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

Sponsor
The Hong Kong Polytechnic University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06030128
Collaborator
(none)
150
1
2
23
6.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: core stabilization exercise
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
75 participants will be randomized into the intervention group. Another 75 participants will be randomized into the waiting list control group.75 participants will be randomized into the intervention group. Another 75 participants will be randomized into the waiting list control group.
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Core Stabilization Exercise Therapy in Chronic Lower Back Pain Management in Community Dwelling Older Adults
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2025
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Core stabilization exercise group

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
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.

No Intervention: waiting list control group

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.

Outcome Measures

Primary Outcome Measures

  1. The Oswestry Low Back Pain Disability Questionnaire [pre-intervention session (T1)]

    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).

  2. The Oswestry Low Back Pain Disability Questionnaire [post-intervention (8 weeks after start of intervention;T2)]

    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).

Secondary Outcome Measures

  1. Visual analogue scale (VAS) score for pain [pre-intervention session (T1)]

    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.

  2. Visual analogue scale (VAS) score for pain [post-intervention (8 weeks after start of intervention;T2)]

    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.

  3. Fear-Avoidance Belief Questionnaire [pre-intervention session (T1)]

    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.

  4. Fear-Avoidance Belief Questionnaire [post-intervention (8 weeks after start of intervention;T2)]

    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.

  5. Surface EMG [pre-intervention session (T1)]

    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.

  6. Surface EMG [post-intervention (8 weeks after start of intervention;T2)]

    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.

  7. IMU-sensor [pre-intervention session (T1)]

    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.

  8. IMU-sensor [post-intervention (8 weeks after start of intervention;T2)]

    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.

  9. Prone instability test [pre-intervention session (T1)]

    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.

  10. Prone instability test [post-intervention (8 weeks after start of intervention;T2)]

    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.

  11. straight leg raise (SLR) [pre-intervention session (T1)]

    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.

  12. straight leg raise (SLR) [post-intervention (8 weeks after start of intervention;T2)]

    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

  13. internal rotation range of motion [pre-intervention session (T1)]

    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.

  14. internal rotation range of motion [post-intervention (8 weeks after start of intervention;T2)]

    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.

  15. FABER test [pre-intervention session (T1)]

    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.

  16. FABER test [post-intervention (8 weeks after start of intervention;T2)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Hong Kong Polytechnic University Hong Kong Hong Kong

Sponsors and Collaborators

  • The Hong Kong Polytechnic University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dr Patrick Kwong, Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT06030128
Other Study ID Numbers:
  • 20230506002
First Posted:
Sep 8, 2023
Last Update Posted:
Sep 8, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 8, 2023