Implementation fidelity of self-administered transcutaneous electrical nerve stimulation (TENS) in patients with chronic back pain: an observational study.

OBJECTIVES: The efficacy of transcutaneous electrical nerve stimulation (TENS) for pain relief has not been reliably established. Inconclusive findings could be due to inadequate TENS delivery and inappropriate outcome assessment. Electronic monitoring devices were used to determine patient compliance with a TENS intervention and outcome assessment protocol, to record pain scores before, during, and after TENS, and measure electrical output settings. METHODS: Patients with chronic back pain consented to use TENS daily for 2 weeks and to report pain scores before, during, and after 1-hour treatments. A ≥ 30% reduction in pain scores was used to classify participants as TENS responders. Electronic monitoring devices "TLOG" and "TSCORE" recorded time and duration of TENS use, electrical settings, and pain scores. RESULTS: Forty-two patients consented to participate. One of 35 (3%) patients adhered completely to the TENS use and pain score reporting protocol. Fourteen of 33 (42%) were TENS responders according to electronic pain score data. Analgesia onset occurred within 30 to 60 minutes for 13/14 (93%) responders. It was not possible to correlate TENS amplitude, frequency, or pulse width measurements with therapeutic response. DISCUSSION: Findings from TENS research studies depend on the timing of outcome assessment; pain should be recorded during stimulation. TENS device sophistication might be an issue and parameter restriction should be considered. Careful protocol design is required to improve adherence and monitoring is necessary to evaluate the validity of findings. This observational study provides objective evidence to support concerns about poor implementation fidelity in TENS research.

Validation of two novel electronic devices to time-link transcutaneous electrical nerve stimulation and pain report in patients with chronic back pain.

OBJECTIVES: The analgesic effectiveness of transcutaneous electrical nerve stimulation (TENS) is uncertain. Negative findings, interpreted as ineffectiveness, might be due to poor methodological quality. Monitoring is necessary to differentiate between ineffectiveness and low implementation fidelity. Electronic data-logging devices, "TLOG" and "TSCORE," were developed to monitor and time-link TENS and pain report. TLOG records the time and duration of TENS use and output parameters; TSCORE records time-stamped pain scores. The purpose was to determine the accuracy, reliability, and acceptability of the devices. METHODS: Forty-two outpatients with chronic back pain consented to use TENS daily for 2 weeks. Treatment times and durations were recorded in paper diaries and compared with TLOG data. Using TSCORE, patients reported pain before, during, and after TENS. Pain scores, reported using TSCORE or paper numerical rating scale at the beginning and end of 2 study visits, were compared using Bland-Altman methodology. RESULTS: The mean (SD) difference between paper and TSCORE pain scores was -0.05 (0.81). Limits of agreement (mean difference ± 1.96 SD) were -1.65 to 1.55. Test-retest reliabilities of paper and TSCORE were comparable: Paper mean (SD) difference was -0.33 (0.66), limits of agreement were -1.62 to 0.96; TSCORE mean (SD) difference was -0.10 (0.31), limits were -0.7 to 0.5. TLOG recorded TENS use accurately and worked reliably for 2 weeks in 84% of cases. An overall 79% of participants preferred TSCORE to paper numerical rating scale. DISCUSSION: TLOG and TSCORE are accurate, reliable, and acceptable devices for monitoring TENS implementation fidelity and pain outcome, with potential for improving TENS research methodology and clinical application.

Postoperative wound oxygen tension with epidural or intravenous analgesia: a prospective, randomized, single-blind clinical trial.

BACKGROUND: Adequate tissue oxygen tension is an essential requirement for surgical-wound healing. The authors tested the hypothesis that epidural anesthesia and analgesia increases wound tissue oxygen tension compared with intravenous morphine analgesia. METHODS: In a prospective, randomized, blind clinical study, the authors allocated patients having major abdominal surgery (n = 32) to receive combined general and epidural anesthesia with postoperative patient-controlled epidural analgesia (epidural group, n = 16), or general anesthesia alone with postoperative patient-controlled intravenous analgesia (intravenous group, n = 16). An oxygen sensor and a temperature sensor were placed subcutaneously in the wound before closure. Wound oxygen tension (P(w)O(2)) and temperature were measured continuously for 24 h. Other variables affecting wound tissue oxygenation and visual analogue scale (VAS) pain scores were also documented. RESULTS: Despite epidural patients having lower body temperatures at the end of surgery (35.7 +/- 0.3) versus 36.3 +/- 0.5 degrees C, = 0.004), they had significantly higher mean P(w)O(2) over the 24 h period, compared with the intravenous group (64.4 +/- 14 vs. 50.7 +/- 15) mmHg, mean (SD), 95% CI difference, -22 to -5, = 0.002). Area under the P(w)O(2) -24 h time curve was also significantly higher in the epidural group (930 +/- 278 vs. 749 +/- 257) mmHg x h, 95% CI difference -344 to -18, = 0.03). VAS pain scores at rest and moving were significantly lower in the epidural group at all times. CONCLUSION: Epidural anesthesia and postoperative analgesia for major abdominal surgery increases wound tissue oxygen tension compared with general anesthesia and intravenous morphine analgesia.