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NCT Number: NCT05832918

Effects of Core Stability 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.

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Key information

Conditions

Chronic Non-Specific Low Back Pain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise therapy

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Reza Salehi

CONTACT

[email protected]

00982122222059

Zeinab Raoufi

CONTACT

[email protected]

00982122222059

Sponsors and collaborators

Lead sponsor

Iran University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 27, 2023
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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