| Literature DB >> 32260313 |
Alfonso Javier Ibáñez-Vera1, Jerónimo Carmelo García-Romero2, José Ramón Alvero-Cruz2, Rafael Lomas-Vega1.
Abstract
Monopolar dielectric radiofrequency (MDR) is a non-invasive treatment for pain based on the local application of electromagnetic signals. The study's goal was to analyze the effects of MDR on the symptoms of fibromyalgia. For this aim, a randomized controlled trial was conducted on 66 female participants (aged 47 17.7) diagnosed with fibromyalgia. Participants were randomly allocated to either an experimental group (n = 23), which received eight 20-minute sessions of MDR; a sham group, which received the same number of sessions of a sham MDR therapy (n = 22); or a control group (n = 21), which received usual care. The outcome variables included pain measured by the visual analogue scale (VAS), score on the hospital anxiety and depression scale (HADS) and quality of life measured by the combined index of fibromyalgia severity (ICAF). A large effect size was observed for the local pain (R2 = 0.46), total ICAF (R2 = 0.42) and ICAF physical factor scores (R2 = 0.38). Significant mean differences were found for the local pain (p = 0.025) and ICAF physical factor (p = 0.031) scores of the experimental group in comparison with the sham group. No statistically significant differences between groups were found in HADS. In conclusion, MDR is more effective than either sham treatment or usual care in the short-term improvement of pain and the physical wellbeing of participants with fibromyalgia.Entities:
Keywords: electromagnetic radiation; fibromyalgia; pain; quality of life
Mesh:
Year: 2020 PMID: 32260313 PMCID: PMC7177294 DOI: 10.3390/ijerph17072465
Source DB: PubMed Journal: Int J Environ Res Public Health ISSN: 1660-4601 Impact factor: 3.390
Figure 1Flow diagram depicting flow of participants through each stage of the trial.
Figure 2Application of monopolar dielectric electromagnetic signals (MDR) on the upper trapezius region.
Sociodemographic characteristics of the sample and baseline comparability of the groups.
| Outcomes | All | Control Group | Sham Group | Experimental Group | ANOVA | ||||
|---|---|---|---|---|---|---|---|---|---|
| Mean | SD | Mean | SD | Mean | SD | Mean | SD | ||
| 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 |
SD: standard deviation; Pain_G: general pain; Pain_L: local pain at upper trapezious; ICAF_T: total ICAF score; ICAF_PF: ICAF Physical Factor; ICAF_EF: ICAF Emotional Factor; ICAF_AC: ICAF Active Coping; ICAF_PC: ICAF Passive Coping.
Scores of the groups in the outcomes variables and results of the analysis of covariance using height as a covariable.
| Variable | Group | Pre | Post | |||||
|---|---|---|---|---|---|---|---|---|
| Mean | SD | Mean | SD | 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 | ||||
Pre: before treatment measures; Post: after treatment measures; SD: standard deviation; R2: effect size; Pain_G: general pain; Pain_L: local pain at upper trapezious; ICAF_T: total ICAF score; ICAF_PF: ICAF Physical Factor; ICAF_EF: ICAF Emotional Factor; ICAF_AC: ICAF Active Coping; ICAF_PC: ICAF Passive Coping.
Within-group differences of the variables.
| Outcomes | Control Group | Sham Group | Experimental Group | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | Lower | Upper | Mean | Lower | Upper | Mean | Lower | Upper | ||||
| 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 |
Pain_G: general pain; Pain_L: local pain at upper trapezius; ICAF_T: total ICAF score; ICAF_PF: ICAF Physical Factor; ICAF_EF: ICAF Emotional Factor; ICAF_AC: ICAF Active Coping; ICAF_PC: ICAF Passive Coping; Lower: lower limit; Upper: upper limit.
Between-group differences of the outcome variables.
| Outcome | Experimental Group vs. | Mean Difference | Standard Error | 95 % Confidence Interval for Mean Difference | ||
|---|---|---|---|---|---|---|
| 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 | |
Pain_G: general pain; Pain_L: local pain at upper trapezious; ICAF_T: total ICAF score; ICAF_PF: ICAF; Physical Factor; ICAF_EF: ICAF Emotional Factor; ICAF_AC: ICAF Active Coping; ICAF_PC: ICAF Passive Coping.