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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05832918




Registration number
NCT05832918
Ethics application status
Date submitted
31/03/2023
Date registered
27/04/2023

Titles & IDs
Public title
Effects of Core Stability Exercises and Cognitive Tasks on Chronic Non-specific Back Pain
Scientific title
Effects of Core Stability Exercises and Cognitive Tasks Compared to General Exercises and Cognitive Tasks on Chronic Non-specific Back Pain
Secondary ID [1] 0 0
IUMS
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Non-specific Low Back Pain 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - exercise therapy

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.

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 interventions: 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 code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Visual analog scale
Timepoint [1] 0 0
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ", "change from baseline at three months "
Primary outcome [2] 0 0
Oswestry Disability Index
Timepoint [2] 0 0
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ", "change from baseline at three months "
Secondary outcome [1] 0 0
Center of pressure (COP) sway range for anteroposterior (AP range)
Timepoint [1] 0 0
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Secondary outcome [2] 0 0
COP sway range for mediolateral (MA range)
Timepoint [2] 0 0
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Secondary outcome [3] 0 0
COP sway velocity
Timepoint [3] 0 0
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Secondary outcome [4] 0 0
Sway area
Timepoint [4] 0 0
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Secondary outcome [5] 0 0
Short-term diffusion coefficient of stabilogram diffusion plot
Timepoint [5] 0 0
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Secondary outcome [6] 0 0
Long-term diffusion coefficient of stabilogram diffusion plot
Timepoint [6] 0 0
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Secondary outcome [7] 0 0
Critical point coordinates.
Timepoint [7] 0 0
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Secondary outcome [8] 0 0
12-item short form health survey
Timepoint [8] 0 0
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Secondary outcome [9] 0 0
Tampa scale for kinesiophobia
Timepoint [9] 0 0
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Secondary outcome [10] 0 0
Fear-avoidance beliefs questionnaire
Timepoint [10] 0 0
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/09/2025
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Iran, Islamic Republic of
State/province [1] 0 0
Iran (the Islamic Republic Of)

Funding & Sponsors
Primary sponsor type
Other
Name
Iran University of Medical Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Zeinab Raoufi, PhD student
Address 0 0
Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Zeinab Raoufi
Address 0 0
Country 0 0
Phone 0 0
00982122222059
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05832918