Protocol summary

Study aim
Determining the effect of core stability exercises and cognitive tasks compared to general exercises and cognitive tasks on pain, disability and postural control of people with non-specific chronic low back pain.
Design
Two-arm parallel-group randomized control trial, single-blind (assessor), Randomization using random blocks method was used for randomization on 34 patients with non-specific chronic back pain, Rand function of Excel software.
Settings and conduct
In many clinical guidelines, exercise therapy is a recommended treatment for low back pain. First, the assessment of the pain intensity and the disability level, as well as postural control using the force plate device, the quality of life, the fear of movement, and the fear-avoidance beliefs, in people with Chronic non-specific back pain will be done in the movement analysis laboratory of the rehabilitation faculty of the Iran University. Finally, the participants will go to the physiotherapy clinic of the rehabilitation faculty of Iran University and will be randomly divided into two groups and will be treated for 16 sessions (3 days a week). At the end of the treatment, the above evaluations will be done again. This study is single-blind (blinding of the assessor).
Participants/Inclusion and exclusion criteria
Non-specific chronic low back pain that has lasted at least 3 months since its onset Pain score of 3 or more on a visual analog scale Not having radicular pain and any neurological symptoms Uncorrected vision impairment Hearing problems Vestibular dysfunctions Previous spinal surgery
Intervention groups
Experimental group: core stability exercises with cognitive tasks Control group: general exercises with cognitive tasks
Main outcome variables
1- Visual analog scale: Questionnaire evaluating pain intensity. Range from 0-10. 2- Oswestry Disability Index: Questionnaire evaluating the level of disability. Range from 0-100

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180429039470N2
Registration date: 2023-08-21, 1402/05/30
Registration timing: registered_while_recruiting

Last update: 2023-08-21, 1402/05/30
Update count: 0
Registration date
2023-08-21, 1402/05/30
Registrant information
Name
Reza Salehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8051
Email address
salehi.re@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-02, 1402/02/12
Expected recruitment end date
2024-01-30, 1402/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of central stability exercises and cognitive tasks compared to general exercises and cognitive tasks on pain, disability and postural control of people with non-specific chronic low back pain.
Public title
Effects of Core Stability Exercises and Cognitive Tasks on Chronic Non-specific Back Pain
Purpose
Treatment
Inclusion/Exclusion criteria
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.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Investigator
Sample size
Target sample size: 34
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be done by the method of variable blocks, which will include four-letter blocks consisting of letters A and B. After that, according to the fact that 34 people are needed in the study and the blocks are four components, 9 random numbers will be prepared, which will determine the arrangement of the four component blocks. Then, the random treatment list will be placed in sealed and numbered envelopes in the form of letters A and B. Letter A will represent CSE exercises with cognitive task and letter B will represent GE exercises with cognitive task. Then, an envelope will be assigned to each patient in the order of entering the study and his group will be determined.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, due to the dissimilarity of the treatment and control groups, there is no possibility of blinding the participants and the therapist. Therefore, in the present study, only for objective evaluations, including assessment of postural stability and postural control strategies, the blinding of the evaluator will be done with respect to the grouping of the subjects under study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
Clinical trials.gov
Secondary trial Id
NCT05832918
Registration date
2023-05-01, 1402/02/11

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Faculty of Rehabilitation Sciences, Madad karan St., Shah Nazari St., Mader Square, Mirdamad
City
Tehran
Province
Tehran
Postal code
1545913487
Approval date
2023-01-21, 1401/11/01
Ethics committee reference number
IR.IUMS.REC.1401.838

Health conditions studied

1

Description of health condition studied
Non-specific low back pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain intensity
Timepoint
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ", "change from baseline at three months "
Method of measurement
Visual analog scale

2

Description
Disability level
Timepoint
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ", "change from baseline at three months "
Method of measurement
Oswestry disability index questionnaire

Secondary outcomes

1

Description
Center of pressure (COP) sway range for anteroposterior (AP range)
Timepoint
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Method of measurement
Force plate device

2

Description
COP sway range for mediolateral (MA range)
Timepoint
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Method of measurement
Force plate device

3

Description
COP sway velocity
Timepoint
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Method of measurement
Force plate device

4

Description
Sway area
Timepoint
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Method of measurement
Force plate device

5

Description
Short-term diffusion coefficient of stabilogram diffusion plot
Timepoint
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Method of measurement
Force plate device

6

Description
Long-term diffusion coefficient of stabilogram diffusion plot
Timepoint
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Method of measurement
Force plate device

7

Description
Critical point coordinates
Timepoint
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Method of measurement
Force plate device

8

Description
Quality of life
Timepoint
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Method of measurement
12-item short form health survey

9

Description
kinesiophobia
Timepoint
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Method of measurement
Tampa scale for kinesiophobia

10

Description
Fear-avoidance beliefs
Timepoint
"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Method of measurement
Fear-avoidance beliefs questionnaire

Intervention groups

1

Description
Intervention group: core stability exercises with cognitive tasks (16 sessions, three times a week of local muscle exercises)
Category
Rehabilitation

2

Description
Control group: general exercises with cognitive tasks (16 sessions, three times a week of global muscle exercises)
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy Clinic, Faculty of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Reza Salehi
Street address
Iran University of Medical Sciences, Faculty of Rehabilitation Sciences, Madadkaran St., Shah Nazari St., Mader Square, Mirdamad
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 2059
Fax
+98 21 2640 5626
Email
Salehi.re@iums.ac.ir
Web page address
https://rehab.iums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Salehi
Street address
Iran University of Medical Sciences, Faculty of Rehabilitation Sciences, Maddkaran St., Shah Nazari St., Mader Square, Mirdamad
City
tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 2059
Email
Salehi.re@iums.ac.ir
Web page address
https://rehab.iums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Salehi
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Iran University of Medical Sciences, Faculty of Rehabilitation Sciences, Madadkaran St., Shah Nazari St., Mader Square, Mirdamad
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 2059
Fax
+98 21 2640 5626
Email
Salehi.re@iums.ac.ir
Web page address
https://rehab.iums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Salehi
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Iran University of Medical Sciences, Faculty of Rehabilitation Sciences, Madadkaran St., Shah Nazari St., Mader Square, Mirdamad
City
Tehran
Province
Tehran
Postal code
15459-13478
Phone
+98 21 2222 2059
Email
Salehi.re@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Salehi
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Iran University of Medical Sciences, Faculty of Rehabilitation Sciences, Madadkaran St., Shah Nazari St., Mader Square, Mirdamad
City
Tehran
Province
Tehran
Postal code
1545913478
Phone
+98 21 2222 2059
Email
Salehi.re@iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Effects of Core Stability Exercises and Cognitive Tasks on Chronic Non-specific Back Pain
When the data will become available and for how long
Starting after publication
To whom data/document is available
This is only available for people working in academic institutions.
Under which criteria data/document could be used
It can be used for advanced analysis and with new topics while maintaining ownership of university data.
From where data/document is obtainable
Salehi.re@iums.ac.ir
What processes are involved for a request to access data/document
It will be done through the email registered in the protocol.
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