Comparison of Analgesic Efficacy between Epidural and Perineural Administration of Autologous Conditioned Serum in the Conservative Treatment of Low Back Pain Due to Lumbar Degenerative Disc Disease: A Randomized, Open-Label, Controlled Clinical Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Ethical Consideration
2.3. Participants
2.4. Interventions
2.5. Outcomes
2.6. Sample Size
2.7. Randomization and Blinding
2.8. Statistical Methods
3. Results
3.1. Participants
3.2. Baseline Data
3.3. Primary Outcome (Change in EQ-5D-5L Index from Baseline to 24 Weeks)
3.4. Primary Outcome (Change in Oswestry Disability Index from Baseline to 24 Weeks)
3.5. Primary Outcome (Change in Roland Morris Questionnaire Score from Baseline to 24 Weeks)
3.6. Outcomes and Estimations (Intra-Group)
3.7. Outcomes and Estimations (Superiority between Groups)
3.8. Outcomes and Estimations (Non-Inferiority)
3.9. Ancillary Analyses
3.10. Adverse Events
4. Discussion
Study Limitations
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Character | Epidural Administration | Perineural Administration | p-Value * | ||
---|---|---|---|---|---|
N | M ± SD (95% CI of M) | N | M ± SD (95% CI of M) | ||
Age (in years) | 50 | 47.06 ± 11.86 (43.69 to 50.43) | 50 | 45.52 ± 15.25 (41.19 to 49.85) | 0.5742 |
Height (in cm) | 50 | 173.74 ± 9.36 (171.08 to 176.40) | 50 | 171.46 ± 9.55 (168.8 to 174.17) | 0.2308 |
Weight (in kg) | 50 | 81.10 ± 16.01 (76.55 to 85.65) | 50 | 78.00 ± 14.38 (73.91 to 82.09) | 0.3109 |
Body mass index (BMI) | 50 | 26.85 ± 4.93 (25.45 to 28.25) | 50 | 26.48 ± 4.05 (25.33 to 27.63) | 0.6836 |
Duration of complaints (in weeks) | 50 | 19.10 ± 19.03 (13.69 to 24.51) | 50 | 19.56 ± 19.27 (14.08 to 25.04) | 0.9047 |
N (%) | N (%) | p-Value ** | |||
Total | 50 (100) | 50 (100) | |||
Gender | 0.3196 | ||||
Female | 23 (46) | 28 (56) | |||
Male | 27 (54) | 22 (44) | |||
Disease phase | 0.4230 | ||||
Acute (>4 weeks) | 7 (14) | 10 (20) | |||
Subacute (4–12 weeks) | 21 (42) | 15 (30) | |||
Chronic (>12 weeks) | 22 (44) | 25 (50) | |||
Side of discomfort | 0.4244 | ||||
Left side | 20 (40) | 20 (40) | |||
Right side | 20 (40) | 15 (30) | |||
Both sides | 10 (20) | 15 (30) | |||
Type of hernia | 0.0951 | ||||
Bulging | 13 (26) | 7 (14) | |||
Extrusion | 6 (12) | 6 (12) | |||
Intravertebral | 2 (4) | 2 (4) | |||
Prolapse | 17 (34) | 28 (56) | |||
Residual | 12 (24) | 5 (10) | |||
Sequestration | 0 (0) | 2 (4) | |||
Predominant level of hernia | 0.5696 | ||||
Th12/L1 | 1 (2) | 0 (0) | |||
L2/L3 | 0 (0) | 1 (2) | |||
L3/L4 | 2 (4) | 1 (2) | |||
L4/L5 | 16 (32) | 20 (40) | |||
L5/S1 | 31 (62) | 28 (56) | |||
Type of discopathy | 0.2821 | ||||
Single level | 13 (26) | Single level | 13 (26) | ||
Multilevel | 37 (74) | Multilevel | 37 (74) | ||
Diabetes | 0.5597 | ||||
No | 49 (98) | No | 49 (98) | ||
Yes | 1 (2) | Yes | 1 (2) | ||
Peripheral vascular disease | 1.0000 | ||||
No | 48 (96) | No | 48 (96) | ||
Yes | 2 (4) | Yes | 2 (4) | ||
Disorders of bone metabolism | 0.5597 | ||||
No | 49 (98) | No | 49 (98) | ||
Yes | 1 (2) | Yes | 1 (2) | ||
Polyneuropathy | 0.3173 | ||||
No | 50 (100) | No | 50 (100) | ||
Yes | 0 (0) | Yes | 0 (0) |
Epidural | Perineural | |||
---|---|---|---|---|
N | M ± SD (95% CI of M) | N | M ± SD (95% CI of M) | |
Numeric Rating Scale (NRS) | ||||
Baseline | 50 | 6.10 ± 1.99 (5.53 to 6.67) | 50 | 5.68 ± 2.17 (5.06 to 6.30) |
Week 4 | 49 | 3.43 ± 2.17 (2.81 to 4.05) | 50 | 3.26 ± 2.18 (2.64 to 3.88) |
Week 12 | 46 | 3.44 ± 2.52 (2.69 to 4.18) | 49 | 2.62 ± 2.17 (2.01 to 3.24) |
Week 24 | 40 | 2.80 ± 2.34 (2.05 to 3.55) | 46 | 2.37 ± 2.12 (1.74 to 3.00) |
Oswestry Disability Index (ODI) | ||||
Baseline | 50 | 18.26 ± 6.04 (16.54 to 19.98) | 50 | 19.60 ± 8.60 (17.16 to 22.04) |
Week 4 | 49 | 12.39 ± 6.87 (10.41 to 14.36) | 50 | 13.78 ± 8.90 (11.25 to 16.31) |
Week 12 | 46 | 11.83 ± 7.26 (9.67 to 13.98) | 49 | 10.31 ± 7.72 (8.09 to 12.52) |
Week 24 | 40 | 9.65 ± 6.65 (7.52 to 11.78) | 46 | 9.91 ± 10.09 (6.92 to 12.91) |
Roland Morris Questionnaire (RMQ) | ||||
Baseline | 50 | 7.40 ± 4.29 (6.18 to 8.62) | 50 | 8.76 ± 5.55 (7.18 to 10.34) |
Week 4 | 49 | 4.84 ± 4.32 (3.60 to 6.08) | 50 | 5.42 ± 4.63 (4.10 to 6.74) |
Week 12 | 46 | 4.41 ± 4.29 (3.14 to 5.69) | 49 | 4.06 ± 4.28 (2.83 to 5.29) |
Week 24 | 40 | 3.08 ± 3.21 (2.05 to 4.10) | 46 | 4.37 ± 5.14 (2.84 to 5.90) |
EQ-5D-5L mobility | ||||
Baseline | 50 | 1.94 ± 0.84 (1.70 to 2.18) | 50 | 2.26 ± 0.96 (1.99 to 2.53) |
Week 4 | 49 | 1.69 ± 0.74 (1.48 to 1.91) | 50 | 1.88 ± 0.85 (1.64 to 2.12) |
Week 12 | 46 | 1.74 ± 0.77 (1.51 to 1.97) | 49 | 1.63 ± 0.81 (1.40 to 1.87) |
Week 24 | 40 | 1.58 ± 0.71 (1.35 to 1.80) | 45 | 1.53 ± 0.87 (1.27 to 1.79) |
EQ-5D-5L self-care | ||||
Baseline | 50 | 1.74 ± 0.78 (1.52 to 1.96) | 50 | 1.84 ± 1.00 (1.56 to 2.12) |
Week 4 | 49 | 1.57 ± 0.71 (1.37 to 1.78) | 50 | 1.64 ± 0.83 (1.41 to 1.88) |
Week 12 | 46 | 1.50 ± 0.75 (1.28 to 1.72) | 49 | 1.57 ± 0.79 (1.34 to 1.80) |
Week 24 | 40 | 1.38 ± 0.59 (1.19 to 1.56) | 45 | 1.49 ± 0.87 (1.23 to 1.75) |
EQ-5D-5L usual activities | ||||
Baseline | 50 | 2.46 ± 0.73 (2.25 to 2.67) | 50 | 2.52 ± 0.91 (2.26 to 2.78) |
Week 4 | 49 | 2.02 ± 0.75 (1.81 to 2.24) | 50 | 2.06 ± 0.87 (1.81 to 2.31) |
Week 12 | 46 | 1.94 ± 0.85 (1.68 to 2.19) | 49 | 1.90 ± 0.80 (1.67 to 2.13) |
Week 24 | 40 | 1.58 ± 0.64 (1.37 to 1.78) | 45 | 1.64 ± 0.83 (1.40 to 1.89) |
EQ-5D-5L pain/discomfort | ||||
Baseline | 50 | 3.06 ± 0.74 (2.85 to 3.27) | 50 | 3.08 ± 0.83 (2.84 to 3.32) |
Week 4 | 49 | 2.45 ± 0.79 (2.22 to 2.68) | 50 | 2.52 ± 0.74 (2.31 to 2.73) |
Week 12 | 46 | 2.44 ± 0.83 (2.19 to 2.68) | 49 | 2.16 ± 0.77 (1.94 to 2.39) |
Week 24 | 40 | 2.13 ± 0.76 (1.88 to 2.37) | 45 | 2.18 ± 0.91 (1.90 to 2.45) |
EQ-5D-5L anxiety/depression | ||||
Baseline | 50 | 2.02 ± 0.87 (1.77 to 2.27) | 50 | 2.24 ± 1.19 (1.90 to 2.58) |
Week 4 | 49 | 1.69 ± 0.77 (1.47 to 1.92) | 50 | 1.90 ± 1.05 (1.60 to 2.20) |
Week 12 | 46 | 1.74 ± 0.95 (1.46 to 2.02) | 49 | 1.59 ± 0.81 (1.36 to 1.83) |
Week 24 | 40 | 1.58 ± 0.71 (1.35 to 1.80) | 45 | 1.56 ± 0.81 (1.31 to 1.80) |
EQ-5D-5L-based Level Sum Score (LSS) | ||||
Baseline | 50 | 11.22 ± 2.74 (10.44 to 12.00) | 50 | 11.94 ± 3.97 (10.81 to 13.07) |
Week 4 | 49 | 9.43 ± 2.94 (8.59 to 10.27) | 50 | 10.00 ± 3.70 (8.95 to 11.05) |
Week 12 | 46 | 9.15 ± 3.61 (8.09 to 10.21) | 49 | 8.86 ± 3.28 (7.92 to 9.80) |
Week 24 | 40 | 8.23 ± 2.67 (7.37 to 9.08) | 45 | 8.40 ± 3.74 (7.28 to 9.52) |
EQ-5D-5L VAS | ||||
Baseline | 50 | 66.14 ± 16.85 (61.35 to 70.93) | 50 | 60.14 ± 20.35 (54.36 to 65.92) |
Week 4 | 49 | 69.94 ± 17.49 (64.92 to 74.96) | 50 | 71.70 ± 15.99 (67.16 to 76.25) |
Week 12 | 46 | 71.74 ± 17.84 (66.44 to 77.04) | 49 | 74.67 ± 15.38 (70.26 to 79.09) |
Week 24 | 40 | 74.75 ± 17.17 (69.26 to 80.24) | 45 | 77.62 ± 14.86 (73.16 to 82.09) |
EQ-5D-5L Index | ||||
Baseline | 50 | 0.805 ± 0.138 (0.766 to 0.844) | 50 | 0.754 ± 0.197 (0.698 to 0.810) |
Week 4 | 49 | 0.875 ± 0.117 (0.842 to 0.909) | 50 | 0.862 ± 0.145 (0.821 to 0.903) |
Week 12 | 46 | 0.872 ± 0.137 (0.832 to 0.913) | 49 | 0.902 ± 0.092 (0.876 to 0.928) |
Week 24 | 40 | 0.913 ± 0.091 (0.884 to 0.942) | 45 | 0.895 ± 0.159 (0.847 to 0.943) |
Epidural Administration | Perineural Administration | |||||||
---|---|---|---|---|---|---|---|---|
Difference to Baseline at | N | M ± SD (95% CI of M) | Cohen’s d | p-Value * | N | M ± SD (95% CI of M) | Cohen’s d | p-Value * |
Numeric Rating Scale (NRS) | ||||||||
Week 4 | 49 | −2.74 ± 2.24 (−3.38 to −2.09) | −1.22 | <0.0001 | 50 | −2.42 ± 2.04 (−3.00 to −1.84) | −1.19 | <0.0001 |
Week 12 | 46 | −2.52 ± 2.51 (−3.27 to −1.78) | −1.00 | <0.0001 | 49 | −3.06 ± 2.49 (−3.77 to −2.35) | −1.23 | <0.0001 |
Week 24 | 40 | −3.08 ± 2.12 (−3.75 to −2.40) | −1.45 | <0.0001 | 46 | −3.09 ± 2.49 (−3.83 to −2.35) | −1.24 | <0.0001 |
Oswestry Disability Index (ODI) | ||||||||
Week 4 | 49 | −5.82 ± 6.34 (−7.64 to −3.99) | −0.92 | <0.0001 | 50 | −5.82 ± 8.21 (−8.15 to −3.49) | −0.71 | <0.0001 |
Week 12 | 46 | −6.26 ± 7.16 (−8.39 to −4.14) | −0.87 | <0.0001 | 49 | −8.96 ± 8.25 (−11.33 to −6.59) | −1.09 | <0.0001 |
Week 24 | 40 | −7.80 ± 8.24 (−10.44 to −5.16) | −0.95 | <0.0001 | 46 | −8.78 ± 9.63 (−11.64 to −5.92) | −0.91 | <0.0001 |
Roland Morris Questionnaire (RMQ) | ||||||||
Week 4 | 49 | −2.53 ± 4.52 (−3.83 to −1.23) | −0.56 | 0.0003 | 50 | −3.34 ± 4.85 (−4.72 to −1.96) | −0.69 | <0.0001 |
Week 12 | 46 | −2.94 ± 3.95 (−4.11 to −1.76) | −0.74 | <0.0001 | 49 | −4.76 ± 5.03 (−6.20 to −3.31) | −0.95 | <0.0001 |
Week 24 | 40 | −3.55 ± 4.49 (−4.99 to −2.11) | −0.79 | <0.0001 | 46 | −3.94 ± 5.35 (−5.52 to −2.35) | −0.74 | <0.0001 |
EQ-5D-5L mobility | ||||||||
Week 4 | 49 | −0.22 ± 1.01 (−0.51 to 0.06) | −0.22 | 0.1247 | 50 | −0.38 ± 0.85 (−0.62 to −0.14) | −0.44 | 0.0028 |
Week 12 | 46 | −0.22 ± 0.84 (−0.47 to 0.03) | −0.26 | 0.0864 | 49 | −0.59 ± 0.93 (−0.86 to −0.32) | −0.63 | 0.0001 |
Week 24 | 40 | −0.38 ± 0.84 (−0.64 to −0.11) | −0.45 | 0.0073 | 45 | −0.60 ± 1.03 (−0.91 to −0.29) | −0.58 | 0.0003 |
EQ-5D-5L self-care | ||||||||
Week 4 | 49 | −0.14 ± 0.74 (−0.35 to 0.07) | −0.19 | 0.1806 | 50 | −0.20 ± 0.76 (−0.42 to 0.01) | −0.26 | 0.0673 |
Week 12 | 46 | −0.24 ± 0.77 (−0.47 to −0.01) | −0.31 | 0.0397 | 49 | −0.22 ± 0.94 (−0.50 to 0.05) | −0.24 | 0.1015 |
Week 24 | 40 | −0.30 ± 0.79 (−0.55 to −0.05) | −0.38 | 0.0213 | 45 | −0.29 ± 0.84 (−0.54 to −0.04) | −0.34 | 0.0263 |
EQ-5D-5L usual activities | ||||||||
Week 4 | 49 | −0.41 ± 0.96 (−0.68 to −0.13) | −0.43 | 0.0044 | 50 | −0.46 ± 0.81 (−0.69 to −0.23) | −0.57 | 0.0002 |
Week 12 | 46 | −0.52 ± 0.94 (−0.80 to −0.24) | −0.56 | 0.0005 | 49 | −0.59 ± 0.98 (−0.87 to −0.31) | −0.61 | 0.0001 |
Week 24 | 40 | −0.83 ± 0.81 (−1.09 to −0.57) | −1.01 | <0.0001 | 45 | −0.80 ± 0.94 (−1.08 to −0.52) | −0.85 | <0.0001 |
EQ-5D-5L pain/discomfort | ||||||||
Week 4 | 49 | −0.59 ± 0.93 (−0.86 to −0.32) | −0.63 | 0.0001 | 50 | −0.56 ± 0.95 (−0.83 to −0.29) | −0.59 | 0.0001 |
Week 12 | 46 | −0.63 ± 0.77 (−0.86 to −0.40) | −0.82 | <0.0001 | 49 | −0.90 ± 0.96 (−1.17 to −0.62) | −0.93 | <0.0001 |
Week 24 | 40 | −0.88 ± 0.91 (−1.17 to −0.58) | −0.96 | <0.0001 | 45 | −0.84 ± 1.09 (−1.17 to −0.52) | −0.78 | <0.0001 |
EQ-5D-5L anxiety/depression | ||||||||
Week 4 | 49 | −0.33 ± 0.99 (−0.61 to −0.04) | −0.33 | 0.0249 | 50 | −0.34 ± 1.00 (−0.63 to −0.06) | −0.34 | 0.0203 |
Week 12 | 46 | −0.33 ± 1.01 (−0.63 to −0.03) | −0.32 | 0.0341 | 49 | −0.59 ± 0.96 (−0.87 to −0.32) | −0.62 | 0.0001 |
Week 24 | 40 | −0.43 ± 1.01 (−0.75 to −0.10) | −0.42 | 0.0112 | 45 | −0.56 ± 1.20 (−0.92 to −0.20) | −0.46 | 0.0033 |
EQ-5D-5L-based Level Sum Score (LSS) | ||||||||
Week 4 | 49 | −1.69 ± 3.27 (−2.63 to −0.75) | −0.52 | 0.0007 | 50 | −1.94 ± 3.18 (−2.85 to −1.04) | −0.61 | 0.0001 |
Week 12 | 46 | −2.04 ± 3.14 (−2.97 to −1.12) | −0.65 | 0.0001 | 49 | −2.90 ± 3.56 (−3.92 to −1.88) | −0.81 | <0.0001 |
Week 24 | 40 | −2.80 ± 3.01 (−3.76 to −1.84) | −0.93 | <0.0001 | 45 | −3.09 ± 3.81 (−4.23 to −1.94) | −0.81 | <0.0001 |
EQ-5D-5L VAS | ||||||||
Week 4 | 49 | 3.57 ± 18.69 (−1.80 to 8.94) | 0.19 | 0.1873 | 50 | 11.56 ± 18.78 (6.22 to 16.90) | 0.62 | 0.0001 |
Week 12 | 46 | 5.94 ± 17.47 (0.75 to 11.12) | 0.34 | 0.0259 | 49 | 14.22 ± 20.49 (8.34 to 20.11) | 0.69 | <0.0001 |
Week 24 | 40 | 6.70 ± 20.70 (0.08 to 13.32) | 0.32 | 0.0474 | 45 | 15.02 ± 19.95 (9.03 to 21.02) | 0.75 | <0.0001 |
EQ-5D-5L Index | ||||||||
Week 4 | 49 | 0.0653 ± 0.150 (0.022 to 0.108) | 0.44 | 0.0037 | 50 | 0.108 ± 0.167 (0.060 to 0.155) | 0.65 | <0.0001 |
Week 12 | 46 | 0.0688 ± 0.144 (0.026 to 0.112) | 0.48 | 0.0023 | 49 | 0.136 ± 0.163 (0.089 to 0.183) | 0.83 | <0.0001 |
Week 24 | 40 | 0.0969 ± 0.138 (0.053 to 0.141) | 0.70 | 0.0001 | 45 | 0.119 ± 0.191 (0.062 to 0.177) | 0.62 | 0.0001 |
Difference between Groups | |||||
---|---|---|---|---|---|
Difference at | Ne | Np | M ± SD (95% CI of M) | Cohen’s d | p-Value * |
Numeric Rating Scale (NRS) | |||||
Week 4 | 49 | 50 | 0.31 ± 2.14 (−0.54 to 1.17) | −0.15 | 0.4670 |
Week 12 | 46 | 49 | −0.54 ± 2.50 (−1.55 to 0.47) | 0.22 | 0.2942 |
Week 24 | 40 | 46 | −0.01 ± 2.33 (−1.01 to 0.99) | 0.01 | 0.9811 |
Oswestry Disability Index (ODI) | |||||
Week 4 | 49 | 50 | 0.00 ± 7.34 (−2.93 to 2.93) | 0.00 | 0.9980 |
Week 12 | 46 | 49 | −2.70 ± 7.74 (−5.85 to 0.46) | 0.35 | 0.0929 |
Week 24 | 40 | 46 | −0.98 ± 9.01 (−4.86 to 2.89) | 0.11 | 0.6155 |
Roland Morris Questionnaire (RMQ) | |||||
Week 4 | 49 | 50 | −0.81 ± 4.69 (−2.68 to 1.06) | 0.17 | 0.3927 |
Week 12 | 46 | 49 | −1.82 ± 4.54 (−3.67 to 0.03) | 0.40 | 0.0538 |
Week 24 | 40 | 46 | −0.38 ± 4.97 (−2.52 to 1.75) | 0.08 | 0.7211 |
EQ-5D-5L mobility | |||||
Week 4 | 49 | 50 | −0.16 ± 0.93 (−0.53 to 0.22) | 0.17 | 0.4087 |
Week 12 | 46 | 49 | −0.37 ± 0.89 (−0.74 to −0.01) | 0.42 | 0.0432 |
Week 24 | 40 | 45 | −0.23 ± 0.95 (−0.63 to 0.18) | 0.24 | 0.2766 |
EQ-5D-5L self-care | |||||
Week 4 | 49 | 50 | −0.06 ± 0.75 (−0.35 to 0.24) | 0.08 | 0.7040 |
Week 12 | 46 | 49 | 0.01 ± 0.86 (−0.34 to 0.37) | −0.02 | 0.9341 |
Week 24 | 40 | 45 | 0.01 ± 0.82 (−0.34 to 0.37) | −0.01 | 0.9504 |
EQ-5D-5L usual activities | |||||
Week 4 | 49 | 50 | −0.05 ± 0.89 (−0.41 to 0.30) | 0.06 | 0.7718 |
Week 12 | 46 | 49 | −0.07 ± 0.96 (−0.46 to 0.32) | 0.07 | 0.7223 |
Week 24 | 40 | 45 | 0.03 ± 0.88 (−0.36 to 0.41) | −0.03 | 0.8969 |
EQ-5D-5L pain/discomfort | |||||
Week 4 | 49 | 50 | 0.03 ± 0.94 (−0.34 to 0.41) | −0.03 | 0.8669 |
Week 12 | 46 | 49 | −0.27 ± 0.88 (−0.62 to 0.09) | 0.31 | 0.1398 |
Week 24 | 40 | 45 | 0.03 ± 1.01 (−0.41 to 0.47) | −0.03 | 0.8894 |
EQ-5D-5L anxiety/depression | |||||
Week 4 | 49 | 50 | −0.01 ± 0.99 (−0.41 to 0.38) | 0.01 | 0.9464 |
Week 12 | 46 | 49 | −0.27 ± 0.98 (−0.67 to 0.14) | 0.27 | 0.1913 |
Week 24 | 40 | 45 | −0.13 ± 1.11 (−0.61 to 0.35) | 0.12 | 0.5909 |
EQ-5D-5L-based Level Sum Score (LSS) | |||||
Week 4 | 49 | 50 | −0.25 ± 3.23 (−1.53 to 1.04) | 0.08 | 0.7054 |
Week 12 | 46 | 49 | −0.86 ± 3.36 (−2.22 to 0.51) | 0.25 | 0.2158 |
Week 24 | 40 | 45 | −0.29 ± 3.46 (−1.78 to 1.21) | 0.08 | 0.7019 |
EQ-5D-5L VAS | |||||
Week 4 | 49 | 50 | 7.99 ± 18.73 (0.51 to 15.46) | −0.43 | 0.0364 |
Week 12 | 46 | 49 | 8.29 ± 19.09 (0.51 to 16.07) | −0.44 | 0.0370 |
Week 24 | 40 | 45 | 8.32 ± 20.30 (−0.45 to 17.10) | −0.41 | 0.0628 |
EQ-5D-5L Index | |||||
Week 4 | 49 | 50 | 0.042 ± 0.159 (−0.021 to 0.106) | −0.27 | 0.1857 |
Week 12 | 46 | 49 | 0.067 ± 0.154 (0.005 to 0.130) | −0.44 | 0.0359 |
Week 24 | 40 | 45 | 0.022 ± 0.168 (−0.051 to 0.095) | −0.13 | 0.5452 |
Epidural | Perineural | |||||
---|---|---|---|---|---|---|
Type of Hernia | N | M ± SD (95% CI of M) | Cohen’s d | N | M ± SD (95% CI of M) | Cohen’s d |
Difference from baseline to week 24: Oswestry Disability Index (ODI) | ||||||
Bulging | 13 | −7.31 ± 6.80 (−11.42 to −3.2) | −1.07 | 7 | −8.43 ± 9.11 (−16.85 to −0.01) | −0.93 |
Extrusion | 6 | −5.83 ± 5.71 (−11.82 to 0.16) | −1.02 | 5 | −20 ± 10.75 (−33.34 to −6.66) | −1.86 |
Prolapse | 11 | −8.82 ± 10.09 (−15.6 to −2.04) | −0.87 | 25 | −5.72 ± 9.08 (−9.47 to −1.97) | −0.63 |
Residual | 8 | −7.63 ± 10.31 (−16.24 to 0.99) | −0.74 | 5 | −6.8 ± 2.77 (−10.25 to −3.36) | −2.45 |
Difference from baseline to week 24: Roland Morris Questionnaire (RMQ) | ||||||
Bulging | 13 | −3.23 ± 4.0652 (−5.69 to −0.77) | −0.79 | 7 | −2.43 ± 3.1 (−5.3 to 0.44) | −0.78 |
Extrusion | 6 | −2.83 ± 2.86 (−5.83 to 0.17) | −0.99 | 5 | −10.6 ± 7.02 (−19.32 to −1.88) | −1.51 |
Prolapse | 11 | −3.73 ± 4.15 (−6.52 to −0.94) | −0.90 | 25 | −2.88 ± 4.94 (−4.92 to −0.84) | −0.58 |
Residual | 8 | −3.63 ± 5.88 (−8.54 to 1.29) | −0.62 | 5 | −3.4 ± 4.39 (−8.86 to 2.06) | −0.77 |
Difference from baseline to week 24: EQ-5D-5L Index | ||||||
Bulging | 13 | 0.07 ± 0.079 (0.022 to 0.118) | 0.88 | 7 | 0.147 ± 0.119 (0.022 to 0.271) | 1.24 |
Extrusion | 6 | 0.101 ± 0.128 (−0.034 to 0.235) | 0.79 | 5 | 0.248 ± 0.238 (−0.048 to 0.543) | 1.04 |
Prolapse | 11 | 0.103 ± 0.181 (−0.019 to 0.225) | 0.57 | 25 | 0.08 ± 0.214 (−0.008 to 0.169) | 0.37 |
Residual | 8 | 0.082 ± 0.15 (−0.044 to 0.207) | 0.55 | 5 | 0.119 ± 0.105 (−0.011 to 0.249) | 1.14 |
Event | Epidural Administration | Perineural Administration |
---|---|---|
Serious adverse reactions | Ø | Ø |
Adverse reactions | ||
Benign headache | 2 | Ø |
Dizziness | Ø | 1 |
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Godek, P.; Szczepanowska-Wolowiec, B.; Golicki, D. Comparison of Analgesic Efficacy between Epidural and Perineural Administration of Autologous Conditioned Serum in the Conservative Treatment of Low Back Pain Due to Lumbar Degenerative Disc Disease: A Randomized, Open-Label, Controlled Clinical Trial. Brain Sci. 2023, 13, 749. https://doi.org/10.3390/brainsci13050749
Godek P, Szczepanowska-Wolowiec B, Golicki D. Comparison of Analgesic Efficacy between Epidural and Perineural Administration of Autologous Conditioned Serum in the Conservative Treatment of Low Back Pain Due to Lumbar Degenerative Disc Disease: A Randomized, Open-Label, Controlled Clinical Trial. Brain Sciences. 2023; 13(5):749. https://doi.org/10.3390/brainsci13050749
Chicago/Turabian StyleGodek, Piotr, Beata Szczepanowska-Wolowiec, and Dominik Golicki. 2023. "Comparison of Analgesic Efficacy between Epidural and Perineural Administration of Autologous Conditioned Serum in the Conservative Treatment of Low Back Pain Due to Lumbar Degenerative Disc Disease: A Randomized, Open-Label, Controlled Clinical Trial" Brain Sciences 13, no. 5: 749. https://doi.org/10.3390/brainsci13050749