Randomized Clinical Trial of Electrostimulation Therapies as an Adjuvant for the Treatment of Temporomandibular Disorders
Abstract
:1. Introduction
2. Materials and Methods
2.1. Trial Design
2.2. Participants
2.3. Interventions
2.4. Results
2.5. Sample Size
2.6. Randomization
2.6.1. Balanced Block Randomization
2.6.2. Concealment of Allocation
2.6.3. Implementation
2.7. Blinding
2.8. Statistical Methods
3. Results
3.1. Flow of Participants
3.2. Recruitment
3.3. Reference Data
3.4. Numbers Analyzed
3.5. Results and Estimation
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Variable | Transcutaneous Electrostimulation and Occlusal Splint (n = 31) | Percutaneous Electrostimulation and Occlusal splint (n = 27) | Occlusal Splint (n = 33) | p-Value | |
---|---|---|---|---|---|
Sex | Female | 28 | 23 | 25 | 0.456 * |
Male | 8 | 4 | 5 | ||
Age | P50 (IQR) | 42 (22) | 30 (24) | 23 (7) | 0.001 + |
TMD Diagnosis | Degenerative | 5 | 3 | 10 | 0.405 * |
Painful | 18 | 15 | 17 | ||
Intra-articular | 7 | 8 | 6 | ||
BMI | Low weight | 1 | 2 | 1 | 0.096 * |
Normal | 11 | 18 | 17 | ||
Overweight | 13 | 4 | 6 | ||
Obesity | 6 | 3 | 9 | ||
Stress | Low | 2 | 6 | 3 | 0.213 * |
Slight | 12 | 12 | 16 | ||
Moderate | 15 | 9 | 14 | ||
Severe | 2 | 0 | 0 | ||
Anxiety | Very low | 14 | 21 | 20 | 0.069 * |
Moderate | 17 | 5 | 12 | ||
Severe | 0 | 1 | 1 | ||
Systemic diseases | No | 14 | 20 | 18 | 0.079 * |
Yes | 17 | 7 | 15 | ||
Drug intake | No | 11 | 19 | 17 | 0.039 * |
Yes | 19 | 8 | 16 | ||
Headache | No | 9 | 12 | 12 | 0.528 * |
Yes | 21 | 15 | 21 | ||
Joint sounds | No | 2 | 3 | 2 | 0.739 * |
Yes | 28 | 24 | 31 | ||
Mouth opening | No | 23 | 18 | 21 | 0.442 * |
Yes | 7 | 10 | 12 |
RMS | Hurst | Joint Pain | Muscle Pain | Mouth Opening | Joint Sounds | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Time | Mean | Std. Dev. | Mean | Std. Dev. | Mean | Std. Dev. | Mean | Std. Dev. | Mean | Std. Dev. | Positive Cases | |
Splint | T0 | 211.305 | 112.350 | 0.090 | 0.044 | 4.091 | 2.740 | 4.394 | 2.900 | 42.818 | 8.520 | 30 |
T1 | 199.108 | 109.820 | 0.097 | 0.068 | 3.424 | 3.130 | 4.364 | 1.980 | 43.545 | 7.770 | 30 | |
T2 | 165.294 | 93.950 | 0.094 | 0.047 | 3.818 | 2.770 | 3.424 | 2.440 | 43.970 | 7.580 | 30 | |
T3 | 205.206 | 93.110 | 0.079 | 0.067 | 2.909 | 2.630 | 2.394 | 2.190 | 45.455 | 6.500 | 30 | |
T4 | 163.345 | 93.440 | 0.079 | 0.067 | 1.970 | 2.660 | 1.545 | 1.470 | 44.758 | 6.370 | 25 | |
T5 | 155.992 | 89.720 | 0.076 | 0.059 | 1.121 | 2.140 | 1.182 | 1.870 | 45.848 | 5.780 | 25 | |
Percutaneous | T0 | 204.359 | 181.550 | 0.095 | 0.036 | 4.963 | 3.500 | 4.667 | 3.120 | 39.889 | 9.970 | 26 |
T1 | 189.746 | 143.570 | 0.108 | 0.075 | 4.481 | 3.340 | 4.259 | 3.180 | 43.185 | 9.410 | 25 | |
T2 | 73.202 | 43.340 | 0.102 | 0.041 | 3.556 | 3.550 | 4.185 | 3.250 | 43.481 | 7.990 | 26 | |
T3 | 197.035 | 55.110 | 0.099 | 0.056 | 2.630 | 2.550 | 3.148 | 3.530 | 46.704 | 6.990 | 25 | |
T4 | 87.320 | 36.620 | 0.086 | 0.035 | 2.667 | 3.150 | 2.815 | 3.180 | 45.370 | 7.020 | 20 | |
T5 | 77.350 | 135.140 | 0.082 | 0.036 | 2.667 | 3.030 | 2.630 | 3.230 | 46.963 | 5.610 | 19 | |
Transcutaneous | T0 | 151.647 | 111.960 | 0.118 | 0.047 | 4.839 | 3.150 | 5.161 | 3.950 | 43.290 | 8.790 | 29 |
T1 | 150.452 | 114.460 | 0.105 | 0.062 | 4.194 | 3.130 | 4.452 | 3.670 | 43.968 | 8.760 | 27 | |
T2 | 102.521 | 73.710 | 0.111 | 0.038 | 3.581 | 3.330 | 3.355 | 3.390 | 44.968 | 7.520 | 28 | |
T3 | 151.049 | 56.910 | 0.100 | 0.040 | 3.613 | 3.140 | 3.839 | 3.130 | 44.290 | 8.570 | 26 | |
T4 | 92.051 | 82.690 | 0.106 | 0.069 | 3.290 | 3.180 | 3.419 | 3.370 | 42.710 | 6.940 | 21 | |
T5 | 91.172 | 69.660 | 0.097 | 0.041 | 3.419 | 3.460 | 2.419 | 0.500 | 44.484 | 6.040 | 19 | |
Pr (>Chisq) by treatment | 0.014 | 0.046 | 0.278 | 0.200 | 0.897 | 0.061 | ||||||
Pr (>Chisq) by session for treatment | 0.019 | 0.947 | 0.041 | 0.200 | 0.011 | 0.213 |
Treatment | Summary | ANOVA | Bonferroni | ||||||
---|---|---|---|---|---|---|---|---|---|
RMS | Mean | Std. Dev. | Prob > F | Splint and Transcutaneous | Splint and Percutaneous | Percutaneous and Transcutaneous | |||
Dif p/Group | p-Value | Dif p/Group | p-Value | Dif p/Group | p-Value | ||||
Splint | 179.980 | 101.020 | 0.6280 | 85.377 | 1.000 | ||||
Percutaneous | 134.550 | 130.430 | −45.430 | 1.000 | |||||
Transcutaneous | 219.930 | 151.740 | 39.946 | 1 | |||||
Hurst | Mean | Std. Dev. | Prob > F | Splint and transcutaneous | Splint and percutaneous | Percutaneous and transcutaneous | |||
Dif p/group | p-value | Dif p/group | p-value | Dif p/group | p-value | ||||
Splint | 0.085 | 0.059 | 0.0013 | 0.011 | 0.194 | ||||
Percutaneous | 0.095 | 0.049 | 0.011 | 0.290 | |||||
Transcutaneous | 0.106 | 0.051 | 0.020 | 0.001 | |||||
Joint pain | Mean | Std. Dev. | Prob > F | Splint and transcutaneous | Splint and percutaneous | Percutaneous and transcutaneous | |||
Dif p/group | p-value | Dif p/group | p-value | Dif p/group | p-value | ||||
Splint | 2.790 | 2.845 | 0.012 | 0.450 | 0.443 | ||||
Percutaneous | 3.222 | 3.312 | 0.431 | 0.480 | |||||
Transcutaneous | 3.672 | 3.231 | 0.882 | 0.009 | |||||
Muscular pain | Mean | Std. Dev. | Prob > F | Splint and transcutaneous | Splint and percutaneous | Percutaneous and transcutaneous | |||
Dif p/group | p-value | Dif p/group | p-value | Dif p/group | p-value | ||||
Splint | 2.629 | 2.489 | 0.0038 | 0.351 | 0.759 | ||||
Percutaneous | 3.248 | 3.277 | 0.618 | 0.125 | |||||
Transcutaneous | 3.600 | 3.443 | 0.970 | 0.003 | |||||
Mouth opening | Mean | Std. Dev. | Prob > F | Splint and transcutaneous | Splint and percutaneous | Percutaneous and transcutaneous | |||
Dif p/group | p-value | Dif p/group | p-value | Dif p/group | p-value | ||||
Splint | 45 | 7.015 | 0.8100 | 0.487 | 1.000 | ||||
Percutaneous | 45 | 45 | −0.221 | 1.000 | |||||
Transcutaneous | 45 | 8 | 0.256 | 1.000 |
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Rodríguez, C.I.; Angeles, F.; Borges, S.A.; Llamosas, E.; Morales, J. Randomized Clinical Trial of Electrostimulation Therapies as an Adjuvant for the Treatment of Temporomandibular Disorders. Dent. J. 2024, 12, 273. https://doi.org/10.3390/dj12080273
Rodríguez CI, Angeles F, Borges SA, Llamosas E, Morales J. Randomized Clinical Trial of Electrostimulation Therapies as an Adjuvant for the Treatment of Temporomandibular Disorders. Dentistry Journal. 2024; 12(8):273. https://doi.org/10.3390/dj12080273
Chicago/Turabian StyleRodríguez, Claudia I., Fernando Angeles, Socorro A. Borges, Eduardo Llamosas, and Julio Morales. 2024. "Randomized Clinical Trial of Electrostimulation Therapies as an Adjuvant for the Treatment of Temporomandibular Disorders" Dentistry Journal 12, no. 8: 273. https://doi.org/10.3390/dj12080273