The aim of this study is to determine the effects of galvanic vestibular stimulation and cervical proprioception training on postural control behavior in chronic neck pain. inclusion criteria for patient group: complaint of neck pain for 3 months or more; no history of head and neck trauma; without referral to upper limb; with a neck disability index score greater than 10%, Visual analogue scale more than 3. Exclusion criteria : Neurological disorders; cervical spine root compression; radiculopathy; preexisting vestibular pathology; connective tissue disease; cervical fracture and dislocation; Ankylosing spondylitis; myelopathy; cervical spine surgery. this study is a randomized controlled clinical trial. 48 patients with nontraumatic neck pain, age between 20 - 50 will participate in this study. Patients will divide in 4 groups of 12 subjects. 12 healthy subjects will participate in study.Galvanic vestibular stimulation will perform 3 times a week for 6 weeks. Cervical proprioception training twice daily will perform for 6 weeks. pressure pain threshold, joint position sense, pain intensity, speed of cop, mean and maximum excursion of center of pressure, rambling , trembling of Center of pressure, frequency component of center of pressure signal will measure before and after of interventions.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016060121459N2
Registration date:2016-09-26, 1395/07/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-26, 1395/07/05
Registrant information
Name
Mohammad Akbari
Name of organization / entity
Dept. of Physical therapy, School of Rehabilitation,Iran University of Medical Sciences.
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8051
Email address
akbari.mo@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Research of Iran University of Medical Sciences
Expected recruitment start date
2016-08-24, 1395/06/03
Expected recruitment end date
2017-06-21, 1396/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of galvanic vestibular stimulation and cervical proprioception training on postural control behavior in chronic neck pain
Public title
Effects of balance stimulation and cervical training on balance performance in chronic neck pain
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria for patient group: complaint of neck pain for 3 months or more without referral to upper limb; age between 20 - 50;; no history of head and neck trauma; with a neck disability index score greater than 10%, VAS more than 3 ; neck pain at least twice during the last twelve months; not participation in exercise training during past 3 months. healthy subjects have not any musculoskeletal disorders. Exclusion criteria : Neurological disorders; cervical spine root compression; radiculopathy; preexisting vestibular pathology; connective tissue disease; cervical fracture and dislocation; Ankylosing spondylitis; mylopathy; cervical spine surgery; history of head and neck trauma, systemic disease; pregnancy; peripheral neuropathy; diabetes; inner ear disease; Rheumatic and inflammatory disease;fibromyalgia; respiratory / metabolic and cardiovascular disorders.
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat highway,Thran, Iran
City
Tehran
Postal code
Approval date
2016-08-08, 1395/05/18
Ethics committee reference number
IR.IUMS.REC 1395.9211342210
Health conditions studied
1
Description of health condition studied
Chronic neck pain
ICD-10 code
M99
ICD-10 code description
Biomechanical lesions, not elsewhere classified
Primary outcomes
1
Description
mean excursion of COP
Timepoint
Before ,immediate after and 6weeks after intervention
Method of measurement
Force plate
2
Description
maximum excursion of COP
Timepoint
Before ,immediate after and 6weeks after intervention
Method of measurement
Force plate
3
Description
Mean speed of COP
Timepoint
Before ,immediate after and 6weeks after intervention
Method of measurement
Force plate
4
Description
Rambling
Timepoint
Before ,immediate after and 6weeks after intervention
Method of measurement
Force plate
5
Description
Trembling
Timepoint
Before ,immediate after and 6weeks after intervention
Method of measurement
Force plate
6
Description
Frequency band of COP
Timepoint
Before ,immediate after and 6weeks after intervention
Method of measurement
Force plate
Secondary outcomes
1
Description
Pain intensity
Timepoint
Before, immediate after and 6 weeks after intervention
Method of measurement
VAS
2
Description
Pressure pain threshold
Timepoint
Before, immediate after and 6 weeks after intervention
Method of measurement
Algometer
3
Description
Joint position sense
Timepoint
Before, immediate after and 6 weeks after intervention
Method of measurement
Laser pointer and distance to reference point during cervical rotation and extension
4
Description
Neck disability level
Timepoint
Before and 6 weeks after intervention
Method of measurement
Neck disability Index
5
Description
Quality of life
Timepoint
Before and 6 weeks after intervention
Method of measurement
Short form12 questionnaire
Intervention groups
1
Description
Galvanic vestibular stimulation will perform3 times a week for 6 weeks.
Category
Rehabilitation
2
Description
cervical proprioception training twice daily will perform for 6 weeks.
Category
Rehabilitation
3
Description
TENS will perform3 times a week for 6 weeks.
Category
Rehabilitation
4
Description
Galvanic vestibular stimulation will perform3 times a week for 6 weeks and cervical proprioception training twice daily will perform for 6 weeks.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
motion analysis Lab of school of rehabilitation sciences
Full name of responsible person
Sayyed Hamed Fazeli
Street address
Shahnazari St, Madar Sq, Mirdamad Blv, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Research of Iran University of Medical Sciences
Full name of responsible person
Mohammad Akbari
Street address
Shahnazari St, Madar Sq, Mirdamad Blvd, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Research of Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Dept. of physical therapy, school of rehabilitation sciences,Iran university of medical sciences
Full name of responsible person
Mohammad Akbari
Position
Ph.D of physical therapy
Other areas of specialty/work
Street address
Shahnazari St, Madar Sq, Mirdamad Blvd
City
Tehran
Postal code
Phone
+98 21 2222 2059
Fax
Email
akbari.mo@iums.ac.ir; Akbarimo43@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of rehabilitation sciences
Full name of responsible person
Mohammad Akbari
Position
Ph.D of Physical therapy
Other areas of specialty/work
Street address
Shahnazari St, Madar Sq, Mirdamad Blvd
City
Tehran
Postal code
Phone
+98 21 2222 2059
Fax
Email
akbari.mo@iums.ac.ir akbarimo43@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of rehabilitation sciences, iran university of medical sciences
Full name of responsible person
Sayyed hamed fazeli
Position
Ph.D candidate in physical therapy
Other areas of specialty/work
Street address
Shahnazari St, Mirdamad Sq, Mirdamad Blvd
City
Tehran
Postal code
Phone
+98 21 2222 2059
Fax
Email
hamed_fazeli62@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)