Dataset Information

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

ABSTRACT:

Aim

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.

Patients and methods

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.

Conclusion

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.

SUBMITTER: Sun Y

PROVIDER: S-EPMC10010744 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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Publications

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

Sun Ya'nan Y An Yi Y Fan Xiran X Liu Changxin C Li Duoduo D Lei Yuan Y Weng Zhiwen Z Gong Yuanyuan Y Wang Xiyou X Yu Changhe C

Journal of pain research 20230309

<h4>Aim</h4>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 success ...[more]

PMID: 36923649

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Project description:ImportanceLumbar spinal stenosis (LSS) is the most common reason for spine surgery in older US adults. There is an evidence gap about nonsurgical LSS treatment options.ObjectiveTo explore the comparative clinical effectiveness of 3 nonsurgical interventions for patients with LSS.Design, setting, and participantsThree-arm randomized clinical trial of 3 years' duration (November 2013 to June 2016). Analysis began in August 2016. All interventions were delivered during 6 weeks with follow-up at 2 months and 6 months at an outpatient research clinic. Patients older than 60 years with LSS were recruited from the general public. Eligibility required anatomical evidence of central canal and/or lateral recess stenosis (magnetic resonance imaging/computed tomography) and clinical symptoms associated with LSS (neurogenic claudication; less symptoms with flexion). Analysis was intention to treat.InterventionsMedical care, group exercise, and manual therapy/individualized exercise. Medical care consisted of medications and/or epidural injections provided by a physiatrist. Group exercise classes were supervised by fitness instructors in senior community centers. Manual therapy/individualized exercise consisted of spinal mobilization, stretches, and strength training provided by chiropractors and physical therapists.Main outcomes and measuresPrimary outcomes were between-group differences at 2 months in self-reported symptoms and physical function measured by the Swiss Spinal Stenosis questionnaire (score range, 12-55) and a measure of walking capacity using the self-paced walking test (meters walked for 0 to 30 minutes).ResultsA total of 259 participants (mean [SD] age, 72.4 [7.8] years; 137 women [52.9%]) were allocated to medical care (88 [34.0%]), group exercise (84 [32.4%]), or manual therapy/individualized exercise (87 [33.6%]). Adjusted between-group analyses at 2 months showed manual therapy/individualized exercise had greater improvement of symptoms and physical function compared with medical care (-2.0; 95% CI, -3.6 to -0.4) or group exercise (-2.4; 95% CI, -4.1 to -0.8). Manual therapy/individualized exercise had a greater proportion of responders (≥30% improvement) in symptoms and physical function (20%) and walking capacity (65.3%) at 2 months compared with medical care (7.6% and 48.7%, respectively) or group exercise (3.0% and 46.2%, respectively). At 6 months, there were no between-group differences in mean outcome scores or responder rates.Conclusions and relevanceA combination of manual therapy/individualized exercise provides greater short-term improvement in symptoms and physical function and walking capacity than medical care or group exercises, although all 3 interventions were associated with improvements in long-term walking capacity.Trial registrationClinicalTrials.gov Identifier: NCT01943435.

Project description:Study designSecondary analysis from a randomized controlled trial on nonsurgical interventions for patients with lumbar spinal stenosis (LSS).ObjectiveThe aim of this study was to assess the responsiveness of the Self-Paced Walking Test (SPWT), Swiss Spinal Stenosis Questionnaire (SSS), and Oswestry Disability Index (ODI) and determine their minimal clinically important differences (MCID) in nonsurgical LSS patients.Summary of background dataLimited information is available about the responsiveness of these tests in nonsurgical LSS population.MethodsA total of 180 participants completed the SPWT, SSS, and ODI at baseline, 2, and 6 months. Responsiveness was assessed by distribution-based method, including effect size and standardized response mean, and anchor-based method, using the patient global index of change (PGIC) as the external anchor to distinguish responders and non-responders. Areas under the curve (AUC) were calculated along with MCIDs for "minimal" and "moderate improvement" subgroups.ResultsThe following values represent 2- and 6-month analyses of each outcome measure, respectively. Standard effect sizes: 0.48 and 0.50 for SPWT, -0.42 and -0.36 for SSS, and -0.29 and -0.25 for ODI. Spearman correlation coefficients between PGIC and outcomes were: 0.44 and 0.39 for SPWT, -0.53 and -0.55 for SSS, and -0.46 and -0.54 for ODI. MCIDs for the "minimal improvement" subgroup were: 375.9 and 319.3 ms for SPWT, -5.3 and -5.8 points for SSS, and -9.3 and -10.8 points for ODI. AUCs was 0.68 to 0.76. MCIDs for the "moderate improvement" subgroup were: 344.2 and 538.2 m for SPWT, -5.5 and -7.5 points for SSS, and -9.1 and -13.6 points for ODI. AUCs ranged from 0.68 to 0.76.ConclusionThe SPWT, SSS, and ODI are responsive outcome measures to assess nonsurgical patients with LSS. This finding, along with the reported MCIDs, can help clinicians to monitor changes in their patients' walking and physical function over time and make clinical decisions. They also provide researchers with reference for future studies in LSS.Level of Evidence: 2.

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.

Dataset Information

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

Aim

Patients and methods

Conclusion

Publications

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

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