Protocol summary
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Study aim
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The Effect of of Dynamic Neuromuscular Stabilization (DNS) Exercises on Core Muscle Activation and Balance in Women with Non-Specific Chronic Low Back Pain
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Design
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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
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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
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Main outcome variables
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Pain, Balance, Mobility / Walking ability, Difficulty performing abdominal breathing
General information
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Reason for update
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Dear Sir/Madam,
With due respect, I would like to inform you that a total of 24 participants were initially enrolled in the present study. However, due to the circumstances caused by the war and the resulting disruption to the research process, only 16 participants were able to complete the post-test assessment, and it was not possible to continue the study procedures for the remaining participants at that time.
Following the establishment of a ceasefire and the restoration of conditions that allowed the study to resume, the remaining available participants underwent the required assessments in order to continue the study and to increase the validity and adequacy of the sample size.
Therefore, considering the change in the final number of participants who completed the assessment stages and the availability of additional data, I kindly request that the relevant information, including the sample size, be amended and updated in the IRCT system so that the registered information accurately reflects the actual course of the study.
Thank you in advance for your kind cooperation and consideration.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20251204068213N1
Registration date:
2026-07-28, 1405/05/06
Registration timing:
retrospective
Last update:
2026-08-18, 1405/05/27
Update count:
1
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Registration date
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2026-07-28, 1405/05/06
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2025-11-11, 1404/08/20
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Expected recruitment end date
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2025-12-21, 1404/09/30
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Actual recruitment start date
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2025-11-11, 1404/08/20
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Actual recruitment end date
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2025-11-22, 1404/09/01
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Trial completion date
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2026-01-09, 1404/10/19
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Scientific title
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The effect of dynamic neuromuscular stability training on core muscle contraction and balance in women with chronic specific low back pain
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Public title
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Investigating the effect of dynamic neuromuscular stabilization exercises on core muscle contraction and balance in women with non-specific chronic low back pain
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 30 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
26
Actual sample size reached:
24
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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).
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2025-10-22, 1404/07/30
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Ethics committee reference number
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IR.ARAKU.REC.1404.035
Health conditions studied
1
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Description of health condition studied
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Chronic non-specific low back pain
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ICD-10 code
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M54.5
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ICD-10 code description
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Low back pain
Primary outcomes
1
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Description
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Core Muscle Contraction
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Timepoint
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At the beginning of the study and after 12 intervention sessions
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Method of measurement
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Diagnostic ultrasound unit
Secondary outcomes
1
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Description
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Balance
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Timepoint
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At the beginning of the study and after 12 intervention sessions
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Method of measurement
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Y Balance Test. Stork Balance Test
Intervention groups
1
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Description
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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).
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Category
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Rehabilitation
2
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Description
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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).
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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The university of Arak
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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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.
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When the data will become available and for how long
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Five months after the publication of the results
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To whom data/document is available
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All individuals, researchers, faculty members, and people with non‑specific chronic low back pain can benefit from this research.
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Under which criteria data/document could be used
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Individuals who wish to review the study may contact the researcher via email to request access to the documentation.
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From where data/document is obtainable
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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.
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What processes are involved for a request to access data/document
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Researchers may receive the requested documentation after sending an email and obtaining confirmation from the researcher.
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Comments
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