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A Comparative Study of Outcomes and Measurements Used in Randomized Controlled Trials for Low Back Pain
1
2
1
Treated by Western Medicine and Traditional Chinese Medicine WU Yining ，WAN Ying ，HU Chaoyue ，SUN
3*
Yanan ，YU Changhe 4*
1.Beijing University of Chinese Medicine，Beijing 100029，China
2.First School of Clinical Medicine，Beijing University of Chinese Medicine，Beijing 100029，China
3.TCM Department，Xuanwu Hospital，Capital Medical University，Beijing 100069，China
4.Tuina and Pain Management Department，Dongzhimen Hospital，Beijing University of Chinese Medicine，Beijing 100007，
China
*
Corresponding authors：SUN Yanan，Attending physician；E-mail：sunny726618@163.com
YU Changhe，Attending physician；E-mail：Yakno2@163.com
【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.
【Key words】 Low black pain；Outcomes；Clinical outcome assessment；Comparative study；Integrated traditional
Chinese medicine & western medicine