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IRCT20230620058545N1 IRCT 2023-07-08 Iran University of Medical Sciences Effect of craniocervical flexion training on neck stability in patients with neck pain The effect of craniocervical flexion training on head and neck dynamic postural response during head perturbation in patients with chronic neck pain 2023-07-01 anticipated 30 Complete https://irct.ir/trial/70825 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Blocked balanced randomization method, by using the generator's list website was applied. Randomized numbers were determined by 4-items blocks before the trial's beginning. Blocks contain 2 even and 2 odd numbers which each number represents each sample. Even numbers represents the samples of intervention group and odd numbers are counted as the samples of placebo group. Physical therapist conserved the results and samples will be uninformed, Blinding description: In this trial, participants will be uninformed about the group that they're belonged to. Both group's participants perform cervical proprioception training. Intervention group perform craniocervical flexion training as well ,but placebo group do craniocervical flexion until 15 mmHg (the minimal detectable change in pressure biofeedback). Participants of each group perform their training separately to remain unknowing about their groups. N/A Cervical dynamic postural instability. Intervention 1: Intervention group: Intervention consists of 6 weeks training (12 sessions); proprioception and craniocervical flexion trainings. Proprioception trainings include cervical movement sense, cervical joint position sense, and oculomotor control which they are all performed in sitting position on chair, with a laser pointer on head, and 90 centimeters distance from the target on the wall. In order to do craniocervical flexion training, physiotherapist educates participants the appropriate performance first and then they are asked to perform it by a pressure sensor and gradually increase the range of craniocervical flexion motion from 20 mmHg to 30 mmHg as the target. Intervention 2: Control group: Control group: Intervention consists of 6 weeks training (12 sessions); proprioception and placebo craniocervical flexion trainings. Proprioception trainings are same as intervention group and include cervical movement sense, cervical joint position sense, and oculomotor control which they are all performed in sitting position on chair, with a laser pointer on head, and 90 centimeters distance from the target on the wall. Placebo craniocervical flexion training has same steps to the original training that consists educating participants about the appropriate performance and doing that by a pressure sensor; but physiotherapist ask them to begin with 8 mmHg and increase the range of craniocervical flexion motion to 10 or 12 mmHg (less than minimal detectable change in pressure biofeedback) as the target. Yes - There is a plan to make this available What will be shared: Title: Head and neck postural angles change Head and neck postural angles change as the primary outcome measurement, will be shared after individuals deidentification. When: Availability period will start after the end of sampling and data analysis, since 2024 and there will be no time limit. To whom: Study results data will be available for all patients, students and researchers work in academic institution or businesses who apply. Conditions: There are no limits to use the study results and applicants can take advantage of unidentified individuals data in other researchesŲŒ health and medical usage. Where to obtain: Applicants can get access to study data at rehabilitation school of IUMS and websites related to scientific journals, after publishing. How to obtain: Applicants must write the application letter to research office of rehabilitation faculty and after justification receipt, they can get access to the study. Also, after publishing in journals, study will be available after the journal approval. Comments:
public Maryam Javani Vardin
IUMS School of Rehabilitation Science, Madadkaran Ave., Shah-nazari Street, Madar Square, Mirdamad Blvd., Tehran
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 2059 javanimaryam97@gmail.com Iran University of Medical Sciences scientific Maryam Javani Vardin
IUMS School of Rehabilitation Science, Madadkaran Ave., Shah-nazari Street, Madar Square, Mirdamad Blvd., Tehran
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 2059 javanimaryam97@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Age range 18-55 years old, able to read and write Persian language Neck pain with or without referral pain to occiput, shoulder or upper limb for at least recent 3 months Pain intensity of less than 60 millimeters, based on visual analog scale Neck disability index range of 5.5 to 15.5 18 years 55 years Both Regular exercise in recent 3 months Physical therapy or manual therapy in recent 3 months or regular antiinflammatory drugs consumption in recent 48 hours Cervical pathologies or obvious postural disorders Cervical disc herniation with radicular pain, myelopathy, radiculopathy, canal stenosis and progressive spondylosis History of surgery or trauma in head and neck Neurological, visual and vestibular disorders Tensional or cervicogenic headache Trigger points as the only pain source M53.2X2 Spinal instabilities, cervical region Rehabilitation Rehabilitation Intervention group: Intervention consists of 6 weeks training (12 sessions); proprioception and craniocervical flexion trainings. Proprioception trainings include cervical movement sense, cervical joint position sense, and oculomotor control which they are all performed in sitting position on chair, with a laser pointer on head, and 90 centimeters distance from the target on the wall. In order to do craniocervical flexion training, physiotherapist educates participants the appropriate performance first and then they are asked to perform it by a pressure sensor and gradually increase the range of craniocervical flexion motion from 20 mmHg to 30 mmHg as the target. Control group: Control group: Intervention consists of 6 weeks training (12 sessions); proprioception and placebo craniocervical flexion trainings. Proprioception trainings are same as intervention group and include cervical movement sense, cervical joint position sense, and oculomotor control which they are all performed in sitting position on chair, with a laser pointer on head, and 90 centimeters distance from the target on the wall. Placebo craniocervical flexion training has same steps to the original training that consists educating participants about the appropriate performance and doing that by a pressure sensor; but physiotherapist ask them to begin with 8 mmHg and increase the range of craniocervical flexion motion to 10 or 12 mmHg (less than minimal detectable change in pressure biofeedback) as the target. Upper and lower cervical postural angles. Timepoint: Before intervention and 6 weeks after intervention. Method of measurement: Dynamic postural angles are measured by quick release system to apply perturbation, camera for recording slow motion videos and kinovea software in order to calculation of angles. Pain intensity. Timepoint: Before intervention and 6 weeks after intervention. Method of measurement: It is measured by visual analogue scale. Neck disability index. Timepoint: Before intervention and 6 weeks after intervention. Method of measurement: It is measured by neck disability index questionnaire. Iran University of Medical Sciences Approved 2023-06-24 Ethics committee of Iran university of medical science IUMS School of Rehabilitation Science, Madadkaran Ave., Shah-nazari Street, Madar Square, Mirdamad Blvd., Tehran Tehran Tehran Iran (Islamic Republic of)