Dataset Information

The Effectiveness of Pharmacopuncture in Patients with Lumbar Spinal Stenosis: A Protocol for a Multi-Centered, Pragmatic, Randomized, Controlled, Parallel Group Study.

ABSTRACT:

Purpose

Lumbar spinal stenosis (LSS) is a chronic degenerative disease. Non-surgical intervention is recommended, considering the risks and benefits for the affected age group, as well as the characteristics of the disease. However, to date, no studies have compared various non-surgical interventions to ascertain the appropriate first-line non-surgical treatment for LSS. Therefore, the objective of this study will be to assess the efficacy of pharmacopuncture as a non-surgical, conservative treatment for LSS.

Patients and methods

A multi-centered, pragmatic, parallel-group study will be conducted. In total, 98 patients will be recruited at seven institutes; recruitment began in May 2022. After two treatment sessions per week over a period of 12 weeks, follow-up assessments will be held at weeks 13, 25, and 53.

Results

The efficacy of pharmacopuncture and conservative care will be pragmatically compared in patients radiologically diagnosed with LSS. Pain severity will be measured using the numeric rating scale and visual analog scale. Walking distance will also be evaluated. Patient-centered evaluations will include the Zurich Claudication Questionnaire, Short-Form 12 for Health-Related Quality of Life, EuroQoL 5 Dimension 5 Levels, and Patient Global Impression of Change.

Conclusion

The results of this study will confirm the efficacy of pharmacopuncture in comparison to conventional non-surgical treatment and will thus facilitate the prioritization of patient-centered interventions for LSS.

Trial registration

This study was registered at Clinicaltrials.gov (registration identifier: NCT05242497) and CRiS (registration identifier: KCT0007145).

SUBMITTER: Lee JY

PROVIDER: S-EPMC9514259 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Publications

The Effectiveness of Pharmacopuncture in Patients with Lumbar Spinal Stenosis: A Protocol for a Multi-Centered, Pragmatic, Randomized, Controlled, Parallel Group Study.

Lee Jee Young JY Park Kyoung Sun KS Kim Suna S Seo Ji Yeon JY Cho Hyun-Woo HW Nam Dongwoo D Park Yeoncheol Y Kim Eun-Jung EJ Lee Yoon Jae YJ Ha In-Hyuk IH

Journal of pain research 20220923

<h4>Purpose</h4>Lumbar spinal stenosis (LSS) is a chronic degenerative disease. Non-surgical intervention is recommended, considering the risks and benefits for the affected age group, as well as the characteristics of the disease. However, to date, no studies have compared various non-surgical interventions to ascertain the appropriate first-line non-surgical treatment for LSS. Therefore, the objective of this study will be to assess the efficacy of pharmacopuncture as a non-surgical, conservat ...[more]

PMID: 36176963

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Project description:Objective: To systematically evaluate the clinical effectiveness of conservative treatments including pharmacological treatments and nonpharmacological treatments on patients with lumbar spinal stenosis. Methods: We searched six electronic databases systematically for randomized clinical trials published between January 2000 and July 2021, including the China National Knowledge Infrastructure, WanFang Data, PubMed, MEDLINE, Embase, and the Cochrane library. The studies focused on the therapeutic effects of pharmacological treatments including calcitonin, antiepileptics, neurotrophic drugs, nonsteroidal anti-inflammatory drugs, Chinese Traditional Medicine, limaprost, and nonpharmacological treatments like physiotherapy for treating lumbar spinal stenosis were included. The outcome was measured using the visual analog scale, Oswestry Dysfunction Index, Japanese Orthopaedic Association Score, and EuroQol Five Dimensions Questionnaire. The quality of eligible studies was assessed by using the Cochrane recommended bias risk assessment tool. Stata was used to conduct the network meta-analysis. Results: A total of 12 randomized control trials with 1,194 patients were included. The network meta-analysis showed that for the visual analog scale, a better therapeutic effect was noted while using Chinese Traditional Medicine and physiotherapy, followed by analgesics drugs and limaprost. Limaprost and calcitonin were better in decreasing the Oswestry Dysfunction Index. In terms of the Japanese Orthopaedic Association Score, the use of traditional Chinese Medicine and limaprost were associated with a better improvement than other treatments. Meanwhile, limaprost combined with analgesics drugs was found to be effective to improve the EuroQol Five Dimensions Questionnaire. Conclusion: Among the commonly used conservative treatments for the treatment of lumbar spinal stenosis, limaprost may have better efficacy in improving the Japanese Orthopaedic Association Score and decreasing the Oswestry Dysfunction Index, with a beneficial effect on decreasing the visual analog scale and improving the EuroQol Five Dimensions Questionnaire. Systematic Review Registration: website, identifier registration number.

Project description:BackgroundThe management of spinal stenosis by surgery has increased rapidly in the past two decades, however, there is still controversy regarding the efficacy of surgery for this condition. Our aim was to investigate the efficacy and comparative effectiveness of surgery in the management of patients with lumbar spinal stenosis.MethodsElectronic searches were performed on MEDLINE, EMBASE, AMED, CINAHL, Web of Science, LILACS and Cochrane Library from inception to November 2014. Hand searches were conducted on included articles and relevant reviews. We included randomised controlled trials evaluating surgery compared to no treatment, placebo/sham, or to another surgical technique in patients with lumbar spinal stenosis. Primary outcome measures were pain, disability, recovery and quality of life. The PEDro scale was used for risk of bias assessment. Data were pooled with a random-effects model, and the GRADE approach was used to summarise conclusions.ResultsNineteen published reports (17 trials) were included. No trials were identified comparing surgery to no treatment or placebo/sham. Pooling revealed that decompression plus fusion is not superior to decompression alone for pain (mean difference -3.7, 95% confidence interval -15.6 to 8.1), disability (mean difference 9.8, 95% confidence interval -9.4 to 28.9), or walking ability (risk ratio 0.9, 95% confidence interval 0.4 to 1.9). Interspinous process spacer devices are slightly more effective than decompression plus fusion for disability (mean difference 5.7, 95% confidence interval 1.3 to 10.0), but they resulted in significantly higher reoperation rates when compared to decompression alone (28% v 7%, P < 0.001). There are no differences in the effectiveness between other surgical techniques for our main outcomes.ConclusionsThe relative efficacy of various surgical options for treatment of spinal stenosis remains uncertain. Decompression plus fusion is not more effective than decompression alone. Interspinous process spacer devices result in higher reoperation rates than bony decompression.

Project description:PurposeTo develop a self-administered diagnostic screening questionnaire for lumbar spinal stenosis (LSS) consisting of items with high content validity and to investigate the diagnostic value of the questionnaire and the items.Patients and methodsA self-reported diagnostic LSS screening questionnaire was developed based on items from the existing literature describing key symptoms of LSS. The screening questionnaire (index test) was to be tested in a cohort of patients with persistent lumbar and/or leg pain recruited from a Danish publicly funded outpatient secondary care spine clinic with clinicians performing the reference test. However, to avoid unnecessary collection of data if the screening questionnaire proved to be of limited value, a case-control design was incorporated into the cohort design including an interim analysis. Additional cases for the case-control study were recruited at two Danish publicly funded spine surgery departments. Prevalence, sensitivity, specificity and diagnostic odds ratio (OR) were calculated for each individual item, and AUC (area under the curve) was calculated to examine the performance of the full questionnaire.ResultsA 13-item Danish questionnaire was developed and tested in 153 cases and 230 controls. The interim analysis was not in favour of continuing the cohort study, and therefore, only results from the case-control study are reported. There was a positive association for all items except the presence of back pain. However, the association was only moderate with ORs up to 3.3. When testing the performance of the whole questionnaire, an AUC of 0.72 was reached with a specificity of 20% for a fixed sensitivity of 95%.ConclusionThe items were associated with LSS and therefore have some potential to identify LSS patients. However, the association was not strong enough to provide sufficient accuracy for a diagnostic tool. Additional dimensions of symptoms of LSS need identification to obtain a reliable questionnaire for screening purposes.

Project description:ObjectiveTo test the equivalence for clinical effectiveness between microdecompression and laminectomy in patients with central lumbar spinal stenosis.DesignMulticentre observational study.SettingProspective data from the Norwegian Registry for Spine Surgery.Participants885 patients with central stenosis of the lumbar spine who underwent surgery at 34 Norwegian orthopaedic or neurosurgical departments. Patients were treated from October 2006 to December 2011.InterventionsLaminectomy and microdecompression.Main outcome measuresThe primary outcome was change in Oswestry disability index score one year after surgery. Secondary endpoints were quality of life (EuroQol EQ-5D), perioperative complications, and duration of surgical procedures and hospital stays. A blinded biostatistician performed predefined statistical analyses in unmatched and propensity matched cohorts.ResultsThe study was powered to detect a difference between the groups of eight points on the Oswestry disability index at one year. 721 patients (81%) completed the one year follow-up. Equivalence between microdecompression and laminectomy was shown for the Oswestry disability index (difference 1.3 points, 95% confidence interval -1.36 to 3.92, P<0.001 for equivalence). Equivalence was confirmed in the propensity matched cohort and full information regression analyses. No difference was found between groups in quality of life (EQ-5D) one year after surgery. The number of patients with complications was higher in the laminectomy group (15.0% v 9.8%, P=0.018), but after propensity matching for complications the groups did not differ (P=0.23). The duration of surgery for single level decompression was shorter in the microdecompression group (difference 11.2 minutes, 95% confidence interval 4.9 to 17.5, P<0.001), but after propensity matching the groups did not differ (P=0.15). Patients in the microdecompression group had shorter hospital stays, both for single level decompression (difference 1.5 days, 95% confidence interval 1.7 to 2.6, P<0.001) and two level decompression (0.8 days, 1.0 to 2.2, P=0.003).ConclusionAt one year the effectiveness of microdecompression is equivalent to laminectomy in the surgical treatment of central stenosis of the lumbar spine. Favourable outcomes were observed at one year in both treatment groups.Trial registration ClinicalTrials.gov NCT02006901.

Dataset Information

The Effectiveness of Pharmacopuncture in Patients with Lumbar Spinal Stenosis: A Protocol for a Multi-Centered, Pragmatic, Randomized, Controlled, Parallel Group Study.

Purpose

Patients and methods

Results

Conclusion

Trial registration

Publications

The Effectiveness of Pharmacopuncture in Patients with Lumbar Spinal Stenosis: A Protocol for a Multi-Centered, Pragmatic, Randomized, Controlled, Parallel Group Study.

Similar Datasets

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