A Comparison of the Effect of a 4.4-MHz Radiofrequency Deep Heating Therapy and Ultrasound on Low Back Pain: A Randomized, Double-Blind, Multicenter Trial
Abstract
:1. Introduction
2. Methods
2.1. Study Design and Participants
2.2. Random Assignment and Blinding Technique
2.3. Intervention
2.4. Outcome Measures
2.5. Sample Size Calculation
2.6. Statistical Analysis
3. Results
3.1. Baseline Characteristics
3.2. Clinical Evaluation
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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RF | US | Total | p Value | ||
---|---|---|---|---|---|
n = 62 (%) | n = 56 (%) | n = 118 | |||
Gender | Male | 13 (21.0) | 13 (23.2) | 26 (20.0) | 0.7339 |
Female | 49 (79.0) | 43 (76.8) | 92 (78.0) | ||
Age (years) | Mean ± SD | 46.5 ± 14.0 | 48.9 ± 12.5 | 47.7 ± 13.3 | 0.3038 |
19 to 39 | 22 (34.9) | 15 (23.8) | 37 (31.1) | 0.7738 | |
40 to 59 | 30 (47.6) | 31 (49.2) | 61 (51.3) | ||
60 to 70 | 11 (17.5) | 10 (15.9) | 21 (17.7) | ||
Height (cm) | Mean ± SD | 162.9 ± 6.5 | 162.2 ± 7.7 | 162.6 ± 7.1 | 0.2837 |
Weight (kg) | Mean ± SD | 59.7 ± 8.7 | 60.8 ± 8.2 | 60.2 ± 8.5 | 0.5382 |
Occupation | Employed | 20 (31.7) | 22 (39.3) | 42 (35.3) | 0.4104 |
Official | 18 (28.6) | 10 (17.8) | 28 (23.5) | ||
Homemaker | 22 (34.9) | 23 (41.1) | 45 (37.8) | ||
Other | 3 (4.8) | 1 (1.8) | 4 (3.4) |
RF (n = 62) (95% CI) | US (n = 56) (95% CI) | p Value | |
---|---|---|---|
ODI (%) | 46.06 ± 13.94 (42.52–49.60) | 44.33 ± 14.68 (40.40–48.26) | 0.5123 |
NRS | 6.21 ± 1.33 (5.87–6.55) | 5.84 ± 1.29 (5.49–6.18) | 0.1285 |
Biering–Sorensen test (s) | 16.74 ± 18.17 (12.13–21.36) | 18.53 ± 15.31 (14.39–22.66) | 0.5696 |
Up-and-go test (s) | 9.07 ± 2.38 (8.47–9.68) | 9.25 ± 2.70 (8.53–9.98) | 0.7024 |
RF (n = 62) | US (n = 56) | p Value b | p Value c | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mean | ± SD | Min | Max | 95% CI | p Value a | Mean | ± SD | Min | Max | 95% CI | p Value a | ||||
ODI (%) | Baseline | 46.06 | 13.94 | 31.11 | 75.56 | 42.52–49.60 | 44.33 | 14.68 | 31.11 | 75.56 | 40.40–48.26 | 0.512 | |||
At 4 weeks | 20.61 | 11.75 | 0.00 | 53.33 | 17.62–23.59 | <0.001 | 22.42 | 13.56 | 0.00 | 73.33 | 18.79–26.05 | <0.001 | 0.439 | ||
At 12 weeks | 19.00 | 12.06 | 0.00 | 53.33 | 15.93–22.06 | <0.001 | 20.44 | 15.21 | 0.00 | 73.33 | 16.36–24.51 | <0.001 | 0.568 | 0.367 | |
NRS | Baseline | 6.21 | 1.33 | 4.00 | 9.00 | 5.87–6.55 | 5.84 | 1.29 | 4.00 | 8.00 | 5.49–6.18 | 0.129 | |||
At 4 weeks | 3.11 | 2.00 | 0.00 | 9.00 | 2.60–3.62 | <0.001 | 3.25 | 1.75 | 0.00 | 7.00 | 2.78–3.72 | <0.001 | 0.694 | ||
At 12 weeks | 2.58 | 1.96 | 0.00 | 9.00 | 2.08–3.08 | <0.001 | 2.86 | 1.76 | 0.00 | 7.00 | 2.39–3.33 | <0.001 | 0.424 | 0.118 | |
Biering–Sorensen test (s) | Baseline | 16.74 | 18.17 | 0.00 | 88.00 | 12.13–21.36 | 18.53 | 15.31 | 0.00 | 74.00 | 14.39–22.66 | 0.570 | |||
At 4 weeks | 32.02 | 29.69 | 0.20 | 150.89 | 24.48–39.56 | <0.001 | 28.66 | 26.23 | 0.00 | 134.21 | 21.63–35.68 | 0.001 | 0.518 | ||
At 12 weeks | 33.20 | 30.09 | 0.00 | 179.81 | 25.56–40.84 | <0.001 | 29.66 | 33.37 | 0.00 | 210.00 | 20.72–38.60 | 0.004 | 0.545 | 0.521 | |
Up-and-go test (s) | Baseline | 9.07 | 2.38 | 5.60 | 17.00 | 8.47–9.68 | 9.25 | 2.70 | 4.12 | 18.00 | 8.53–9.98 | 0.702 | |||
4 weeks | 7.90 | 2.18 | 4.60 | 15.00 | 7.35–8.45 | <0.001 | 8.33 | 2.34 | 4.80 | 14.00 | 7.70–8.96 | <0.001 | 0.303 | ||
12 weeks | 8.15 | 2.40 | 5.06 | 17.00 | 7.54–8.76 | <0.001 | 8.43 | 2.42 | 4.60 | 16.00 | 7.78–9.08 | <0.001 | 0.528 | 0.669 |
RF (n = 62) | US (n = 56) | p Value | |
---|---|---|---|
N (%) | N (%) | ||
NASS at 4 weeks | |||
1 | 35 (56.45) | 28 (50.00) | |
2 | 20 (32.26) | 20 (35.71) | |
3 | 3 (4.84) | 4 (7.14) | |
4 | 0 (0.00) | 0 (0.00) | 0.783 |
NASS at 12 weeks | |||
1 | 37 (59.68) | 30 (53.57) | |
2 | 17 (27.42) | 16 (28.57) | |
3 | 4 (6.45) | 6 (10.71) | |
4 | 0 (0.00) | 0 (0.00) | 0.658 |
Pain medication administered | |||
Yes | 4 (6.45) | 14 (25.00) | |
No | 58 (93.55) | 42 (75.00) | 0.048 |
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Lee, J.H.; Do, J.G.; Park, H.J.; Lee, Y.-T.; Kim, S.J. A Comparison of the Effect of a 4.4-MHz Radiofrequency Deep Heating Therapy and Ultrasound on Low Back Pain: A Randomized, Double-Blind, Multicenter Trial. J. Clin. Med. 2022, 11, 5011. https://doi.org/10.3390/jcm11175011
Lee JH, Do JG, Park HJ, Lee Y-T, Kim SJ. A Comparison of the Effect of a 4.4-MHz Radiofrequency Deep Heating Therapy and Ultrasound on Low Back Pain: A Randomized, Double-Blind, Multicenter Trial. Journal of Clinical Medicine. 2022; 11(17):5011. https://doi.org/10.3390/jcm11175011
Chicago/Turabian StyleLee, Jung Hwan, Jong Geol Do, Hee Jin Park, Yong-Taek Lee, and Sang Jun Kim. 2022. "A Comparison of the Effect of a 4.4-MHz Radiofrequency Deep Heating Therapy and Ultrasound on Low Back Pain: A Randomized, Double-Blind, Multicenter Trial" Journal of Clinical Medicine 11, no. 17: 5011. https://doi.org/10.3390/jcm11175011