Non-invasive interactive neurostimulation (InterX™) reduces acute pain in patients following total knee replacement surgery: a randomised, controlled trial

Ashok K Nigam, Drena M Taylor, Zulia Valeyeva, Ashok K Nigam, Drena M Taylor, Zulia Valeyeva

Abstract

Background: Adequate post-operative pain relief following total knee replacement (TKR) is very important to optimal post-operative recovery. Faster mobilisation and rehabilitation ultimately results in optimum recovery outcomes, but pain is often the limiting factor. This study evaluates the potential clinical benefit of the InterX neurostimulation device on pain reduction and rehabilitative outcome.

Methods: A clinical trial under the Hywel Dda Clinical Audit Committee to validate the clinical benefit of Non-invasive Interactive Neurostimulation (NIN) therapy using the InterX device was performed in patients undergoing TKR. 61 patients were randomised to treatment groups in blocks of two from the Theatre Operation List. The control group received the standard hospital course of pain medication and rehabilitation twice daily for 3 post-op days. The experimental group received 8 sessions of NIN therapy over 3 post-op days in addition to the standard course received by the Control group. Pain and range of motion were collected as the primary study measures.

Results: Sixty one subjects were enrolled and randomised, but 2 subjects (one/group) were excluded due to missing data at Baseline/Final; one subject in the InterX group was excluded due to pre-existing rheumatoid pain conditions confounding the analysis. The experimental group pre- to post-session Verbal Rating Scale for pain (VRS) showed that NIN therapy consistently reduced the pain scores by a mean of 2.3 points (SE 0.11). The NIN pre-treatment score at Final was used for the primary ANCOVA comparison, demonstrating a significantly greater cumulative treatment effect of a mean 2.2 (SE 0.49) points pain reduction (p = 0.002). Control subjects only experienced a mean 0.34 (SE 0.49) point decrease in pain. Ninety degrees ROM was required to discharge the patient and this was attained as an average despite the greater Baseline deficit in the InterX group. Eight control patients and three experimental patients did not achieve this ROM.

Conclusions: The results clearly demonstrated the clinical benefit of NIN therapy as a supplement to the standard rehabilitation protocol. The subjects receiving InterX fared significantly better clinically. Within a relatively short 3-day period of time, patients in the experimental group obtained the necessary ROM for discharge and did it experiencing lower levels of pain than those in the control group.

Figures

Figure 1
Figure 1
A) Current Density B) Interactive Waveform Figure 1a - Current amplitude and density: TENS compared to InterX. Figure 1b - Interactive waveform.
Figure 2
Figure 2
Flexible array and device placement on operated leg.
Figure 3
Figure 3
CONSORT Chart.
Figure 4
Figure 4
VRS pain scores during joint mobilisation.
Figure 5
Figure 5
Distribution of VRS patient pain scores during flexion at Final time point. The chart shows the level of pain for each patient in the Control group and in the InterX group at both pre-NIN therapy and at post-NIN therapy. At Final post-NIN therapy, 27 of 28 patient had only Mild or No pain (0-3, VRS).
Figure 6
Figure 6
Change in VRS pain scores for severe pain sub-groups (VRS > 6). Error bars are Standard Deviation
Figure 7
Figure 7
Increase in range of motion during rehabilitation. Error bars are Standard Deviation. Figures rounded to nearest degree.

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