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Clinical Trials/NCT06944730
NCT06944730RecruitingNot Applicable

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 Hong Kong Polytechnic University1 site in 1 country60 target enrollmentStarted: June 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
60
Locations
1
Primary Endpoint
Segmental movement stability

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Structural Exercise

Experimental

Single armed dumbbell row, push up and single legged deadlift exercises, done three times per week for eight weeks

Intervention: Structural Exercise (Behavioral)

Isolated Trunk Exercise

Experimental

Plank, side bridge, and bird dog isometric holds, done three times per week over eight weeks training

Intervention: Isolated Trunk Exercise (Behavioral)

Control

Sham Comparator

Back school education where participants are taught about healthy seating position, how to carry loads, and maintaining an active daily lifestyle.

Intervention: Back school (Behavioral)

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

Secondary Outcomes

  • LAP performance(Same day as first day of intervention and within one week after intervention)
  • Muscle synergy(Same day as first day of intervention and within one week after intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

SUTANTO Dhananjaya

Post-Doctorate Fellow

The Hong Kong Polytechnic University

Study Sites (1)

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