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临床试验/NCT06030128
NCT06030128已完成不适用

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

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
The Oswestry Low Back Pain Disability Questionnaire

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: 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.

结局指标

主要结局

The Oswestry Low Back Pain Disability Questionnaire

时间窗: 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

时间窗: 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).

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Patrick Kwong

Assistant Professor

The Hong Kong Polytechnic University

研究点 (1)

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