The Effect of Transcutaneous Posterior Tibial Nerve Stimulation on Pain and Quality of Life in Patients with Fibromyalgia: A Single-Blind, Randomized Controlled Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design and Participants
2.2. Randomization and Blinding
2.3. Baseline Assessment and Outcome Measures
2.4. Intervention
2.5. Sample Size and Statistical Analyses
3. Results
4. Discussion
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Group 1 (Duloxetine + TPTNS) (n = 22) | Group 2 (Duloxetine) (n = 30) | p Value | |
---|---|---|---|
Mean ± SD | Mean ± SD | ||
Age (years) | 43.18 ±12.22 | 49.43 ± 11.54 | 0.066 i |
BMI (kg/m2) | 27.71 ± 4.21 | 28.44 ± 3.84 | 0.515 i |
N (%) | N (%) | ||
Marital Status | 0.639 f | ||
Married | 19 (86.4) | 28 (93.3) | |
Single | 3 (13.6) | 2 (6.7) | |
Education | (N/A) | ||
Literate | 3 (13.6) | 0 | |
Elementary school | 9(40.9) | 16 (53.3) | |
High school | 5 (22.7) | 11 (36.7) | |
University | 5 (22.7) | 3 (10.0) | |
Smoker | 0.468 f | ||
Yes | 5 (22.7) | 4 (13.3) | |
No | 17 (77.3) | 26 (86.7) |
Group 1 (Duloxetine + TPTNS) (n = 22) | Group 2 (Duloxetine) (n = 30) | P2 Value | ||
---|---|---|---|---|
NRS activity | Baseline | 7.68 ± 1.94 | 7.57 ± 2.01 | 0.836 m |
1st month | 6.05 ± 2.13 * | 6.40 ± 1.89 * | 0.563 m | |
3rd month | 5.95 ± 2.01 * | 6.37 ± 1.79 * | 0.271 m | |
P1 value | <0.001 f | <0.001 f | ||
NRS rest | Baseline | 6.55 ± 2.18 | 6.40 ± 2.24 | 0.816 i |
1st month | 5.14 ± 2.08 * | 5.50 ± 1.85 * | 0.427 m | |
3rd month | 5.09 ± 2.14 * | 5.33 ± 1.90 * | 0.718 m | |
P1 Value | 0.003 r | <0.001 r | ||
SF MPQ | ||||
Sensory | Baseline | 17.45 ± 8.50 | 17.63 ± 8.56 | 0.993 m |
1st month | 15.23 ± 9.11 | 15.03 ± 8.68 * | 1.00 m | |
3rd month | 14.05 ± 8.06 * | 14.13 ± 7.74 * | 0.985 m | |
P1 Value | <0.001 r | <0.001 f | ||
Affective | Baseline | 7.27 ± 3.83 | 7.27 ± 3.70 | 0.985 m |
1st month | 6.41 ± 3.29 | 6.30 ± 3.12 | 0.869 m | |
3rd month | 6.05 ± 3.44 * | 6.07 ± 3.28 * | 0.878 m | |
P1 Value | 0.023 f | 0.005 f | ||
Total | Baseline | 24.73 ± 11.76 | 24.90 ± 11.71 | 0.978 m |
1st month | 21.64 ± 11.87 | 21.33 ± 11.24 * | 0.985 m | |
3rd month | 20.09 ± 10.85 * | 20.20 ± 10.33 * | 0.896 m | |
P1 Value | <0.001 r | <0.001 f | ||
VAS | Baseline | 7.06 ± 2.21 | 7.12 ± 2.22 | 0.941 m |
1st month | 5.28 ± 2.49 * | 5.78 ± 2.22 * | 0.676 m | |
3rd month | 5.19 ± 2.25 * | 5.69 ± 2.14 * | 0.553 m | |
P1 Value | <0.001 r | <0.001 f | ||
Present Pain Intensity | Baseline | 2.64 ± 0.79 | 2.60 ± 0.72 | 0.934 m |
1st month | 2.00 ± 0.87 * | 2.07 ± 0.83 * | 0.646 m | |
3rd month | 2.05 ± 0.72 * | 2.13 ± 0.68 * | 0.518 m | |
P1 Value | <0.001 f | <0.001 f | 0.934 m | |
FIQ | Baseline | 45.82 ± 7.81 | 50.20 ± 8.77 | 0.068 i |
1st month | 38.82 ± 8.57 * | 46.17 ± 10.44 * | 0.084 m | |
3rd month | 34.18 ± 10.72 * | 41.47 ± 13.38 * | 0.167 m | |
P1 Value | <0.001 r | <0.001 r |
SF-36 | Group 1 (Duloxetine + TPTNS) (n = 22) | Group 2 (Duloxetine) (n = 30) | P2 Value | |
---|---|---|---|---|
Physical functioning | Baseline | 43.64 ± 24.11 | 47.00 ± 25.31 | 0.631 i |
1st month | 49.09 ± 22.18 | 50.00 ± 23.16 | 0.459 m | |
3rd month | 46.36 ± 22.53 | 50.00 ± 22.89 | 0.960 m | |
P1 Value | 0.065 r | 0.217 r | ||
Role-Physical | Baseline | 22.73 ± 30.77 | 23.33 ± 31.44 | 0.951 m |
1st month | 17.05 ± 24.86 | 18.33 ± 27.02 | 0.973 m | |
3rd month | 17.05 ± 28.23 | 19.17 ± 29.86 | 0.782 m | |
P1 Value | 0.325 f | 0.307 f | ||
Role-Emotional | Baseline | 12.12 ± 26.32 | 13.33 ± 28.50 | 0.940 m |
1st month | 12.12 ± 26.32 | 13.33 ± 28.50 | 0.914 m | |
3rd month | 9.09 ± 23.42 | 11.11 ± 26.74 | 0.894 m | |
P1 Value | 0.549 f | 0.549 f | ||
Vitality | Baseline | 25.23 ± 18.80 | 25.00 ± 18.98 | 0.926 m |
1st month | 28.86 ± 17.92 * | 29.00 ± 18.86 * | 0.915 m | |
3rd month | 27.95 ± 17.71 | 28.50 ± 19.26 | 0.862 m | |
P1 Value | 0.004 f | 0.001 f | ||
Mental health | Baseline | 43.64 ± 23.03 | 46.00 ± 23.62 | 0.720 i |
1st month | 49.09 ± 19.37 | 50.53 ± 20.49 | 0.858 m | |
3rd month | 46.18 ± 21.93 | 48.40 ± 22.47 | 0.985 m | |
P1 Value | 0.128 r | 0.216 r | ||
Social functioning | Baseline | 41.48 ± 26.56 | 46.58 ± 26.40 | 0.495 i |
1st month | 49.43 ± 26.30 | 48.67 ± 26.09 | 0.482 m | |
3rd month | 46.59 ± 28.13 | 48.25 ± 27.57 | 0.509 m | |
P1 Value | 0.294 r | 0.108 f | ||
Bodily pain | Baseline | 38.52 ± 18.12 | 39.58 ± 18.08 | 0.835 i |
1st month | 43.52 ± 24.54 | 44.67 ± 22.72 | 0.953 m | |
3rd month | 41.59 ± 22.80 | 43.25 ± 21.47 | 0.902 m | |
P1 Value | 0.295 r | 0.150 r | ||
General health perception | Baseline | 32.95 ± 17.91 | 34.00 ± 18.63 | 0.925 m |
1st month | 31.36 ± 19.10 | 32.67 ± 19.77 | 0.906 i | |
3rd month | 30.45 ± 18.96 | 32.00 ± 19.72 | 0.696 m | |
P1 Value | 0.254 r | 0.368 f |
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Sarı, İ.F.; İlhanlı, İ.; Mızrak, T.; Kulaklı, F.; Kasap, Z. The Effect of Transcutaneous Posterior Tibial Nerve Stimulation on Pain and Quality of Life in Patients with Fibromyalgia: A Single-Blind, Randomized Controlled Trial. J. Clin. Med. 2023, 12, 4989. https://doi.org/10.3390/jcm12154989
Sarı İF, İlhanlı İ, Mızrak T, Kulaklı F, Kasap Z. The Effect of Transcutaneous Posterior Tibial Nerve Stimulation on Pain and Quality of Life in Patients with Fibromyalgia: A Single-Blind, Randomized Controlled Trial. Journal of Clinical Medicine. 2023; 12(15):4989. https://doi.org/10.3390/jcm12154989
Chicago/Turabian StyleSarı, İlker Fatih, İlker İlhanlı, Tuba Mızrak, Fazıl Kulaklı, and Zerrin Kasap. 2023. "The Effect of Transcutaneous Posterior Tibial Nerve Stimulation on Pain and Quality of Life in Patients with Fibromyalgia: A Single-Blind, Randomized Controlled Trial" Journal of Clinical Medicine 12, no. 15: 4989. https://doi.org/10.3390/jcm12154989
APA StyleSarı, İ. F., İlhanlı, İ., Mızrak, T., Kulaklı, F., & Kasap, Z. (2023). The Effect of Transcutaneous Posterior Tibial Nerve Stimulation on Pain and Quality of Life in Patients with Fibromyalgia: A Single-Blind, Randomized Controlled Trial. Journal of Clinical Medicine, 12(15), 4989. https://doi.org/10.3390/jcm12154989