Dataset Information

Effectiveness of Acupotomy Combined with Epidural Steroid Injection for Lumbosacral Radiculopathy: A Randomized Controlled Pragmatic Pilot Study.

ABSTRACT: 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.

SUBMITTER: Lee JH

PROVIDER: S-EPMC10818306 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature

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Effectiveness of Acupotomy Combined with Epidural Steroid Injection for Lumbosacral Radiculopathy: A Randomized Controlled Pragmatic Pilot Study.

Lee Jin-Hyun JH Lee Sang-Hyun SH Suh Hae Sun HS Hwang Man-Suk MS Jang Semin S Choi Sooil S Lim Young-Soo YS Byun Sang Hyun SH Yoon Sang-Hoon SH Park Sukhee S Park Tae-Yong TY

Medicina (Kaunas, Lithuania) 20240119 1

<i>Background and Objectives</i>: 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. <i>Materials and Methods</i>: 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 ran ...[more]

PMID: 38276054

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Project description:BackgroundPrevious systemic reviews have examined the efficacy of individual therapeutic agents, but which type of treatment is superior to another has not been pooled or analyzed. The objective of the current study was to compare the clinical effectiveness of epidural steroid injection (ESI) versus conservative treatment for patients with lumbosacral radicular pain.MethodsA systematic search was conducted with MEDLINE, EMBASE, and CENTRAL databases with a double-extraction technique for relevant studies published between 2000 and January 10, 2019. The randomized controlled trials which directly compared the efficacy of ESI with conservative treatment in patients with lumbosacral radicular pain were included. Outcomes included visual analog scale, numeric rating scale, Oswetry disability index, or successful events. Two reviewers extracted data and evaluated the methodological quality of papers using the Cochrane Collaboration Handbook. A meta-analysis was performed using Revman 5.2 software. The heterogeneity of the meta-analysis was also assessed.ResultsOf 1071 titles initially identified, 6 randomized controlled trials (249 patients with ESI and 241 patients with conservative treatment) were identified and included in this meta-analysis. The outcome of the pooled analysis showed that ESI was beneficial for pain relief at short-term and intermediate-term follow-up when compared with conservative treatment, but this effect was not maintained at long-term follow-up. Successful event rates were significantly higher in patients who received ESI than in patients who received conservative treatment. There were no statistically significant differences in functional improvement after ESI and conservative treatment at short-term and intermediate-term follow-up. The limitations of this meta-analysis resulted from the variation in types of interventions and small sample size.ConclusionsAccording to the results of this meta-analysis, the use of ESI is more effective for alleviating lumbosacral radicular pain than conservative treatments in terms of short-term and intermediate-term. Patients also reported more successful outcomes after receiving ESI when compared to conservative treatment. However, this effect was not maintained at long-term follow-up. This meta-analysis will help guide clinicians in making decisions for the treatment of patients with lumbosacral radicular pain, including the use of ESI, particularly in the management of pain at short-term.

Project description:BackgroundThe prevalence of low back pain with radiculopathy in general population varies from 9.9% to 25%, which can be due to bony narrowing of the lateral recess or due to prolapsed intervertebral disc. Transforaminal epidural injection of a mixture of long-acting anaesthetic (bupivacaine) and particulate steroids (depomedrol) has been a treatment modality in patients not responding to initial physiotherapy and neuropathic pain medications.MethodsTo analyze the effectiveness of transforaminal epidural steroid injection (TFESI) in the treatment of low back pain with radiculopathy, a retrospective case series evaluating the records of patients that received TFESI (1 mL 0.5% bupivacaine +1 ml/40 mg depomedrol) under C-arm guidance from January 2015 to December 2018 (3 years) at Upendra Devkota Memorial-National Institute of Neurological and Allied Sciences (UDM-NINAS), their lumbo-sacral MRI and the pre-procedure, 1-week and 3-month numeric pain rating scale, were analyzed. Successful treatment (reduction of pain scale by more than 50% of baseline at 3 months) in the patients with bony recess stenosis and those with prolapsed intervertebral disc was compared.ResultsOut of 67 patients that received TFESI, 35 (52.23%) could be followed up. The mean age was 55.8 ± 14.39 years and 51.3% were females. 68.57% had L5 and 20% had S1 radiculopathy. Bony recess stenosis was seen in the aged 40% and PIVD was the cause of radiculopathy in 60%. The median duration of radicular pain prior to intervention was 3 months. TFESI was effective as the mean numeric pain scale before injection was 8.97 ± 1.32 which reduced to 3.91 ± 3.23 (paired t test p value < 0.001) at 1 week post injection and 3.23 ± 3.34 (paired t test p value < 0.001) at 3 months post injection. Twenty-six of the 35 patients (75.29%) had more than 50% pain relief compared to baseline at 3 months and were satisfied. Nine patients continued to have pain; however, only one required a surgical intervention. The effectiveness of TFESI was not significantly different in different ages (Fisher's exact test p value 0.182) and in different anatomic levels (Fisher's exact test p value 0.241). Six out of eight patients with bony recess stenosis benefited as compared to 14 out of 19 patients with PIVD, though it was not statistically significant (Fischer's exact test p value 0.688). There were no adverse events recorded.ConclusionTFESI is a safe and efficacious treatment modality in patients with radicular low back pain especially in aged patients in whom surgery under general anaesthesia is not free from risk.

Project description:ObjectiveTo evaluate whether an epidural steroid injection or gabapentin is a better treatment for lumbosacral radiculopathy.DesignA multicenter randomized study conducted between 2011 and 2014. Computer generated randomization was stratified by site. Patients and evaluating physicians were blinded to treatment outcomes.SettingsEight military, Veterans Administration, and civilian hospitals.Participants145 people with lumbosacral radicular pain secondary to herniated disc or spinal stenosis for less than four years in duration and in whom leg pain is as severe or more severe than back pain.InterventionsParticipants received either epidural steroid injection plus placebo pills or sham injection plus gabapentin.Main outcome measuresAverage leg pain one and three months after the injection on a 0-10 numerical rating scale. A positive outcome was defined as a ≥ 2 point decrease in leg pain coupled with a positive global perceived effect. All patients had one month follow-up visits; patients whose condition improved remained blinded for their three month visit.ResultsThere were no significant differences for the primary outcome measure at one month (mean pain score 3.3 (SD 2.6) and mean change from baseline -2.2 (SD 2.4) in epidural steroid injection group versus 3.7 (SD 2.6) and -1.7 (SD 2.6) in gabapentin group; adjusted difference 0.4, 95% confidence interval -0.3 to 1.2; P=0.25) and three months (mean pain score 3.4 (SD 2.7) and mean change from baseline -2.0 (SD 2.6) versus 3.7 (SD 2.8) and -1.6 (SD 2.7), respectively; adjusted difference 0.3, -0.5 to 1.2; P=0.43). Among secondary outcomes, one month after treatment those who received epidural steroid injection had greater reductions in worst leg pain (-3.0, SD 2.8) than those treated with gabapentin (-2.0, SD 2.9; P=0.04) and were more likely to experience a positive successful outcome (66% v 46%; number needed to treat=5.0, 95% confidence interval 2.8 to 27.0; P=0.02). At three months, there were no significant differences between treatments.ConclusionsAlthough epidural steroid injection might provide greater benefit than gabapentin for some outcome measures, the differences are modest and are transient for most people.Trial registration ClinicalTrials.gov Identifier: NCT01495923.

Dataset Information

Effectiveness of Acupotomy Combined with Epidural Steroid Injection for Lumbosacral Radiculopathy: A Randomized Controlled Pragmatic Pilot Study.

Publications

Effectiveness of Acupotomy Combined with Epidural Steroid Injection for Lumbosacral Radiculopathy: A Randomized Controlled Pragmatic Pilot Study.

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