Transcutaneous Electrical Nerve Stimulation (TENS)/Cutaneous Stimulation

Transcutaneous Electrical Nerve Stimulation (TENS)/Cutaneous Stimulation

PEP Topic 
Chronic Pain
Description 

Transcutaneous electrical nerve stimulation (TENS)/cutaneous stimulation is a process involving electrodes placed on the skin over muscles or nerves with a power device generating pulse widths of less than 70 mA (Forst, Nguyen, Forst, Disselhoff, Pohlmann, & Pfutzner, 2004). TENS specifically for patients with cancer has been studied related to pain management.

Forst,T., Nguyen, M., Forst, S., Disselhoff, B., Pohlmann, T., & Pfutzner, A. (2004). Impact of low frequency transcutaneous electrical nerve stimulation on symptomatic diabetic neuropathy using the new Salutaris device. Diabetes, Nutrition and Metabolism, 17(3), 163–168.

Effectiveness Not Established

Research Evidence Summaries

Bennett, M.I., Johnson, M.I., Brown, S.R., Radford, H., Brown, J.M., & Searle, R.D. (2010). Feasibility study of transcutaneous electrical nerve stimulation (TENS) for cancer bone pain. Journal of Pain, 11, 351–359.

doi: 10.1016/j.jpain.2009.08.002
Print

Study Purpose:

To determine the feasibility of conducting a larger phase III trial to investigate the effectiveness of TENS for control of cancer-related bone pain

Intervention Characteristics/Basic Study Process:

Patients were randomized to receive either active TENS at the first application and placebo TENS at the second application, or vice versa. Researchers responsible for outcome assessments were blinded to patient group. Placebo TENS was delivered using devices that were identical in appearance but delivered no current output. Patients were informed that sometimes they would feel a tingling sensation and sometimes they might not feel this. Patients were instructed not to tell the research observer any sensations they were feeling. Pain intensity measures were obtained at baseline, then repeated after 30 and 60 minutes of TENS application. Patients returned for the second TENS application two to seven days later and experienced an identical procedure. TENS application was given using a single channel device, and placement was based on recommendations for conventional TENS of the International Association for the Study of Pain. Pain was assessed at rest and on a patient-specified movement. Patients continued their current pain medication regimen.

Sample Characteristics:

  • The study reported on a sample of 24 randomized patients, with 19 analyzed.
  • Mean patient age was 72 years, with a range of 40–91 years. 
  • The sample was 75% male (18) and 25% female (6). 
  • The majority of patients had prostate cancer. Additional types included breast, lung, thyroid, and renal.
  • All patients had radiologic evidence of bone metastases, pain rated as at least 3 on a 10-point rating scale, and an expected survival of longer than four weeks.
  • Most (87%) were being treated with strong opioids, including morphine, fentanyl, or oxycodone, 79% had previous radiotherapy, and 33% had received biophosphonates.
  • The most common sites of painful bone metastases were pelvis, lumbosacral spine, and lower limbs.
  • The majority of patients had an Eastern Cooperative Oncology Group performance status of 1 or 2.
  • Patients were on stable pain medication regimens.

Setting:

  • Multisite
  • Outpatient setting in the United Kingdom

Study Design:

A randomized, controlled, double-blind, crossover design was used.

Measurement Instruments/Methods:

  • Numerical pain rating scale (1–10)
  • Verbal rating scale (four categories from no pain to severe pain)
  • Short Form McGill Pain Questionnaire (SF-MPQ)
  • Patient satisfaction questionnaire designed by authors regarding benefit, ease of use, and impact on pain or rest

Results:

The mean pain change in pain intensity score for active TENS was –0.84 compared with placebo TENS of –2.16. The mean change with movement was –2.32 for active TENS compared with placebo change of –2.0. at one hour. The mean pain relief on movement was higher with active TENS. The difference in proportion of patients who reported good or very good pain relief on movement with active TENS by verbal ratings was 36.8% (95% CI 7.5–66.2%). There were no clear patient preferences between active and placebo TENS. Three patients experienced adverse events, increased pain with TENS application, that were deemed likely to be or definitely related to TENS use.

Conclusions:

TENS has the potential to provide improved pain relief on movement in patients with bone pain.

Limitations:

The study had a small sample, with less than 30 patients.

Nursing Implications:

The purpose of this study was to determine feasibility and use findings to plan for a phase III study, rather than to determine intervention effect. Findings suggest that TENS may be more effective in pain relief on movement than for pain relief at rest for bone pain. Findings also showed an effect on the measure of pain relief, but not on the measure of pain intensity. This suggests that pain relief measurement may be more useful in clinical trials than just measurement of pain severity at given points in time.

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
Print

Study Purpose:

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.

Sample Characteristics:

  • 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:

  • Setting was not described.

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Multiple phases of care
  • APPLICATIONS: Palliative care

Study Design:

  • A repeated measures design with no control group was used to evaluate the intervention.

Measurement Instruments/Methods:

  • 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.

Results:

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.

Conclusions:

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.

Limitations:

  • 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

Nursing Implications:

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.

Ricci, M., Pirotti, S., Scarpi, E., Burgio, M., Maltoni, M., Sansoni, E., & Amadori, D. (2012). Managing chronic pain: Results from an open-label study using MC5-A Calmare® device. Supportive Care in Cancer, 20, 405–412.

doi: 10.1007/s00520-011-1128-6
Print

Study Purpose:

To assess the efficacy and acceptability of the MC5-A Calmare® device

Intervention Characteristics/Basic Study Process:

The Calmare device produces electrical nerve stimulation that is transmitted to nociceptors in order to modulate the pain response. Electrodes were placed on the skin according to the area of pain to be treated. Patients could receive up to a maximum of four treatments per day. Ten 30-minute sessions of the stimulation therapy for two consecutive weeks were delivered Monday through Friday. Pre- and post-treatment assessments were done after the first week and after the tenth day of treatment. Patients continued their usual regimen of analgesics.

Sample Characteristics:

  • The study reported on a sample of 73 patients.
  • Median patient age was 66 years, with a range of 28–87 years.
  • The sample was 52% male and 48% female.
  • The sample included patient with cancer and noncancer patients as well.
  • Of the patients with cancer, 56% had nociceptive pain and 34% had neuropathic pain; most had pain duration greater than three months; and 58% were on strong opioids.

Setting:

  • Single site
  • Inpatient and outpatient settings

Phase of Care and Clinical Applications:

Patients were undergoing long-term follow-up care.

The study has clinical applicability for end-of-life and palliative care; and elderly care.

Study Design:

A prospective, exploratory, single-group, quasi-experimental design was used.

Measurement Instruments/Methods:

Numerical rating scale (NRS)

Results:

Participants had an overall decrease in pain. Mean value at the beginning of treatment was 5.4 for those with cancer and decreased to 1.4 at the end of the second week (p < 0.0001) and to 2.6 at the two-week poststudy follow-up (p < 0.0001). After the tenth day of treatment, mean value was 2.9 (p < 0.0001), and after the second week of follow-up, the mean one month of treatment pain reduction was 4.0 and 5.2 in patients with cancer and noncancer patients, respectively. No side effects were reported. Among those patients with cancer-related pain, 64% were deemed complete responders, and 7% achieved a partial response. No adverse effects were seen.

Conclusions:

This pilot study demonstrated that cutaneous electrostimulation with the MC5-A Calmare® device was effective in chronic pain treatment.

Limitations:

  • The sample was small, with less than 100 participants.
  • The study had a limited follow-up time frame.

Nursing Implications:

Findings suggest that use of this device may provide benefit as adjunctive treatment for chronic pain control. Further well-designed research is needed to validate findings further.

Systematic Review/Meta-Analysis

Hurlow, A., Bennett, M.I., Robb, K.A., Johnson, M.I., Simpson, K.H., & Oxberry, S.G. (2012). Transcutaneous electric nerve stimulation (TENS) for cancer pain in adults. Cochrane Database of Systematic Reviews, 3, CD006276.

doi: 10.1002/14651858.CD006276.pub3
Print

Purpose:

To review and summarize the evidence regarding the effect of transcutaneous electric nerve stimulation (TENS) for management of cancer-related pain

The type of study is systematic review.

Search Strategy:

Databases searched were MEDLINE, CINAHL, PEDro, AMED, EMBASE, PsycINFO, and the Cochrane Central Register of Controlled Trials.

An extensive listing of search terms per database are provided.

Studies were included in the review if they evaluated TENS-administered monophasic or biphasic pulsed electrical currents, reported on participants 18 years or older, and were randomized controlled trials (RCTs) not involving active treatment control.

Studies reporting on percutaneous interventions were excluded.

Literature Evaluated:

The total of four references were retrieved.

The Jadad scale was used for evaluation as well as the Cochrane risk of bias tool.

Sample Characteristics:

Three studies were included in the review; two studies were added to prior review of two studies.

Sample range across studies was 15–49, with a total of 68 patients included in the review.

Results:

Results were inconclusive due to lack of suitable RCTs for inclusion. One study indicated that bone pain may improve with TENS, but this was not well designed and underpowered. Two studies showed no significant difference with TENS.

Conclusions:

No conclusions regarding the effectiveness of TENS can be made.

Limitations:

  • The review included few studies with variable quality.
  • Studies were underpowered.

Nursing Implications:

There is insufficient evidence to determine whether TENS is effective for management of pain in patients with cancer.

Robb, K.A., Bennett, M.I., Johnson, M.I., Simpson, K.J., & Oxberry, S.G. (2008). Transcutaneous electric nerve stimulation (TENS) for cancer pain in adults. Cochrane Database of Systematic Reviews, 3, CD006276.

doi: 10.1002/14651858.CD006276.pub2
Print

Purpose:

To determine the effectiveness of transcutaneous electric nerve stimulation (TENS) in management of cancer-related pain and to provide guidance for optimal parameters of TENS for pain relief

Search Strategy:

Databases searched were The Cochrane Library, MEDLINE, Embase, CINAHL, AMED, PEDro, and PsycINFO. Hand-searching of reference lists of articles retrieved was also done.

MeSH terms were Neoplasms [*complications]; Pain [etiology;*therapy] Randomized controlled trials as Topic; Transcutaneous Electric Nerve Stimulation (TENS) [*methods] Adults; Humans. An extensive listing of search strategies and terms for each database used are provided.

Studies were included in the review if they

  • Were a randomized controlled trial (RCT) where the control group was either receiving no treatment or no active stimulation/placebo
  • Evaluated TENS administered with a standard device that delivered mono or biphasic electrical currents
  • Reported on TENS delivery that provided a strong but comfortable sensation in either the area where pain was present or over nerve bundles proximal to the site of pain
  • Reported on adult patients with cancer-related pain
  • Reported pain outcomes.

Studies were excluded if they

  • Compared TENS with active treatment
  • Used percutaneous electrical stimulation
  • Evaluated TENS delivered at a reported intensity that was mild or barely perceptible.

Literature Evaluated:

The search identified 36 studies from 1975 to 2008, and reference lists identified an additional 7 studies. Only two studies met all inclusion criteria. Study quality was assessed using the Oxford Quality Scale (Jadad scale).

Sample Characteristics:

  • The final sample of two studies included in the review encompassed a total of 54 patients: 41 entered in one study and 13 in the other.
  • All patients were 18 years of age or older and had experienced persistent cancer-related pain for three months or longer.
  • One study was done in patients receiving palliative care at the end of life.

Results:

The majority of studies initially retrieved from the search were eliminated due to design that was either not an RCT or where clinical results were not reported. No meta-analysis could be done due to the small sample size with final studies included. In one study, TENS was compared to sham TENS in women. The only outcome measure with significant differences between groups was one dimension of a patient satisfaction questionnaire. In the other study, there were no significant differences between groups.

Conclusions:

No conclusions regarding the effectiveness of TENS could be made due to the lack of studies that met criteria.

Limitations:

This review was limited by the inclusion criteria that TENS had to be compared to no treatment. The ethics of having such a control or placebo group in patients with chronic pain and in end-of-life care is questionable, and the inability to find enough studies that met this strict criteria is not surprising. Results were inconclusive due to lack of suitable RCTs.

Nursing Implications:

There is little data to demonstrate effectiveness of TENS for cancer-related pain. In patients with chronic pain, the insistence upon a placebo control group in an RCT is not reasonable and appropriate, and such limitations will not serve to advance knowledge in this area. Additional research with adequate sample sizes is needed in this area.

Guideline/Expert Opinion

National Comprehensive Cancer Network. (2011). NCCN Clinical Practice Guidelines in Oncology: Adult cancer pain [v. 2.2011]. Retrieved from http://www.nccn.org/professionals/physician_gls/pdf/pain.pdf

http://www.nccn.org/professionals/physician_gls/pdf/pain.pdf
Print

Type of Resource/Evidence-Based Process:

These guidelines do not provide any information about search strategy or any specific evaluation of evidence. Notes state that most direct evidence is of low quality, but recommendations do result from unanimous consensus.

Guidelines & Recommendations:

The guidelines provide detailed recommendations regarding:

  • Screening and assessment
  • Management of pain in opioid-naive as well as opioid-tolerant patients
  • Ongoing care of adult patients with cancer and related pain management
  • Comprehensive pain assessment and use of pain ratings
  • Interventions for specific types of pain syndromes
  • Opioid prescribing, titration, and ongoing management
  • Management of adverse effects related to opioids
  • Psychosocial support and patient and family education
  • Nonpharmacologic interventions.

Limitations:

In general, opioids are first-line interventions. The NCCN guidelines suggest that antidepressants and anticonvulsants can be first-line treatments for adjuvant pain, although the recommendation for using them as such is still based on anecdotal experience or guidelines relating to patients who do not have cancer.

Nursing Implications:

The NCCN guidelines provide comprehensive algorithms for pain management, from screening to ongoing maintenance. The guidelines recommend considering a variety of nonpharmacologic interventions. Psychosocial support, including coping-skills training, is recommended, as is comprehensive patient and family education. The guidelines provide useful information and an overview of the full range of pain management. The work points to the ongoing need to consider multiple adjuvant and supportive interventions to achieve pain relief that works for the individual patient.


Menu