Protocol summary

Summary
Patients with neck pain are the second largest group after patients with Low back pain that attended to physical therapy. Clinical experience and research indicated that significant sensorimotor cervical proprioceptive disturbances might be an important factor in the maintenance, recurrence, or progression of various symptoms in some patients with neck pain. There is evidence that specific treatment programs that have trained cervical joint position sense, eye-neck coordination, and gaze stability result improvements not only in sensorimotor impairments but also in neck pain and disability. The aim of this study is comparing the effects of traditional exercises and sensory-motor training exercises on joint position sense, kinematics, inter segmental coordination, dynamic balance, pain and disability in people with chronic non-specific neck Pain. In this study forty patients with non-specific neck pain are randomly allocated to either a control group or specific exercise group. Patients in control group receive TENS, stretch and training deep flexors and extensors muscles and those in second group receive control group exercises plus sensory-motor exercises. The intervention period was 12 session. Also, in this study both the investigator and the participant are blind to the nature of the treatment. Assessments will performed pre and post treatment. Outcome measures are: joint position error, kinematic items, dynamic balance, pain (Visual Analogue Scales) and dis ability (Neck Disability Index).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201604046798N1
Registration date: 2016-06-02, 1395/03/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-06-02, 1395/03/13
Registrant information
Name
Maryam Saadat
Name of organization / entity
Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61133322678
Email address
saadat.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur Univercity of Medical Science
Expected recruitment start date
2016-05-30, 1395/03/10
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of traditional and sensory-motor training exercises on joint position sense,kinematics,inter segmental coordination,dynamic balance,pain and disability in people with chronic non-specific neck Pain
Public title
Comparing the effects of traditional and sensory-motor training exercises on joint position sense,kinematics,inter segmental coordination,dynamic balance,pain and disability in people with chronic non-specific neck Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: People between 18 and 45 years; reported neck pain for more than three months ; The minimum severity of pain according to VAS , 4 to 10 cm; Proprioception error is greater than 3 ° in both directions of movement of the neck ; cervical vertigo Exclusion criteria : Any specific reason for neck pain , such as disc protrusion ; severe osteoarthritis ; rheumatoid diseases and trauma; surgery in the neck.vestibular system disorders; neurological disorder, central nervous system involvement including stroke , multiple sclerosis , Parkinson's , etc; history of diabetes Other muscoloSkeletal disorder such as hip problems , knee and ankle joints or spine in the last three months
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committe Jundishapur University of Medical Science
Street address
Ahva Jundishapur University of Medical Sciences ; Ahvaz
City
Ahvaz
Postal code
61357-15794
Approval date
2016-02-09, 1394/11/20
Ethics committee reference number
IR.AJUMS.REC.1394.520

Health conditions studied

1

Description of health condition studied
Neck pain
ICD-10 code
M50-9
ICD-10 code description
Cervical disc disorder, unspecified

Primary outcomes

1

Description
Joint position sense, Kinematic items, Stability index
Timepoint
Before and after 12 session teratment
Method of measurement
Motion analizer

Secondary outcomes

1

Description
Pain and Disability level
Timepoint
Before and after 12 sessions treatment
Method of measurement
Visual analog scale , Neck disability index

Intervention groups

1

Description
CONTROL:TENS, postural education,stretch,deep flexor and extesor training
Category
Rehabilitation

2

Description
control group exercises plus joint position training, eye-head coordination exercise, balance training
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Public Hospital and Private Clinics
Full name of responsible person
Street address
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor Of Research, Ahvaz Jundishapour Univercity of Medical Science
Full name of responsible person
Mr.Fatalizadeh
Street address
Ahvaz Jundishapour Univercity of Medical Sciense, Ahvaz, Iran
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor Of Research, Ahvaz Jundishapour Univercity of Medical Science
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
Ahvaz Rehabilitation School
Full name of responsible person
Maryam Saadat
Position
Physical Therapy PhD Student
Other areas of specialty/work
Street address
Rehabilitation School, Golestan Hospital, Opposite MRI,Ahvaz,Iran
City
Ahvaz
Postal code
6163763433
Phone
+98 61 3332 2678
Fax
Email
saadat.m@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapour of Medical Science
Full name of responsible person
Salehi Reza
Position
PhD of Physicaltherapy
Other areas of specialty/work
Street address
Rehabilitation School, Golestan Hospital, Opposite MRI , Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 3374 3102
Fax
Email
salehi200@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Rehabilitation School
Full name of responsible person
Saadat Maryam
Position
Physicaltherapy PhD Candidate
Other areas of specialty/work
Street address
33, Marjan Aveneue, Melirah Street, Ahvaz,Iran
City
Ahvaz
Postal code
6163763433
Phone
+98 61 3332 2678
Fax
+98 61 3337 7543
Email
saadat.m@ajums.ac.ir; maryamsaadat2008@yahoo.com
Web page address
www.ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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