Transcutaneous electrical nerve stimulation for acute pain
This is a second update of a Cochrane Review originally published in Issue 2, 2009. Transcutaneous Electrical Nerve Stimulation (TENS) is a non‐pharmacological agent, based on delivering low voltage electrical currents to the skin. TENS is used by people to treat a variety of pain conditions.
To assess the analgesic effectiveness of TENS, as a sole treatment, for acute pain in adults.
We searched the following databases up to 3 December 2014: the Cochrane Central Register of Controlled Trials (CENTRAL), in the Cochrane Library; MEDLINE; EMBASE; CINAHL; and AMED. We also checked the reference lists of included trials.
We included randomised controlled trials (RCTs) of adults with acute pain (< 12 weeks) if they examined TENS given as a sole treatment and assessed pain with subjective pain scales. Trials were eligible if they compared TENS to placebo TENS, no treatment controls, pharmacological interventions or non‐pharmacological interventions. We excluded trials on experimental pain, case reports, clinical observations, letters, abstracts or reviews. Also we excluded trials investigating the effect of TENS on pain during childbirth (labour), primary dysmenorrhoea or dental procedures. Studies where TENS was given with another treatment as part of the formal trial design were excluded. We did not restrict any articles based on language of publication.
Data collection and analysis
Two review authors independently assessed study eligibility and carried out study selection, data extraction, 'Risk of bias' assessment and analyses of data. We extracted data on the following: types of participants and pain condition, trial design and methods, treatment parameters, adverse effects, and outcome measures. We contacted trial authors for additional information if necessary.
We included 12 trials in the original review (2009) and included no further trials in the first update (2011). An additional seven new trials met the inclusion criteria in this second update. In total, we included 19 RCTs involving 1346 participants at entry, with 11 trials awaiting classification either because the full text was unavailable or information in the full text failed to clarify eligibility. We excluded most trials because TENS was given in combination with another treatment as part of the formal study design or TENS was not delivered using appropriate TENS technique. The types of acute pain included in this Cochrane Review were procedural pain, e.g. cervical laser treatment, venepuncture, screening flexible sigmoidoscopy and non‐procedural pain, e.g. postpartum uterine contractions and rib fractures. We pooled data for pain intensity for six trials (seven comparisons) comparing TENS with placebo but the I2 statistic suggested substantial heterogeneity. Mean difference (MD) with 95% confidence intervals (CIs) on a visual analogue scale (VAS, 100 mm) was ‐24.62 mm (95% CI ‐31.79 to ‐17.46) in favour of TENS. Data for the proportion of participants achieving ≥ 50% reduction in pain was pooled for four trials (seven comparisons) and relative risk was 3.91 (95% CI 2.42 to 6.32) in favour of TENS over placebo. We pooled data for pain intensity from five trials (seven comparisons) but the I2 statistic suggested considerable heterogeneity. MD was ‐19.05 mm (95% CI ‐27.30 to ‐10.79) in favour of TENS using a random‐effects model. It was not possible to pool other data. There was a high risk of bias associated with inadequate sample sizes in treatment arms and unsuccessful blinding of treatment interventions. Seven trials reported minor adverse effects, such as mild erythema and itching underneath the electrodes and participants disliking TENS sensation.
This Cochrane Review update includes seven new trials, in addition to the 12 trials reviewed in the first update in 2011. The analysis provides tentative evidence that TENS reduces pain intensity over and above that seen with placebo (no current) TENS when administered as a stand‐alone treatment for acute pain in adults. The high risk of bias associated with inadequate sample sizes in treatment arms and unsuccessful blinding of treatment interventions makes definitive conclusions impossible. There was incomplete reporting of treatment in many reports making replication of trials impossible.
Mark I Johnson, Carole A Paley, Tracey E Howe, Kathleen A Sluka
Plain language summary
Transcutaneous Electrical Nerve Stimulation (TENS) to treat acute pain in adults
Acute pain is pain of recent onset and limited duration. Acute pain is associated with surgery, physical trauma (e.g. broken bones, burns and cuts) and medical procedures (e.g. venepuncture and sigmoidoscopy). Transcutaneous Electrical Nerve Stimulation (TENS) is a treatment to relieve pain by administering mild electrical currents to the body using electrode pads attached to the surface of the skin.
Does TENS relieve acute pain in adults?
We included 19 clinical trials published up to 3 December 2014, which examined 1346 people. The trials administered TENS to produce a strong non painful 'tingling' sensation at the site of acute pain. The trials assessed TENS for cervical laser treatment, venepuncture, sigmoidoscopy, rib fractures and uterine contractions after childbirth. We did not include trials that assessed TENS for pain associated with childbirth, dental procedures and menstruation because they have been the subject of other Cochrane Reviews. Eleven trials are awaiting classification.
TENS was better than placebo TENS (delivering no electrical current) at reducing the intensity of acute pain but the reduction in pain was not consistent across all trials. This finding was based on an analysis of only six of the 19 trials. There was an insufficient number patients to make a firm conclusion.
A small number of patients experienced itching and redness beneath the TENS pads or disliked the sensation produced by TENS.
Overall we concluded that TENS may reduce the intensity of acute pain in some patients but the quality of evidence was weak. TENS is inexpensive, safe and can be self‐administered. We recommended that TENS should be considered as a treatment option given on its own or in combination with other treatments.
Quality of the evidence
The quality of the evidence was moderate to low because sample sizes were small and some patients were aware that they were receiving TENS or placebo.
Mark I Johnson, Carole A Paley, Tracey E Howe, Kathleen A Sluka
Implications for practice
In this update we identified seven additional trials to the 12 trials reviewed in 2011. The analysis of 19 RCTs with 1346 participants provides tentative evidence that TENS reduces pain intensity over and above that seen with placebo (no current) TENS when administered as a stand‐alone treatment for acute pain in adults. However, the high risk of bias associated with inadequate sample sizes in treatment arms and unsuccessful blinding of treatment interventions makes definitive conclusions impossible. The additional analyses conducted in this second update strengthen evidence presented in Walsh 2009. Whether TENS should be considered as a potential treatment option for patients and clinicians managing acute pain remains a matter for debate, although TENS compares favourably to many alternatives because it can be self‐administered, safe, inexpensive and readily available to patients over the counter.
Implications for research
There was incomplete reporting of treatment in many reports, making replication of trials impossible. Further adequately powered research trials are required to provide a comprehensive assessment of the role of TENS as a sole treatment in acute pain management. Bennett 2011 has provided criteria and operational guidelines for the design of a robust RCT on TENS. PaPaS guidance suggests that a sample size of ≥ 200 participants per treatment arm is necessary for a low risk of bias in RCTs. The Consolidated Standards of Reporting Trials (CONSORT) statement has been revised for non‐pharmacological treatments (Boutron 2008); this should be adopted to ensure better reporting of all aspects of trial design and subsequent reporting. In particular, appropriate sequence generation and allocation concealment methods should be used and reported. Sample size calculations should be performed to determine appropriate participant numbers. Complete details of the TENS application should be provided to allow subgroup analysis between trials. Appropriate TENS technique should be used including a strong non‐painful TENS sensation at the site of pain. A clear description of missing data and how they are analysed is required. Outcome assessor blinding should be adopted as a key element of future trial design. Blinding of participants is accepted as a challenge in TENS trials but should be addressed nevertheless. Finally, future trials should adopt a common policy of reporting means and SDs for continuous data to enable data extraction for subsequent meta‐analysis.