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NCT Number: NCT06944730

Movement Quality and Balance Improvement in People With Chronic Low Back Pain Following 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.

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Key information

Conditions

Chronic Low Back Pain (CLBP)

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Structural exercise

Behavioral

Multi-joint limb movement with force vector through the spine. The spine is held at neutral position

Isolated Trunk Exercise

Behavioral

Holding the spine in neutral position with no limb movement, with static loading through the spine

Back School

Behavioral

Patient education that has been proven to not be effective and has been used as control in past low back pain intervention studies

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

  1. LAP performance

    Time frame: Same day as first day of intervention and within one week after intervention

    time required to complete the lift and place test with lesser time indicating greater performance

  2. Muscle synergy

    Time frame: Same day as first day of intervention and within one week after intervention

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Dhananjaya Sutanto, Ph.D.

CONTACT

[email protected]

+852 9680 7397

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study 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

Acronym: CLBP

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 25, 2025
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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