Sponsor study identifier
observational
140
1 country
1
Study Start
August 1, 2017
Actual (reported)Primary Completion
March 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Low back pain (LBP) is a severe epidemic in the world. Despite its high prevalence, 90% of the cases have no identifiable cause. Approximately 44% of them experience recurrent LBP within one year and 10% of them develop chronic LBP that lasts for three months or more. Mechanically, the lumbar spine is unstable and requires spinal muscle to maintain spinal stability and to prevent injuries. Lumbar multifidus (LM) muscle is thought to be the major spinal stabilizer responsible for spinal stability and spinal proprioception. Prior studies have revealed that increased fat infiltration, atrophy or activation deficits of LM in patients with LBP as compared to asymptomatic individuals. Unfortunately, inconsistent findings have also been reported. Although prior research attempted to determine if abnormal LM characteristics can inform clinical decision-making, their results are limited because they only investigated a single LM characteristic at a time, which might not reflect the actual LM condition. Further, many studies adopted cross-sectional design that could not reveal the casual relations between abnormal LM characteristics and LBP. As such, the current study aims to identify specific LM characteristics that can predict new episode of LBP in asymptomatic individuals, and recurrent/chronic LBP in individuals with LBP at baseline.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 1, 2017
Actual (reported)December 23, 2017
Actual (reported)January 2, 2018
Actual (reported)March 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
11-point numeric pain rating scale (NPRS) for low back pain
The current pain intensity of each participant will be quantified by an 11-point NPRS, where 0 means no pain and 10 means the worst imaginable pain.
2 years
Morphometry of lumbar multifidus
2 years
Proprioception of lumbar multifidus
2 years
Stiffness of lumbar multifidus
2 years
Fatty infiltration of lumbar multifidus
2 years
Participants will be followed up over 2 years to monitor the course of low back pain
Participants will be followed up over 2 years to monitor the incidence and course of low back pain
Symptomatic participants should have LBP that requires medical consultation(s) in the last three months, and have LBP intensity of at least 5 on the 11-point numeric pain rating scale at baseline. Asymptomatic participants should be pain free at baseline, and should not have LBP in the last year nor LBP lasting more than a week in the last 3 years.
Queen Mary Hospital
Hong Kong, Hong Kong
Arnold Wong, PhD
The Hong Kong Polytechnic University
First Submitted
December 23, 2017
First Posted
January 2, 2018
Study Start
August 1, 2017
Actual (reported)Primary Completion
March 31, 2022
Estimated (date passed)Efficacy of a Multimodal Physical Activity Intervention in Patients With Chronic Nonspecific Low Back Pain
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 10, 2021
Record last verified: 2021-02
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Source: ClinicalTrials.gov.
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