Impact of transcutaneous electrical nerve stimulation on sleep in chronic low back pain: a real-world retrospective cohort study

Shai N Gozani, Thomas C Ferree, Martin Moynihan, Xuan Kong, Shai N Gozani, Thomas C Ferree, Martin Moynihan, Xuan Kong

Abstract

Objective: The purpose of this study was to determine if transcutaneous electrical nerve stimulation (TENS) improves sleep in chronic low back pain (CLBP).

Background: There is uncertainty over the effectiveness of TENS in CLBP. In most studies, pain intensity has been the primary outcome measure. Although sleep abnormalities are common in CLBP, sleep outcomes have not been evaluated in most studies of TENS effectiveness. Subjective and objective sleep measures are often inconsistent in CLBP, suggesting that perception of sleep and actual sleep may differ.

Methods: This retrospective cohort study evaluated TENS for CLBP over 10 weeks. The source database included demographics, pain characteristics, pain intensity and interference on an 11-point numerical rating scale, adherence and actigraphic sleep data from real-world TENS users. Key inclusion criteria were CLBP with self-reported history of back injury and baseline pain interference with sleep ≥4. Study participants were stratified into improved and unimproved groups based on changes in pain interference with sleep (improved ≥1-point decrease). Actigraphic sleep metrics were compared between the two groups for weeks 1-2 and weeks 9-10.

Results: The inclusion criteria were met by 554 TENS users. There were 282 (50.9%) participants in the improved group and 272 (49.1%) in the unimproved group. The two groups had similar baseline characteristics and high TENS adherence. At the weeks 1-2 assessment, there were no differences among actigraphic sleep. At the weeks 9-10 assessment, there was a difference in total sleep time, with the improved group sleeping 29 minutes longer. In addition, the periodic leg movement (PLM) index was lower in the improved group.

Conclusion: Regular TENS improved self-reported and objective sleep measures in individuals with CLBP. When compared to the unimproved group, the improved group had longer total sleep time and fewer PLMs. Sleep may be an important outcome for TENS effectiveness in CLBP.

Keywords: actigraphy; chronic low back pain; chronic pain; periodic leg movements; sleep; total sleep time; transcutaneous electrical nerve stimulation.

Conflict of interest statement

Disclosure SNG, TCF, MM, and XK are employees and shareholders of NeuroMetrix, Inc. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
Schematic illustrating timing of pain ratings, actigraphic sleep assessments and therapy evaluation period for study participants.

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