Test-Retest reliability and concurrent validity of novel nerve testing device for thermal detection and thermal pain thresholds

Figures & data

Table 1. Results mean (SD) in °C of all Trials.

Test	Prototype T1	Prototype T2	TSA-2 Trial
WDT	32.27 (1.68)	32.65 (2.05)	34.39 (0.63)
CD	26.18 (1.86)	26.23 (1.77)	29.88 (0.87)
HPT	40.71 (2.19)	40.95 (2.44)	42.14 (1.85)
CPT	16.57 (5.07)	17.66 (5.26)	16.79 (10.72)

Notes: T1, prototype testing trial one; T2, prototype testing trial two; TSA, Medoc TSA-2, Advanced Thermosensory Stimulator, Israel; WDT, warm detection threshold; CDT, cold detection threshold; HPT, heat pain threshold; CPT, Cold Pain Threshold.

Table 2. Test-Retest reliability results.

Parameter	Difference (T1–T2)			ICC			SEM (%) (˚C)	LoA (°C)
	Mean Difference ± SD (°C)	95% CI of mean (°C)	p	ICC	p	Lower LoA to Upper LoA		Lower LoA to Upper LoA
WDTlog	0.00 ± 0.03	−0.03 to 0.02	0.600	0.54	0.140	−1.09–0.88	0.02 (4%)	−0.06 to +0.05
CDTlog	0.00 ± 0.04	−0.03 to 0.03	0.939	0.29	0.322	−3.11–0.82	0.03 (5%)	−0.08 to +0.08
HPT	−0.24 ± 2.25	−1.85 to 1.37	0.742	0.71	0.047*	−0.26–0.93	1.22 (3%)	−4.67 to +4.18
CPT	−1.08 ± 3.35	−3.48 to 1.31	0.332	0.88	0.002*	0.56–0.97	1.74 (10%)	−7.64 to +5.47

Notes: Level of significance: *p ≤ 0.05; T1, Trial one with prototype; T2, Trial two with prototype; WDT, warm detection threshold; CDT, cold detection threshold; HPT, heat pain threshold; CPT, Cold Pain Threshold; SD, standard deviation; CI, confidence interval; ICC, intraclass correlation coefficient; LoA, limits of agreement according to Bland and Altman [30]; SEM, standard error of measurement.

Figure 1. Bland-Altman Plot for prototype trials. Notes: (A)WDT Prototype Trail 1 compared to Prototype Trial 2; (B) CDT Prototype Trail 1 compared to Prototype Trial 2; (C) HPT Prototype Trail 1 compared to Prototype Trial 2; (D) CPT Prototype Trail 1 compared to Prototype Trial 2; The middle horizontal red line represents the mean difference between prototype trial 1 and prototype trial 2; upper and lower blue lines indicate upper and lower limits of agreement, mean difference ±1.96× SD. CDT, cold detection threshold; WDT, warm detection threshold; HPT, heat pain threshold; CPT, cold pain threshold.

Table 3. Oneway ANOVA and Post Hoc Analysis Results for Prototype Trials Compared to TSA-2 Trial.

Test (TSA-2 trials)	Group	Post Hoc Tukey Test TSA-2			ANOVA	Effect size
		Mean difference, °C	95% CI, °C	p	p	η2
WDT	T1	2.12	0.37 to 3.86	0.015*
	T2	1.73	−0.01 to 3.47	0.052
	Between groups				0.013*	0.276
CDT	T1	3.71	1.97 to 5.44	0.000**
	T2	3.65	1.91 to 5.39	0.000**
	Between groups				0.000**	0.576
HPT	T1	1.42	−0.99 to 3.84	0.324
	T2	1.18	−1.23 to 3.60	0.456
	Between groups				0.310	0.083
CPT	T1	0.22	−8.01 to 8.52	0.998
	T2	−0.87	−9.17 to 7.44	0.964
	Between groups				0.943	0.004

Notes: level of significance: *p ≤ 0.05, **p ≤ 0.001; T1, Trial one with prototype; T2, Trial two with prototype; WDT, warm detection threshold; CDT, cold detection threshold; HPT, heat pain threshold; CPT, Cold Pain Threshold; CI, confidence interval.

Figure 2. Bland Altman plot of differences against averages for prototype trials and TSA-2 trial with the line of best fit. Notes: (A)WDT Prototype Trial 1; (B) WDT Prototype Trial 2; (C) CDT Prototype Trial 1; (D) CDT Prototype Trial 2; (E) HPT Prototype Trial 1; (F) HPT Prototype Trial 2; (G) CPT Prototype Trial 1; (H) CPT Prototype Trial 2; The upper and lower confidence (prediction) limits for an individual at 95% confidence intervals in blue with ordinary least squares line of best fit in red. CDT, cold detection threshold; WDT, warm detection threshold; HPT, heat pain threshold; CPT, cold pain threshold.

Table 4. Limits of agreement for prototype trials with TSA-2.

Trial	Parameter	LoA
		Lower LoA –Upper LoA (°C)
Prototype T1 compared to TSA-2 Trial	WDTlog	−0.08 to +0.02
	CDTlog	−0.12 to 0.00
	HPT	−6.25 to +3.40
	CPT	−20.33 to +19.90
Prototype T2 compared to TSA-2 Trial	WDTlog	−0.07 to +0.03
	CDTlog	−0.11 to 0.00
	HPT	−7.58 to +5.21
	CPT	−19.17 to +20.91

Notes: T1, Trial one with prototype; T2, Trial two with prototype; WDT, warm detection threshold; CDT, cold detection threshold; HPT, heat pain threshold; CPT, Cold Pain Threshold; LoA, limits of agreement according to Bland and Altman [30].

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