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Recruiting NCT06944730

Movement Quality and Balance Improvement in People With Chronic Low Back Pain Following Trunk Muscle Training

No phase Interventional Chronic Low Back Pain (CLBP)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Structural Exercise, Isolated Trunk Exercise, Back school.
Who it may be relevant to
Registry conditions: Chronic Low Back Pain (CLBP). Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • Behavioral Structural Exercise
    Multi-joint limb movement with force vector through the spine. The spine is held at neutral position
  • Behavioral Isolated Trunk Exercise
    Holding the spine in neutral position with no limb movement, with static loading through the spine
  • Behavioral Back school
    Patient education that has been proven to not be effective and has been used as control in past low back pain intervention studies

Primary outcome measures

  • Lower lumbar active range of motion [Time frame: Same day as first day of intervention and within one week after intervention]
  • Segmental movement coordination [Time frame: Same day as first day of intervention and within one week after intervention]
  • Segmental movement stability [Time frame: Same day as first day of intervention and within one week after intervention]
  • Postural stability [Time frame: Same day as first day of intervention and within one week after intervention]
  • Postural Control [Time frame: Same day as first day of intervention and within one week after intervention]
  • Perceived pain [Time frame: Same day as first day of intervention and within one week after intervention]
  • Perceived disability [Time frame: Same day as first day of intervention and within one week after intervention]
  • 5RSTS time [Time frame: Same day as first day of intervention and within one week after intervention]
Secondary outcome measures (2)
  • LAP performance [Time frame: Same day as first day of intervention and within one week after intervention]
  • Muscle synergy [Time frame: Same day as first day of intervention and within one week after intervention]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • The Hong Kong Polytechnic University — Hong Kong

Publications

  • 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. PMID 39855104
  • 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. PMID 36535534
  • 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. PMID 1490034
  • 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. PMID 35270557
  • 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. PMID 29194127

Identifiers

NCT: NCT06944730 · HongKongPU RS · 2022.176

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗