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

NCT ID: NCT05832918

Last Updated: 2025-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-02

Study Completion Date

2025-12-15

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:

1. 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?
2. 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?
3. 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?
4. 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.

Conditions

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Chronic Non-specific Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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core stability exercises with cognitive tasks group

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.

Group Type EXPERIMENTAL

exercise therapy

Intervention Type OTHER

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.

general exercises with cognitive tasks group

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.

Group Type ACTIVE_COMPARATOR

exercise therapy

Intervention Type OTHER

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.

Interventions

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exercise therapy

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.

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Iran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Reza Salehi

Iran University of Medical Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zeinab Raoufi, PhD student

Role: PRINCIPAL_INVESTIGATOR

Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences

Reza Salehi, PhD

Role: STUDY_DIRECTOR

Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences

Locations

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Iran University of Medical Sciences

Tehran, Iran (the Islamic Republic Of), Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Zeinab Raoufi

Role: CONTACT

00982122222059

Reza Salehi

Role: CONTACT

00982122222059

Facility Contacts

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Reza Salehi, Associate Professor

Role: primary

0098212222059

Zeinab Raoufi, PhD candidate

Role: backup

0098212222059

References

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Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

Access external resources that provide additional context or updates about the study.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8167732/

Efficacy of Core Stability in Non-Specific Chronic Low Back Pain

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8741254/

Determinants of quality of life in individuals with chronic low back pain: a systematic review

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3454540/

Chapter 3. European guidelines for the management of acute nonspecific low back pain in primary care

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2387160/

Effects of attention on the control of locomotion in individuals with chronic low back pain

https://pubmed.ncbi.nlm.nih.gov/23601702/

Compensatory but not anticipatory adjustments are altered in older adults during lateral postural perturbations

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4082574/

Aging and balance control in response to external perturbations: role of anticipatory and compensatory postural mechanisms

https://pubmed.ncbi.nlm.nih.gov/8961451/

Inefficient muscular stabilization of the lumbar spine associated with low back pain. A motor control evaluation of transversus abdominis

https://pubmed.ncbi.nlm.nih.gov/31726292/

Anticipatory postural control differs between low back pain and pelvic girdle pain patients in the absence of visual feedback

https://pubmed.ncbi.nlm.nih.gov/11713638/

Changes in motor planning of feedforward postural responses of the trunk muscles in low back pain

https://pubmed.ncbi.nlm.nih.gov/8552278/

Open-loop and closed-loop postural control mechanisms in Parkinson's disease: increased mediolateral activity during quiet standing

https://pubmed.ncbi.nlm.nih.gov/8224055/

Open-loop and closed-loop control of posture: a random-walk analysis of center-of-pressure trajectories

https://pubmed.ncbi.nlm.nih.gov/7589299/

Age-related changes in open-loop and closed-loop postural control mechanisms

https://pubmed.ncbi.nlm.nih.gov/27712027/

Clinical practice guidelines for the noninvasive management of low back pain: A systematic review by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7588406/

Which specific modes of exercise training are most effective for treating low back pain? Network meta-analysis

https://pubmed.ncbi.nlm.nih.gov/15733046/

Trunk muscle stabilization training plus general exercise versus general exercise only: randomized controlled trial of patients with recurrent low back pain

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8630919/

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

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5293521/

Core Stability Exercise Versus General Exercise for Chronic Low Back Pain

https://pubmed.ncbi.nlm.nih.gov/27128390/

Motor Control Exercise for Nonspecific Low Back Pain: A Cochrane Review

https://pubmed.ncbi.nlm.nih.gov/33992272/

Systematic reviews evaluating the effectiveness of motor control exercises in patients with non-specific low back pain do not consider its principles - A review

https://pubmed.ncbi.nlm.nih.gov/20434467/

Dual-task interference during initial learning of a new motor task results from competition for the same brain areas

https://pubmed.ncbi.nlm.nih.gov/31066022/

The Effects of Cognitive Loading on Motor Behavior in Injured Individuals: A Systematic Review

https://pubmed.ncbi.nlm.nih.gov/29332033/

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

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3524111/

A meta-analysis of core stability exercise versus general exercise for chronic low back pain

https://pubmed.ncbi.nlm.nih.gov/12127181/

Attention and the control of posture and gait: a review of an emerging area of research

https://pubmed.ncbi.nlm.nih.gov/24636612/

Effect of dual-tasking on dynamic postural control in individuals with and without nonspecific low back pain

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5648929/

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

https://pubmed.ncbi.nlm.nih.gov/26864057/

Does core stability exercise improve lumbopelvic stability (through endurance tests) more than general exercise in chronic low back pain? A quasi-randomized controlled trial

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5908986/

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

https://pubmed.ncbi.nlm.nih.gov/7615030/

The effects of visual input on open-loop and closed-loop postural control mechanisms

https://pubmed.ncbi.nlm.nih.gov/22341985/

Theories and control models and motor learning: clinical applications in neuro-rehabilitation

https://pubmed.ncbi.nlm.nih.gov/25317504/

Comparing core stability and traditional trunk exercise on chronic low back pain patients using three functional lumbopelvic stability tests

https://pubmed.ncbi.nlm.nih.gov/16778675/

The Oswestry Disability Index, the Roland-Morris Disability Questionnaire, and the Quebec Back Pain Disability Scale: translation and validation studies of the Iranian versions

https://pubmed.ncbi.nlm.nih.gov/24254494/

Validation of the Persian version of the fear avoidance belief questionnaire in patients with low back pain

https://pubmed.ncbi.nlm.nih.gov/10488681/

Fear of movement/(re)injury and muscular reactivity in chronic low back pain patients: an experimental investigation

https://pubmed.ncbi.nlm.nih.gov/25925506/

Translation and validation of the Persian version of the STarT Back Screening Tool in patients with nonspecific low back pain

Other Identifiers

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IUMS

Identifier Type: -

Identifier Source: org_study_id

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