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

Primary Purpose

Chronic Non-specific Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
exercise therapy
Sponsored by
Iran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Non-specific Low Back Pain focused on measuring Low back pain, Disability, Postural control, Core Stability Exercise, cognitive task

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Iran University of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

core stability exercises with cognitive tasks group

general exercises with cognitive tasks group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Visual analog scale
Questionnaire evaluating pain intensity. Total score range from 0-10 (higher scores mean more pain)
Oswestry Disability Index
Questionnaire evaluating the level of disability. Total score range from 0-100 (higher scores mean more disability)

Secondary Outcome Measures

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.
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.
COP sway velocity
COP sway velocity is one kind of COP displacement evaluation method characterized as traditional linear measures for evaluating postural control stability.
Sway area
Sway area is one kind of COP displacement evaluation method characterized as traditional linear measures for evaluating postural control stability.
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.
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.
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)
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)
Tampa scale for kinesiophobia
Questionnaire evaluating the kinesiophobia because of feeling re-injury. Total score range from 17-68 (higher scores mean more kinesiophobia)
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)

Full Information

First Posted
March 31, 2023
Last Updated
May 25, 2023
Sponsor
Iran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05832918
Brief Title
Effects of Core Stability Exercises and Cognitive Tasks on Chronic Non-specific Back Pain
Official Title
Effects of Core Stability Exercises and Cognitive Tasks Compared to General Exercises and Cognitive Tasks on Chronic Non-specific Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2023 (Actual)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
March 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Iran University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Non-specific Low Back Pain
Keywords
Low back pain, Disability, Postural control, Core Stability Exercise, cognitive task

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
core stability exercises with cognitive tasks group
Arm Type
Experimental
Arm Description
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.
Arm Title
general exercises with cognitive tasks group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
exercise therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual analog scale
Description
Questionnaire evaluating pain intensity. Total score range from 0-10 (higher scores mean more pain)
Time Frame
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ", "change from baseline at three months "
Title
Oswestry Disability Index
Description
Questionnaire evaluating the level of disability. Total score range from 0-100 (higher scores mean more disability)
Time Frame
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ", "change from baseline at three months "
Secondary Outcome Measure Information:
Title
Center of pressure (COP) sway range for anteroposterior (AP range)
Description
AP range is one kind of COP displacement evaluation method characterized as traditional linear measures for evaluating postural control stability.
Time Frame
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Title
COP sway range for mediolateral (MA range)
Description
MA range is one kind of COP displacement evaluation method characterized as traditional linear measures for evaluating postural control stability.
Time Frame
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Title
COP sway velocity
Description
COP sway velocity is one kind of COP displacement evaluation method characterized as traditional linear measures for evaluating postural control stability.
Time Frame
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Title
Sway area
Description
Sway area is one kind of COP displacement evaluation method characterized as traditional linear measures for evaluating postural control stability.
Time Frame
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Title
Short-term diffusion coefficient of stabilogram diffusion plot
Description
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.
Time Frame
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Title
Long-term diffusion coefficient of stabilogram diffusion plot
Description
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.
Time Frame
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Title
Critical point coordinates.
Description
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)
Time Frame
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Title
12-item short form health survey
Description
Questionnaire evaluating the quality of life. Total score range from 0-100 (higher scores mean better quality of life)
Time Frame
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Title
Tampa scale for kinesiophobia
Description
Questionnaire evaluating the kinesiophobia because of feeling re-injury. Total score range from 17-68 (higher scores mean more kinesiophobia)
Time Frame
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Title
Fear-avoidance beliefs questionnaire
Description
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)
Time Frame
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zeinab Raoufi
Phone
00982122222059
Email
zraoofi93@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Reza Salehi
Phone
00982122222059
Email
Salehi.re@iums.ac.ir
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeinab Raoufi, PhD student
Organizational Affiliation
Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Reza Salehi, PhD
Organizational Affiliation
Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Iran University of Medical Sciences
City
Tehran
State/Province
Iran (the Islamic Republic Of)
ZIP/Postal Code
1449614535
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reza Salehi, Associate Professor
Phone
0098212222059
Email
Salehi.re@iums.ac.ir
First Name & Middle Initial & Last Name & Degree
Zeinab Raoufi, PhD candidate
Phone
0098212222059
Email
zraoofi93@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
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Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8167732/
Description
Efficacy of Core Stability in Non-Specific Chronic Low Back Pain
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8741254/
Description
Determinants of quality of life in individuals with chronic low back pain: a systematic review
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3454540/
Description
Chapter 3. European guidelines for the management of acute nonspecific low back pain in primary care
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2387160/
Description
Effects of attention on the control of locomotion in individuals with chronic low back pain
URL
https://pubmed.ncbi.nlm.nih.gov/23601702/
Description
Compensatory but not anticipatory adjustments are altered in older adults during lateral postural perturbations
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4082574/
Description
Aging and balance control in response to external perturbations: role of anticipatory and compensatory postural mechanisms
URL
https://pubmed.ncbi.nlm.nih.gov/8961451/
Description
Inefficient muscular stabilization of the lumbar spine associated with low back pain. A motor control evaluation of transversus abdominis
URL
https://pubmed.ncbi.nlm.nih.gov/31726292/
Description
Anticipatory postural control differs between low back pain and pelvic girdle pain patients in the absence of visual feedback
URL
https://pubmed.ncbi.nlm.nih.gov/11713638/
Description
Changes in motor planning of feedforward postural responses of the trunk muscles in low back pain
URL
https://pubmed.ncbi.nlm.nih.gov/8552278/
Description
Open-loop and closed-loop postural control mechanisms in Parkinson's disease: increased mediolateral activity during quiet standing
URL
https://pubmed.ncbi.nlm.nih.gov/8224055/
Description
Open-loop and closed-loop control of posture: a random-walk analysis of center-of-pressure trajectories
URL
https://pubmed.ncbi.nlm.nih.gov/7589299/
Description
Age-related changes in open-loop and closed-loop postural control mechanisms
URL
https://pubmed.ncbi.nlm.nih.gov/27712027/
Description
Clinical practice guidelines for the noninvasive management of low back pain: A systematic review by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7588406/
Description
Which specific modes of exercise training are most effective for treating low back pain? Network meta-analysis
URL
https://pubmed.ncbi.nlm.nih.gov/15733046/
Description
Trunk muscle stabilization training plus general exercise versus general exercise only: randomized controlled trial of patients with recurrent low back pain
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8630919/
Description
Effects of core stabilization exercise and strengthening exercise on proprioception, balance, muscle thickness and pain related outcomes in patients with subacute nonspecific low back pain: a randomized controlled trial
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5293521/
Description
Core Stability Exercise Versus General Exercise for Chronic Low Back Pain
URL
https://pubmed.ncbi.nlm.nih.gov/27128390/
Description
Motor Control Exercise for Nonspecific Low Back Pain: A Cochrane Review
URL
https://pubmed.ncbi.nlm.nih.gov/33992272/
Description
Systematic reviews evaluating the effectiveness of motor control exercises in patients with non-specific low back pain do not consider its principles - A review
URL
https://pubmed.ncbi.nlm.nih.gov/20434467/
Description
Dual-task interference during initial learning of a new motor task results from competition for the same brain areas
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The Effects of Cognitive Loading on Motor Behavior in Injured Individuals: A Systematic Review
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Effect of dual tasking on anticipatory and compensatory postural adjustments in response to external perturbations in individuals with nonspecific chronic low back pain: Electromyographic analysis
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A meta-analysis of core stability exercise versus general exercise for chronic low back pain
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https://pubmed.ncbi.nlm.nih.gov/12127181/
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Attention and the control of posture and gait: a review of an emerging area of research
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Effect of dual-tasking on dynamic postural control in individuals with and without nonspecific low back pain
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Effectiveness of core stabilization exercises and routine exercise therapy in management of pain in chronic non-specific low back pain: A randomized controlled clinical trial
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Effects of McGill stabilization exercises and conventional physiotherapy on pain, functional disability and active back range of motion in patients with chronic non-specific low back pain
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The effects of visual input on open-loop and closed-loop postural control mechanisms
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Theories and control models and motor learning: clinical applications in neuro-rehabilitation
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The Oswestry Disability Index, the Roland-Morris Disability Questionnaire, and the Quebec Back Pain Disability Scale: translation and validation studies of the Iranian versions
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https://pubmed.ncbi.nlm.nih.gov/24254494/
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Validation of the Persian version of the fear avoidance belief questionnaire in patients with low back pain
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https://pubmed.ncbi.nlm.nih.gov/10488681/
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Fear of movement/(re)injury and muscular reactivity in chronic low back pain patients: an experimental investigation
URL
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Description
Translation and validation of the Persian version of the STarT Back Screening Tool in patients with nonspecific low back pain

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

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