Zurich Claudication Questionnaire Research Articles

Is the presence of foraminal stenosis associated with outcome in lumbar spinal stenosis patients treated with posterior microsurgical decompression

BackgroundWe aim to investigate associations between preoperative radiological findings of lumbar foraminal stenosis with clinical outcomes after posterior microsurgical decompression in patients with predominantly central lumbar spinal stenosis (LSS).MethodsThe study was an additional analysis in the NORDSTEN Spinal Stenosis Trial. In total, 230 men and 207 women (mean age 66.8 (SD 8.3)) were included. All patients underwent an MRI including T1- and T2-weighted sequences. Grade of foraminal stenosis was dichotomized into none to moderate (0–1) and severe (2–3) category using Lee’s classification system. The Oswestry Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ), and numeric rating scale (NRS) for back and leg pain were collected at baseline and at 2-year follow-up. Primary outcome was a reduction of 30% or more on the ODI score. Secondary outcomes included the mean improvement on the ODI, ZCQ, and NRS scores. We performed multivariable regression analyses with the radiological variates foraminal stenosis, Pfirrmann grade, Schizas score, dural sac cross-sectional area, and the possible plausible confounders: patients’ gender, age, smoking status, and BMI.ResultsThe cohort of 437 patients presented a high degree of degenerative changes at baseline. Of 414 patients with adequate imaging of potential foraminal stenosis, 402 were labeled in the none to moderate category and 12 in the severe category. Of the patients with none to moderate foraminal stenosis, 71% achieved at least 30% improvement in ODI. Among the patients with severe foraminal stenosis, 36% achieved at least 30% improvement in ODI. A significant association between severe foraminal stenosis and less chance of reaching the target of 30% improvement in the ODI score after surgery was detected: OR 0.22 (95% CI 0.06, 0.83), p=0.03. When investigating outcome as continuous variables, a similar association between severe foraminal stenosis and less improved ODI with a mean difference of 9.28 points (95%CI 0.47, 18.09; p=0.04) was found. Significant association between severe foraminal stenosis and less improved NRS pain in the lumbar region was also detected with a mean difference of 1.89 (95% CI 0.30, 3.49; p=0.02). No significant association was suggested between severe foraminal stenosis and ZCQ or NRS leg pain.ConclusionIn patients operated with posterior microsurgical decompression for LSS, a preoperative severe lumbar foraminal stenosis was associated with higher proportion of patients with less than 30% improvement in ODI.Trial registrationThe study is registered at ClinicalTrials.gov (22.11.2013) under the identifier NCT02007083.

Lumbar paraspinal muscle morphology is associated with spinal degeneration in patients with lumbar spinal stenosis

BACKGROUND CONTEXTLumbar spinal stenosis (LSS) has been reported to induce changes in paraspinal muscle morphology, but objective physical function and degenerative spine conditions are rarely assessed. PURPOSETo identify factors associated with paraspinal muscle morphology using objective physical and degenerative spine assessments in patients with LSS. STUDY DESIGN/SETTINGCross-sectional design. PATIENT SAMPLESeventy patients with neurogenic claudication caused by LSS, receiving outpatient physical therapy. OUTCOME MEASURESCross-sectional area (CSA) and functional CSA (FCSA) of the multifidus, erector spinae, and psoas muscles, the severity of stenosis, disc degeneration, and endplate abnormalities were evaluated by magnetic resonance imaging, as well as sagittal spinopelvic alignment by X-ray. Objective physical assessments included pedometry and claudication distance. Patient-reported outcomes included the numerical rating scale of low back pain, leg pain, and leg numbness, and the Zurich Claudication Questionnaire. METHODSTo assess the impact of LSS on paraspinal muscles, FCSA and FCSA/CSA were compared between the dominant and nondominant sides based on the patients’ neurogenic symptoms, and multivariable regression analyses adjusted for age, sex, height, and weight were performed; p<.05 was considered significant. RESULTSSeventy patients were analyzed. At one level below the maximum stenotic level, erector spinae FCSA on the dominant side was significantly lower than that on the nondominant side. In the multivariable regression analyses, at one level below the symptomatic level, disc degeneration, endplate abnormalities, and lumbar spinopelvic alignment, such as decreased lumbar lordosis and increased pelvic tilt, were negatively associated with multifidus FCSA and FCSA/CSA ratio. A significant association was observed between dural sac CSA and erector spinae FCSA. Throughout L1/2 to L5/S, disc degeneration, endplate abnormalities, and lumbar spinopelvic alignment were negatively associated with multifidus and erector spinae FCSA or FCSA/CSA. CONCLUSIONSLumbar paraspinal muscle asymmetry caused by LSS was observed only in erector spinae. Disc degeneration, endplate abnormalities, and lumbar spinopelvic alignment, rather than spinal stenosis and LSS symptoms, were more associated with paraspinal muscle atrophy or fat infiltration.

Validation and reliability of the Persian version of the Zurich Claudication Questionnaire in patients with lumbar spinal stenosis

One of the applicable tools introduced as a specific tool for assessing claudication in patients with lumbar spinal stenosis is the Zurich Claudication Questionnaire (ZCQ). This questionnaire has been validated in different populations of patients. The present study aimed to determine the validation status of the Persian version of ZCQ. After professional translation of the ZCQ by native English translators, it was executed twice before surgery with 1 day interval on 45 Iranian patients with spinal stenosis. The reliability was assessed by determining the Chronbach's Alpha coefficient as well as intraclass correlation coefficient (ICC). To assess the concurrent validity, the correlation across the 3 domains of the questionnaire was calculated by the Pearson's correlation test and the content validity was determined using a panel of experts. To assess test-retest reliability, the ICC for ZCQ for symptom severity, functional disability, and satisfaction domains were 0.80, 0.82, and 0.78, indicating acceptable reliability. Regarding internal consistency, Cronbach's alpha coefficients for the Persian version of ZCQ for the 3 above domains were shown to be 0.96, 0.92, and 0.90 respectively. On the subject of content validity, the 3 questionnaire's domains were marked as relevant with the content validity indices of 0.88, 0.82, and 0.80 respectively. Concerning concurrent validity, all 3 domains of the Persian ZCQ correlated strongly with 1 another. The ZCQ questionnaire with the same original structure is completely functional and reliable in the Iranian patient community.

Objective outcome measures may demonstrate continued change in functional recovery in patients with ceiling effects of subjective patient-reported outcome measures after surgery for lumbar degenerative disorders

Background ContextThe 6-minute walking test (6WT) has been previously shown to be a reliable and valid outcome measure. It is unclear if the 6WT may further help to detect differences in well performing patients that reach a ceiling effect in PROMs after surgery. PurposeTo evaluate changes and timing of change in objective functional impairment (OFI) as measured with the smartphone-based 6WT in relation to patient-reported outcome measures (PROMs) after surgery for degenerative lumbar disorders (DLD). Study designProspective observational cohort study. Patient SampleFifty consecutive patients undergoing surgery for DLD. Outcome MeasuresPatients self-determined their OFI using the 6WT application (6WT-app) and completed a set of paper-based PROMs before, 6 weeks and 3 months after surgery. MethodsFifty patients undergoing surgery for DLD were assessed preoperatively (baseline), 6 weeks (6W) and 3 months (3M) postoperatively. Paired sample t-tests were used to establish significant changes in raw 6-minute walking distance (6WD) and standardized Z-scores, as well as PROMs. Pearson correlation coefficient was used to define the relationship between 6WT and PROMs. Floor and ceiling effects were assessed for each PROM (visual analogue scale [VAS], core outcome measure index [COMI], Zurich claudication questionnaire [ZCQ]). ResultsMean 6WT results improved from 377 m (standard deviation - SD 137; Z-score: 1.8, SD 1.8) to 490 m (SD 126; -0.7, SD 1.5) and 518 m (SD 112; -0.4, SD 1.41; all p<.05) at 6W and 3M follow-up. No significant improvement was observed between 6W and 3M for the ZCQ, VAS back and leg pain. While correlation between 6WT and all PROMs were weak at baseline, correlation coefficient increased to moderate at 3M. A considerable ceiling effect (best possible score) was observed, most notably for the ZCQ physical performance, VAS back and leg pain in 24%, 20%, and 16% of patient at 6W and in 30%, 24%, and 28% at 3M. ConclusionSObjective functional tests can describe the continued change in the physical recovery of a patient and may help to detect differences in well performing groups as well as in cases where patients' PROM results cannot further improve because of a ceiling effect.

Neuropathic Pain Was Associated with Central Sensitivity Syndrome in Patients with Preoperative Lumbar Spinal Stenosis Using the painDETECT and Central Sensitization Inventory Questionnaires: A Cross-Sectional Study.

Lumbar spinal stenosis (LSS) patients have been reported to have neuropathic pain and central sensitivity syndrome (CSS). These associations have been reported in other diseases but are unknown in preoperative LSS patients. We aimed to investigate the association between neuropathic pain and CSS in preoperative LSS patients using the painDETECT and the Central Sensitization Inventory (CSI) questionnaires. This cross-sectional study was conducted from November 2021 to March 2022. The data were collected regarding demographics and pain, including neuropathic pain, numbness, LSS severity, physical function, quality of life, and CSS. Patients were divided into two groups, patients with acute and chronic pain, and further classified into three categories based on the clinical phenotype of patients in each group. Independent variables included age, gender, type of LSS (bilateral or unilateral symptoms), Numerical Rating Scale of leg pain, CSI, and the Zurich Claudication Questionnaire (ZCQ) for symptom severity and physical function. The dependent variable was painDETECT. Multiple regression analysis using the forced entry method examined the association between painDETECT and CSI. Of the 119 patients with preoperative LSS, 106 were included. The mean age of the participants was 69.9 years, and 45.3% were female. Neuropathic pain was present in 19.8%, and CSS was present in 10.4%. The CSI (β = 0.468, p < 0.001) and ZCQ for symptom severity (β = 0.304, p < 0.01) were significantly associated with the painDETECT, explaining 47.8% of the variance in the painDETECT score. There is an association between neuropathic pain and CSS in patients with preoperative LSS using the painDETECT and CSI questionnaires.

126 Objective Functional Outcome Measures Expose Relevant Ceiling Effects Inherent to Subjective Patient-Reported Outcome Measures in Patients Undergoing Surgery for Lumbar Degenerative Disorders

INTRODUCTION: Patient-reported outcome measures (PROMs) may be subject to relevant floor and ceiling effects which may induce substantial bias to the outcome assessment after spine surgery. METHODS: In a prospective study, 50 patients were assessed preoperatively, 6-weeks and 3-months postoperatively for objective functional impairment using the smartphone-based 6-minute walking test (6WT) as well as a set of widely used PROMs. Paired sample t-tests were used to establish significant difference between the changes in raw 6-minute walking distance (6WD) and PROMs at baseline, 6-weeks and 3-months follow-up. Floor and ceiling effect were considered present if &gt;15% achieved the worst and best status. Pearson correlation coefficients were used to define the relationship between 6WT and PROMs at 6-weeks and 3-months. RESULTS: The mean 6WD improved from 377 m preoperative to 490 m and 517 m at 6-weeks and 3-months follow-up (p &lt; 0,05). While all PROMs improved from pre- to six-week postoperative, no significant improvement was observed beyond the 6-weeks follow up in the Core Outcome Measure Index (COMI), the Zurich Claudication Questionnaire (ZCQ) Symptoms Severity Scale, the ZCQ Physical Performance Scale, VAS Back and Leg pain. A ceiling effect was observed for the COMI, the ZCQ Symptoms Severity Scale, the ZCQ Physical Performance Scale, VAS back and VAS leg pain in 2%, 4%, 24%, 20% and 16% of patient at the 6-weeks follow up. Correlation between the 6WD and PROMs significantly increased from the 6-weeks to 12-weeks follow up. CONCLUSIONS: PROMs reach their best possible score in a relevant number of patients early after surgery for DLD while objective functional outcome continues to improve beyond the 6-weeks follow-up. Objective measures of function may expose relevant ceiling effects observed by PROMs and describe the continued recovery of patient.

Efficacy of surgical treatment on polypharmacy of elderly patients with lumbar spinal canal stenosis: retrospective exploratory research

BackgroundPolypharmacy is a growing public health problem occurring in all healthcare settings worldwide. Elderly patients with lumbar spinal canal stenosis (LSS) who manifest low back and neuropathic pain and have a high frequency of comorbidity are predicted to take many drugs. However, no studies have reported polypharmacy in elderly patients with LSS. Thus, we aimed to review the polypharmacy among elderly LSS patients with elective surgeries and examine how the surgical treatment reduces the polypharmacy.MethodsWe retrospectively enrolled all the patients aged ≥ 65 years who underwent spinal surgery for LSS between April 2020 and March 2021. The prescribed drugs of participants were directly checked by pharmacists in the outpatient department preoperatively and 6-month and 1-year postoperatively. The baseline characteristics were collected beside the patient-based outcomes including Roland–Morris Disability Questionnaire, Zurich Claudication Questionnaire, and Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ). The cutoff number of drugs for polypharmacy was defined as 6. The prescription drugs were divided into 9 categories: drugs for neuropsychiatric, cardiovascular, respiratory, digestive, endocrine metabolic, and urinary renal diseases; blood products; pain relief medication; and others.ResultsA total of 102 cases were finally analyzed, with a follow-up rate of 78.0%. Of the participants, the preoperative polypharmacy prevalence was 66.7%. The number of drugs 6-month and 1-year postoperatively was significantly less than the preoperative one. The proportions of polypharmacy at 6 months and 1 year after surgery significantly decreased to 57.8% and 55.9%, respectively. When the prescribed drugs were divided into 9 categories, the number of drugs for pain relief and digestive diseases was significantly reduced after surgery. The multi-variable analysis revealed that a higher score in the psychological disorder of JOABPEQ was associated with 3 or more drugs decreased 1-year postoperatively (OR, 2.5; 95% CI: 1.0–6.1).ConclusionPolypharmacy prevalence was high among elderly LSS patients indicated for lumbar spinal surgery. Additionally, our data showed that lumbar spinal surgery was effective in reducing polypharmacy among elderly LSS patients. Finally, the multi-variable analysis indicated that better psychological condition was associated with the reduction of prescribed drugs after lumbar spinal surgery.

Branched-chain amino acids plus vitamin D supplementation promote increased muscle strength following lumbar surgery for lumbar spinal stenosis: a randomized trial

BACKGROUND CONTEXTAdequate nutrition is essential to address the surgical stress response and mitigate loss of muscle mass, strength, and functionality in older adults with lumbar spinal stenosis (LSS). However, it is unknown whether amino acids and/or vitamin D are beneficial in older adults following lumbar surgery for LSS. PURPOSETo evaluate whether branched-chain amino acids (BCAA) plus vitamin D supplementation could attenuate the loss of muscle mass and strength, accelerate the return of functional mobility, and improve clinical outcomes following lumbar surgery for LSS. STUDY DESIGN/SETTINGA single-center, single-blind randomized controlled trial. PATIENT SAMPLEEighty patients who received lumbar surgery for LSS. OUTCOME MEASURESThe primary outcome was the Zurich claudication questionnaire (ZCQ), and secondary outcomes included knee muscle strength, muscle mass measured by bioelectrical impedance analysis, gait speed and a timed up-and-go test (TUG) at 12 weeks postoperatively. Follow-up assessment was performed for the ZCQ at 52 weeks postoperatively. METHODSPatients ingested the supplementation (BCAA group: BCAA plus vitamin D, Nonamino acid group: nonamino acid) twice daily for 3 weeks from the day after surgery, and received two hours of postoperative inpatient rehabilitation 5 times a week. RESULTSNo significant differences were observed in the mean changes on the ZCQ between the two groups at 12 weeks and 52 weeks. At 2 weeks postoperatively, the nonamino acid group showed significant deterioration compared with the BCAA group for strengths of knee extensor and knee flexor (p < .01). At 12 weeks, the BCAA group showed significant improvements in knee extensor strength and knee flexor strength compared with the nonamino acid group (p <.01). There were no significant differences in mean changes of muscle mass, maximum gait speed, and TUG at 12 weeks between two groups. CONCLUSIONSBCAA plus vitamin D supplementation did not improve LSS-related clinical outcomes after lumbar surgery for LSS, even though muscle strength increased. Future studies should focus on long-term outcomes for muscle mass and physical function, including development of sarcopenia and frailty.

SURGICAL MANAGEMENT OF LUMBAR STENOSIS IN THE PRESENCE OF DEGENERATIVE SPONDYLOLISTHESIS: ARE DECOMPRESSION AND FUSION OR INTERSPINOUS PROCESS DEVICE SUPERIOR TO DECOMPRESSION ALONE? A SYSTEMATIC REVIEW AND META-ANALYSIS

AimsTo compare the efficacy of decompression alone (DA) with i) decompression and fusion (DF) and ii) interspinous process device (IPD) in the treatment of lumbar stenosis with degenerative spondylolisthesis. Outcomes of interest were both patient-reported measures of postoperative pain and function, as well as the perioperative measures of blood loss, operation duration, hospital stay, and reoperation.MethodsData were obtained from electronic searches of five online databases. Included studies were limited to randomised-controlled trials (RCTs) which compared DA with DF or IPD using patient-reported outcomes such as the Oswestry Disability Index (ODI) and Zurich Claudication Questionnaire (ZCQ), or perioperative data.Patient-reported data were reported as part of the systematic review, while meta-analyses were conducted for perioperative outcomes in MATLAB using the DerSimonian and Laird random-effects model. Forest plots were generated for visual interpretation, while heterogeneity was assessed using the I2-statistic.ResultsA total of 13 articles met the eligibility criteria. Of these, eight compared DA with DF and six studies compared DA with IPD. Patient-rated outcomes reported included the ODI and ZCQ, with mixed results for both types of comparisons. Overall, there were few statistically significant and no clinically significant differences in patient-rated outcomes. Study quality varied greatly across the included articles.Meta-analysis of perioperative outcomes revealed DF to result in greater blood loss than DA (MD = 406.74 ml); longer operation duration (MD = 108.91 min); and longer postoperative stay in hospital (MD = 2.84 days). Use of IPD in comparison to DA led to slightly reduced operation times (MD = –25.18 min), but a greater risk of reoperation compared to DA (RR = 2.70).ConclusionCurrently there is no evidence for the use of DF or IPD over DA in both patient-rated and perioperative outcomes. Indeed, both procedures can potentially lead to greater cost and risk of complications, and therefore, a stronger evidence base for their use should be established before they are promoted as routine options in patients with degenerative spondylolisthesis.

A Protocol for a Single-Centered, Pragmatic, Randomized, Controlled, Parallel Trial Comparing Comprehensive Nonsurgical Therapy Options for Individuals with Lumbar Spinal Stenosis.

Lumbar spinal stenosis (LSS) is a long-term degenerative disease. Considering the risks and advantages of the patient's age range and the characteristics of the condition, non-surgical treatment is recommended. To determine the best first-line non-surgical therapy for LSS, few studies have examined different non-surgical therapies. Therefore, the main objective of this study is to determine whether the selection of comprehensive Chinese medicine (CM) treatment for LSS is more successful than non-surgical conservative treatment. In this two-armed, parallel, single-centered, pragmatic randomized controlled study, 94 LSS participants will be randomized to receive 24 sessions of comprehensive CM therapy or conservative treatment for 3 months, with follow-up assessments at 6, 9, 12, and 15 months. The primary outcome will be based on the success rate of the Zurich Claudication Questionnaire (ZCQ) for the most clinical important difference (MCID) at 3 and 15 months. Secondary outcomes include Numerical Rating Scale (NRS) scores for back and leg pain, ZCQ scores, Oswestry Disability Index scores for lumbar dysfunction, and Short-Form 12 scores for health-related quality of life at 3, 6, 9, 12, and 15 months. Adverse events and incidences of surgery will be reported anytime during the trial and follow-up. This protocol examines the comparative efficacy of comprehensive CM therapy compared with conventional care through a pragmatic randomized controlled trial to present data to facilitate clinical or policy decision-making. The outcomes will make it easier to decide which patient-centered treatments to prioritize for LSS.

Decompression via unilateral biportal endoscopy for severe degenerative lumbar spinal stenosis: A comparative study with decompression via open discectomy.

Previous studies have shown that the Unilateral Biportal Endoscopy is an effective and safety surgery for sufficient decompression of degenerative lumbar spinal stenosis. However, data are lacking in terms of its benefits when compared with conventional open lumbar discectomy (OLD), especially in patients with severe degenerative lumbar spinal stenosis (DLSS). To compare the clini cal outcomes of two types decompressive surgery: unilateral biportal endoscopy-unilateral laminectomy bilateral decompression (UBE-ULBD) and conventional open lumbar discectomy (OLD) in severe degenerative lumbar spinal stenosis (DLSS). We retrospectively analyzed patients who underwent UBE-ULBD (n = 50, operated at 50 levels; UBE-ULBD group) and conventional open lumbar discectomy (n = 59, operated at 47 levels; OLD group) between February 2019 and July 2021. All patients were diagnosed with severe stenosis based on the Schizas classification (Grade C or D) on MRI. We compared radiographic and clinical outcome scores [including the visual analog scale (VAS), Oswestry Disability Index (ODI), and Zurich Claudication Questionnaire (ZCQ)] between the 2 groups at 1 year of follow-up. The radiographic evaluation included the cross-sectional area (CSA) of the thecal sac and paraspinal muscles on MRI. Fasting blood was drawn before and 1 and 7 days after the operation to detect creatine kinase (CK). Surgical data perioperative complications were also investigated. The baseline demographic data of the 2 groups were comparable, including VAS, ODI and ZCQ scores, the cross-sectional area of the thecal sac and paraspinal muscles and creatine kinase levels. The dural sac CSA significantly increased post -operatively in both groups, which confirmed they benefited from comparable decompressive effects. The operative duration in the OLD group was less than the UBE-ULBD group (43.9 ± 5.6 min vs. 74.2 ± 9.3 min, p < 0.05). The OLD group was associated with more estimated blood loss than the UBE-ULBD group (111.2 ± 25.0 ml vs. 41.5 ± 22.2 ml, P < 0.05). The length of hospital stay (HS) was significantly longer in the OLD group than in the UBE-ULBD group (6.8 ± 1.6 vs. 4.0 ± 1.4 days, P < 0.05). The VAS, ODI, and ZCQ scores improved in both groups after the operation. Serum creatine kinase values in the UBE-ULBD group were significantly lower than in the OLD group at 1 day after surgery (108. 1 ± 11.9 vs. 347.0 ± 19.5 U/L, P < 0.05). The degree of paraspinal muscle atrophy in the UBE-ULBD group was significantly lower than in the OLD group at 1 year (4.50 ± 0.60 vs. 11.42 ± 0.87, P < 0.05). UBE-ULBD and conventional OLD demonstrate comparable short-term clinical outcomes in treating severe DLSS. However, UBE-ULBD surgery was associated with a shorter hospital stay, less EBL and paravertebral muscle injury than OLD surgery.

Validity of outcome measures used in randomized clinical trials and observational studies in degenerative lumbar spinal stenosis

It is unclear whether outcome measures used in degenerative lumbar spinal stenosis (DLSS) have been validated for this condition. Cross-sectional analysis of studies for DLSS included in systematic reviews (SA) and meta-analyses (MA) indexed in the Cochrane Library. We extracted all outcome measures for pain and disability. We assessed whether the studies provided external references for the validity of the outcome measures and the quality of the validation studies. Out of 20 SA/MA, 95 primary studies used 242 outcome measures for pain and/or disability. Most commonly used were the VAS (n = 69), the Oswestry Disability Index (n = 53) and the Zurich Claudication Questionnaire (n = 22). Although validation references were provided in 45 (47.3%) primary studies, only 14 validation studies for 9 measures (disability n = 7, pain and disability combined n = 2) were specifically validated in a DLSS population. The quality of the validation studies was mainly poor. The Zurich Claudication Questionnaire was the only disease specific tool with adequate validation for assessing treatment response in DLSS. To compare results from clinical studies, outcome measures need to be validated in a disease specific population. The quality of validation studies need to be improved and the validity in studies adequately cited.

A Prospective, Observational, Open-Label, Non-Randomized, Multicenter Study Measuring Functional Outcomes in a Novel Interspinous Fusion Device in Subjects with Low Back Pain: REFINE Study.

Lumbar degenerative disease and the accompanying pain and dysfunction affect a significant number of patients in the USA and around the world. As surgery and innovation are moving towards minimally invasive treatments, this study looks to explore interspinous fixation as a standalone posterior approach to treat lumbar degenerative disc disease in the presence of neurogenic claudication and spinal stenosis. This study was approved by an institutional review board (IRB) and is actively enrolling in a single-arm, multicenter, prospective, open-label fashion. Patients are followed with reporting at 3months, and 12months for primary endpoint analysis of efficacy and safety based on improved composite endpoints relative to baseline, with success defined as greater than 20mm back pain reduction in Visual Analog Scale 100mm (VAS) while standing or walking, greater than 20mmleg pain reduction in VAS while standing or walking, Zurich Claudication Questionnaire (ZCQ) improvement of 0.5 or greater in two or three domains, Oswestry Disability Index (ODI) improvement of a least 10points and no reoperations or revisions at the index level(s). Secondary endpoints included a multidimensional assessment in the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1 and Patient Global Impression of Change (PGIC). In this interim 3-month analysis, 82% of patients reported they were improved from the procedure, while 65% of patients demonstrated clinical meaningful improvement in their pain and function, as defined by the VAS, ODI, and ZCQ. There was only one adverse event and no complications were identified at last clinic research follow-up visit. This interim analysis of the first 20% of the enrolled patients out to 3months was to determine safety of the procedure and report on adverse events, acknowledging the heterogeneity of surgical specialty. Further follow-up and greater numbers are needed as the study is ongoing. ClinicalTrials.gov identifier, NCT05504499.

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

PurposeLumbar 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 MethodsA 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.ResultsThe 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.ConclusionThe 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 registrationThis study was registered at Clinicaltrials.gov (registration identifier: NCT05242497) and CRiS (registration identifier: KCT0007145).

The association between preoperative MRI findings and clinical improvement in patients included in the NORDSTEN spinal stenosis trial

PurposeTo investigate potential associations between preoperative MRI findings and patient reported outcome measures (PROMs) after surgery for lumbar spinal stenosis (LSS).MethodsThe NORDSTEN trial included 437 patients. We investigated the association between preoperative MRI findings such as morphological grade of stenosis (Schizas grade), quantitative grade of stenosis (dural sac cross-sectional area), disc degeneration (Pfirrmann score), facet joint tropism and fatty infiltration of the multifidus muscle, and improvement in patient reported outcome measures (PROMs) 2 years after surgery. We dichotomized each radiological parameter into a moderate or severe category. PROMs i.e., Oswestry Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ) and Numeric rating scale (NRS) for back and leg pain were collected before surgery and at 2 year follow-up. In the primary analysis, we investigated the association between MRI findings and ODI score (dichotomized to ≥ 30% improvement or not). In the secondary analysis, we investigated the association between MRI findings and the mean improvement on the ODI-, ZCQ- and NRS scores. We used multivariable regression models adjusted for patients’ gender, age, smoking status and BMI.ResultsThe primary analysis showed that severe disc degeneration (Pfirrmann score 4–5) was significantly associated with less chance of achieving a 30% improvement on the ODI score (OR 0.54, 95% CI 0.34, 0.88). In the secondary analysis, we detected no clinical relevant associations.ConclusionSevere disc degeneration preoperatively suggest lesser chance of achieving 30% improvement in ODI score after surgery for LSS. Other preoperative MRI findings were not associated with patient reported outcome.

A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of Degenerative Spondylolisthesis and Stenosis: Results from the Total Posterior Spine System (TOPS) IDE Study.

Prospective randomized Food and Drug Administration investigational device exemption clinical trial. The purpose of the present study is to report the 1-year clinical and radiographic outcomes and safety profile of patients who underwent lumbar facet arthroplasty through implantation of the Total Posterior Spine System (TOPS) device. Lumbar facet arthroplasty is one proposed method of dynamic stabilization to treat grade-1 spondylolisthesis with stenosis; however, there are currently no Food and Drug Administration-approved devices for facet arthroplasty. Standard demographic information was collected for each patient. Radiographic parameters and patient-reported outcome measures were assessed preoperatively and at regular postoperative intervals. Complication and reoperation data were also collected for each patient. At the time of this study, 153 patients had undergone implantation of the TOPS device. The mean surgical time was 187.8 minutes and the mean estimated blood loss was 205.7cc. The mean length of hospital stay was 3.0 days. Mean Oswestry Disability Index, Visual Analog Score leg and back, and Zurich Claudication Questionnaire scores improved significantly at all postoperative time points ( P >0.001). There were no clinically significant changes in radiographic parameters, and all operative segments remained mobile at 1-year follow-up. Postoperative complications occurred in 11 patients out of the 153 patients (7.2%) who underwent implantation of the TOPS device. Nine patients (5.9%) underwent a total of 13 reoperations, 1 (0.6%) of which was for device-related failure owing to bilateral L5 pedicle screw loosening. Lumbar facet arthroplasty with the TOPS device demonstrated a statistically significant improvement in all patient-reported outcome measures and the ability to maintain motion at the index level while limiting sagittal translation with a low complication rate.

GOLDIC Therapy in Degenerative Lumbar Spinal Stenosis: Randomized, Controlled Trial

Aim: Comparison of the efficacy of conservative treatment methods: epidural GOLDIC serum, epidural steroid injections, manual therapy. Materials & methods: A randomized, controlled trial. Three groups, each containing 30 patients. GOLDIC or steroid injections (dexamethasone) epiduralversus manual therapy. Assessment: initial assessment and 4 (T1), 12 (T2) and 24 (T3) weeks after the last intervention. Primary outcomes: Pain intensity in numeric rating scale, Oswestry disability index, Zurich claudication questionnaire, EQ-5D-5L questionnaire. Results: GOLDIC has shown the highest mean differences and number of cases with minimal important difference among groups for every primary outcome. Conclusion: GOLDIC therapy could be a new option for the nonoperative, symptomatic treatment of degenerative lumbar spinal stenosis and is not inferior to epidural steroid injections and manual therapy.

Degenerative Lumbar Spondylolisthesis Patients With Movement-related Low Back Pain Have Less Postoperative Satisfaction After Decompression Alone.

Retrospective analysis of prospectively collected multicenter observational data. The aim was to examine the preoperative factors affecting postoperative satisfaction following posterior lumbar interbody fusion (PLIF) and microendoscopic muscle-preserving interlaminar decompression (ME-MILD) in patients with degenerative lumbar spondylolisthesis (DLS). The technique involved in DLS surgery may either be decompression alone or decompression-fixation. Poor performance may occur after either of these surgical treatments. The author hypothesized that evaluating the correlation between preoperative quality of life and postoperative performance would aid in determining the optimal procedure. This study included 138 patients who underwent surgery for 1-level mild DLS. The authors performed PLIF for 79 patients and ME-MILD for 59 patients. When the satisfaction subscale of the Zurich Claudication Questionnaire exceeded 2 points, postoperative satisfaction was considered poor. The clinical characteristics were investigated. Responses to preoperative health-related quality of life questionnaires, such as the Japanese Orthopedic Association Back Pain Evaluation Questionnaire (JOABPEQ), short form-36 health survey (SF-36), and visual analog scale, were compared between the satisfied and unsatisfied groups. In the PLIF group, no endogenous factors influenced postoperative satisfaction. The ME-MILD cohort's satisfied and unsatisfied patients differed significantly in terms of preoperative lumbar spine dysfunction ( P <0.001) items of the JOABPEQ, role physical ( P =0.03), and role emotional ( P =0.03) items of the SF-36. A strong correlation ( r =-0.609 P =0.015) was found between preoperative lumbar spine dysfunction and postoperative satisfaction. In the ME-MILD group, preoperative lumbar spine function was correlated with postoperative satisfaction. Decompression alone may be ineffective in cases with decreased lumbar spine function prior to surgery. The degree of low back pain on movement should be considered before selecting the surgical method. 3.

Supervised physical therapy versus surgery for patients with lumbar spinal stenosis: a propensity score-matched analysis

BackgroundPrevious studies comparing surgical with nonsurgical treatment for lumbar spinal stenosis (LSS) reported that surgery is superior to nonsurgical treatments, but intensive and adequate volume of physical therapy were rarely performed. The purpose of this study was to compare the 1-year follow-up outcomes of patients with LSS treated with supervised physical therapy or surgery using propensity score-matched analysis.MethodsA total of 224 patients with LSS who received supervised physical therapy (n = 38) or surgery (n = 186) were included, of which 66 were matched on baseline demographics, radiological findings, and patient-reported outcomes. The physical therapy group received supervised physical therapy twice weekly for 6 weeks. The physical therapy sessions included manual therapy, individually tailored exercises, cycling, and body-weight supported treadmill walking. The surgery group underwent decompression surgery with or without spinal fusion. A propensity score analysis was performed using a one-to-one nearest neighbor approach.ResultsThe surgery group showed greater improvements in Zurich claudication questionnaire symptom severity and physical function, SF-36 physical functioning, bodily pain, and mental health, but had more severe stenosis and symptoms and mental health problems than the physical therapy group at baseline (P < 0.05). After propensity score matching, there were no significant differences in baseline characteristics, and all clinical outcomes at 1 year, except for a higher percentage of responders achieving minimum clinically important difference in the role-emotional subscale of SF-36 in the surgery group (P < 0.05).ConclusionsWhen baseline characteristics were considered, supervised physical therapy yielded similar effects to lumbar surgery. These results suggest that supervised physical therapy is preferred over surgery as first-choice treatment, to prevent complications and to minimize health care costs, especially in mild to moderate cases of LSS.

Interspinous process device versus conventional decompression for lumbar spinal stenosis: 5-year results of a randomized controlled trial.

Interspinous process distraction devices (IPDs) can be implanted to treat patients with intermittent neurogenic claudication (INC) due to lumbar spinal stenosis. Short-term results provided evidence that the outcomes of IPD implantation were comparable to those of decompressive surgery, although the reoperation rate was higher in patients who received an IPD. This study focuses on the long-term results. Patients with INC and spinal stenosis at 1 or 2 levels randomly underwent either decompression or IPD implantation. Patients were blinded to the allocated treatment. The primary outcome was the Zurich Claudication Questionnaire (ZCQ) score at 5-year follow-up. Repeated measurement analysis was applied to compare outcomes over time. In total, 159 patients were included and randomly underwent treatment: 80 patients were randomly assigned to undergo IPD implantation, and 79 underwent spinal bony decompression. At 5 years, the success rates in terms of ZCQ score were similar (68% of patients who underwent IPD implantation had a successful recovery vs 56% of those who underwent bony decompression, p = 0.422). The reoperation rate at 2 years after surgery was substantial in the IPD group (29%), but no reoperations were performed thereafter. Long-term visual analog scale score for back pain was lower in the IPD group than the bony decompression group (p = 0.02). IPD implantation is a more expensive alternative to decompressive surgery for INC but has comparable functional outcome during follow-up. The risk of reoperation due to absence of recovery is substantial in the first 2 years after IPD implantation, but if surgery is successful this positive effect remains throughout long-term follow-up. The IPD group had less back pain during long-term follow-up, but the clinical relevance of this finding is debatable.