Core Stabilization Exercise Therapy in Chronic Lower Back Back Management in Community Dwelling Older Adults

Study Overview
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Brief Summary
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Objectives: To develop an exercise program for older adults with low back pain. And,to develop a clinical prediction rule that could identify a subgroup of people with NSLBP Participants: 150 people aged between 40 to 80 with non-specific low back pain (NSLBP) for more than 6 months and is able to ambulate independently will be invited to join the study. People who had 1) previous spinal surgery; 2) LBP attributable to current pregnancy; 3) acute fracture, recent fall, tumour, or bone infection; and 4) experience of practising core-stability exercises in the past 6 months will be excluded. Study details will be explained to participants and written consent will be obtained prior the study. 75 participants will be randomized into the intervention group. Another 75 participants will be randomized into the waiting list control group. Assessment Participants will undergo two comprehensive assessments before and after the training, which includes: Surface electromyogram (EMG) on the lumbar spine and abdominal muscle, Inertial measurement unit (IMU) sensor for trunk movement, clinical assessment including. Prone instability test. Subjective assessments: Visual analogue scale score for pain, The Oswestry Low Back Pain Disability Questionnaire and Roland-Morris Disability Questionnaire. Intervention - 16 session structured exercise program All participants will undergo a 16 session exercise program for 2 months. Each session will last for 60minutes. The exercise program will be arranged in a group format with class size ranging from 6 - 8 per class Subjects will be divided into experimental and control groups. Participants in the control group will not receive exercise training at first but were evaluated at the same time as participants in the experimental group. The participant in the control group completed the exercise training after the post-assessment.

Detailed Description
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People with non-specific low back pain (NSLBP) demonstrate diversified clinical signs and symptoms. It is because the cause of NSLBP is multifaceted. Due to the varied pathophysiology and clinical behavior, the 'one-suit-all' approach of physiotherapy treatment prescription for people with NSLBP is usually less effective in reducing pain and improving daily function. Research on identifying subgroups of patients with NSLBP who would benefit from physiotherapy interventions could provide clinicians evidence-based guidelines and enhance the cost-effectiveness of health care service. Earlier research showed that people with NSLBP demonstrated a delay in core muscle activation and general wasting of the trunk and core muscle. These pathological changes support the use of core stability training (e.g., Pilates exercise) to manage people with NSLBP. However, effectiveness of core stability training have not been studied extensively in older adults.

Official Title
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Core Stabilization Exercise Therapy in Chronic Lower Back Pain Management in Community Dwelling Older Adults

Conditions
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Older Adults, Chronic Low-back Pain, Core Stabilization Exercise Therapy

Intervention / Treatment
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* Behavioral: core stabilization exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1）people aged between 40 to 80 with non-specific low back pain (NSLBP) for more than 6 months ；2）people is able to ambulate independently Exclusion Criteria: 1) previous spinal surgery; 2) LBP attributable to current pregnancy; 3) acute fracture, recent fall, tumour, or bone infection; and 4) experience of practising core-stability exercises in the past 6 months

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 75 participants will be randomized into the intervention group. Another 75 participants will be randomized into the waiting list control group.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Core stabilization exercise group<br>All participants will undergo 16 session exercise program for 2 months. Each session will last for 60minutes. The exercise program will be arranged in a group format with class size ranging from 6 - 8per class. Subjects will be divided into experimental and control groups. | Behavioral: core stabilization exercise<br>* All participants will undergo a 16 session exercise program for 2 months. Each session will last for 60minutes. The exercise program will be arranged in a group format with class size ranging from 6-8 per class. Subjects will be divided into experimental and control groups.<br>|
| No Intervention: waiting list control group<br>Participants in the control group will not receive exercise training at first but were evaluated at the same time as participants in the experimental group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Oswestry Low Back Pain Disability Questionnaire | is a widely used questionnaire designed to assess the level of disability and functional impairment in individuals with lower back pain. The questionnaire consists of 10 sections, each focusing on a different aspect of daily living that might be affected by back pain, such as personal care, lifting, walking, sitting, standing, sleeping, sexual life, social life, and traveling. Each section is scored on a scale of 0 to 5, with higher scores indicating greater disability. The scores for all sections are then summed and converted to a percentage, which can range from 0% (no disability) to 100% (maximum disability). | pre-intervention session (T1) | 
| The Oswestry Low Back Pain Disability Questionnaire | is a widely used questionnaire designed to assess the level of disability and functional impairment in individuals with lower back pain. The questionnaire consists of 10 sections, each focusing on a different aspect of daily living that might be affected by back pain, such as personal care, lifting, walking, sitting, standing, sleeping, sexual life, social life, and traveling. Each section is scored on a scale of 0 to 5, with higher scores indicating greater disability. The scores for all sections are then summed and converted to a percentage, which can range from 0% (no disability) to 100% (maximum disability). | post-intervention (8 weeks after start of intervention;T2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale (VAS) score for pain | The Visual Analogue Scale (VAS) is a tool commonly used to measure a person's pain intensity. The scale typically consists of a 10cm horizontal line. Anchored by two verbal descriptors, one for each symptom extreme. For pain intensity, the scale is most often anchored by No Pain at one end and Worst Imaginable Pain at the other. Patients are asked to mark a point along the line that represents their current level of pain. | pre-intervention session (T1) | 
| Visual analogue scale (VAS) score for pain | The Visual Analogue Scale (VAS) is a tool commonly used to measure a person's pain intensity. The scale typically consists of a 10cm horizontal line. Anchored by two verbal descriptors, one for each symptom extreme. For pain intensity, the scale is most often anchored by No Pain at one end and Worst Imaginable Pain at the other. Patients are asked to mark a point along the line that represents their current level of pain. | post-intervention (8 weeks after start of intervention;T2) | 
| Fear-Avoidance Belief Questionnaire | Participants finish the questionnaire with the help of investigators to assess how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability. The scale score range from 0 - 96, a higher score indicates a higher level of fear avoidance beliefs. | pre-intervention session (T1) | 
| Fear-Avoidance Belief Questionnaire | Participants finish the questionnaire with the help of investigators to assess how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability. The scale score range from 0 - 96, a higher score indicates a higher level of fear avoidance beliefs. | post-intervention (8 weeks after start of intervention;T2) | 
| Surface EMG | EMG-sensors attached to the skin overlying the erector spinae at the T4 vertebrae (approximately 2-3 cm from the midline of the back) on both sides. | pre-intervention session (T1) | 
| Surface EMG | EMG-sensors attached to the skin overlying the erector spinae at the T4 vertebrae (approximately 2-3 cm from the midline of the back) on both sides. | post-intervention (8 weeks after start of intervention;T2) | 
| IMU-sensor | IMU-sensors attached to the skin overlying the erector spinae at the T3 and L1 vertebrae(approximately 3-4 cm from the midline of the back), Pelvis(S2) and femur. IMU-sensors were positioned unilaterally on the right side. | pre-intervention session (T1) | 
| IMU-sensor | IMU-sensors attached to the skin overlying the erector spinae at the T3 and L1 vertebrae(approximately 3-4 cm from the midline of the back), Pelvis(S2) and femur. IMU-sensors were positioned unilaterally on the right side. | post-intervention (8 weeks after start of intervention;T2) | 
| Prone instability test | Participants will assume a face-down position on a bench, allowing their legs to dangle off the edge so that their feet touch the ground. Manual pressure will then be applied on various lumbar spine segments to induce pain. If pain occurs, participants then raise their legs off the ground before the application of back-to-front pressure is repeated. A reduction in pain when lifting the legs indicates the ability to actively stabilize the spine, signifying a positive test result. In such cases, a stability-focused exercise regimen would be appropriate for the individual. | pre-intervention session (T1) | 
| Prone instability test | Participants will assume a face-down position on a bench, allowing their legs to dangle off the edge so that their feet touch the ground. Manual pressure will then be applied on various lumbar spine segments to induce pain. If pain occurs, participants then raise their legs off the ground before the application of back-to-front pressure is repeated. A reduction in pain when lifting the legs indicates the ability to actively stabilize the spine, signifying a positive test result. In such cases, a stability-focused exercise regimen would be appropriate for the individual. | post-intervention (8 weeks after start of intervention;T2) | 
| straight leg raise (SLR) | The Straight Leg Raise (SLR) test is a commonly used diagnostic procedure to evaluate for the presence of lumbar radiculopathy, often caused by a herniated disc. During the test, the patient lies flat on their back on an examination table. The examiner then lifts one of the patient's straightened legs by the ankle, keeping the knee extended. | pre-intervention session (T1) | 
| straight leg raise (SLR) | The Straight Leg Raise (SLR) test is a commonly used diagnostic procedure to evaluate for the presence of lumbar radiculopathy, often caused by a herniated disc. During the test, the patient lies flat on their back on an examination table. The examiner then lifts one of the patient's straightened legs by the ankle, keeping the knee extended | post-intervention (8 weeks after start of intervention;T2) | 
| internal rotation range of motion | When the knee is in a position of flexion between 30 and 90 degrees, there are approximately 45 degrees external and 25 degrees internal rotation. Rotatory motion decreases with further extension and, at 5 degrees of flexion, the knee has 23 degrees external and 10 degrees internal rotation. | pre-intervention session (T1) | 
| internal rotation range of motion | When the knee is in a position of flexion between 30 and 90 degrees, there are approximately 45 degrees external and 25 degrees internal rotation. Rotatory motion decreases with further extension and, at 5 degrees of flexion, the knee has 23 degrees external and 10 degrees internal rotation. | post-intervention (8 weeks after start of intervention;T2) | 
| FABER test | The FABER test is used to identify the presence of hip pathology by attempting to reproduce pain in the hip, lumbar spine or sacroiliac region. The test is a passive screening tool for musculoskeletal pathologies, such as hip, lumbar spine, or sacroiliac joint dysfunction, or an iliopsoas spasm. | pre-intervention session (T1) | 
| FABER test | The FABER test is used to identify the presence of hip pathology by attempting to reproduce pain in the hip, lumbar spine or sacroiliac region. The test is a passive screening tool for musculoskeletal pathologies, such as hip, lumbar spine, or sacroiliac joint dysfunction, or an iliopsoas spasm. | post-intervention (8 weeks after start of intervention;T2) |