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IRCT20251027067790N1 IRCT 2025-11-28 Tehran University of Medical Sciences Effects of core stability exercises on neck pain. Effects of adding core stability exercises to neck stability exercises and Mulligan's spinal mobilization technique on pain, range of motion and neck disability index in patients with chronic non-specific neck pain. 2025-11-10 anticipated 22 Complete https://irct.ir/trial/87227 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be allocated to the intervention and control groups using a block randomization method with balanced blocks of four and a 1:1 allocation ratio. The random sequence will be generated using Random Allocation Software. The person responsible for generating the random sequence will not be involved in any stage of intervention delivery, participant assessment, or data analysis. After confirming participants’ eligibility based on inclusion and exclusion criteria, each set of four participants will form a block, and the software will randomly assign two participants to the intervention group and two to the control group, ensuring balance and randomness throughout the study. To maintain allocation concealment, each participant’s random code will be placed in identical, sealed envelopes. These envelopes will be opened in order of participant enrollment by a person not involved in the intervention process, revealing each participant’s group assignment, Blinding description: This study will use a double-blind design, meaning that both the participants and the assessor will be unaware of the type of intervention each participant receives (treatment or control group). The intervention will be delivered by a therapist different from the assessor, who will measure the outcomes only before and after the intervention, without access to group allocation. N/A Chronic Non-Specific Neck Pain. Intervention 1: Intervention group: This group receives cervical stabilization exercises, Mulligan mobilization (SNAGs) and core stabilization exercises. this intervention is performed 3 sessions per week for 8 weeks, totaling 24 sessions. Intervention 2: Control group: This group receives cervical stabilization exercises and Mulligan mobilization (SNAGs). this intervention is performed 3 sessions per week for 8 weeks, totaling 24 sessions. Yes - There is a plan to make this available What will be shared: Some data, such as the mean age and study-related outcome information, can be shared. When: The access period begin 6 months after publication of the results. To whom: The data will be available to researchers affiliated with academic and scientific instititions. Conditions: The data are only permitted for scientific research analyses, not for commercial or promotional purposes. Analyses must comply with research ethics and maintain data confidentiality. Requests must be submitted formally, along with a research proposal and ethics approval. Data will only be made available after review and approval by the principal research team. Where to obtain: Fatemeh Razmkhah fatemeh.razmkhah76@gmail.com How to obtain: Requestors must submit a formal research proposal along with their ethics approval to the principal research team. After review and approval of the proposal, the de-identified data will be provided in an appropriate format. The review and data delivery process typically takes approximately 4–6 weeks. Comments:
public Fatemeh Razmkhah
No. 23, Khayambashi Alley, North Nabard Street, Piroozi Street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1766633894 +98 21 3305 3591 fatemeh.razmkhah76@gmail.com Tehran University of Medical Sciences scientific Fatemeh Razmkhah
No. 23, Khayambashi Alley, North Nabard Street, Piroozi Street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1766633894 +98 21 3305 3591 fatemeh.razmkhah76@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Pain intensity should be at least 4 out of 10 The Neck Disability Index score should be at least out of 50 Neck pain that has persisted for at least 3 months, either continuously or recurrently. Non-specific neck pain (pain in the neck region without a pathological cause, with or without radiation to the arm) The ratio of trunk flexor endurance Test to trunk extensor endurance Test is less than 0/5 or greater than 1/5 Men and women aged between 20 and 55 years 20 years 55 years Both Having a specific cause for neck pain Signs of infection Inflammatory disorder Tumor Osteoporosis Fracture or traumatic injury Disk herniation medically diagnosed as requiring surgical intervention. Pregnancy People who had neck surgery within the last 6 months Use of medications affecting pain, inflammation, or musculoskeletal function—such as NSAIDs, analgesics, muscle relaxants, corticosteroids, or antidepressants—within the week prior to the study. History of lumbar spine surgery, such as discectomy or laminectomy. History of dizziness before enrollment and during the study period. Uncontrolled blood pressure before enrollment and during the study period. Rehabilitation Rehabilitation Intervention group: This group receives cervical stabilization exercises, Mulligan mobilization (SNAGs) and core stabilization exercises. this intervention is performed 3 sessions per week for 8 weeks, totaling 24 sessions. Control group: This group receives cervical stabilization exercises and Mulligan mobilization (SNAGs). this intervention is performed 3 sessions per week for 8 weeks, totaling 24 sessions. Pain intensity: Chronic non-specific neck pain, with or without radiation to the arms, lasting at least three months, will be assessed. Timepoint: Pain intensity will be measured at three time points: before the intervention, after the completion of the intervention (after 24 treatment sessions), and one month post-intervention. Method of measurement: The Visual Analog Scale (VAS) will be used to evaluate the average pain experienced by participants during the past week. This tool consists of a 10-centimeter horizontal line, with one end representing no pain (score 0) and the other end representing the worst imaginable pain (score 10). Participants will be asked to indicate their pain over the past week by marking a point on the line. The distance from the beginning of the line to the mark will be measured in millimeters, and the final pain intensity score will be reported as a number between 0 and 10. Functional disability. Timepoint: Functional disability will be measured at three time points: before the intervention, after the completion of the intervention (after 24 treatment sessions), and one month post-intervention. Method of measurement: In this study, the Persian version of the Neck Disability Index (NDI) questionnaire, scored from 0 (no disability) to 50 (severe disability) is used to assess the level of neck disability. Cervical range of motion. Timepoint: Cervical range of motion will be measured at three time points: before the intervention, after the completion of the intervention (after 24 treatment sessions), and one month post-intervention. Method of measurement: In this study cervical range of motion is measured using a standard goniometer in the direction of flexion, extension, rotation and lateral bending. Dynamic balance (Y-Balance Test). Timepoint: Dynamic Balance will be measured at three time points: before the intervention, after the completion of the intervention (after 24 treatment sessions), and one month post-intervention. Method of measurement: In this study, dynamic balance is assessed using the Y-Balance Test in the anterior, posteromedial, and posterolateral directions. The distances reached by the participant’s reaching leg in these directions are measured by the examiner using a measuring tape. Patient global impression of change (PGIC). Timepoint: Patient global impression of change will be measured at two time points: after the completion of the intervention (after 24 treatment sessions), and one month post-intervention. Method of measurement: In this study, the patient’s global impression of change after treatment is evaluated using the Patient Global Impression of Change (PGIC) scale. This instrument is a 7-point scale that asks the patient to subjectively rate the overall changes in their condition compared to the beginning of treatment. The response options range from “very much worse” to “very much improved.” Higher scores indicate greater patient satisfaction with the treatment outcome. Tehran University of Medical Sciences Approved 2025-10-14 ethics committee of tehran university of medical sciences School of Rehabilitation, Tehran University of Medical Sciences, corner of Safialishah Street, Enqelab Street, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)