- Structural and Criterion Validity of a New 6-item Roland–Morris Disability Questionnaire (RMDQ-6) on Patients with Chronic Lower Back Pain Receiving Integrative Medicine
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Yoon Jae Lee, Gyu Chan Shim, Changsop Yang, Chang-Hyun Han
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Perspect Integr Med. 2023;2(3):182-189. Published online October 23, 2023
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DOI: https://doi.org/10.56986/pim.2023.10.006
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 Graphical Abstract
 Abstract
 PDF Supplementary Material
 - Background
Lower back pain (LBP) is a leading cause of disability worldwide. The Roland–Morris Disability Questionnaire (RMDQ) has been widely used to assess functional impairment in patients with LBP. However, its length and redundancy calls for a more concise and optimized version.
Methods
We conducted a secondary analysis of data from two randomized controlled trials comparing pharmacopuncture and physical therapy for chronic LBP. We focused on 132 patients with moderate-to-severe symptoms and analyzed their baseline data to evaluate the structural validity of the RMDQ. We used R packages lavaan and semPlot for confirmatory factor analysis (CFA). Model fit were assessed through various indices, including comparative fit index, Tucker–Lewis index, root mean square error of approximation, and standardized root mean squared residual.
Results
A total of 18 items were ultimately removed to produce a streamlined 6-item structure. Our model met the fit index criteria, yielding a one-domain, 6-item RMDQ structure. While the relative indices fell slightly short of the ideal values, the RMDQ-6 derived through CFA correlated well with the original version.
Conclusion
This study developed a more concise version of RMDQ through CFA to optimize its structural configuration. This concise instrument can be proposed as an efficient tool to assess the functionality of patients with LBP.
- A Study Protocol for a Multicenter, Pragmatic, Randomized Controlled, Parallel-Grouped Pilot Clinical Trial: Effectiveness of Non-Pharmacological Versus Pharmacological Treatments for Non-Acute Lumbar Disc Herniation
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Hui Yan Zhao, Purumea Jun, Chaewon Lee, In-Hyuk Ha, Chang-Hyun Han
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Perspect Integr Med. 2023;2(1):59-64. Published online February 21, 2023
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DOI: https://doi.org/10.56986/pim.2023.02.009
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Graphical Abstract
Abstract
PDFSupplementary Material
 - Background
This study was the development of a protocol for the comparison between the efficacy of non-pharmacological and pharmacological treatment approaches for lumbar disc herniation in a pragmatic environment to obtain real-world based study data.
Methods
The protocol sets out a two-armed, parallel, multicenter pragmatic, randomized-controlled trial (RCT) which will be conducted in four spine specialist hospitals in Korea to determine cost-efficiency.
Results
The study will enroll 36 participants and allocate patients into either the non-pharmacological treatment group or the pharmacological treatment group in a 1:2 ratio. Patients must have evidence of disc-related disease diagnosed using MRI, as well as having lower back pain or radiating leg pain (numeric rating scale score ≥ 5). The treatment will last for 8 weeks with a 26-week follow-up. The primary outcome will be measured using the Oswestry Disability Index score from Week 9. Secondary outcomes related to lower back pain and radiating leg pain will be measured using the scores from the numeric rating scale, the visual analogue scale, the European Quality of Life 5 Dimensions 5 Level Version), the 12-item Short Form Survey, and the patient global impression of change.
Conclusion
This is the first protocol for a pragmatic RCT evaluating the efficacy, safety, and cost-efficiency of non-pharmacological and pharmacological treatment strategies in a clinical setting. Following the basis of this protocol, RCTs may play an important role in establishing guidelines for treating radiating leg pain and lower back pain and provide effective information to clinicians in practical settings.
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