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Clinical Trials/NCT06030128
NCT06030128CompletedNot Applicable

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

The Hong Kong Polytechnic University1 site in 1 country150 target enrollmentStarted: September 15, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
150
Locations
1
Primary Endpoint
The Oswestry Low Back Pain Disability Questionnaire

Study Overview

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.

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
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
40 Years to 80 Years (Adult, Older Adult)
Sex
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

Arms & Interventions

Core stabilization exercise group

Experimental

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.

Intervention: core stabilization exercise (Behavioral)

waiting list control group

No Intervention

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.

Outcomes

Primary Outcomes

The Oswestry Low Back Pain Disability Questionnaire

Time Frame: 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).

The Oswestry Low Back Pain Disability Questionnaire

Time Frame: 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).

Secondary Outcomes

  • FABER test(post-intervention (8 weeks after start of intervention;T2))
  • Fear-Avoidance Belief Questionnaire(post-intervention (8 weeks after start of intervention;T2))
  • IMU-sensor(post-intervention (8 weeks after start of intervention;T2))
  • Prone instability test(post-intervention (8 weeks after start of intervention;T2))
  • Visual analogue scale (VAS) score for pain(post-intervention (8 weeks after start of intervention;T2))
  • Surface EMG(post-intervention (8 weeks after start of intervention;T2))
  • internal rotation range of motion(post-intervention (8 weeks after start of intervention;T2))
  • straight leg raise (SLR)(post-intervention (8 weeks after start of intervention;T2))
  • Visual analogue scale (VAS) score for pain(pre-intervention session (T1))
  • Fear-Avoidance Belief Questionnaire(pre-intervention session (T1))
  • Surface EMG(pre-intervention session (T1))
  • IMU-sensor(pre-intervention session (T1))
  • Prone instability test(pre-intervention session (T1))
  • straight leg raise (SLR)(pre-intervention session (T1))
  • internal rotation range of motion(pre-intervention session (T1))
  • FABER test(pre-intervention session (T1))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr Patrick Kwong

Assistant Professor

The Hong Kong Polytechnic University

Study Sites (1)

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