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

Not Applicable

Recruiting

• Conditions: Chronic Non-specific Low Back Pain
• Interventions: Other: exercise therapy

• Registration Number: NCT05832918
• Lead Sponsor: Iran University of Medical Sciences

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:

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

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 Timeline

• Study First Submitted: 2023-03-31
• Study First Submitted QC: 2023-04-15
• Study First Posted: 2023-04-27
• Study Start: 2023-05-02
• Status Verified: 2024-05
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-01
• Primary Completion: 2024-11-30
• Study Completion: 2025-09-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
core stability exercises with cognitive tasks group	exercise therapy	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.
general exercises with cognitive tasks group	exercise therapy	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.

Primary Outcome Measures

Name	Time	Method
Visual analog scale	"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)
Oswestry Disability Index	"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 Outcome Measures

Name	Time	Method
COP sway range for mediolateral (MA range)	"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.
COP sway velocity	"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.
Sway area	"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.
12-item short form health survey	"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)
Tampa scale for kinesiophobia	"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)
Critical point coordinates.	"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)
Fear-avoidance beliefs questionnaire	"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)
Center of pressure (COP) sway range for anteroposterior (AP range)	"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.
Short-term diffusion coefficient of stabilogram diffusion plot	"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.
Long-term diffusion coefficient of stabilogram diffusion plot	"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.

Trial Locations

Locations (1)

Iran University of Medical Sciences; 🇮🇷 Tehran, Iran (the Islamic Republic Of), Iran, Islamic Republic of