History
# Registration date Revision Id
2 2026-08-18, 1405/05/27 391808
1 2026-07-28, 1405/05/06 388432
Changes made to previous revision
This is the first revision

Protocol summary

Study aim
The Effect of of Dynamic Neuromuscular Stabilization (DNS) Exercises on Core Muscle Activation and Balance in Women with Non-Specific Chronic Low Back Pain
Design
This study will be conducted as a randomized single-blind clinical trial on 16 women with non-specific chronic low back pain. The participants will be divided into two groups: control and exercise; one group will receive DNS exercises, while the other group will serve as the control group in the study
Settings and conduct
This study will be conducted at Arak University. After obtaining informed consent, participants will be randomly assigned to either an exercise or a control group. The exercise group will perform DNS exercises focused on core activation and balance for four weeks (three sessions per week) at the university gym. The study is designed as a single-blind randomized clinical trial, with the assessor blinded to group allocation to reduce bias.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:1.Ageed 18 to 30 years. 2.Female gender. 3.Chronic non-specific low back pain more than 3 months. 4.Informed consent to participate in the study. 5.Clinical confirmation by a physician; Exclusion Criteria: 1.lumbar surgery. 2.Low back pain of traumatic or structural origin with neurological symptoms. 3.Neurological, cardiovascular, or respiratory diseases affecting motor function. 4.Absence from more than two consecutive sessions or three non-consecutive sessions. 5.Unwillingness to cooperate
Intervention groups
Intervention Group : Female patients with non-specific chronic low back pain who received a DNS exercise program to assess its effect on core muscle activation and balance. Control Group: Female patients with non-specific chronic low back pain who received no exercise or therapeutic intervention
Main outcome variables
Pain, Balance, Mobility / Walking ability, Difficulty performing abdominal breathing

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251204068213N1
Registration date: 2026-07-28, 1405/05/06
Registration timing: retrospective

Last update: 2026-07-28, 1405/05/06
Update count: 1
Registration date
2026-07-28, 1405/05/06
Registrant information
Name
Zeynab Shafiei simakani
Name of organization / entity
The University of Arak
Country
Iran (Islamic Republic of)
Phone
+98 86 3262 9024
Email address
z-shafei.03@msc.araku.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-11-11, 1404/08/20
Expected recruitment end date
2025-12-21, 1404/09/30
Actual recruitment start date
2025-11-11, 1404/08/20
Actual recruitment end date
2025-11-22, 1404/09/01
Trial completion date
2026-01-09, 1404/10/19
Scientific title
The effect of dynamic neuromuscular stability training on core muscle contraction and balance in women with chronic specific low back pain
Public title
Investigating the effect of dynamic neuromuscular stabilization exercises on core muscle contraction and balance in women with non-specific chronic low back pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 30 years Female gender Diagnosis of chronic non-specific low back pain with persistent pain for more than 3 months Healthy psychological and cognitive functioning, assessed based on the following criteria: a) No reported history of psychological or cognitive disorders b) Participants' ability to understand and complete study instructions during clinical interview c) Confirmation through clinical judgment by an experienced physician
Exclusion criteria:
Previous back surgery, spinal tumors, deformities, or infections Low back pain of traumatic or structural origin, or low back pain with neurological symptoms Previous neurological or cardiopulmonary diseases, including chronic obstructive pulmonary disease, which had severely affected motor function Unwillingness to continue cooperating with you in the course of work
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 20
Actual sample size reached: 16
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomization will be conducted as simple randomization at the individual level. The sequence of group assignments will be generated prior to participant enrollment using a random number table created in Excel. To ensure allocation concealment, the generated sequence will be kept by an individual outside the research team, and the researcher will remain unaware of the assignment order; thus, the risk of systematic bias in the enrollment process will be reduced. Each eligible participant, after screening and providing informed consent, will be assigned sequentially according to the predetermined random sequence into one of the two study groups (exercise group and control group).
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, due to the nature of the exercise interventions, blinding of participants and researchers is not feasible; since the type of exercise is evident to both participants and researchers, as well as to data collectors and outcome assessors, they are necessarily aware of the group allocation. However, the data analyst responsible for the statistical analysis of the results will remain blinded to the group assignments in order to prevent bias in the final analysis. Information regarding group allocation will only be provided to the analyst through specific coding.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Arak University
Street address
Arak. Sardasht. Basij Square. Karbala Boulevard. Arak University
City
Arak
Province
Markazi
Postal code
3848177584
Approval date
2025-10-22, 1404/07/30
Ethics committee reference number
IR.ARAKU.REC.1404.035

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
Core Muscle Contraction
Timepoint
At the beginning of the study and after 12 intervention sessions
Method of measurement
Diagnostic ultrasound unit

Secondary outcomes

1

Description
Balance
Timepoint
At the beginning of the study and after 12 intervention sessions
Method of measurement
Y Balance Test. Stork Balance Test

Intervention groups

1

Description
Intervention group: Participants in the Dynamic neuromuscular exercises group received 12 sessions of 50 minutes each over 4 weeks (three sessions per week). Each session consisted of 5 minutes of warm-up, 40 minutes of main exercises, and 5 minutes of cool-down. The main exercises included six movements based on the DNS approach (diaphragmatic breathing, dead-bug, rolling to the side, bear-crawl, side plank, and transition to sitting and kneeling positions). Each exercise was performed in 2 sets of 10 repetitions, with 2 minutes of rest between exercises. An experienced physiotherapist provided verbal feedback to ensure adherence to the three DNS principles (abdominal breathing, sagittal stability, and simultaneous agonist-antagonist contraction).
Category
Rehabilitation

2

Description
The control group did not perform dynamic neuromuscular stability exercises, but they did perform abdominal muscle sonography in two phases (pre-test and post-test). Additionally, dynamic balance tests and static balance tests were also conducted in two phases (pre-test and post-test).
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Kimia Ultrasound
Full name of responsible person
Kimia Mohammadi
Street address
Imam Khomeini Street, Dr. Hesabi Intersection, Next to Parsian Bank, Professor Hesabi Building, B-1
City
Arak
Province
Markazi
Postal code
۳۸۱۳۸۴۷۶۷۴
Phone
+98 86 3224 2525
Email
Kimiaadrian1400@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The university of Arak
Full name of responsible person
Shahnaz Shahrjerdi
Street address
Arak, Sardasht, Basij Square, Karbala boulevard, Arak University, Department of Physiology and Sports Pathology
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3262 9024
Email
s-shahrjerdi@araku.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The university of Arak
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
The university of Arak
Full name of responsible person
Shahnaz Shahrjerdi
Position
PhD in Sport Medicine
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Faculty of Sports Sciences, Department of Sports Physiology and Pathology, Arak University, Karbala Boulevard, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848177484
Phone
+98 86 3262 9024
Email
s-shahrjerdi@araku.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Arak
Full name of responsible person
Shahnaz Shahrjerdi
Position
PhD in sports Medicine
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Faculty of Sports Sciences, Department of Sports Physiology and Pathology, Arak University, Karbala Boulevard, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3262 9024
Email
s-shahrjerdi@araku.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The University of Arak
Full name of responsible person
Shahnaz Shahrjerdi
Position
PhD in Sports Medicine
Latest degree
Ph.D.
Other areas of specialty/work
Sports Medicine
Street address
Faculty of Sports Sciences, Department of Sports Physiology and Pathology, Arak University, Karbala Boulevard, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3262 9024
Email
s-shahrjerdi@araku.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
All research data will be made available after publication, except for any data that could lead to the identification of participants. Only de‑identified data or aggregated data related to the primary outcome variables will be shared, if needed.
When the data will become available and for how long
Five months after the publication of the results
To whom data/document is available
All individuals, researchers, faculty members, and people with non‑specific chronic low back pain can benefit from this research.
Under which criteria data/document could be used
Individuals who wish to review the study may contact the researcher via email to request access to the documentation.
From where data/document is obtainable
They should first contact Dr. Shahrjerdi via email at s‑shahrjerdi@araku.ac.ir and then follow up by calling +98‑939‑032‑8958. They may also visit the Arak University Library, located in Sardasht, Karbala Boulevard, Arak University.
What processes are involved for a request to access data/document
Researchers may receive the requested documentation after sending an email and obtaining confirmation from the researcher.
Comments
Loading...