Zurich Claudication Questionnaire Physical Function Research Articles

Effectiveness and safety of interspinous spacer versus decompressive surgery for lumbar spinal stenosis: A meta-analysis of randomized controlled trials.

A meta-analysis of randomized controlled trials. Our meta-analysis was conducted to investigate whether interspinous spacer (IS) results in better performance for patients with lumbar spinal stenosis (LSS) when compared with decompressive surgery (DS). DS and IS are common surgeries for the treatment of LSS. However, controversy remains as to whether the IS is superior to DS. We comprehensively searched PubMed, EMBASE, and Cochrane Central Register of Controlled Trials for prospective randomized controlled trials that compared IS versus DS for LSS. The retrieved results were last updated on July 30, 2023. Eight studies involving 852 individuals were included in the meta-analysis. The pooled data indicated that IS was superior to DS considering shorter operation time (P = .003), lower dural violation rate (P = .002), better Zurich Claudication Questionnaire Physical function score (P = .03), and smaller foraminal height decrease (P = .004), but inferior to DS considering the higher rate of reoperation (P < .0001). There was no significant difference between the 2 groups regarding hospital stay (P = .26), blood loss (P = .23), spinous process fracture (P = .09), disc height decrease (P = .87), VAS leg pain score (P = .43), VAS back pain score (P = .26), Oswestry Disability Index score (P = .08), and Zurich Claudication Questionnaire symptom severity (P = .50). In summary, we considered that IS had similar effects with DS in hospital stay, blood loss, spinous process fracture, disc height decrease, VAS score, Oswestry Disability Index score, and Zurich Claudication Questionnaire Symptom severity, and was better in some indices such as operation time, dural violation, Zurich Claudication Questionnaire Physical function, and foraminal height decrease than DS. However, due to the higher rate of reoperation in the IS group, we considered that both IS and DS were acceptable strategies for treating LSS. As a novel technique, further well-designed studies with longer-term follow-up are needed to evaluate the effectiveness and safety of IS.

External Validation of the Minimum Clinically Important Difference in the Timed-up-and-go Test After Surgery for Lumbar Degenerative Disc Disease.

Prospective observational cohort study. The aim of this study was to provide external validation of the minimum clinically important difference (MCID) of the Timed-up-and-go (TUG) test. The TUG test is one of the best explored and most frequently applied objective task-based functional outcome measure in patients with lumbar degenerative disc disease (DDD). The increased use of the TUG test is based on its solid psychometric properties; however, an external validation of the originally determined MCID is lacking. Forty-nine patients with lumbar DDD, scheduled for elective spine surgery, were assessed pre- and 6-weeks (W6) postoperative. MCID values were calculate for raw TUG test times (seconds) and standardized TUG z scores using three different computation methods and the following established patient-reported outcome measures (PROMs) as anchors: Visual Analog Scales (VAS), Core Outcome Measures Index Back, Zurich Claudication Questionnaire (ZCQ). The three computation methods generated a range of MCID values, depending on the PROM used as anchor, from 0.9 s (z score of 0.3) based on the VAS leg pain to 3.0 seconds (z score of 2.7) based on the ZCQ physical function scale. The average MCID of the TUG test across all anchors and computation methods was 2.1 s (z score of 1.5). According to the average MCID of raw TUG test values or TUG z scores, 41% and 43% of patients classified as W6 responders to surgery, respectively. This study confirms the ordinally reported TUG MCID values in patients undergoing surgery for lumbar. A TUG test time change of 2.1 seconds (or TUG z score change of 1.5) indicates an objective and clinically meaningful change in functional status. This report facilitates the interpretation of TUG test results in clinical routine as well as in research.Level of Evidence: 3.

Evaluation of the 6-minute walking test as a smartphone app-based self-measurement of objective functional impairment in patients with lumbar degenerative disc disease.

Digital transformation enables new possibilities to assess objective functional impairment (OFI) in patients with lumbar degenerative disc disease (DDD). This study examines the psychometric properties of an app-based 6-minute walking test (6WT) and determines OFI in patients with lumbar DDD. The maximum 6-minute walking distance (6WD) was determined in patients with lumbar DDD. The results were expressed as raw 6WDs (in meters), as well as in standardized z-scores referenced to age- and sex-specific values of spine-healthy volunteers. The 6WT results were assessed for reliability and content validity using established disease-specific patient-reported outcome measures. Seventy consecutive patients and 330 volunteers were enrolled. The mean 6WD was 370 m (SD 137 m) in patients with lumbar DDD. Significant correlations between 6WD and the Core Outcome Measures Index for the back (r = -0.31), Zurich Claudication Questionnaire (ZCQ) symptom severity (r = -0.32), ZCQ physical function (r = -0.33), visual analog scale (VAS) for back pain (r = -0.42), and VAS for leg pain (r = -0.32) were observed (all p < 0.05). The 6WT revealed good test-retest reliability (intraclass correlation coefficient 0.82), and the standard error of measurement was 58.3 m. A 4-tier severity stratification classified patients with z-scores > -1 (no OFI), -1 to -1.9 (mild OFI), -2 to -2.9 (moderate OFI), and ≤ -3 (severe OFI). The smartphone app-based self-measurement of the 6WT is a convenient, reliable, and valid way to determine OFI in patients with lumbar DDD. The 6WT app facilitates the digital evaluation and monitoring of patients with lumbar DDD.

Normative data of a smartphone app-based 6-minute walking test, test-retest reliability, and content validity with patient-reported outcome measures.

The 6-minute walking test (6WT) is used to determine restrictions in a subject's 6-minute walking distance (6WD) due to lumbar degenerative disc disease. To facilitate simple and convenient patient self-measurement, a free and reliable smartphone app using Global Positioning System coordinates was previously designed. The authors aimed to determine normative values for app-based 6WD measurements. The maximum 6WD was determined three times using app-based measurement in a sample of 330 volunteers without previous spine surgery or current spine-related disability, recruited at 8 centers in 5 countries (mean subject age 44.2 years, range 16-91 years; 48.5% male; mean BMI 24.6 kg/m2, range 16.3-40.2 kg/m2; 67.9% working; 14.2% smokers). Subjects provided basic demographic information, including comorbidities and patient-reported outcome measures (PROMs): visual analog scale (VAS) for both low-back and lower-extremity pain, Core Outcome Measures Index (COMI), Zurich Claudication Questionnaire (ZCQ), and subjective walking distance and duration. The authors determined the test-retest reliability across three measurements (intraclass correlation coefficient [ICC], standard error of measurement [SEM], and mean 6WD [95% CI]) stratified for age and sex, and content validity (linear regression coefficients) between 6WD and PROMs. The ICC for repeated app-based 6WD measurements was 0.89 (95% CI 0.87-0.91, p < 0.001) and the SEM was 34 meters. The overall mean 6WD was 585.9 meters (95% CI 574.7-597.0 meters), with significant differences across age categories (p < 0.001). The 6WD was on average about 32 meters less in females (570.5 vs 602.2 meters, p = 0.005). There were linear correlations between average 6WD and VAS back pain, VAS leg pain, COMI Back and COMI subscores of pain intensity and disability, ZCQ symptom severity, ZCQ physical function, and ZCQ pain and neuroischemic symptoms subscores, as well as with subjective walking distance and duration, indicating that subjects with higher pain, higher disability, and lower subjective walking capacity had significantly lower 6WD (all p < 0.001). This study provides normative data for app-based 6WD measurements in a multicenter sample from 8 institutions and 5 countries. These values can now be used as reference to compare 6WT results and quantify objective functional impairment in patients with degenerative diseases of the spine using z-scores. The authors found a good to excellent test-retest reliability of the 6WT app, a low area of uncertainty, and high content validity of the average 6WD with commonly used PROMs.

Therapeutic Advantages of Frequent Physical Therapy Sessions for Patients With Lumbar Spinal Stenosis.

A retrospective study of a randomized clinical trial and a prospective study of patients with lumbar spinal stenosis (LSS). The aim of this study was to identify the effects of the number of physical therapy (PT) sessions on clinical outcomes of patients with LSS. Supervised PT for patients with LSS has been reported to lead to better short-term outcomes in terms of disability and leg pain than unsupervised exercise. However, no studies have investigated the relationship between the number of PT sessions and the therapeutic effects in patients with LSS. All patients received exercise therapy for 6 weeks. Included were 43 patients receiving supervised PT twice a week (P2 group), 38 patients receiving supervised PT once a week (P1 group), and 43 patients receiving a home exercise program alone (HE group). Clinical outcomes were measured using the Zurich Claudication Questionnaire (ZCQ), a numerical rating scale (NRS) of back pain and leg pain, the Japanese Orthopedic Association Back Pain Evaluation Questionnaire (JOABPEQ) at baseline and at 6 weeks. At 6 weeks, the P2 group showed significant improvements in ZCQ physical function, back and leg pain on the NRS compared with the P1 group (P < 0.05). Compared with the HE group, the P2 group showed significant improvements in ZCQ symptom severity and physical function, back and leg pain on the NRS, and JOABPEQ gait disturbance (P < 0.05). There were no significant differences in mean changes after 6 weeks between the P1 and HE groups. Six weeks of supervised PT twice a week resulted in significant short-term improvements in symptom severity, physical function, back and leg pain, and gait disturbance compared with once a week and/or home exercise alone. Patients with LSS should be treated with intensive and supervised exercise programs to obtain maximum benefit of exercise therapy. 3.

Supervised physical therapy vs. home exercise for patients with lumbar spinal stenosis: a randomized controlled trial

BACKGROUND CONTEXTExercise has been reported to improve short-term outcomes for patients with LSS in terms of disability and back and leg pain. However, no studies have compared supervised exercise with unsupervised exercise or quantified physical activity using a pedometer to confirm compliance with a home exercise program. PURPOSETo compare the effectiveness of supervised physical therapy (PT) with unsupervised exercise for patients with lumbar spinal stenosis (LSS). STUDY DESIGN/SETTINGA single-center, open-label, randomized controlled trial. PATIENT SAMPLEPatients presenting with symptoms of neurogenic claudication caused by LSS, which was confirmed by magnetic resonance imaging. OUTCOME MEASURESThe primary outcome was improvement in symptom severity scores on the Zurich Claudication Questionnaire (ZCQ) at 6 weeks. Secondary outcomes included physical function on the ZCQ, self-paced walking test (SPWT) performance, pain indicated using a numerical rating scale (NRS), and the number of daily steps measured by pedometer. METHODSPatients with LSS were randomized to a PT group, who performed supervised PT twice a week for 6 weeks, or a home exercise (HE) group. PT sessions included manual therapy, individually tailored stretching and strengthening exercises, cycling, and body weight-supported treadmill walking. RESULTSForty-three patients were randomly allocated to the PT group and 43 patients to the HE group. Compared with the HE group, the PT group had greater percentage of responders achieving minimum clinically important difference in ZCQ symptom severity (difference for percentage between groups [95%confidence interval], 30.2% [9.1–48.6], p=.01), ZCQ physical function (32.6% [11.6–50.6], p<.01), walking distance on the SPWT (39.5% [18.8–56.7], p<.01), leg pain on the NRS (34.9% [13.9–52.7], p<.01), and number of daily steps (25.6% [4.9–43.9], p=.01). CONCLUSIONSSupervised PT for patients with LSS resulted in significant short-term improvements in symptom severity, physical function, walking distance, pain, and physical activity compared with unsupervised exercise.

Impact of sagittal spinopelvic alignment on clinical outcomes and health-related quality of life after decompression surgery without fusion for lumbar spinal stenosis.

Patients with lumbar spinal stenosis (LSS) tend to bend forward to relieve neurological symptoms. They therefore have a positive sagittal vertical axis (SVA). The importance of the SVA value is well known in the field of adult spinal deformity; however, little is known about its impact on LSS. The authors sought to investigate the impact of sagittal spinopelvic alignment on clinical outcome and health-related quality of life (HRQOL) after decompression surgery for LSS. The authors retrospectively reviewed 83 patients who underwent lumbar decompression without fusion between January 2014 and September 2015 with a minimum follow-up of 2 years. Standing whole-spine radiographs were examined preoperatively and at final follow-up. Based on the SVA, patients were allocated to a sagittal balance group (group B; SVA < 50 mm) or a sagittal imbalance group (group I; SVA ≥ 50 mm). The authors compared the groups using Japanese Orthopaedic Association (JOA), Zurich Claudication Questionnaire (ZCQ), Roland-Morris Disability Questionnaire (RMDQ), and the 8-item Short Form Health Survey (SF-8) scores. Preoperative groups B (group pre-B) and I (group pre-I) included 58 and 25 patients, respectively. Preoperative sagittal malalignment had negative effects on the JOA score recovery rate, postoperative ZCQ physical function domain score, and numeric rating scale (NRS) score of postoperative low-back pain (LBP), but no significant effects were observed for RMDQ and SF-8 domain scores. Postoperatively, groups B (group post-B) and I (group post-I) included 60 and 23 patients, respectively. Group post-I had a significantly worse JOA score recovery rate, postoperative symptom severity domain score in the ZCQ, and NRS score for postoperative LBP. Similarly, the postoperative RMDQ score and the Physical Component Summary score of the SF-8 were significantly worse in group post-I. Positive SVA had significantly negative effects on clinical outcome and HRQOL in LSS patients after lumbar decompression surgery.

Percutaneous Interspinous Spacer vs Decompression in Patients with Neurogenic Claudication: An Alternative in Selected Patients?

BACKGROUNDStandalone interspinous process devices (IPDs) to treat degenerative lumbar spinal stenosis with neurogenic intermittent claudication (NIC) have shown ambiguous results in the literature.OBJECTIVETo show that a minimally invasive percutaneous IPD is safe and noninferior to standalone decompressive surgery (SDS) for patients with degenerative lumbar spinal stenosis with NIC.METHODSA multicenter, international, randomized, controlled trial (RCT) was con- ducted. One hundred sixty-three patients, enrolled at 19 sites, were randomized 1:1 to treatment with IPD or SDS and were followed for 24 mo.RESULTSThere was significant improvement in Zurich Claudication Questionnaire physical function, as mean percentage change from baseline, for both the IPD and the SDS groups at 12 mo (primary endpoint) and 24 mo (−32.3 ± 32.1, −37.5 ± 22.8; and −37.9 ± 21.7%, −35.2 ± 22.8, both P < .001). IPD treatment was not significantly noninferior (margin: 10%) to SDS treatment at 12 mo (P = .172) but was significantly noninferior at 24 mo (P = .005). Symptom severity, patient satisfaction, visual analog scale leg pain, and SF-36 improved in both groups over time. IPD showed lower mean surgical time and mean blood loss (24 ± 11 min and 6 ± 11 mL) compared to SDS (70 ± 39 min and 189 ± 148 mL, both P < .001). Reoperations at index level occurred in 18.2% of the patients in the IPD group and in 9.3% in the SDS group.CONCLUSIONConfirming 3 recent RCTs, we could show that IPD as well as open decompression achieve similar results in relieving symptoms of NIC in highly selected patients. However, despite some advantages in secondary outcomes, a higher reoperation rate for IPD is confirmed.

Twelve-month results of a clinical pilot study utilizing pedicle-lengthening osteotomy for the treatment of lumbar spinal stenosis

Lumbar spinal stenosis (LSS) is a common condition that leads to significant disability, particularly in the elderly. Current therapeutic modalities for LSS have certain drawbacks when applied to this patient population. The object of this study was to define the 12-month postoperative outcomes and complications of pedicle-lengthening osteotomies for symptomatic LSS. A prospective, single-treatment clinical pilot study was conducted. A cohort of 19 patients (mean age 60.9 years) with symptomatic LSS was treated by pedicle-lengthening osteotomy procedures at 1 or 2 levels. All patients had symptoms of neurogenic claudication or radiculopathy secondary to LSS and had not improved after a minimum 6-month course of nonoperative treatment. Eleven patients had a Meyerding Grade I degenerative spondylolisthesis in addition to LSS. Clinical outcomes were measured using the Oswestry Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ), 12-Item Short-Form Health Survey (SF-12), and a visual analog scale (VAS). Procedural variables, neurological outcomes, adverse events, and radiological imaging (plain radiographs and CT scans) were collected at the 1.5-, 3-, 6-, 9-, and 12-month time points. The pedicle-lengthening osteotomies were performed through percutaneous approaches with minimal blood loss in all cases. There were no operative complications. Four adverse events occurred during the follow-up period. Clinically, significant improvement was observed in the mean values of each of the outcome scales (comparing preoperative and 12-month values): ODI scores improved from 52.3 to 28.1 (p < 0.0001); the ZCQ physical function domain improved from 2.7 to 1.8 (p = 0.0021); the SF-12 physical component scale improved from 27.0 to 37.9 (p = 0.0024); and the VAS score for leg pain while standing improved from 7.2 to 2.7 (p < 0.0001). Imaging studies, reviewed by an independent radiologist, showed no evidence of device subsidence, migration, breakage, or heterotopic ossification. Thin-slice CT documented healing of the osteotomy site in all patients at the 6-month time point and an increase in the mean cross-sectional area of the spinal canal of 115%. Treatment of patients with symptomatic LSS with a pedicle-lengthening osteotomy procedure provided substantial enlargement of the area of the spinal canal and favorable clinical results for both disease-specific and non-disease-specific outcome measures at the 12-month time point. Future studies are needed to compare this technique to alternative therapies for lumbar stenosis.

Interspinous Spacer Implant in Patients with Lumbar Spinal Stenosis: Preliminary Results of a Multicenter, Randomized, Controlled Trial

A prospective, randomized, controlled trial was conducted to compare clinical outcomes in patients treated with an investigational interspinous spacer (Superion) versus those treated with an FDA-approved spacer (X-STOP). One hundred sixty-six patients with moderate lumbar spinal stenosis (LSS) unresponsive to conservative care were treated randomly with the Superion (n = 80) or X-STOP (n = 86) interspinous spacer. Study subjects were followed through 6 months posttreatment. Zurich Claudication Questionnaire (ZCQ) symptom severity scores improved 30% with Superion and 25% with X-STOP (both P < 0.001). Similar changes were noted in ZCQ physical function with improvements of 32% with Superion and 27% with X-STOP (both P < 0.001). Mean ZCQ patient satisfaction score ranged from 1.7 to 2.0 in both groups at all follow-up visits. The proportion of subjects that achieved at least two of three ZCQ clinical success criteria at 6 months was 75% with Superion and 67% with X-STOP. Axial pain decreased from 55 ± 27 mm at pretreatment to 22 ± 26 mm at 6 months in the Superion group (P < 0.001) and from 54 ± 29 mm to 32 ± 31 mm with X-STOP (P < 0.001). Extremity pain decreased from 61 ± 26 mm at pretreatment to 18 ± 27 mm at 6 months in the Superion group (P < 0.001) and from 64 ± 26 mm to 22 ± 30 mm with X-STOP (P < 0.001). Back function improved from 38 ± 13% to 21 ± 19% with Superion (P < 0.001) and from 40 ± 13% to 25 ± 16% with X-STOP (P < 0.001). Preliminary results suggest that the Superion interspinous spacer and the X-STOP each effectively alleviate pain and improve back function in patients with moderate LSS who are unresponsive to conservative care.

Minimally invasive treatment of lumbar spinal stenosis with a novel interspinous spacer

PurposeTo assess the safety and effectiveness of a novel, minimally invasive interspinous spacer in patients with moderate lumbar spinal stenosis (LSS).MethodsA total of 53 patients (mean age, 70 ± 11 years; 45% female) with intermittent neurogenic claudication secondary to moderate LSS, confirmed on imaging studies, were treated with the Superion® Interspinous Spacer (VertiFlex, Inc, San Clemente, CA) and returned for follow-up visits at 6 weeks, 1 year, and 2 years. Study endpoints included axial and extremity pain severity with an 11-point numeric scale, Zurich Claudication Questionnaire (ZCQ), back function with the Oswestry Disability Index (ODI), health-related quality of life with the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores from the SF-12, and adverse events.ResultsAxial and extremity pain each decreased 54% (both P < 0.001) over the 2-year follow-up period. ZCQ symptom severity scores improved 43% (P < 0.001) and ZCQ physical function improved 44% (P < 0.001) from pre-treatment to 2 years post-treatment. A statistically significant 50% improvement (P < 0.001) also was noted in back function. PCS and MCS each improved 40% (both P < 0.001) from pre-treatment to 2 years. Clinical success rates at 2 years were 83%–89% for ZCQ subscores, 75% for ODI, 78% for PCS, and 80% for MCS. No device infection, implant breakage, migration, or pull-out was observed, although two (3.8%) patients underwent explant with subsequent laminectomy.ConclusionModerate LSS can be effectively treated with a minimally invasive interspinous spacer. This device is appropriate for select patients who have failed nonoperative treatment measures for LSS and meet strict anatomical criteria.

Technical Advances in Minimally Invasive Surgery

Literature review, technique overview, prospective and retrospective data analysis. To review current minimally invasive surgery (MIS) methods of decompression for lumbar spinal stenosis and present a decompression technique using a flexible microblade shaver system. Several MIS decompression techniques for stenosis have been developed to minimize damage to soft tissues and reduce the amount of posterior element resection. Decompression using linearly configured instruments may not be able to adequately address stenosis in the neural foramen. A flexible microblade shaver system is able to traverse the foramen, removing bone and ligament, using a ventral to dorsal approach, rather than medial to lateral. This enables it to effectively decompress the lateral recess and neural foramen while sparing posterior structures. Brief literature review of current MIS decompression techniques is presented. MIS decompression using a flexible microblade shaver system is described with 1 year outcomes from a small pilot study and a retrospective chart review at 2 centers. A small postmarket pilot study (n = 9) with 1 year results showed positive patient outcomes using Visual Analog Scale (decrease by 73%), Oswestry Disability Index(50% improvement), Zurich Claudication Questionnaire physical function and symptom severity (improved by 72% and 31%, respectively), and Short-Form 36 (SF-36) Physical Component Score (36% improvement). Sixty-seven patients from a retrospective chart review at 2 centers had an average of 2 levels per patient decompressed using a flexible microblade shaver system. No patient has returned for additional surgery and there have been no cases of neurologic impairment. Current decompression techniques may result in inadequate decompression of the neural foramen or excessive resection of the facet joint. MIS decompression using a flexible microblade shaver system represents a way to perform an effective, facet-preserving decompression for patients with lumbar spinal stenosis.