A Comparative Study of Outcomes and Measurements Used in Randomized Controlled Trials for Low Back Pain Treated by Western Medicine and Traditional Chinese Medicine
Bibliographic record
Abstract
Background Low back pain (LBP) is the leading cause of hypokinesia globally. Currently, the reporting of outcomes in clinical trials for LBP lacks consistency, utility, and standardization, and the results of studies in the same field cannot be combined for comparison. Thus, the homogeneity and utility of outcomes need to be enhanced. Objective To assess the quality of randomized controlled trials (RCTs) for LBP and their outcome reports, then to analyze the variations of reported outcomes and measurements among different interventions for LBP, and to explore homogeneous and practical outcome indices for LBP. Methods Four clinical trials registry platforms (Complementary Medicine Field Trials Register, Back and Neck Review Group Trials Register, ClinicalTrials.gov, WHO ICTRP) and seven databases (Cochrane Library, PubMed, Web of Science, CNKI, Wanfang Data, SinoMed, VIP) were searched for RCTs about LBP treated by traditional Chinese medicine (TCM) , western medicine (WM) and integrated traditional Chinese and western medicine (TCM-WM) published during 2017 to 2021. Information was extracted and analyzed descriptively. Results In total, 1 014 RCTs of LBP with WM treatment, 624 RCTs of LBP with TCM treatment, and 392 RCTs of LBP with integrated TCM-WM treatment were included. Overall, the quality of RCTs was low and the reporting of outcome in different interventions was deficient. Through our assessment, the total Jadad score was 2 (2, 4) for RCTs of LBP with WM treatment, 2 (2, 3) for RCTs of LBP with TCM treatment, and 2 (2, 2) for those of LBP with integrated TCM-WM treatment, with more than 50% of the RCTs having a total Jadad score of 2, and more than 10% having a Jadad score of 3. More than 80% of the RCTs had an outcome score of 1. The number of indices reported in RCTs about WM for LBP ranged from 1 to 8 (with a median value of 2) , and the top five outcome domains reported with frequency were pain level (28.2%) , physical function (28.0%) , hospital-related outcomes (8.0%) , economic indices (8.0%) , and adverse events/effects (8.0%) , and the top three scales used to evaluate outcomes were the Visual Analogue Scale (VAS) /Verbal Rating Scale (VRS) , the Oswestry Disability Index (ODI) , and Japanese Orthopaedic Association Score (JOA) . The number of indices reported in RCTs about TCM for LBP ranged from 1 to 6 (with a median value of 2) , and the top five outcome domains reported with frequency were pain level (45%) , physical function (27%) , others (14%) , overall quality of life (5%) , and musculoskeletal and connective tissue outcomes (2%) , and the main scales used included VAS/VRS, ODI, short-form McGill Pain Questionnaire (SF-MPQ) , the Numerical Rating Scale/ Numeric Pain Rating Scale (NRS/NPRS) , Roland-Morris Disability Questionnaire (RMDQ/RMD) , and 12-Item Short Form Health Survey/ 36-Item Short Form Health Survey (SF-12/SF-36) . The number of indices reported in RCTs for LBP with integrated TCM-WM treatment was 1-12 (with a median value of 2) , and the top five outcome domains reported with high frequency were physical function (39%) , pain level (34%) , others (9%) , overall quality of life (5%) , and musculoskeletal and connective tissue outcomes (4%) , and the scales used with high frequency were VAS/VRS, ODI, JOA, SF-12/SF-36, RMDQ, and NRS/NPRS. The evaluation dimensions of outcomes for three interventions were all mainly based on pain level and physical function, and the measurements were focused on the VAS/VRS scale (WM: 22.16%, TCM: 32.97%, integrated TCM-WM: 30.94%) and the ODI/CODI scale (WM: 15.88%, TCM: 18.74%, integrated TCM-WM: 20.07%) , and the common outcome indices with corresponding measurements were pain level (VAS/VRS) , physical function (ODI/RMD) , overall quality of life (SF-12/SF-36) and imaging results (X-ray/CT/MRI) . Conclusion By means of quality evaluation and data analysis, the result showed that all RCTs for LBP and their outcome reports had low-quality. The main outcome assessments among three interventions were pain level and physical function, and the main measurements were the VAS/VRS scale and the ODI/CODI scale. Pain level, physical function, quality of life, and imaging results were commonly reported through varied interventions. In brief, the results provide a basis for the future construction of Core Outcome Sets (COS) and Intervention-related Specific Outcome Sets (In-SOS) for LBP.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.400 | 0.648 |
| Meta-epidemiology (narrow) | 0.003 | 0.001 |
| Meta-epidemiology (broad) | 0.019 | 0.026 |
| Bibliometrics | 0.021 | 0.020 |
| Science and technology studies | 0.002 | 0.006 |
| Scholarly communication | 0.008 | 0.009 |
| Open science | 0.003 | 0.005 |
| Research integrity | 0.005 | 0.003 |
| Insufficient payload (model declined to judge) | 0.005 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; the direct Gemma label and the distilled Codex classifier agree on what is shown here.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".