greater than 5 out of 10, or numbness that bothered the participant at least “a little bit.” Additionally, participants had to be adults with a life expectancy of longer than three months and an Eastern Cooperative Oncology Group performance status score of 0–2.
- Setting was not described.
Phase of Care and Clinical Applications:
- PHASE OF CARE: Multiple phases of care
- APPLICATIONS: Palliative care
- A repeated measures design with no control group was used to evaluate the intervention.
- Numerical Rating Scale (0–10) for pain
- Brief Pain Inventory (questions 2–5 and 9)
- Eastern Cooperative Oncology Group Chemotherapy-Induced Peripheral Neuropathy 20 scale
- All measurements were performed pre- and post-intervention.
- Comparisons were made between baseline day 1 and days 14, 30, 60, and 90.
Improvement in pain was found at all secondary endpoints (days 14, 30, 60, 90), with a statistically significant difference in pain between baseline and day 30 (p = 0.0049) and change over time (p = 0.0002). Sensory and motor components of the chemotherapy-induced peripheral neuropathy scale also were found to improve with statistically significant sensory improvement between baseline and day 30 (adjusted p = 0.0007) and change over time (p < 0.0001). For the motor component, significant findings included improvement between baseline and days 14, 30, and 60 (adjusted p = 0.0143, 0.1035, 0.0094, respectively) and change over time (p = 0.0019). Improvements in all components of the Brief Pain Inventory were found (i.e., “interference with normal life,” which were maintained for mood, sleep, relationships, etc). Pain interference with walking was improved significantly between baseline and day 30 (p = 0.0003). Use of opioids did not change.
Scrambler therapy improved acute and chronic pain among patients with cancer. Additionally, it had a lasting effect three months post-treatment. Quality of life also was improved with this pain treatment. Further study is needed to determine generalizability of these findings to other patients with cancer.
- Small sample (less than 100)
- Risk of bias (no control group)
- Risk of bias (no blinding)
- Risk of bias (no random assignment)
- Risk of bias (no appropriate attentional control condition)
- Unintended interventions or applicable interventions not described that would influence results
- Findings not generalizable
- Intervention expensive, impractical, or training needs
- Other limitations/explanation: What opioids and dose the participants were taking during the study, who delivered the intervention, and the expense of the intervention or training needs were unclear. Additionally, findings are not generalizable to other patients with cancer because of the lack of a control group or attentional control condition and the small, heterogeneous sample.
- Questionable protocol fidelity
Scrambler therapy appears to be a promising intervention for cancer-related pain and has no adverse effects. Because who delivers this treatment and its expense are unclear from this article, the implications to nursing are unclear. However, nurses knowing about this treatment is important because it may become a common method for treating cancer-related pain in the future.
Smith, T.J., Coyne, P.J., Parker, G.L., Dodson, P., & Ramakrishnan, V. (2010). Pilot trial of a patient-specific cutaneous electrostimulation device (MC5-A Calmare®) for chemotherapy-induced peripheral neuropathy. Journal of Pain and Symptom Management, 40, 883-891.doi: 10.1016/j.jpainsymman.2010.03.022
Evaluate the impact on chemotherapy-induced peripheral neuropathy (CIPN) associated with the MC5-A Calmare® therapy device.
Intervention Characteristics/Basic Study Process:
Participants were recruited from the clinical oncology practice by physician referral and advertisements in the waiting rooms. The MC5-A device was applied daily to areas of CIPN determined and assigned to dermatomes. The treatment time was 60 minutes for 10 days. The MC5-A device is intended to induce modulation of pain responses with low frequency simulation to nerves with surface electrodes, raising the “gate” threshold for pain at the spinal cord. Patients were evaluated at baseline and at the end of weeks 1 and 2 of treatment, and then at the end of weeks 4, 8, and 12. Subjects rated their pain immediately before and after treatment.
- N = 16 (were evaluable)
- MEAN AGE = 58.6 years (SD = 10.6 years)
- MALES = 22%, FEMALES = 77%
- KEY DISEASE CHARACTERISTICS: The most frequent diagnoses were breast and colon cancer. The most common chemotherapy drugs that were used were taxanes, platinum, and bortezomib. All subjects had unstable CIPN for at least three months.
- OTHER KEY SAMPLE CHARACTERISTICS: Ten subjects were Caucasian, 6 were African American, 1 was Native American, and 1 reported "other." Ten patients were previously treated for pain with opioids; 4 were treated with gabapentin monotherapy; and others were treated with various drug combinations.
- SITE: Single site
- SETTING TYPE: Outpatient
- LOCATION: Massey Cancer Center, Virginia Commonwealth University, in Richmond, VA
Phase of Care and Clinical Applications:
- PHASE OF CARE: Active treatment
- CLINICAL APPLICATIONS: Late effects and survivorship
- Pain numeric rating scale (for pain right now)
- Quality of life measured by The Uniscale
- Change in use of pain drugs
- Toxicity measured by the Cancer Therapy Evaluation Program, North Central Cancer Treatment Group Symptom Experience Diary
Fifteen of the 16 subjects reported a 20% reduction in their pain score by the end of the study. The pain score was reduced 59% from 5.81 pre-treatment to 2.38 at the end of the 10 days ( P < 0.0001 by paired t-test ). The daily reduction in pain score was 1.02 during the 10 days of treatment. After treatment was discontinued, pain scores returned to pretreatment levels. No changes in opioid doses occurred during the course of the study, with patients on average receiving 110-150 oral morphine equivalents per day. There were no changes in quality of life or symptoms (as evaluated by the Symptom Assessment Diary).
Although 15 of 16 patients experienced a reduction in their pain, drawing any significant conclusions is difficult with such a small sample in a prospective study.
- Small sample of less than 30
- Single site
- Not a randomized, double-blind study
- Short-term follow up period
- There was no discussion of changes in any non-opioid or coanalgesic medications for pain.
- Although the authors reported no changes in daily opioid intake during the study, it is not clear how this was determined.
- Changes in pain were measured only immediately pre- and post-intervention, so it is not clear if any effect occurred during the day other than immediately after the treatment.
MCA-5 therapy required patients to return to the clinic daily for 10 days post-treatment. This expectation may be impractical for many patients. Also, not all facilities would have someone available and skilled to do the procedure. The cost of the therapy could be an issue as well. Further research is needed to evaluate the potential benefits of this type of therapy, and longer term follow-up is needed. Consideration of background medications for pain in analysis of results is important for subgroup analysis. Research in this area using a sham-controlled procedure would be helpful to rule out placebo effect.