Protocol summary

Study aim
Investigating the effect of adding dual task to functional exercises on proprioception, range of motion, pain, and fear of movement in people with chronic nonspecific low back pain
Design
The sample size of the study was estimated using G*Power software. Calculations were made based on a statistical power of 0.8, a significance level of α = 0.05, and a medium effect size of 0.25, and the final sample size increased to 45 people.
Settings and conduct
Dezful City Energy Plus Club.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of chronic non-specific low back pain by a specialist Pain duration ≥ 3 months Age range 25-60 years Pain intensity 3-7 on the Numeric Pain Rating Scale (NPRS) Body mass index (BMI) < 30 kg/m2 Exclusion criteria: History of spinal surgery Regular exercise for back pain in the past 6 months Use of analgesic, anti-inflammatory, opioid, or immunosuppressive medications Movement, mental, cognitive, hearing, visual, or communication disabilities (preventing full protocol implementation) History of spinal trauma or fracture, cancer, severe osteoporosis, neurodegenerative diseases (such as Parkinson's), or illiteracy
Intervention groups
Experimental group 1: (Single-task exercise): Performed the exercise protocol without additional cognitive task. Experimental group 2: (Dual exercise + exercise protocol): Performed the basic low back pain exercise protocol with simultaneous cognitive task (dual task). Control group: A passive intervention.
Main outcome variables
lumbar proprioception, lumbar range of motion, pain intensity, fear of movement.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180627040251N19
Registration date: 2026-07-15, 1405/04/24
Registration timing: prospective

Last update: 2026-07-15, 1405/04/24
Update count: 0
Registration date
2026-07-15, 1405/04/24
Registrant information
Name
Hassan Sadeghi
Name of organization / entity
Kharazmi University
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8001
Email address
hassan.sadeghi81@yahoo.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-07-21, 1405/04/30
Expected recruitment end date
2026-09-21, 1405/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding dual task to functional training on proprioception, range of motion, pain, and kinesiophobia in people with chronic non-specific low back pain
Public title
The effect of adding dual task to functional training on proprioception, range of motion, pain, and kinesiophobia in people with chronic non-specific low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of chronic non-specific low back pain by a specialist physician Duration of pain ≥ 3 months Age range 25 to 60 years Self-reported pain intensity 3 to 7 using the Numeric Pain Rating Scale (NPRS) Body mass index (BMI) less than 30 kg/m2
Exclusion criteria:
History of spinal surgery Having a regular exercise program related to back pain exercises in the past 6 months Undergoing treatment for pain or taking analgesic, anti-inflammatory, opioid or immunosuppressive drugs If they have a motor, mental or cognitive disability, or hearing, vision or communication disorders that prevent them from completing the protocol, they will be excluded from the study Individuals with a history of spinal trauma or fracture, cancer, (severe osteoporosis, spondyloarthropathy, spondylolisthesis, systemic inflammatory disease, illiteracy, diagnosed neurodegenerative diseases (such as Parkinson's) will be excluded from the study
Age
From 25 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
This study is a three-group randomized clinical trial with a pretest-posttest design and randomized control groups in the form of a randomized clinical trial (RCT). Eligible participants will be randomly divided into the following three groups: Experimental Group 1: (Single-task exercise): Perform the exercise protocol without additional cognitive task. Experimental Group 2: (Dual exercise + exercise protocol): Perform the basic low back pain exercise protocol with a simultaneous cognitive task (dual task). Control group: An inactive intervention.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a **single-blind randomized controlled clinical trial**. The study follows a **pretest–posttest design** with two intervention groups and one control group. In this study, the outcome assessor will be blinded to group allocation.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kharazmi University Ethics Committee
Street address
Tehran – Shahid Mofatteh Street, before Enghelab Street – No. 43.
City
Tehran
Province
Tehran
Postal code
۱۴۹۱۱-۱۵۷۱۹
Approval date
2026-05-26, 1405/03/05
Ethics committee reference number
IR.KHU.REC.1405.028

Health conditions studied

1

Description of health condition studied
chronic non-specific low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain

Primary outcomes

1

Description
Back proprioception
Timepoint
Outcome variables are measured at two time points: before and after the fatigue protocol.
Method of measurement
Lumbar proprioception is assessed using a hand-held goniometer and the method of Newcomer et al. (2000). The subject, standing with eyes closed, recreates a 30-degree angle of lumbar flexion in three attempts. The mean absolute error of the three repetitions in degrees is recorded as the reconstruction error score, with higher scores indicating poorer proprioception.

Secondary outcomes

1

Description
Lumbar range of motion
Timepoint
Outcome variables are measured at two time points: before and after the protocol.
Method of measurement
The range of motion of lumbar flexion and extension is measured using the modified Schober test. After marking reference points on the spine, the subject is asked to bend forward and backward as much as possible. The distance between the two points is measured with a tape measure, and the average of the three repetitions is recorded as the final score.

2

Description
Pain
Timepoint
Outcome variables are measured at two time points: before and after the protocol.
Method of measurement
Pain intensity is measured using a visual analog scale (VAS) consisting of a 10-cm horizontal line with two ends, "no pain" (score 0) and "worst possible pain" (score 10). The subject is asked to mark a point on the line and the distance from the zero point is recorded as the pain score. This assessment will be performed at pre-test and post-test.

3

Description
kinesiophobia
Timepoint
Outcome variables are measured at two time points: before and after the protocol.
Method of measurement
kinesiophobia is measured using the Tampa Scale (TSK) consisting of 17 questions on a 4-point Likert scale (1 to 4). The range of scores varies from 17 to 68, with higher scores indicating greater fear of movement. A score of 37 or less is interpreted as low fear and a score above 37 as high fear of movement.

Intervention groups

1

Description
Intervention group:(Single-task training): Performing the training protocol without additional cognitive task
Category
Rehabilitation

2

Description
Intervention group: (Dual exercise + training protocol): Performing a basic back pain training protocol along with a simultaneous cognitive task (dual task).
Category
Rehabilitation

3

Description
Control group: No exercise intervention.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Kharazmi University
Full name of responsible person
Shokouh Yousef Shanesaz
Street address
Shahid Keshvari Sports Complex, Kosha Street, between Shohareh and Hesari, Shahid Haghani Highway, Tehran (Mirdamad neighborhood
City
Tehran
Province
Tehran
Postal code
33111-15447
Phone
+98 21 2222 8001
Email
info@khu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kharazmi University
Full name of responsible person
Dr Alireza Harifi
Street address
Vice-Chancellery for Research and Technology, 43 Shahid Mofatteh Street, just before the intersection with Enghelab Street, Tehran, Islamic Republic of Iran.
City
Tehran
Province
Tehran
Postal code
۱۴۹۱۱-۱۵۷۱۹
Phone
+98 21 2222 8001
Email
Research@khu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kharazmi University
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
Kharazmi University
Full name of responsible person
Shokouh Yousef Shanesaz
Position
Postgraduate student
Latest degree
Bachelor
Other areas of specialty/work
Sport Medicine
Street address
No. 385, Nezami Street, between Motahari and Khayyam
City
Dezful
Province
Khouzestan
Postal code
6461175579
Phone
+98 61 4252 0083
Email
shanesazshokouh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Hassan Sadeghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Shahid Keshvari Sports Complex, Kosha Street, between Shohareh and Hesari, Shahid Haghani Highway, Tehran (Mirdamad neighborhood)
City
Tehran
Province
Tehran
Postal code
33111-15447
Phone
+98 21 2222 8001
Email
hassan.sadeghi81@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Hassan Sadeghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Shahid Keshvari Sports Complex, Kosha Street, between Shohareh and Hesari, Shahid Haghani Highway, Tehran (Mirdamad neighborhood)
City
Tehran
Province
Tehran
Postal code
33111-15447
Phone
+98 21 2222 8001
Email
hassan.sadeghi81@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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