Clinical trial NCT06030128: Core Stabilization Exercise Therapy in Chronic Lower Back Back Management in Community Dwelling Older Adults
Official title: Core Stabilization Exercise Therapy in Chronic Lower Back Pain Management in Community Dwelling Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Low-back Pain
Older Adults
Core Stabilization Exercise Therapy
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 75 participants will be randomized into the intervention group. Another 75 participants will be randomized into the waiting list control group.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Oswestry Low Back Pain Disability Questionnaire
timeFrame: pre-intervention session (T1)
measure: The Oswestry Low Back Pain Disability Questionnaire
timeFrame: post-intervention (8 weeks after start of intervention;T2)
Secondary outcomes:
measure: Visual analogue scale (VAS) score for pain
timeFrame: pre-intervention session (T1)
measure: Visual analogue scale (VAS) score for pain
timeFrame: post-intervention (8 weeks after start of intervention;T2)
measure: Fear-Avoidance Belief Questionnaire
timeFrame: pre-intervention session (T1)
measure: Fear-Avoidance Belief Questionnaire
timeFrame: post-intervention (8 weeks after start of intervention;T2)
measure: Surface EMG
timeFrame: pre-intervention session (T1)
measure: Surface EMG
timeFrame: post-intervention (8 weeks after start of intervention;T2)
measure: IMU-sensor
timeFrame: pre-intervention session (T1)
measure: IMU-sensor
timeFrame: post-intervention (8 weeks after start of intervention;T2)
measure: Prone instability test
timeFrame: pre-intervention session (T1)
measure: Prone instability test
timeFrame: post-intervention (8 weeks after start of intervention;T2)
measure: straight leg raise (SLR)
timeFrame: pre-intervention session (T1)
measure: straight leg raise (SLR)
timeFrame: post-intervention (8 weeks after start of intervention;T2)
measure: internal rotation range of motion
timeFrame: pre-intervention session (T1)
measure: internal rotation range of motion
timeFrame: post-intervention (8 weeks after start of intervention;T2)
measure: FABER test
timeFrame: pre-intervention session (T1)
measure: FABER test
timeFrame: post-intervention (8 weeks after start of intervention;T2)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
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