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J Pain Res. 2016 Jun 28;9:469-79. doi: 10.2147/JPR.S111035. eCollection 2016.

Fixed-site high-frequency transcutaneous electrical nerve stimulation for treatment of chronic low back and lower extremity pain.

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1
NeuroMetrix, Inc., Waltham, MA, USA.

Abstract

OBJECTIVE:

The objective of this study was to determine if fixed-site high-frequency transcutaneous electrical nerve stimulation (FS-TENS) is effective in treating chronic low back and lower extremity pain.

BACKGROUND:

Transcutaneous electrical nerve stimulation is widely used for treatment of chronic pain. General-purpose transcutaneous electrical nerve stimulation devices are designed for stimulation anywhere on the body and often cannot be used while the user is active or sleeping. FS-TENS devices are designed for placement at a pre-determined location, which enables development of a wearable device for use over extended time periods.

METHODS:

Study participants with chronic low back and/or lower extremity pain self-administered an FS-TENS device for 60 days. Baseline, 30-, and 60-day follow-up data were obtained through an online questionnaire. The primary outcome measure was the patient global impression of change. Pain intensity and interference were assessed using the Brief Pain Inventory. Changes in use of concomitant pain medications were evaluated with a single-item global self-rating.

RESULTS:

One hundred and thirty participants were enrolled, with 88 completing the 60-day follow-up questionnaire. Most participants (73.9%) were 50 years of age or older. At baseline, low back pain was identified by 85.3%, lower extremity pain by 71.6%, and upper extremity pain by 62.5%. Participants reported widespread pain, at baseline, with a mean of 3.4 (standard deviation 1.1) pain sites. At the 60-day follow-up, 80.7% of participants reported that their chronic pain had improved and they were classified as responders. Baseline characteristics did not differentiate non-responders from responders. There were numerical trends toward reduced pain interference with walking ability and sleep, and greater pain relief in responders. There was a large difference in use of concomitant pain medications, with 80.3% of responders reporting a reduction compared to 11.8% of non-responders.

CONCLUSION:

FS-TENS is a safe and effective option for treating chronic low back and lower extremity pain. These results motivate the use of FS-TENS in development of wearable analgesic devices.

KEYWORDS:

chronic pain; patient global impression of change; transcutaneous electrical nerve stimulation; wearable

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