Effects of Monopolar Dielectric Radiofrequency Signals on the Symptoms of Fibromyalgia: A Single-Blind Randomized Controlled Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Design
2.2. Intervention
2.3. Outcome Measures
2.3.1. Pain
2.3.2. Quality of Life
2.3.3. Mood
2.3.4. Other measures
2.4. Statistical Analysis
3. Results
4. Discussion
5. Conclusions
Author Contributions
Funding
Conflicts of Interest
References
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Outcomes | All | Control Group | Sham Group | Experimental Group | ANOVA | ||||
---|---|---|---|---|---|---|---|---|---|
Mean | SD | Mean | SD | Mean | SD | Mean | SD | p-Value | |
Age | 49.00 | 7.17 | 50.63 | 6.69 | 47.78 | 6.32 | 48.57 | 8.25 | 0.461 |
Height | 1.64 | 0.05 | 1.64 | 0.04 | 1.67 | 0.03 | 1.62 | 0.05 | 0.003 |
Weight | 65.47 | 4.11 | 65.05 | 4.03 | 64.89 | 2.14 | 66.33 | 5.33 | 0.485 |
BMI | 24.39 | 2.40 | 24.36 | 2.40 | 23.29 | 1.20 | 25.36 | 2.81 | 0.024 |
Years diagnosed | 6.58 | 2.53 | 6.43 | 2.66 | 6.82 | 2.08 | 6.48 | 2.87 | 0.861 |
Pain_G | 6.80 | 1.62 | 6.57 | 1.33 | 7.09 | 1.93 | 6.74 | 1.57 | 0.567 |
Pain_L | 6.86 | 2.07 | 6.76 | 1.81 | 6.36 | 2.66 | 7.43 | 1.53 | 0.218 |
HADS | 28.20 | 6.31 | 29.29 | 5.39 | 27.20 | 8.91 | 28.09 | 4.16 | 0.576 |
ICAF_T | 20.99 | 10.18 | 18.72 | 11.83 | 22.98 | 8.00 | 21.16 | 10.45 | 0.395 |
ICAF_PF | 60.52 | 11.78 | 55.86 | 14.74 | 64.55 | 8.08 | 60.91 | 10.64 | 0.050 |
ICAF_EF | 23.42 | 10.40 | 20.71 | 12.17 | 25.18 | 7.26 | 24.22 | 11.13 | 0.340 |
ICAF_AC | 67.64 | 26.89 | 61.52 | 25.86 | 72.64 | 21.59 | 68.43 | 31.96 | 0.399 |
ICAF_PC | 37.70 | 15.43 | 35.10 | 17.08 | 40.91 | 12.05 | 37.00 | 16.79 | 0.456 |
Variable | Group | Pre | Post | |||||
---|---|---|---|---|---|---|---|---|
Mean | SD | Mean | SD | p-Value | R2 | Power | ||
Pain_G | Control | 6.57 | 1.33 | 6.67 | 1.49 | 0.001 | 0.254 | 0.953 |
Sham | 7.09 | 1.93 | 6.64 | 1.87 | ||||
Experimental | 6.74 | 1.57 | 4.91 | 2.43 | ||||
Pain_L | Control | 6.76 | 1.81 | 7.33 | 1.35 | <0.001 | 0.455 | 1.000 |
Sham | 6.36 | 2.66 | 5.91 | 2.11 | ||||
Experimental | 7.43 | 1.53 | 3.61 | 2.62 | ||||
HADS | Control | 29.29 | 5.39 | 32.35 | 5.49 | 0.456 | 0.032 | 0.179 |
Sham | 27.20 | 8.91 | 29.00 | 5.40 | ||||
Experimental | 28.09 | 4.16 | 31.91 | 4.69 | ||||
ICAF_T | Control | 18.72 | 11.83 | 18.05 | 10.63 | <0.001 | 0.422 | 1.000 |
Sham | 22.98 | 8.00 | 17.07 | 6.92 | ||||
Experimental | 21.16 | 10.45 | 9.61 | 11.05 | ||||
ICAF_PF | Control | 55.86 | 14.74 | 56.33 | 14.21 | <0.001 | 0.381 | 0.999 |
Sham | 64.55 | 8.08 | 53.82 | 12.34 | ||||
Experimental | 60.91 | 10.64 | 41.17 | 16.24 | ||||
ICAF_EF | Control | 20.71 | 12.17 | 19.57 | 12.31 | <0.001 | 0.284 | 0.976 |
Sham | 25.18 | 7.26 | 18.55 | 6.62 | ||||
Experimental | 24.22 | 11.13 | 14.17 | 8.54 | ||||
ICAF_AC | Control | 61.52 | 25.86 | 60.43 | 20.23 | 0.032 | 0.131 | 0.651 |
Sham | 72.64 | 21.59 | 67.55 | 26.13 | ||||
Experimental | 68.43 | 31.96 | 77.39 | 25.32 | ||||
ICAF_PC | Control | 35.10 | 17.08 | 31.81 | 17.20 | 0.076 | 0.100 | 0.513 |
Sham | 40.91 | 12.05 | 44.18 | 12.55 | ||||
Experimental | 37.00 | 16.79 | 29.65 | 17.22 |
Outcomes | Control Group | Sham Group | Experimental Group | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Mean | Lower | Upper | p-Value | Mean | Lower | Upper | p-Value | Mean | Lower | Upper | p-Value | |
Pain_G | 0.26 | −0.38 | 0.89 | 0.418 | 0.09 | −0.70 | 0.88 | 0.818 | 1.81 | 1.20 | 2.42 | <0.001 |
Pain_L | −0.46 | −1.47 | 0.55 | 0.360 | 0.25 | −1.00 | 1.50 | 0.693 | 3.76 | 2.79 | 4.72 | <0.001 |
HADS | −3.29 | −7.22 | 0.65 | 0.100 | 0.31 | −4.56 | 5.19 | 0.898 | −3.44 | −7.21 | 0.33 | 0.073 |
ICAF_T | 0.10 | −2.92 | 3.13 | 0.947 | 5.88 | 2.13 | 9.62 | 0.003 | 12.40 | 9.51 | 15.30 | <0.001 |
ICAF_PF | −0.82 | −6.39 | 4.75 | 0.768 | 12.59 | 5.69 | 19.48 | 0.001 | 19.69 | 14.37 | 25.02 | <0.001 |
ICAF_EF | 0.84 | −2.50 | 4.18 | 0.616 | 7.37 | 3.24 | 11.51 | 0.001 | 10.70 | 7.50 | 13.89 | <0.001 |
ICAF_AC | 3.08 | −5.37 | 11.52 | 0.468 | 5.20 | −5.26 | 15.67 | 0.322 | −10.39 | −18.48 | −2.31 | 0.013 |
ICAF_PC | 2.94 | −2.75 | 8.63 | 0.304 | −3.05 | −10.09 | 4.00 | 0.389 | 7.75 | 2.31 | 13.19 | 0.006 |
Outcome | Experimental Group vs. | Mean Difference | Standard Error | 95 % Confidence Interval for Mean Difference | p-Value | |
---|---|---|---|---|---|---|
Upper bound | Lower bound | |||||
Pain_G | Control Group | 1.617 | 0.662 | −0.024 | 3.259 | 0.055 |
Sham Group | 1.720 | 0.798 | −0.259 | 3.698 | 0.109 | |
Pain_L | Control Group | 3.659 | 0.677 | 1.982 | 5.337 | <0.001 |
Sham Group | 2.242 | 0.816 | 0.220 | 4.263 | 0.025 | |
HADS | Control Group | 0.188 | 1.604 | −3.788 | 4.164 | 1.000 |
Sham Group | −4.720 | 1.933 | −9.513 | 0.073 | 0.055 | |
ICAF_T | Control Group | 9.259 | 3.167 | 1.407 | 17.111 | 0.016 |
Sham Group | 8.170 | 3.818 | −1.295 | 17.635 | 0.112 | |
ICAF_PF | Control Group | 15.196 | 4.345 | 4.426 | 25.966 | 0.003 |
Sham Group | 13.980 | 5.237 | 0.998 | 26.963 | 0.031 | |
ICAF_EF | Control Group | 5.992 | 3.159 | −1.839 | 13.823 | 0.191 |
Sham Group | 5.031 | 3.808 | −4.409 | 14.470 | 0.578 | |
ICAF_AC | Control Group | −16.340 | 8.119 | −36.466 | 3.785 | 0.149 |
Sham Group | −5.932 | 9.786 | −30.192 | 18.328 | 1.000 | |
ICAF_PC | Control Group | 4.265 | 5.327 | −8.940 | 17.469 | 1.000 |
Sham Group | 13.451 | 6.421 | −2.466 | 29.368 | 0.124 |
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Ibáñez-Vera, A.J.; García-Romero, J.C.; Alvero-Cruz, J.R.; Lomas-Vega, R. Effects of Monopolar Dielectric Radiofrequency Signals on the Symptoms of Fibromyalgia: A Single-Blind Randomized Controlled Trial. Int. J. Environ. Res. Public Health 2020, 17, 2465. https://doi.org/10.3390/ijerph17072465
Ibáñez-Vera AJ, García-Romero JC, Alvero-Cruz JR, Lomas-Vega R. Effects of Monopolar Dielectric Radiofrequency Signals on the Symptoms of Fibromyalgia: A Single-Blind Randomized Controlled Trial. International Journal of Environmental Research and Public Health. 2020; 17(7):2465. https://doi.org/10.3390/ijerph17072465
Chicago/Turabian StyleIbáñez-Vera, Alfonso Javier, Jerónimo Carmelo García-Romero, José Ramón Alvero-Cruz, and Rafael Lomas-Vega. 2020. "Effects of Monopolar Dielectric Radiofrequency Signals on the Symptoms of Fibromyalgia: A Single-Blind Randomized Controlled Trial" International Journal of Environmental Research and Public Health 17, no. 7: 2465. https://doi.org/10.3390/ijerph17072465