Effectiveness of Acupotomy Combined with Epidural Steroid Injection for Lumbosacral Radiculopathy : A Randomized Controlled Pragmatic Pilot Study
Background and Objectives: This pilot study aimed to evaluate the clinical effectiveness, cost-effectiveness, and safety of acupotomy combined with epidural steroid injection (ESI) in lumbosacral radiculopathy and examine its feasibility for the main study. Materials and Methods: This randomized, controlled, two-arm, parallel, assessor-blinded, pragmatic study included 50 patients with severe lumbosacral radiculopathy who had insufficient improvement after an ESI. Patients were randomized (1:1 ratio) into a combined treatment (acupotomy + ESI, experimental) and an ESI single treatment (control) group. Both groups underwent a total of two ESIs once every 2 weeks; the experimental group received eight additional acupotomy treatments twice a week for 4 weeks. Types of ESI included interlaminar, transforaminal, and caudal approaches. Drugs used in ESI comprised a 5-10 mL mixture of dexamethasone sodium phosphate (2.5 mg), mepivacaine (0.3%), and hyaluronidase (1500 IU). The primary outcome was the difference in changes from baseline in the Oswestry Disability Index (ODI) scores between the groups at weeks 4 and 8. The incremental cost-utility ratio (ICUR) was calculated to evaluate the cost-effectiveness between the groups. Adverse events (AEs) were assessed at all visits. Results: Mean ODI scores for the experimental and control groups were -9.44 (95% confidence interval [CI]: -12.71, -6.17) and -2.16 (95% CI: -5.01, 0.69) at week 4, and -9.04 (95% CI: -12.09, -5.99) and -4.76 (95% CI: -7.68, -1.84) at week 8, respectively. The difference in ODI score changes was significant between the groups at week 4 (p = 0.0021). The ICUR of the experimental group versus the control group was as economical as 18,267,754 won/quality-adjusted life years. No serious AEs were observed. Conclusions: These results demonstrate the potential clinical effectiveness and cost-effectiveness of acupotomy combined with ESI for lumbosacral radiculopathy and its feasibility for a full-scale study. Larger, long-term follow-up clinical trials are needed to confirm these findings.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:60 |
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| Enthalten in: |
Medicina (Kaunas, Lithuania) - 60(2024), 1 vom: 19. Jan. |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Lee, Jin-Hyun [VerfasserIn] |
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| Links: |
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| Themen: |
Acupotomy |
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| Anmerkungen: |
Date Completed 06.02.2024 Date Revised 06.02.2024 published: Electronic Citation Status MEDLINE |
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| doi: |
10.3390/medicina60010175 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM367664623 |
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| 100 | 1 | |a Lee, Jin-Hyun |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Effectiveness of Acupotomy Combined with Epidural Steroid Injection for Lumbosacral Radiculopathy |b A Randomized Controlled Pragmatic Pilot Study |
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| 520 | |a Background and Objectives: This pilot study aimed to evaluate the clinical effectiveness, cost-effectiveness, and safety of acupotomy combined with epidural steroid injection (ESI) in lumbosacral radiculopathy and examine its feasibility for the main study. Materials and Methods: This randomized, controlled, two-arm, parallel, assessor-blinded, pragmatic study included 50 patients with severe lumbosacral radiculopathy who had insufficient improvement after an ESI. Patients were randomized (1:1 ratio) into a combined treatment (acupotomy + ESI, experimental) and an ESI single treatment (control) group. Both groups underwent a total of two ESIs once every 2 weeks; the experimental group received eight additional acupotomy treatments twice a week for 4 weeks. Types of ESI included interlaminar, transforaminal, and caudal approaches. Drugs used in ESI comprised a 5-10 mL mixture of dexamethasone sodium phosphate (2.5 mg), mepivacaine (0.3%), and hyaluronidase (1500 IU). The primary outcome was the difference in changes from baseline in the Oswestry Disability Index (ODI) scores between the groups at weeks 4 and 8. The incremental cost-utility ratio (ICUR) was calculated to evaluate the cost-effectiveness between the groups. Adverse events (AEs) were assessed at all visits. Results: Mean ODI scores for the experimental and control groups were -9.44 (95% confidence interval [CI]: -12.71, -6.17) and -2.16 (95% CI: -5.01, 0.69) at week 4, and -9.04 (95% CI: -12.09, -5.99) and -4.76 (95% CI: -7.68, -1.84) at week 8, respectively. The difference in ODI score changes was significant between the groups at week 4 (p = 0.0021). The ICUR of the experimental group versus the control group was as economical as 18,267,754 won/quality-adjusted life years. No serious AEs were observed. Conclusions: These results demonstrate the potential clinical effectiveness and cost-effectiveness of acupotomy combined with ESI for lumbosacral radiculopathy and its feasibility for a full-scale study. Larger, long-term follow-up clinical trials are needed to confirm these findings | ||
| 650 | 4 | |a Journal Article | |
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| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a acupotomy | |
| 650 | 4 | |a epidural steroid injection | |
| 650 | 4 | |a integrative medicine | |
| 650 | 4 | |a pilot projects | |
| 650 | 4 | |a radiculopathy | |
| 650 | 4 | |a randomized controlled trial | |
| 650 | 7 | |a Steroids |2 NLM | |
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| 700 | 1 | |a Suh, Hae Sun |e verfasserin |4 aut | |
| 700 | 1 | |a Hwang, Man-Suk |e verfasserin |4 aut | |
| 700 | 1 | |a Jang, Semin |e verfasserin |4 aut | |
| 700 | 1 | |a Choi, Sooil |e verfasserin |4 aut | |
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| 700 | 1 | |a Byun, Sang Hyun |e verfasserin |4 aut | |
| 700 | 1 | |a Yoon, Sang-Hoon |e verfasserin |4 aut | |
| 700 | 1 | |a Park, Sukhee |e verfasserin |4 aut | |
| 700 | 1 | |a Park, Tae-Yong |e verfasserin |4 aut | |
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