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

May 3, 2025 updated by: Reza Salehi, Iran University of Medical Sciences

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Iran, Islamic Republic of
    • Iran (the Islamic Republic Of)
      • Tehran, Iran (the Islamic Republic Of), Iran, Islamic Republic of, 1449614535
        • Recruiting
        • Iran University of Medical Sciences
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
Active Comparator: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index
Time Frame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ", "change from baseline at three months "
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
Visual analog scale
Time Frame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ", "change from baseline at three months "
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 "
Center of pressure (COP) sway range for anteroposterior (AP range)
Time Frame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
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)
Time Frame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
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
Time Frame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
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
Time Frame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
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
Time Frame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
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
Time Frame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
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.
Time Frame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
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
Time Frame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
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
Time Frame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
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
Time Frame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
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 "

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iran University of Medical Sciences

Investigators

  • Principal Investigator: Zeinab Raoufi, PhD student, Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences
  • Study Director: Reza Salehi, PhD, Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2023

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

December 15, 2025

Study Registration Dates

First Submitted

March 31, 2023

First Submitted That Met QC Criteria

April 15, 2023

First Posted (Actual)

April 27, 2023

Study Record Updates

Last Update Posted (Actual)

May 7, 2025

Last Update Submitted That Met QC Criteria

May 3, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IUMS (Isfahan University of Medical Sciences)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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