Relationship of Success Rate for Balloon Adhesiolysis with Clinical Outcomes in Chronic Intractable Lumbar Radicular Pain: A Multicenter Prospective Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Patients
2.2. Intervention: Percutaneous Epidural Decompression and Adhesiolysis Using an Inflatable Balloon Catheter
2.3. Outcome Assessment and Follow-Up
2.4. Statistical Analysis
3. Results
3.1. Demographics
3.2. Ballooning Success Rate Groups for Multiple Target Sites
3.3. The Estimated Proportions of Successful Responders
3.4. The Estimated Mean Changes in the Back and Leg Pain, and ODI
3.5. Observed Complications
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
References
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Parameter | Below 50% (n = 48) | 50–85% (n = 79) | 85–100% (n = 148) | p-Value |
---|---|---|---|---|
Age, years | 68.9 (12.2) | 61.9 (12.8) | 61.6 (13.1) | 0.003 |
Gender, n (%) | ||||
Male/female | 22/26 (45.8/54.2) | 48/31 (60.8/39.2) | 79/69 (53.4/46.6) | 0.251 |
Body mass index, kg/m2 | 23.2 (4.1) | 24.8 (2.9) | 24.2 (2.9) | 0.019 |
Areas of pain, n (%) | 0.943 | |||
Back/leg/both | 7/4/37 (14.6/8.3/77.1) | 11/8/60 (13.9/10.1/76.0) | 17/17/114 (11.5/11.5/77.0) | |
Duration of pain (months) | 12.0 (4.0–24.0) | 12.0 (7.0–36.0) | 12.0 (6.0–24.0) | 0.771 |
Concurrent disease, n (%) | ||||
Diabetes | 10 (20.8) | 8 (10.1) | 27 (18.2) | 0.189 |
Hypertension | 30 (62.5) | 38 (48.1) | 74 (50.0) | 0.244 |
Cardiovascular disease | 14 (29.2) | 35 (44.3) | 43 (29.1) | 0.053 |
Spinal stenosis grading, n (%) | ||||
Central canal (A/B/C/D) | 9/11/9/1 (18.8/22.9/18.8/2.1) | 16/15/23/0 (20.3/19.0/29.1/0.0) | 35/20/25/3 (23.6/13.5/16.9/2.0) | 0.355 |
Foraminal (mild/moderate/severe) | 11/17/20 (22.9/35.4/41.7) | 28/22/24 (35.4/27.8/30.4) | 51/33/34 (34.5/22.3/23.0) | 0.190 |
Spondylolisthesis, n (%) | 6 (12.5) | 5 (6.3) | 13 (8.8) | 0.480 |
MQS, points | 11.8 (8.0–15.0) | 11.0 (8.0–12.2) | 8.0 (7.6–11.2) | 0.100 |
Pain intensity (NRS) | ||||
Back | 7.0 (4.0–8.0) | 6.0 (4.0–7.0) | 6.0 (4.0–8.0) | 0.414 |
Leg | 7.0 (5.5–8.0) | 6.0 (5.0–8.0) | 7.0 (5.0–8.0) | 0.515 |
ODI (%) | 34.0 (24.5–39.5) | 30.0 (23.0–38.0) | 28.0 (22.0–35.0) | 0.071 |
BDI, points | 7.0 (5.0–10.0) | 6.0 (5.0–9.0) | 6.0 (4.0–11.0) | 0.595 |
Parameter | Below 50% (n = 48) | 50–85% (n = 79) | 85–100% (n = 148) | p-Value |
---|---|---|---|---|
Target level, n (%) | 0.284 | |||
1 level (L3-4/L4-5/L5-S1) 2 levels (L3-4-5/L4-5-S1) 3 levels (L2-3-4-5/L3-4-5-S1) 4 levels (L2-3-4-5-S1) | 0/24/3 (0.0/50.0/6.3) 5/15 (10.4/31.3) 0/1 (0.0/2.1) 0 (0.0) | 2/31/10 (2.5/39.2/12.7) 9/24 (11.4/30.4) 0/3 (0.0/3.8) 0 (0.0) | 2/56/9 (1.4/37.8/6.1) 21/40 (14.2/27.0) 5/12 (3.4/8.1) 3 (2.0) | |
Target site, n (%) | 0.302 | |||
Left/right/both/central/Lt, central/Rt, central/both, central | 8/6/14/1/4/5/ 10 (16.7/12.5/29.2/2.1/8.3/10.4/20.8) | 13/6/24/2/4/7/23 (16.5/7.6/30.4/2.5/5.1/8.9/29.1) | 19/13/40/17/17/12/30 (12.8/8.8/27.0/11.5/11.5/8.1/20.3) | |
Number of target sites, n (%) | 0.368 | |||
2–3/4–5/above 6 | 18/22/8 (37.5/45.8/16.7) | 21/35/23 (26.6/44.3/29.1) | 54/57/37 (36.5/38.5/25.0) |
Follow-Up (Months) | Below 50% (n = 48), Estimated Proportion (95% CI) | 50–85% (n = 79), Estimated Proportion (95% CI) | 85–100% (n = 148), Estimated Proportion (95% CI) | p- Value | |
---|---|---|---|---|---|
Successful | 1 | 0.688 (0.556–0.819) | 0.633 (0.527–0.739) | 0.662 (0.586–0.738) | 0.812 |
Responder | 3 | 0.542 (0.401–0.683) | 0.582 (0.474–0.691) | 0.628 (0.551–0.706) | 0.528 |
6 | 0.292 (0.163–0.420) | 0.468 (0.358–0.578) | 0.507 (0.426–0.587) | 0.038 |
Variables * | Time (Months) | Below 50% (n = 48) Values (95% CI) | 50–85% (n = 79) Values (95% CI) | 85–100% (n = 148) Values (95% CI) | p-Value † |
---|---|---|---|---|---|
GPES | 1 | 4.80 (4.43–5.17) | 4.83 (4.55–5.11) | 4.86 (4.64–5.09) | 0.955 |
3 | 4.86 (4.05–5.67) | 4.23 (3.47–4.99) | 4.48 (3.98–4.99) | 0.532 | |
6 | 4.09 (3.68–4.49) | 4.31 (4.01–4.61) | 4.88 (4.64–5.12) | 0.001 |
Complication | Number (%) |
---|---|
Dura matter puncture | 9 (3.3) |
Subdural injection | 5 (1.8) |
Vascular injection | 4 (1.5) |
Disc injection | 6 (2.2) |
Hypotension | 4 (1.5) |
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Share and Cite
Park, J.-Y.; Ji, G.Y.; Lee, S.W.; Park, J.K.; Ha, D.; Park, Y.; Cho, S.-S.; Moon, S.H.; Shin, J.-W.; Kim, D.J.; et al. Relationship of Success Rate for Balloon Adhesiolysis with Clinical Outcomes in Chronic Intractable Lumbar Radicular Pain: A Multicenter Prospective Study. J. Clin. Med. 2019, 8, 606. https://doi.org/10.3390/jcm8050606
Park J-Y, Ji GY, Lee SW, Park JK, Ha D, Park Y, Cho S-S, Moon SH, Shin J-W, Kim DJ, et al. Relationship of Success Rate for Balloon Adhesiolysis with Clinical Outcomes in Chronic Intractable Lumbar Radicular Pain: A Multicenter Prospective Study. Journal of Clinical Medicine. 2019; 8(5):606. https://doi.org/10.3390/jcm8050606
Chicago/Turabian StylePark, Jun-Young, Gyu Yeul Ji, Sang Won Lee, Jin Kyu Park, Dongwon Ha, Youngmok Park, Seong-Sik Cho, Sang Ho Moon, Jin-Woo Shin, Dong Joon Kim, and et al. 2019. "Relationship of Success Rate for Balloon Adhesiolysis with Clinical Outcomes in Chronic Intractable Lumbar Radicular Pain: A Multicenter Prospective Study" Journal of Clinical Medicine 8, no. 5: 606. https://doi.org/10.3390/jcm8050606