Effects of Core Stability Exercises and Cognitive Tasks on Chronic Non-specific Back Pain

Study Overview
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Brief Summary
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This randomized control trial study aims to compare the effect of core stability exercises and cognitive tasks with general exercises and cognitive tasks on pain, disability, and postural control strategies of chronic non-specific low back pain patients. The main questions are: Are core stability exercises and cognitive tasks more effective than general exercises and cognitive tasks in reducing the pain of chronic non-specific low back pain patients? Are core stability exercises and cognitive tasks more effective than general exercises and cognitive tasks in reducing the disability of chronic non-specific low back pain patients? Are core stability exercises and cognitive tasks more effective than general exercises and cognitive tasks in improving postural stability parameters of chronic non-specific low back pain patients? Are core stability exercises and cognitive tasks more effective than general exercises and cognitive tasks in improving stabilogram diffusion analysis parameters of chronic non-specific low back pain patients? This study is designed to apply two exercise protocols on two groups of 17 people with non-specific back pain. Group A will receive core stability exercises along with cognitive tasks, and group B will receive general exercises along with cognitive tasks.

Detailed Description
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Patients will be aged between 18-50 years. All patients meeting the inclusion criteria will receive 16 training sessions (thrice a week). The primary outcome measure will be pain and disability. Secondary outcome measures will be postural control strategies (including postural control stability and stabilogram diffusion analysis), quality of life, fear of movement, and fear-avoidance beliefs that will be assessed before and after training sessions and at 3-month follow-up; only primary outcomes will be evaluated in each group.

Official Title
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Effects of Core Stability Exercises and Cognitive Tasks Compared to General Exercises and Cognitive Tasks on Chronic Non-specific Back Pain

Conditions
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Chronic Non-specific Low Back Pain

Intervention / Treatment
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* Other: exercise therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Orthopedist-confirmed diagnosis of chronic nonspecific low back pain that has lasted at least three months since its onset. Pain score of 3 or more on a visual analog scale. Pain during quiet standing. Cognitive level above 24 based on mini-mental state examination (MMSE). Exclusion Criteria: Radicular pain and any neurological signs. Uncorrected vision impairment. Hearing problems. Vestibular dysfunctions. Cognitive deficit. Previous spinal surgery. Severe deformity or injury to the lower extremities.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: core stability exercises with cognitive tasks group<br>This research will use core stability exercises to strengthen local muscles (transversus abdominis and multifidus) based on the training program provided by Shamsi et al., which is modified from the exercise program of Koumantakis et al.. Participants will be treated for six weeks, three sessions a week, and 16 sessions. We will also combine stabilization exercises with cognitive tasks. | Other: exercise therapy<br>* Exercise therapy is one of the rehabilitation methods that is defined as a regimen or plan of physical activities designed and prescribed to facilitate the patient's recovery from diseases and any conditions which disturb their movement and activity of daily life or maintain a state of well-being through neuro re-education, gait training, and therapeutic exercises.<br>|
| Active Comparator: general exercises with cognitive tasks group<br>This research will use general exercises to strengthen global muscles (abdominal flexor muscles and back extensor muscles) based on the training program provided by Shamsi et al.(110), which is modified by Koumantakis et al.. Participants will be treated for six weeks, three sessions a week, and 16 sessions. We will also combine general exercises with cognitive tasks. | Other: exercise therapy<br>* Exercise therapy is one of the rehabilitation methods that is defined as a regimen or plan of physical activities designed and prescribed to facilitate the patient's recovery from diseases and any conditions which disturb their movement and activity of daily life or maintain a state of well-being through neuro re-education, gait training, and therapeutic exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale | Questionnaire evaluating pain intensity. Total score range from 0-10 (higher scores mean more pain) | Baseline (pre-intervention), change from baseline immediately after the intervention at five weeks , change from baseline at three months  | 
| Oswestry Disability Index | Questionnaire evaluating the level of disability. Total score range from 0-100 (higher scores mean more disability) | Baseline (pre-intervention), change from baseline immediately after the intervention at five weeks , change from baseline at three months  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Center of pressure (COP) sway range for anteroposterior (AP range) | AP range is one kind of COP displacement evaluation method characterized as traditional linear measures for evaluating postural control stability. | Baseline (pre-intervention), change from baseline immediately after the intervention at five weeks  | 
| COP sway range for mediolateral (MA range) | MA range is one kind of COP displacement evaluation method characterized as traditional linear measures for evaluating postural control stability. | Baseline (pre-intervention), change from baseline immediately after the intervention at five weeks  | 
| COP sway velocity | COP sway velocity is one kind of COP displacement evaluation method characterized as traditional linear measures for evaluating postural control stability. | Baseline (pre-intervention), change from baseline immediately after the intervention at five weeks  | 
| Sway area | Sway area is one kind of COP displacement evaluation method characterized as traditional linear measures for evaluating postural control stability. | Baseline (pre-intervention), change from baseline immediately after the intervention at five weeks  | 
| Short-term diffusion coefficient of stabilogram diffusion plot | The short-term diffusion coefficient is the slope of the open-loop part of the stabilogram diffusion plot, indicating stochastic activity in open loop control phase in a quiet standing position. | Baseline (pre-intervention), change from baseline immediately after the intervention at five weeks  | 
| Long-term diffusion coefficient of stabilogram diffusion plot | The long-term diffusion coefficient is the slope of the close loop part of the stabilogram diffusion plot, indicating stochastic activity in the immediate loop control phase in the quiet standing position. | Baseline (pre-intervention), change from baseline immediately after the intervention at five weeks  | 
| Critical point coordinates. | Critical point coordinates are the estimated values of the time intervals and mean square displacements defining the stabilogram-diffusion critical points (the point that open-loop control changed to close loop control) | Baseline (pre-intervention), change from baseline immediately after the intervention at five weeks  | 
| 12-item short form health survey | Questionnaire evaluating the quality of life. Total score range from 0-100 (higher scores mean better quality of life) | Baseline (pre-intervention), change from baseline immediately after the intervention at five weeks  | 
| Tampa scale for kinesiophobia | Questionnaire evaluating the kinesiophobia because of feeling re-injury. Total score range from 17-68 (higher scores mean more kinesiophobia) | Baseline (pre-intervention), change from baseline immediately after the intervention at five weeks  | 
| Fear-avoidance beliefs questionnaire | Questionnaire evaluating fear of pain and consequent avoidance of physical activity because of their fear. Total score range from 0-66 (higher scores mean more fear of pain) | Baseline (pre-intervention), change from baseline immediately after the intervention at five weeks  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low back pain, Disability, Postural control, Core Stability Exercise, cognitive task