Effect of Percutaneous Electric Stimulation with High-Frequency Alternating Currents on the Sensory-Motor System of Healthy Volunteers: A Double-Blind Randomized Controlled Study
Abstract
:1. Introduction
2. Methods
2.1. Design
2.2. Subjects
2.3. Intervention
2.4. Outcome Measures
2.4.1. Maximum Isometric Finger Flexion Strength and Myotonometry
2.4.2. Mechanical Detection Threshold and Pressure Pain Threshold
2.4.3. Antidromic Sensory Nerve Action Potential (SNAP)
2.4.4. Temperature of Forearm and Arm
2.4.5. Adverse Effects and Subjective Perception
2.5. Assessment of Blinding Success
2.6. Statistical Analysis
3. Results
3.1. Maximum Isometric Finger Flexion Strength and Myotonometry
3.2. Pressure Pain Threshold and Mechanical Detection Threshold
3.3. Antidromic Sensory Nerve Action Potential (SNAP) and Temperature
3.4. Subjective Variables and Adverse Effects
3.5. Blinding Assessment
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Outcomes | All Participants (n = 60) | 10 kHz Group (n = 20) | 20 kHz Group (n = 20) | Sham Group (n = 20) | Between Groups Differences (p Value) |
---|---|---|---|---|---|
Age (years) Mean (SD) | 21.6 (3.4) | 22.9 (4.8) | 20.8 (1.9) | 21.0 (2.5) | (p = 0.09) a |
Gender (Male) n (%) | 26 (43.3%) | 11(45.0%) | 9(55.0%) | 6 (30.0 %) | (p = 0.28) b |
Weight (kg) Mean (SD) | 67.5 (13.2) | 71.7 (15.7) | 65.2 (11.6) | 65.5 (11.6) | (p = 0.21) a |
Height (m) Mean (SD) | 1.70 (0.09) | 1.74 (0.10) | 1.69 (0.07) | 1.68 (0.09) | (p = 0.09) a |
Body mass index(kg/m2) Mean (SD) | 23.2 (3.2) | 23.7 (3.9) | 22.6 (3.3) | 23.2 (2.4) | (p = 0.56) a |
Nondominant hand (Left) n (%) | 57 (95.0%) | 19(95.0%) | 20(100.0%) | 18 (90.0 %) | (p = 0.77) c |
Outcomes | Sham Group | 10 kHz Group | 20 kHz Group | ||||||
---|---|---|---|---|---|---|---|---|---|
% Mean (CI95%) | During Minus Pre | Post 0 Minus Pre | Post 15 Minus Pre | During Minus Pre | Post 0 Minus Pre | Post 15 Minus Pre | During Minus Pre | Post 0 Minus Pre | Post 15 Minus Pre |
Strength | NA | −1.1 (−7.5 to 5.2) | −3.5 (−11.3 to 4.2) | NA | −8.5 (−14.9 to −2.1) p = 0.002 | −9.5 (−17.3 to −1.8) p = 0.004 | NA | −12.0 (−18.3 to −5.6) p < 0.001 | −11.5 (−9.3 to −3.8) p = 0.002 |
Myotonometry Frequency | 1.7 (−3.7 to 7.0) | 0.4 (−4.4 to 5.1) | 1.6 (−2.7 to 6.0) | 6.8 (1.3 to 12.3) p = 0.009 | 3.8 (−1.1 to 8.6) | 3.1 (−1.4 to 7.5) | 4.3 (−1.4 to 10.0) | 7.1 (2.1 to 12.1) p = 0.002 | 6.7 (2.1 to 11.3) p = 0.001 |
Myotonometry Decrement | −1.6 (−11.5 to 8.2) | 0.8 (−7.9 to 9.6) | 3.6 (−4.7 to 12.0) | 10.1 (0.1 to 20.2) p = 0.0049 | 7.5 (−1.4 to 16.5) | 11.0 (2.4 to 19.5) p = 0.006 | 2.4 (−8.0 to 12.7) | 3.9 (−5.4 to 13.1) | 6.3 (−2.5 to 15.1) |
Myotonometry Stiffness | 4.7 (−1.1 to 10.4) | 2.6 (−2.5 to 7.8) | 2.5 (−2.5 to 7.4) | 10.7 (4.8 to 16.6) p < 0.001 | 6.3 (1.0 to 11.6) p = 0.011 | 2.4 (−2.7 to 7.5) | 4.7 (−1.4 to 10.7) | 8.5 (3.1 to 13.9) p < 0.001 | 8.0 (2.8 to 13.2) p < 0.001 |
Pain Pressure Threshold | −6.5 (−20.2 to 8.1) | −6.2 (−17.9 to 5.5) | −7.4 (−20.1 to 5.3) | −7.9 (−22.1 to 6.2) | −0.7 (−12.4 to 11.0) | −2.6 (−15.3 to 10.0) | −4.6 (−18.8 to 9.5) | −5.6 (−17.2 to 6.1) | −4.3 (−16.9 to 8.4) |
Amplitude SNAP | NA | 29.0 (−9.1 to 67.2) | 26.5 (−7.5 to 60.5) | NA | 21.8 (−16.4 to 59.9) | 20.9 (−13.1 to 54.9) | NA | 31.2 (−6.9 to 69.3) | 10.1 (−23.9 to 44.1) |
Nerve Speed Conduction | NA | −5.5 (−14.2 to 3.3) | −6.1 (−15.1 to 2.9) | NA | −0.1 (−8.9 to 8.7) | −0.4 (−9.4 to 8.6) | NA | −2.0 (−10.8 to 6.7) | −5.5 (−14.5 to 3.5) |
Forearm Temperature | 0.8 (−2.3 to 3.8) | 0.7 (−1.8 to 3.3) | 0.8 (−2.2 to 3.9) | −1.6 (−4.6 to 1.5) | −1.4 (−3.9 to 1.2) | −2.1 (−5.2 to 1.0) | 1.2 (−1.8 to 4.3) | 0.9 (−1.7 to 3.4) | 0.6 (−2.5 to 3.7) |
Hand Temperature | −2.4 (−7.5 to 2.7) | −2.7 (−7.1 to 1.6) | −4.1 (−9.2 to 1.0) | −3.1 (−8.2 to 2.0) | −2.1 (−6.4 to 2.2) | −3.3 (−8.5 to 1.8) | −1.4 (−6.5 to 3.7) | −2.3 (−6.7 to 2.0) | −4.1 (−9.3 to 1.0) |
Outcomes | Change Sham minus Change 10 kHz | Change Sham minus Change 20 kHz | Change 10 kHz minus Change 20 kHz | ||||||
---|---|---|---|---|---|---|---|---|---|
% Mean (CI95%) | During Intervention | Post 0 min | Post 15 min | During Intervention | Post 0 min | Post 15 min | During Intervention | Post 0 min | Post 15 min |
Strength | NA | −7.3 (−16.4 to 1.7) | −6.0 (−17.0 to 5.0) | NA | −10.8 (−19.8 to −1.8) p = 0.01 | −8.0 (−19.0 to 3.0) | NA | −3.5 (−12.5 to 5.5) | −2.0 (−13.0 to 8.9) |
Myotonometry Frequency | 5.1 (−1.8 to 12.1) | 3.4 (−2.7 to 9.5) | 1.5 (−4.1 to 7.1) | 2.6 (−4.4 to 9.7) | 6.7 (0.5 to 12.9) p = 0.03 | 5.1 (−0.6 to 10.8) | −2.5 (−9.6 to 4.7) | 3.3 (−2.9 to 9.6) | 3.6 (−2.1 to 9.4) |
Myotonometry Decrement | 11.8 (−1.0 to 24.5) | 6.7 (4.6 to 18.0) | 7.3 (−3.5 to 18.2) | 4.0 (−8.9 to 16.9) | 3.0 (−8.4 to 14.5) | 2.7 (−8.3 to 13.6) | −7.7 (−20.8 to 5.3) | −3.7 (−15.3 to 7.9) | −4.7 (−15.8 to 6.4) |
Myotonometry Stiffness | 6.1 (−1.4 to 13.5) | 3.7 (−3.0 to 10.3) | −0.1 (−6.5 to 6.3) | −0.02 (−7.5 to 7.5) | 5.8 (−0.9 to 12.5) | 5.5 (−0.9 to 12.0) | −6.0 (−13.7 to 1.6) | 2.2 (−4.6 to 9.0) | 5.6 (−0.9 to 12.2) |
Pressure Pain Threshold | −1.9 (−20.0 to 16.2) | 5.5 (−9.4 to 20.4) | 7.0 (−9.3 to 23.3) | 1.4 (16.6 to 19.5) | 0.7 (−16.6 to 14.3) | 9.7 (−6.6 to 26.0) | 3.3 (−14.7 to 21.4) | −4.9 (−19.8 to 10.5) | 2.7 (−13.6 to 19.0) |
Amplitude SNAP | NA | −7.3 (−61.2 to 46.7) | −5.5 (−53.7 to 42.6) | NA | 2.1 (−51.8 to 56.1) | −16.4 (−64.5 to 31.7) | NA | 9.4 (−44.5 to 63.3) | −10.9 (−59.0 to 37.3) |
Nerve Speed Conduction | NA | 5.4 (−7.0 to 17.8) | −3.6 (−81.1 to 73.9) | NA | −3.4 (−15.8 to 9.0) | −16.6 (−94.1 to 61.0) | NA | −1.9 (−14.3 to 10.5) | −13.0 (−90.5 to 64.6) |
Forearm Temperature | −2.3 (−6.2 to 1.5) | −2.7 (−5.3 to 1.2) | −2.9 (−6.9 to 1.09 | 0.5 (−3.4 to 4.3) | 0.1 (−3.1 to 3.4) | −0.2 (−4.1 to 3.7) | 2.8 (−1.1 to 6.7) | 2.2 (−1.1 to 5.5) | 2.7 (−1.2 to 6.6) |
Hand Temperature | −0.7 (−7.2 to 5.8) | 0.7 (−4.9 to 6.2) | 0.8 (−5.7 to 7.4) | 1.1 (−5.4 to 7.6) | 0.4 (−5.1 to 6.0) | −0.001 (−6.6 to 6.5) | 1.7 (−4.8 to 8.2) | −0.2 (−5.8 to 5.3) | −0.8 (−7.4 to 5.7) |
n (%) | 10 kHz (n = 20) | 20 kHz (n = 20) | Sham Stimulation (n = 20) | p Value (a)(b) |
---|---|---|---|---|
Pain sensation | 0 (0%) | 1 (5%) | 0 (0%) | p = 0.36 |
Numbness | 8 (40%) | 4 (20%) | 3 (15%) | p = 0.15 |
Cold sensation | 8 (40%) | 5 (25%) | 0 (0%) | p = 0.34 |
Loss strength | 8 (40%) | 8 (40%) | 2 (10%) | p = 0.057 |
Heaviness sensation | 2 (10%) | 5 (25%) | 4 (20%) | p = 0.37 |
Tingle sensation | 5 (25%) | 1 (5%) | 0 (0%) | p = 0.02 |
Inflammation | 0 (0%) | 0 (0%) | 0 (0%) | NA |
Erythema | 0 (0%) | 0 (0%) | 0 (0%) | NA |
Hot sensation | 0 (0%) | 0 (0%) | 0 (0%) | NA |
Mean (SD) | 10 kHz (n = 20) | 20 kHz (n = 20) | Sham Stimulation (n = 20) | p Value (c) |
Pain intervention (0–10) | 4.95 (1.9) | 3.45 (1.9) | 3.2 (1.8) | 0.19 |
Unpleasant (0–10) | 4.75 (2.1) | 4.5 (2.0) | 4.5 (1.6) | 0.87 |
Participants Results | ||||
---|---|---|---|---|
Methods | Index | p-value | 95% confidence interval | Conclusion |
James | 0.44 | 0.098 | 0.37 to 0.51 | Blinded |
Bang − Active/2 × 5 | 0.8 | 0 | 0.72 to 0.87 | Unblinded |
Bang − Placebo/2 × 5 | −0.72 | 1 | −0.92 to −0.53 | Opposite Guess * |
Assessor Results | ||||
Methods | Index | p-value | 95% confidence interval | Conclusion |
James | 0.35 | <0.001 | 0.24 to 0.45 | Unblinded |
Bang − Active/2 × 5 | 0.52 | <0.001 | 0.36 to 0.69 | Unblinded |
Bang − Placebo/2 × 5 | 0.47 | <0.001 | 0.25 to 0.70 | Unblinded |
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Álvarez, D.M.-C.; Serrano-Muñoz, D.; Fernández-Pérez, J.J.; Gómez-Soriano, J.; Avendaño-Coy, J. Effect of Percutaneous Electric Stimulation with High-Frequency Alternating Currents on the Sensory-Motor System of Healthy Volunteers: A Double-Blind Randomized Controlled Study. J. Clin. Med. 2022, 11, 1832. https://doi.org/10.3390/jcm11071832
Álvarez DM-C, Serrano-Muñoz D, Fernández-Pérez JJ, Gómez-Soriano J, Avendaño-Coy J. Effect of Percutaneous Electric Stimulation with High-Frequency Alternating Currents on the Sensory-Motor System of Healthy Volunteers: A Double-Blind Randomized Controlled Study. Journal of Clinical Medicine. 2022; 11(7):1832. https://doi.org/10.3390/jcm11071832
Chicago/Turabian StyleÁlvarez, David Martín-Caro, Diego Serrano-Muñoz, Juan José Fernández-Pérez, Julio Gómez-Soriano, and Juan Avendaño-Coy. 2022. "Effect of Percutaneous Electric Stimulation with High-Frequency Alternating Currents on the Sensory-Motor System of Healthy Volunteers: A Double-Blind Randomized Controlled Study" Journal of Clinical Medicine 11, no. 7: 1832. https://doi.org/10.3390/jcm11071832