- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07686237
Core Stability Training in Young Adults With Chronic Non-Specific Low Back Pain
Effects of Core Stability Training on Functional Recovery in Young Adults With Chronic Non-Specific Low Back Pain
Chronic non-specific low back pain is common among young adults and can lead to persistent pain, reduced physical function, decreased muscle strength, and impaired balance, affecting daily activities and quality of life. Core stability exercises are widely used in rehabilitation programs for low back pain, but the effectiveness of Swiss ball-based core stability training in young adults with chronic non-specific low back pain remains unclear.
The purpose of this study is to investigate whether Swiss ball-based core stability training can reduce pain and improve functional recovery in young men with chronic non-specific low back pain compared with conventional mat-based lumbar muscle exercises. Participants will be randomly assigned to either a Swiss ball core stability training group or a mat-based lumbar muscle training group and will complete a 6-week exercise intervention program.
The study will evaluate changes in pain intensity, disability related to low back pain, lumbar muscle strength, and dynamic balance ability. The study hypothesizes that Swiss ball-based core stability training will produce greater improvements in pain relief, physical function, muscle strength, and balance than conventional mat-based lumbar muscle exercises.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Guangxi
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Guilin, Guangxi, China, 541004
- Guangxi Normal University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male participants aged 18 to 25 years.
- Diagnosis of chronic non-specific low back pain characterized by pain or discomfort located between the lower rib margin and the gluteal folds, with or without lower limb pain.
- No signs of nerve root compression and a negative straight leg raise test.
- No identifiable specific pathological or anatomical cause of low back pain.
- Baseline pain intensity score greater than 2 and less than 9 on the Visual Analog Scale (VAS).
- Duration of low back pain symptoms longer than 12 weeks.
- No treatment for low back pain received within the previous month.
- Willingness to participate in the study and provide written informed consent.
Exclusion Criteria:
- Failure to meet the diagnostic criteria for chronic non-specific low back pain.
- History of spinal trauma or spinal surgery.
- Presence of severe cardiovascular diseases, such as uncontrolled hypertension.
- Presence of severe metabolic diseases, such as gout.
- Presence of severe infectious diseases, such as pneumonia.
- Diagnosed structural spinal disorders, including lumbar disc herniation, spondylolisthesis, spinal stenosis, or other identifiable pathological anatomical abnormalities.
- Any medical condition that would prevent safe participation in the exercise intervention as determined by the investigators.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Swiss ball-based core stability training
Participants in this arm will perform core stability training using a Swiss ball as the primary exercise equipment.
Before the formal training session, participants will complete a 5-minute supervised warm-up consisting of dynamic stretching exercises focusing on the spine, shoulders, and hips, together with light running and jumping activities for the lower extremities.
The core stability program consists of six exercise components performed in a progressive sequence from easier to more difficult tasks, with gradual reductions in the base of support to increase instability and challenge trunk control.
As participants adapt to the intervention over time, the training load will be periodically increased to optimize therapeutic effects.
Following each training session, participants will complete 5 minutes of static stretching exercises as a cool-down activity.
|
Participants in this arm will perform core stability training using a Swiss ball as the primary exercise equipment.
Before the formal training session, participants will complete a 5-minute supervised warm-up consisting of dynamic stretching exercises focusing on the spine, shoulders, and hips, together with light running and jumping activities for the lower extremities.
The core stability program consists of six exercise components performed in a progressive sequence from easier to more difficult tasks, with gradual reductions in the base of support to increase instability and challenge trunk control.
As participants adapt to the intervention over time, the training load will be periodically increased to optimize therapeutic effects.
Following each training session, participants will complete 5 minutes of static stretching exercises as a cool-down activity.
|
|
Active Comparator: Mat-based lumbar muscle exercises
Participants in this arm will perform lumbar muscle exercises using a mat as the primary exercise surface.
Apart from the exercise equipment used, the overall training protocol will be identical to that of the Swiss ball-based core stability training group.
Before the formal training session, participants will complete the same 5-minute supervised warm-up program consisting of dynamic stretching exercises and light running and jumping activities.
After each training session, participants will also perform 5 minutes of static stretching exercises as a cool-down activity.
|
Participants in this arm will perform lumbar muscle exercises using a mat as the primary exercise surface.
Apart from the exercise equipment used, the overall training protocol will be identical to that of the Swiss ball-based core stability training group.
Before the formal training session, participants will complete the same 5-minute supervised warm-up program consisting of dynamic stretching exercises and light running and jumping activities.
After each training session, participants will also perform 5 minutes of static stretching exercises as a cool-down activity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: From enrollment to the end of treatment at 6 weeks
|
Pain intensity will be assessed using the Visual Analog Scale (VAS).
Participants will rate their current level of low back pain on a 10-cm scale ranging from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable."
Higher scores indicate greater pain intensity.
|
From enrollment to the end of treatment at 6 weeks
|
|
Low back disability
Time Frame: From enrollment to the end of treatment at 6 weeks
|
Low back-related disability will be assessed using the Oswestry Disability Index (ODI), a widely used measure of functional impairment associated with low back pain.
The questionnaire consists of 10 items evaluating the impact of low back pain on activities of daily living.
Each item is scored from 0 to 5, and the total score is converted into a percentage, with higher scores indicating greater disability.
|
From enrollment to the end of treatment at 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lumbar muscle strength
Time Frame: From enrollment to the end of treatment at 6 weeks
|
Lumbar flexor and extensor muscle strength will be measured using a Hoggan MicroFET 2 handheld dynamometer.
Lumbar flexion strength will be assessed in the supine position, and lumbar extension strength will be assessed in the prone position.
Participants will perform maximal isometric contractions against the dynamometer for approximately 3 seconds.
Each test will be repeated five times, and the highest recorded value will be used for analysis.
Muscle strength values will be recorded in pounds (lb).
|
From enrollment to the end of treatment at 6 weeks
|
|
Dynamic balance ability
Time Frame: From enrollment to the end of treatment at 6 weeks
|
Dynamic balance ability will be assessed using the Y-Balance Test (YBT).
Participants will perform reach tasks in the anterior, posteromedial, and posterolateral directions while maintaining single-leg stance.
Reach distances will be normalized to lower limb length and expressed as a composite score percentage.
Higher scores indicate better dynamic balance performance.
|
From enrollment to the end of treatment at 6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2018010748
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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