The main objective is to evaluate the effect of craniocervical flexion training (CCFT) along with proprioception training (ProT) on head and neck postural control in patients with chronic neck pain, and to compare it with placebo group which perform only the (ProT).
In addition, the effect of this training on pain intensity and neck disability index will be evaluated.
Design
Two groups, parallel, 30 samples, randomized controlled trial, randomized by blocked balanced randomization method, single blinded (participants blinding)
Settings and conduct
The postural stability test equipments place at an empty room separately from the intervention site. Trainings will be performed at exercise section of physical therapy clinic, with supervision of physical therapist.
In this study participants are blinded. Grouping is done before study beginning and samples will not know about that. Explanation of treatment method to both groups will be similar. Also, participants perform their trainings separately.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age range 18-55 years
Neck pain with or without referral pain for at least 3 months
Pain intensity of less than 60 millimeters, based on visual analog scale
Neck disability index range of 5.5 to 15.5
Exclusion criteria:
Any regular treatment in recent 3 months
Cervical pathologies or obvious postural disorders
Cervical myelopathy or radiculopathy
History of head and neck trauma or surgery
Tensional or cervicogenic headache
Intervention groups
Both group's participants perform cervical proprioception training. Intervention group perform craniocervical flexion training as well ,but placebo group do craniocervical flexion with the target pressure less than 15 mmHg (the minimal detectable change in pressure biofeedback).
Main outcome variables
Head and upper cervical spine postural angles
Lower cervical spine postural angles
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230620058545N1
Registration date:2023-07-08, 1402/04/17
Registration timing:registered_while_recruiting
Last update:2023-07-08, 1402/04/17
Update count:0
Registration date
2023-07-08, 1402/04/17
Registrant information
Name
Maryam Javani Vardin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 2059
Email address
javanimaryam97@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-01, 1402/04/10
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of craniocervical flexion training on head and neck dynamic postural response during head perturbation in patients with chronic neck pain
Public title
Effect of craniocervical flexion training on neck stability in patients with neck pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran university of medical science
Street address
IUMS School of Rehabilitation Science, Madadkaran Ave., Shah-nazari Street, Madar Square, Mirdamad Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2023-06-24, 1402/04/03
Ethics committee reference number
IR.IUMS.REC.1401.065
Health conditions studied
1
Description of health condition studied
Cervical dynamic postural instability
ICD-10 code
M53.2X2
ICD-10 code description
Spinal instabilities, cervical region
Primary outcomes
1
Description
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.
Secondary outcomes
1
Description
Pain intensity
Timepoint
Before intervention and 6 weeks after intervention
Method of measurement
It is measured by visual analogue scale.
2
Description
Neck disability index
Timepoint
Before intervention and 6 weeks after intervention
Method of measurement
It is measured by neck disability index questionnaire.
Intervention groups
1
Description
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.
Category
Rehabilitation
2
Description
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.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Sepanta physiotherapy clinic
Full name of responsible person
Maryam Javani Vardin
Street address
No. 98, Shahid Atayi (4th) Street, 1st square, Fardis town
City
Fardis
Province
Alborz
Postal code
3175796469
Phone
+98 26 3666 6675
Email
javanimaryam97@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Kazem Mousavizade
Street address
IUMS school of rehabilitation science, Madadkaran Ave., Shah-nazari Street, Madar Square, Mirdamad Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 2059
Email
javanimaryam97@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
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
Iran University of Medical Sciences
Full name of responsible person
Maryam Javani Vardin
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
IUMS School of Rehabilitation Science, Madadkaran Ave., Shah-nazari Street, Madar Square, Mirdamad Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 2059
Fax
Email
javanimaryam97@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Javani Vardin
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
IUMS School of Rehabilitation Science, Madadkaran Ave., Shah-nazari Street, Madar Square, Mirdamad Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 2059
Fax
Email
javanimaryam97@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Javani Vardin
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
IUMS School of Rehabilitation Science, Madadkaran Ave., Shah-nazari Street, Madar Square, Mirdamad Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 2059
Fax
Email
javanimaryam97@gmail.com
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
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 the data will become available and for how long
Availability period will start after the end of sampling and data analysis, since 2024 and there will be no time limit.
To whom data/document is available
Study results data will be available for all patients, students and researchers work in academic institution or businesses who apply.
Under which criteria data/document could be used
There are no limits to use the study results and applicants can take advantage of unidentified individuals data in other researches، health and medical usage.
From where data/document is obtainable
Applicants can get access to study data at rehabilitation school of IUMS and websites related to scientific journals, after publishing.
What processes are involved for a request to access data/document
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.