Upper Cervical Manipulation and Manual Massage Do Not Modulate Sympatho-Vagal Balance or Blood Pressure in Women: A Randomized, Placebo-Controlled Clinical Trial
Abstract
1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Participants
2.3. Procedures
2.4. Randomization
2.5. Interventions
2.6. Outcome Measures
2.7. Data Analysis
3. Results
3.1. Blood Pressure
3.2. Heart Rate Variability—Time-Domain
3.3. Heart Rate Variability—Frequency-Domain
4. Discussion
4.1. Limitation
4.2. Future Research Recommendation
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
Abbreviations
ANS | Autonomic Nervous System |
BP | Blood Pressure |
CONSORT | Consolidated Standards of Reporting Trials |
CM | Cervical Spinal Manipulation |
HRV | Heart Rate Variability |
MM | Manual Massage |
NCD | Non-Communicable Diseases |
SHAM | Simulated Cervical Spinal Manipulation |
SPIRIT | Standard Protocol Items: Recommendations for Interventional Trials |
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Resting Blood Pressure (mmHg) | Upper CM | Manual Massage | SHAM | Control |
---|---|---|---|---|
Systolic Blood Pressure | 105 | 110 | 109 | 107 |
Diastolic Blood Pressure | 70 | 68 | 75 | 70 |
Dominant Limb | Age (Years) | Body Mass (kg) | Height (m) | BMI (kg/m2) | Physical Activity Level (min) | |
---|---|---|---|---|---|---|
n = 15 | R = 13; L = 2 | 21 (9) | 57.30 (11.90) | 1.65 (0.07) | 21.99 (3.34) | 290 (710) |
Diastolic Blood Pressure mmHg_lf | 0.39 | 0.945 |
HF POWER ms2_lf | 0.88 | 0.483 |
LF POWER ms2_lf | 0.48 | 0.869 |
LF-HF RATIO _lf | 1.20 | 0.335 |
LN (RMSSD) ms_lf | 0.32 | 0.921 |
Mean R-R ms_lf | 1.06 | 0.415 |
PNN50%_lf | 0.47 | 0.856 |
RMSSD ms_lf | 0.28 | 0.954 |
SDNN ms_lf | 0.55 | 0.788 |
Systolic Blood Pressure mmHg_lf | 0.39 | 0.946 |
TOTAL POWER ms2_lf | 0.79 | 0.573 |
Systolic Blood Pressure | |||||||
---|---|---|---|---|---|---|---|
Protocol | Baseline | Post-0 | Post-15 min | Post-30 min | Post-45 min | Post-60 min | Within Condition |
Control | 107 (13) | 108 (14) | 106 (10) | 105 (12) | 107 (11) | 109 (11) | 0.539 |
ES (r) (classification) | 0.08 (no effect) | 0.18 (small) | 0.16 (small) | 0.21 (small) | 0.10 (small) | ||
Sham | 109 (11) | 109 (9) | 107 (9) | 108 (10) | 107 (13) | 107 (9) | 0.504 |
ES (r) (classification) | 0.06 (no effect) | 0.25 (small) | 0.13 (small) | 0.14 (small) | 0.19 (small) | ||
CM | 105 (14) | 106 (11) | 112 (12) | 111 (8) | 108 (12) | 108 (15) | 0.160 |
ES (r) (classification) | 0.16 (small) | 0.21 (small) | 0.14 (small) | 0.11 (small) | 0.01 (no effect) | ||
MM | 110 (10) | 108 (9) | 109 (14) | 108 (7) | 108 (8) | 108 (6) | 0.221 |
ES (r) (classification) | 0.21 (small) | 0.04 (no effect) | 0.22 (small) | 0.15 (small) | 0.22 (small) |
Diastolic Blood Pressure | |||||||
---|---|---|---|---|---|---|---|
Protocol | Baseline | Post-0 | Post-15 min | Post-30 min | Post-45 min | Post-60 min | Within Condition |
Control | 70 (12) | 71 (7) | 70 (8) | 72 (12) | 74 (10) * | 76 (6) | 0.000 * |
ES (r) (classification) | 0.08 (no effect) | 0.13 (small) | 0.06 (no effect) | 0.66 (large) | 0.49 (medium) | ||
Sham | 75 (11) | 71 (17) | 73 (9) | 73 (7) | 74 (11) | 76 (9) | 0.068 |
ES (r) (classification) | 0.28 (small) | 0.19 (small) | 0.02 (no effect) | 0.03 (no effect) | 0.17 (small) | ||
CM | 70 (7) | 71 (7) | 72 (6) | 71 (8) | 70 (9) | 71 (8) | 0.238 |
ES (r) (classification) | 0.12 (small) | 0.36 (medium) | 0.24 (small) | 0.14 (small) | 0.25 (small) | ||
MM | 68 (8) | 71 (7) | 73 (8) | 72 (6) | 71 (5) | 72 (6) | 0.225 |
ES (r) (classification) | 0.26 (small) | 0.40 (medium) | 0.32 (medium) | 0.20 (small) | 0.26 (small) |
RMSSDms | |||||||
---|---|---|---|---|---|---|---|
Baseline | Post-0 min | Post-15 min | Post-30 min | Post-45 min | Post-60 min | Within Condition | |
Control | 40.05 (43.5) | 63.39 (48.23) | 61.52 (26.37) | 49.30 (24.58) | 63.49 (36.73) | 52.23 (35.94) | 0.008 * |
ES (r) (classification) | 0.56 (large) * | 0.57 (large) * | 0.16 (small) | 0.39 (medium) | 0.28 (small) | ||
Sham | 41.88 (42.51) | 79.44 (55.99) | 71.10 (23.02) | 60.53 (39.03) | 75.76 (46.31) | 54.08 (33.68) | 0.007 * |
ES (r) (classification) | 0.51 (large) | 0.60 (large) * | 0.39 (medium) | 0.49 (medium) | 0.17 (small) | ||
CM | 32.86 (18.58) | 59.37 (49.07) | 56.91 (34.55) | 49.91 (45.99) | 48.71 (52.16) | 58.04 (52.27) | 0.008 * |
ES (r) (classification) | 0.51 (large) | 0.60 (large) * | 0.39 (medium) | 0.49 (medium) | 0.17 (small) * | ||
MM | 38.05 (33.86) | 57.11 (40.27) | 52.61 (30.84) | 64.02 (33.74) | 52.63 (31.04) | 56.78 (32.42) | 0.159 |
ES (r) (classification) | 0.47 (medium) | 0.29 (small) | 0.32 (medium) | 0.31 (medium) | 0.31 (medium) | ||
SDNNms | |||||||
Control | 52.84 (35.68) | 73.50 (57.76) | 79.16 (29.03) | 78.12 (29.79) | 78.85 (25.45) | 79.01 (23.18) | 0.036 * |
ES (r) (classification) | 0.23 (small) | 0.42 (medium) | 0.42 (medium) | 0.55 (large) * | 0.44 (medium) | ||
Sham | 62.08 (40.69) | 74.55 (32.98) | 77.42 (27.26) | 79.53 (2348) | 81.55 (25.88) | 71.88 (36.25) | 0.260 |
ES (r) (classification) | 0.21 (small) | 0.30 (medium) | 0.37 (medium) | 0.28 (small) | 0.34 (medium) | ||
CM | 47.19 (27.95) | 62.64 (34.83) | 86.43 (27.46) | 76.26 (31.27) | 93.21 (26.07) | 79.01 (45.66) | 0.008 * |
ES (r) (classification) | 0.24 (small) | 0.46 (medium) | 0.39 (medium) | 0.60 (large) * | 0.58 (large) * | ||
MM | 54.03 (30.39) | 67.39 (19.49) | 69.79 (26.40) | 78.49 (29.63) | 71.23 (32.15) | 79.01 (29.03) | 0.027 * |
ES (r) (classification) | 0.23 (small) | 0.30 (medium) | 0.37 (medium) | 0.48 (medium) | 0.58 (large) | ||
pNN50% | |||||||
Control | 14.00 (37) | 46.00 (41) | 33.00 (32) | 30.00 (33) | 37.00 (38) | 28.00 (30) | 0.034 * |
ES (r) (classification) | 0.52 (large) | 0.42 (medium) | 0.10 (small) | 0.27 (small) | 0.16 (small) | ||
Sham | 24.00 (38) | 54.00 (47) | 47.00 (25) | 40.00 (24) | 46.00 (27) | 40.00 (38) | 0.019 * |
ES (r) (classification) | 0.53 (large) | 0.51 (large) | 0.41 (medium) | 0.46 (medium) | 0.20 (small) | ||
CM | 9.00 (24) | 41.00 (39) | 32.00 (30) | 30.00 (32) | 29.00 (36) | 35.00 (32) | 0.013 * |
ES (r) (classification) | 0.54 (large) * | 0.54 (large) * | 0.39 (medium) | 0.44 (medium) | 0.58 (large) * | ||
MM | 17.00 (40) | 34.00 (41) | 32.00 (43) | 31.00 (32) | 34.00 (29) | 32.00 (27) | 0.040 * |
ES (r) (classification) | 0.32 (medium) | 0.50 (large) | 0.49 (medium) | 0.43 (medium) | 0.43 (medium) | ||
LN (RMSSD) (ms) | |||||||
Control | 3.69 (0.93) | 4.25 (0.82) | 4.12 (0.52) | 3.90 (0.47) | 4.15 (0.63) | 3.96 (0.64) | 0.020 * |
ES (r) (classification) | 0.57 (large) * | 0.49 (medium) | 0.16 (small) | 0.35 (medium) | 0.28 (small) | ||
Sham | 3.73 (0.91) | 4.37 (0.88) | 4.26 (0.31) | 4.10 (0.58) | 4.33 (0.72) | 3.99 (0.65) | 0.006 * |
ES (r) (classification) | 0.51 (large) | 0.61 (large) * | 0.40 (medium) | 0.49 (medium) | 0.16 (small) | ||
CM | 3.49 (0.54) | 4.08 (0.78) | 4.04 (0.52) | 3.91 (0.82) | 3.89 (0.90) | 4.06 (0.85) | 0.008 * |
ES (r) (classification) | 0.53 (large) | 0.57 (large) * | 0.49 (medium) | 0.49 (medium) | 0.62 (large) * | ||
MM | 3.64 (0.80) | 4.04 (0.70) | 3.96 (0.57) | 4.16 (0.64) | 3.96 (0.54) | 4.04 (0.57) | 0.139 |
ES (r) (classification) | 0.48 (medium) | 0.35 (medium) | 0.35 (medium) | 0.34 (medium) | 0.35 (medium) | ||
MEAN iR-R (ms) | |||||||
Control | 760.27 (93.89) | 832.38 (141.16) | 864.56 (105.99) | 844.58 (64.55) | 875.01 (113.64) | 833.73 (187.20) | 0.002 * |
ES (r) (classification) | 0.55 (large) * | 0.66 (large) * | 0.58 (large) * | 0.69 (large) * | 0.55 (large) * | ||
Sham | 830.15 (198.40) | 919.70 (187.45) | 897.00 (229.02) | 866.99 (214.50) | 918.14 (179.70) | 833.73 (204.33) | 0.008 * |
ES (r) (classification) | 0.57 (large) * | 0.62 (large) * | 0.44 (medium) | 0.48 (medium) | 0.28 (small) | ||
CM | 764.71 (159.71) | 857.01 (112.75) | 859.38 (131.51) | 853.64 (76.45) | 846.67 (123.12) | 913.03 (133.61) | 0.003 * |
ES (r) (classification) | 0.53 (large) | 0.60 (large) * | 0.58 (large) * | 0.55 (large) * | 0.66 (large) * | ||
MM | 779.00 (87.89) | 838.71 (134.60) | 861.39 (116.44) | 829.93 (167.58) | 860.01 (128.53) | 866.62 (116.20) | 0.001 * |
ES (r) (classification) | 0.26 (small) | 0.51 (large) | 0.41 (medium) | 0.73 (large) * | 0.58 (large) * |
TOTAL POWER ms2 | |||||||
---|---|---|---|---|---|---|---|
Baseline | Post-0 min | Post-15 min | Post-30 min | Post-45 min | Post-60 min | Within Condition | |
Control | 1346.67 (2004.78) | 2464.36 (4455.47) | 2471.27 (2486.22) | 3302.12 (2981.87) | 3039.01 (2798.19) | 3107.56 (2753.03) | 0.033 * |
ES (r) (classification) | 0.42 (medium) | 0.35 (medium) | 0.23 (small) | 0.57 (large) * | 0.17 (small) | ||
Sham | 1968.19 (2919.92) | 2381.00 (3796.07) | 3111.46 (1751.67) | 3021.98 (1302.74) | 3334.23 (5174.11) | 2605.74 (2370.88) | 0.497 |
ES (r) (classification) | 0.34 (medium) | 0.33 (medium) | 0.31 (medium) | 0.31 (medium) | 0.22 (small) | ||
CM | 944.18 (704.78) | 2464.36 (3450.03) | 2439.50 (1410.69) | 3021.98 (3887.12) | 2381.87 (4353.62) | 3242.34 (5241.07) | 0.001 * |
ES (r) (classification) | 0.27 (small) | 0.31 (medium) | 0.55 (large) * | 0.51 (large) | 0.74 (large) * | ||
MM | 1844.65 (1933.13) | 2160.07 (3516.33) | 2339.49 (2221.31) | 3236.94 (3368.09) | 2320.10 (2588.11) | 3087.02 (1161.28) | 0.049 * |
ES (r) (classification) | 0.07 (small) | 0.21 (small) | 0.42 (medium) | 0.39 (medium) | 0.44 (medium) | ||
LF POWER ms2 | |||||||
Control | 650.67 (1237.53) | 1467.53 (2658.45) | 1540.16 (1464.43) | 1539.34 (1543.21) | 1795.87 (1438.67) | 1900.21 (1514.26) | 0.115 |
ES (r) (classification) | 0.27 (small) | 0.37 (medium) | 0.31 (medium) | 0.38 (medium) | 0.29 (small) | ||
Sham | 927.42 (1570.22) | 1081.43 (1200.03) | 1540.16 (653.86) | 1554.75 (1032.19) | 1795.87 (1428.13) | 1282.71 (1741.09) | 0.529 |
ES (r) (classification) | 0.08 (no effect) | 0.22 (small) | 0.17 (small) | 0.29 (small) | 0.30 (medium) | ||
CM | 544.98 (281.41) | 1050.85 (2108.26) | 1402.23 (834.30) | 1359.34 (1595.44) | 1896.11 (1917.92) | 2027.90 (3582.68) | 0.001 * |
ES (r) (classification) | 0.10 (small) | 0.35 (medium) | 0.41 (medium) | 0.49 (medium) | 0.71 (large) * | ||
MM | 677.05 (1051.34) | 800.48 (648.48) | 1415.73 (1146.53) | 1359.34 (1230.96) | 1479.18 (594.68) | 1632.17 (965.79) | 0.115 |
ES (r) (classification) | 0.01 (no effect) | 0.14 (small) | 0.14 (small) | 0.20 (small) | 0.25 (small) | ||
HF POWER ms2 | |||||||
Control | 693.30 (782.99) | 1907.67 (2228.37) | 1201.11 (2288.40) | 1174.41 (1585.22) | 1734.03 (1695.55) | 784.84 (1655.61) | 0.091 |
ES (r) (classification) | 0.31 (medium) | 0.21 (small) | 0.14 (small) | 0.21 (small) | 0.05 (no effect) | ||
Sham | 971.18 (1469.83) | 1152.90 (2539.24) | 1792.10 (1614.62) | 1734.03 (885.14) | 1734.03 (2310.83) | 1026.63 (1422.45) | 0.15 |
ES (r) (classification) | 0.37 (medium) | 0.53 (large) | 0.40 (medium) | 0.47 (medium) | 0.08 (no effect) | ||
CM | 381.95 (530.48) | 1311.49 (1728.06) | 1247.38 (977.78) | 843.58 (1808.54) | 679.32 (2591.78) | 1271.04 (2771.01) | 0.073 |
ES (r) (classification) | 0.48 (medium) | 0.36 (medium) | 0.38 (medium) | 0.29 (small) | 0.41 (medium) | ||
MM | 778.91 (1426.57) | 1331.16 (2020.04) | 1345.73 (675.12) | 1726.65 (1992.47) | 1109.43 (2271.16) | 1271.04 (1486.11) | 0.130 |
ES (r) (classification) | 0.41 (medium) | 0.24 (small) | 0.32 (medium) | 0.22 (small) | 0.23 (small) | ||
LF/HF RATIO | |||||||
Control | 0.98 (0.83) | 1.00 (0.37) | 1.28 (1.29) | 1.14 (1.93) | 1.10 (2.22) | 1.87 (2.74) | 0.111 |
ES (r) (classification) | 0.04 (no effect) | 0.12 (small) | 0.28 (small) | 0.18 (small) | 0.42 (medium) | ||
Sham | 1.19 (1.09) | 0.82 (0.76) | 0.89 (0.76) | 0.93 (0.53) | 0.86 (0.81) | 1.87 (2.01) | 0.149 |
ES (r) (classification) | 0.23 (small) | 0.35 (medium) | 0.36 (medium) | 0.13 (small) | 0.17 (small) | ||
CM | 1.34 (0.91) | 0.94 (1.18) | 1.05 (1.17) | 1.17 (1.08) | 1.23 (1.51) | 1.12 (1.87) | 0.98 |
ES (r) (classification) | 0.27 (small) | 0.02 (no effect) | 0.05 (no effect) | 0.14 (small) | 0.17 (small) | ||
MM | 1.38 (1.18) | 0.69 (0.67) | 0.78 (1.09) | 0.80 (0.55) | 0.94 (0.97) | 1.49 (2.14) | 0.022 * |
ES (r) (classification) | 0.30 (medium) | 0.10 (small) | 0.01 (no effect) | 0.24 (small) | 0.55 (large) * |
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Monteiro, E.R.; Pescatello, L.S.; Garcia, G.H.; de Meirelles, A.G.; de Oliveira, F.; de Souza, R.C.; Nogueira, L.A.C.; Lopes, A.J.; Moreira-Gonçalves, D. Upper Cervical Manipulation and Manual Massage Do Not Modulate Sympatho-Vagal Balance or Blood Pressure in Women: A Randomized, Placebo-Controlled Clinical Trial. Healthcare 2025, 13, 2554. https://doi.org/10.3390/healthcare13202554
Monteiro ER, Pescatello LS, Garcia GH, de Meirelles AG, de Oliveira F, de Souza RC, Nogueira LAC, Lopes AJ, Moreira-Gonçalves D. Upper Cervical Manipulation and Manual Massage Do Not Modulate Sympatho-Vagal Balance or Blood Pressure in Women: A Randomized, Placebo-Controlled Clinical Trial. Healthcare. 2025; 13(20):2554. https://doi.org/10.3390/healthcare13202554
Chicago/Turabian StyleMonteiro, Estêvão Rios, Linda S. Pescatello, Gustavo Henrique Garcia, Alexandre Gonçalves de Meirelles, Francine de Oliveira, Rafael Cotta de Souza, Leandro Alberto Calazans Nogueira, Agnaldo José Lopes, and Daniel Moreira-Gonçalves. 2025. "Upper Cervical Manipulation and Manual Massage Do Not Modulate Sympatho-Vagal Balance or Blood Pressure in Women: A Randomized, Placebo-Controlled Clinical Trial" Healthcare 13, no. 20: 2554. https://doi.org/10.3390/healthcare13202554
APA StyleMonteiro, E. R., Pescatello, L. S., Garcia, G. H., de Meirelles, A. G., de Oliveira, F., de Souza, R. C., Nogueira, L. A. C., Lopes, A. J., & Moreira-Gonçalves, D. (2025). Upper Cervical Manipulation and Manual Massage Do Not Modulate Sympatho-Vagal Balance or Blood Pressure in Women: A Randomized, Placebo-Controlled Clinical Trial. Healthcare, 13(20), 2554. https://doi.org/10.3390/healthcare13202554