Clinical trial NCT06944730: Movement Quality and Balance Improvement in People With Chronic Low Back Pain Following Trunk Muscle Training
Official title: Trunk and Lower Limb Movement Quality and Stability Improvement in People With Chronic Low Back Pain Following Different Types of Isometric Trunk Muscle Training
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Low Back Pain (CLBP)
Keywords: movement quality
balance
trunk muscle training
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this project is to assess if Chronic Low Back Pain (CLBP) participant's movement quality and balance variables can change after training that decreases their pain and disability. It will also compare the difference between structural exercise (SE) and isolated trunk exercise (ITE). The main questions it aims to answer are:

1. What are the effect of the training on the participant's movement quality and balance.
2. What are the difference between different types of trunk muscle training on people with CLBP.

Researchers will compare SE, ITE and control. Control group will receive back school education that was shown not to be effective in reducing pain and disability.

Participants will:

1. Do home and in-lab based SE or ITE training, or maintain active daily living over 2 months.
2. Complete the pain and disability questionnaire and do several physical functioning tests while having their trunk and lower limb movement and muscle activation measured.

Detailed description: Both ITE and SE training are equalized in terms of training intensity based on rate of perceived exertion, training duration per session, training frequency, and intervention period. Training intensity measurement does not use other methods of quantification as ITE training does not increase heart rate or blood lactate significantly regardless of the intensity.

Eligibility criteria: Inclusion Criteria:

* body mass index (BMI) 18-25 kg/m2
* experiencing intermittent pain lasting at least 3 months
* had Oswestry Disability Index (ODI) score ranging between 17% and 45%.

Exclusion Criteria:

* exercise contraindication based on physical activity readiness questionnaire
* indication or diagnosis of other chronic diseases (such as cancer, cardiovascular disease, diabetes, bone fracture, or infection)
* artificial lower limb joints, history of spinal surgery, walking aid use
* personal mobility restrictions (due to connective tissue diseases, rheumatoid arthritis, or central nervous system disorders)
* pregnancy or within 1 year post partum

Primary outcomes:
measure: Lower lumbar active range of motion
timeFrame: Same day as first day of intervention and within one week after intervention
measure: Segmental movement coordination
timeFrame: Same day as first day of intervention and within one week after intervention
measure: Segmental movement stability
timeFrame: Same day as first day of intervention and within one week after intervention
measure: Postural stability
timeFrame: Same day as first day of intervention and within one week after intervention
measure: Postural Control
timeFrame: Same day as first day of intervention and within one week after intervention
measure: Perceived pain
timeFrame: Same day as first day of intervention and within one week after intervention
measure: Perceived disability
timeFrame: Same day as first day of intervention and within one week after intervention
measure: 5RSTS time
timeFrame: Same day as first day of intervention and within one week after intervention
Secondary outcomes:
measure: LAP performance
timeFrame: Same day as first day of intervention and within one week after intervention
measure: Muscle synergy
timeFrame: Same day as first day of intervention and within one week after intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Billy CL So, Prof.
role: STUDY_DIRECTOR
References:
citation: Sutanto D, Ho CY, Wong SHS, Pranata A, Yang Y. Difference in movement coordination and variability during Five-Repetition Sit-to-Stand between people with and without Chronic Low back pain. J Biomech. 2025 Mar;181:112531. doi: 10.1016/j.jbiomech.2025.112531. Epub 2025 Jan 19.
citation: Sutanto D, Yang YJ, Wong SH. A novel physical functioning test to complement subjective questionnaires in chronic low back pain assessments. Spine J. 2023 Apr;23(4):558-570. doi: 10.1016/j.spinee.2022.12.008. Epub 2022 Dec 17.
citation: Panjabi MM. The stabilizing system of the spine. Part I. Function, dysfunction, adaptation, and enhancement. J Spinal Disord. 1992 Dec;5(4):383-9; discussion 397. doi: 10.1097/00002517-199212000-00001.
citation: Sutanto D, Ho RST, Poon ETC, Yang Y, Wong SHS. Effects of Different Trunk Training Methods for Chronic Low Back Pain: A Meta-Analysis. Int J Environ Res Public Health. 2022 Mar 1;19(5):2863. doi: 10.3390/ijerph19052863.
citation: Chiarotto A, Boers M, Deyo RA, Buchbinder R, Corbin TP, Costa LOP, Foster NE, Grotle M, Koes BW, Kovacs FM, Lin CC, Maher CG, Pearson AM, Peul WC, Schoene ML, Turk DC, van Tulder MW, Terwee CB, Ostelo RW. Core outcome measurement instruments for clinical trials in nonspecific low back pain. Pain. 2018 Mar;159(3):481-495. doi: 10.1097/j.pain.0000000000001117.