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

Trunk and Lower Limb Movement Quality and Stability Improvement in People With Chronic Low Back Pain Following Different Types of Isometric Trunk Muscle Training

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Low Back Pain (CLBP)
• Intervention / Treatment: Behavioral: Structural Exercise; Behavioral: Isolated Trunk Exercise; Behavioral: Back school

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dhananjaya Sutanto, Ph.D.; Phone Number: +852 9680 7397; Email: dhananjaya.sutanto@polyu.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • The Hong Kong Polytechnic University
    • Contact: Billy CL So, Professor; Phone Number: +85227664377; Email: billy.so@polyu.edu.hk
    • Contact: Kitman Lau; Phone Number: +85234003983; Email: kitman.lau@polyu.edu.hk
    • Contact: Dhananjaya Sutanto, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Structural Exercise; Single armed dumbbell row, push up and single legged deadlift exercises, done three times per week for eight weeks	Behavioral: Structural Exercise; Multi-joint limb movement with force vector through the spine. The spine is held at neutral position
Experimental: Isolated Trunk Exercise; Plank, side bridge, and bird dog isometric holds, done three times per week over eight weeks training	Behavioral: Isolated Trunk Exercise; Holding the spine in neutral position with no limb movement, with static loading through the spine
Sham Comparator: Control; Back school education where participants are taught about healthy seating position, how to carry loads, and maintaining an active daily lifestyle.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower lumbar active range of motion	active range of motion of the lower lumbar area during five-repetitions sit-to-stand test.	Same day as first day of intervention and within one week after intervention
Segmental movement coordination	Lumbar-to-pelvis and pelvis-to-femur movement coordination as quantified by mean absolute relative phase angle during five-repetitions sit-to-stand. Smaller number indicates greater coordination between the two segments.	Same day as first day of intervention and within one week after intervention
Segmental movement stability	lumbar-to-pelvis and pelvis-to-femur movement stability as quantified by deviation phase during five-repetitions sit-to-stand. Greater number indicates lesser segmental movement stability.	Same day as first day of intervention and within one week after intervention
Postural stability	Center-of-pressure normalized mean velocity during Y-balance test. Smaller number indicate greater stability	Same day as first day of intervention and within one week after intervention
Postural Control	normalized leg reach during y-balance test, with larger number indicating greater postural control.	Same day as first day of intervention and within one week after intervention
Perceived pain	score from numerical pain rating scale from zero (0) to ten (10), with 0 indicating no pain.	Same day as first day of intervention and within one week after intervention
Perceived disability	Score based on oswestry disability index scoring from zero (0) to one hundred (100) percent, with zero indicating no disability.	Same day as first day of intervention and within one week after intervention
5RSTS time	Time required to complete five-repetitions sit-to-stand with smaller time indicating better performance.	Same day as first day of intervention and within one week after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LAP performance	time required to complete the lift and place test with lesser time indicating greater performance	Same day as first day of intervention and within one week after intervention
Muscle synergy	Muscle synergy as measured by the surface electromyography (SEMG) output of the latissimus dorsi, longissimus pars thoracis, longissimus pars lumborum, external oblique, rectus abdominis, gluteus maximus and biceps femoris muscle both on left and right side during all functional tests. SEMG signals would then be processed using non-negative matrix factorization to find the underlying muscle synergies	Same day as first day of intervention and within one week after intervention

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Study Director: Billy CL So, Prof., The Hong Kong Polytechnic University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: April 10, 2025
• First Submitted That Met QC Criteria: April 17, 2025
• First Posted (Actual): April 25, 2025

Study Record Updates

• Last Update Posted (Actual): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: balance; movement quality; trunk muscle training
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: HongKongPU RS; 2022.176 (Other Identifier: CUHK-NTEC CREC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual participant pre and post outcome measures along with anonymized individual participant demographic data
• IPD Sharing Time Frame: Beginning 3 months and ending 3 years after the publication of results
• IPD Sharing Access Criteria: a proposal that describes planned analyses must be submitted to primary investigator, and once agreed, data sharing agreement would then signed prior to data sharing.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No