Chronic Low Back Pain (CLBP)CLBPNCT06944730
Movement Quality and Balance Improvement in People With Chronic Low Back Pain Following Trunk Muscle Training
A study testing Structural Exercise, Isolated Trunk Exercise and Back school in people with Chronic Low Back Pain (CLBP), run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Chronic Low Back Pain (CLBP)
- What is being tested?
- Structural Exercise, Isolated Trunk Exercise and Back school
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2022to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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%.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hong Kong
Billy CL So, Professor, +85227664377, billy.so@polyu.edu.hk
Kitman Lau, +85234003983, kitman.lau@polyu.edu.hk
About this study
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
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:
- What are the effect of the training on the participant's movement quality and balance.
- What are the difference between different types of trunk muscle training on people with CLBP.
Read more
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:
- Do home and in-lab based SE or ITE training, or maintain active daily living over 2 months.
- Complete the pain and disability questionnaire and do several physical functioning tests while having their trunk and lower limb movement and muscle activation measured.
Read the 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.
- Conditions
- Chronic Low Back Pain (CLBP)
- Being tested
- Structural Exercise, Isolated Trunk Exercise, Back school
- Keywords
- movement quality, balance, trunk muscle training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structural ExerciseBehavioural
Multi-joint limb movement with force vector through the spine. The spine is held at neutral position
Isolated Trunk ExerciseBehavioural
Holding the spine in neutral position with no limb movement, with static loading through the spine
Back schoolBehavioural
Patient education that has been proven to not be effective and has been used as control in past low back pain intervention studies
| Study group | Role | What they receive |
|---|---|---|
| Structural Exercise | Experimental | Single armed dumbbell row, push up and single legged deadlift exercises, done three times per week for eight weeks Receives: Behavioral: Structural Exercise |
| Isolated Trunk Exercise | Experimental | Plank, side bridge, and bird dog isometric holds, done three times per week over eight weeks training Receives: Behavioral: Isolated Trunk Exercise |
| Control | Sham comparator | Back school education where participants are taught about healthy seating position, how to carry loads, and maintaining an active daily lifestyle. Receives: Behavioral: Back school |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower lumbar active range of motion
active range of motion of the lower lumbar area during five-repetitions sit-to-stand test.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Same day as first day of intervention and within one week after intervention
Secondary outcomes (2)
LAP performance
time required to complete the lift and place test with lesser time indicating greater performance
Measured: 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
Measured: Same day as first day of intervention and within one week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start1 Jun 2022
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back Pain (CLBP)Studies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SUTANTO Dhananjaya, The Hong Kong Polytechnic University
- Investigators
- Billy CL So, Prof., Study director, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944730
- Sponsor's protocol ID
- HongKongPU RS
- Other IDs
- 2022.176
- Acronym
- CLBP
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant pre and post outcome measures along with anonymized individual participant demographic data
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.
PubMed 39855104Sutanto 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.
PubMed 36535534Panjabi 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.
PubMed 1490034Sutanto 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.
PubMed 35270557Chiarotto 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.
PubMed 29194127
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06944730
- Acronym / sponsor ID
- CLBP / HongKongPU RS
- Conditions
- Chronic Low Back Pain (CLBP)
- Keywords
- movement quality, balance, trunk muscle training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What are the effect of the training on the participant's movement quality and balance.
- 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:
- Do home and in-lab based SE or ITE training, or maintain active daily living over 2 months.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Structural Exercise | Experimental | Behavioral: Structural ExerciseSingle armed dumbbell row, push up and single legged deadlift exercises, done three times per week for eight weeks |
| Isolated Trunk Exercise | Experimental | Behavioral: Isolated Trunk ExercisePlank, side bridge, and bird dog isometric holds, done three times per week over eight weeks training |
| Control | Sham comparator | Behavioral: Back schoolBack school education where participants are taught about healthy seating position, how to carry loads, and maintaining an active daily lifestyle. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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%.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structural ExerciseMulti-joint limb movement with force vector through the spine. The spine is held at neutral position | Behavioural | Structural Exercise |
| Isolated Trunk ExerciseHolding the spine in neutral position with no limb movement, with static loading through the spine | Behavioural | Isolated Trunk Exercise |
| Back schoolPatient education that has been proven to not be effective and has been used as control in past low back pain intervention studies | Behavioural | Control |
Primary outcome
Lower lumbar active range of motion
Time frame: Same day as first day of intervention and within one week after intervention
active range of motion of the lower lumbar area during five-repetitions sit-to-stand test.
Segmental movement coordination
Time frame: Same day as first day of intervention and within one week after intervention
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.
Segmental movement stability
Time frame: Same day as first day of intervention and within one week after intervention
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.
Postural stability
Time frame: Same day as first day of intervention and within one week after intervention
Center-of-pressure normalized mean velocity during Y-balance test. Smaller number indicate greater stability
Postural Control
Time frame: Same day as first day of intervention and within one week after intervention
normalized leg reach during y-balance test, with larger number indicating greater postural control.
Perceived pain
Time frame: Same day as first day of intervention and within one week after intervention
score from numerical pain rating scale from zero (0) to ten (10), with 0 indicating no pain.
Perceived disability
Time frame: Same day as first day of intervention and within one week after intervention
Score based on oswestry disability index scoring from zero (0) to one hundred (100) percent, with zero indicating no disability.
5RSTS time
Time frame: Same day as first day of intervention and within one week after intervention
Time required to complete five-repetitions sit-to-stand with smaller time indicating better performance.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Background: PubMed 39855104Sutanto 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.
- Background: PubMed 36535534Sutanto 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.
- Background: PubMed 1490034Panjabi 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.
- Background: PubMed 35270557Sutanto 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.
- Background: PubMed 29194127Chiarotto 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.
- Individual participant dataSharing planned: Yes. Anonymized individual participant pre and post outcome measures along with anonymized individual participant demographic data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Billy CL So, Prof. study director
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structural Exercise, Isolated Trunk Exercise and Back school in people with Chronic Low Back Pain (CLBP), run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dhananjaya Sutanto, Ph.D. (+852 9680 7397, dhananjaya.sutanto@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower lumbar active range of motion (time frame: Same day as first day of intervention and within one week after intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06944730, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.