- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03933267
Cervical Sensorimotor Control Training in Chronic Neck Pain
Effects of Cervical Sensorimotor Control Training in Nonspecific Chronic Neck Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study is Randomized Control Trail , which is being conducted in physical therapy Out patient department of Pakistan Railway hospital (April 2019-July 2019) . Sample size of 18 individual was calculated using Epitool with 95% confidence interval (CI), and power 80%. Individual will be screened out according to inclusion criteria. Individuals will be allocated randomly into two groups , 9 in cervical Sensori-motor training group and 9 in conventional physiotherapy protocol group by sealed envelope method.
Both groups will receive conventional physiotherapy protocol (hot pack, stretching exercises and strengthening exercises) for neck pain in common and the experimental group will receive cervical sensorimotor control training in addition to conventional protocol.
Assessment will be done on baseline and 6th week.
Data will be analysed on SPSS version 21.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Rawalpindi, Punjab, Pakistan, 40100
- Pakistan Railway Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age between 20 to 50 years
- Non specific neck pain
- Insidious neck pain for at least 3 month
- Average pain intensity over the past week >4 on Numeric Pain Rating Scale(NPRS)
Exclusion Criteria:
- Previous history of neck and head trauma or surgery
- Inflammatory joint disease
- Systemic conditions
- Cognitive impairment
- Taking four or more medications
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Group I
This group of participant will receive Cervical sensorimotor control training exercises.
In addition to it conventional physical therapy protocol will be given.
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Cervical sensory motor training exercises consisting of cervical position sense and cervical movement sense exercises with 3 levels of difficulty and 5 repetitions * 3 sets for each exercise will be given. Some exercises are: Head relocation with laser feedback: head relocation to neutral and predetermined position with eyes opened (in horizontal / vertical direction) (5 reps x 3 sets) Head relocation to neutral, predetermined and to specific targets with eyes opened (in diagonal directions) (5 reps x 3 sets) Head relocation to neutral and predetermined position with eyes closed (in all directions)(5 reps x 3 sets) In addition to it conventional physical therapy protocol consisting of Generalized stretching and cervical strengthening exercises along with joint mobility.
Other Names:
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Active Comparator: Group II Control
this group of participant will receive Conventional physical therapy protocol.
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conventional physical therapy protocol consisting of Generalized stretching and cervical strengthening exercises along with joint mobility exercises will be given to patients.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cervical Joint position error
Time Frame: Baseline
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The task is to return head to the starting position as accurately as possible.
Three trials will be performed of right and left rotation and extension.
An average absolute error of > 4.5° in any direction is indicative of a deficit in cervical joint position sense
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Baseline
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Cervical Joint position error
Time Frame: post 6th week
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The task is to return head to the starting position as accurately as possible.
Three trials will be performed of right and left rotation and extension.
An average absolute error of > 4.5° in any direction is indicative of a deficit in cervical joint position sense
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post 6th week
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Clinical test of sensory interaction and balance (CTSIB)
Time Frame: Baseline
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This test is design to assess how well an older adult is using sensory inputs when one or more sensory systems are compromise.
Begin timing each trial using a stopwatch.
The trial is over when (a) the participant opens his/her eyes in an eyes closed condition, (b) raises arms from sides, (c) loses balance and requires manual assistance to prevent a fall
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Baseline
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Clinical test of sensory interaction and balance (CTSIB)
Time Frame: post 6th week
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This test is design to assess how well an older adult is using sensory inputs when one or more sensory systems are compromise.
Begin timing each trial using a stopwatch.
The trial is over when (a) the participant opens his/her eyes in an eyes closed condition, (b) raises arms from sides, (c) loses balance and requires manual assistance to prevent a fall
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post 6th week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric pain rating scale (NPRS)
Time Frame: Baseline
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Numeric pain rating scale (NPRS) is an 11 point (0-10) Scale used to measure pain.
Patient verbally select value between (0-10) on the basis of intensity of pain.
(0) means No pain and (10) means maximum pain experienced at baseline.
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Baseline
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Numeric pain rating scale (NPRS)
Time Frame: post 6th week
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Numeric pain rating scale (NPRS) is an 11 point (0-10) Scale used to measure pain.
Patient verbally select value between (0-10) on the basis of intensity of pain.
(0) means No pain and (10) means maximum pain experienced at 6th week of intervention.
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post 6th week
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Neck Disability Index (NDI):
Time Frame: Baseline
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Neck Disability Index (NDI) is a questionnaire designed to assess how neck pain has affected patient's ability to manage in everyday life.
It has total 10 sections, For each section the total possible score is 5: if the first statement is marked the section score = 0, if the last statement is marked it = 5.
If all ten sections are completed the score is calculated and converted into percentages.
The maximum Score of Neck Disability Index (NDI) is 50.
It is measured at Baseline before Intervention.
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Baseline
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Neck pain and disability index (NDI):
Time Frame: post 6th week
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Neck Disability Index (NDI) is a questionnaire designed to assess how neck pain has affected patient's ability to manage in everyday life.
It has total 10 sections, For each section the total possible score is 5: if the first statement is marked the section score = 0, if the last statement is marked it = 5.
If all ten sections are completed the score is calculated and converted into percentages.
The maximum Score of Neck Disability Index (NDI) is 50.
It is measured after 6th week of Intervention.
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post 6th week
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CROM (inclinometer)
Time Frame: Baseline
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A cervical range of motion (CROM) inclinometer will be use to assess cervical range of motion in flexion, extension, left right lateral flexion and left-right rotation.
Participants will be seated upright and asked to actively move their neck in each direction.
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Baseline
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CROM (inclinometer)
Time Frame: post 6th week
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A cervical range of motion (CROM) inclinometer will be use to assess cervical range of motion in flexion, extension, left right lateral flexion and left-right rotation.
Participants will be seated upright and asked to actively move their neck in each direction.
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post 6th week
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Patient-Specific Functional Scale (PSFS)
Time Frame: baseline
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The patient-specific functional scale (PSFS) will be use to assess participants' functional status.
Participants will be ask to nominate 3 to 5 activities that they are unable to do or having difficulty doing because of their neck pain.
These activities will be rated on a 0-10 scale, where 0 is unable to perform the activity and 10 is able to perform the activity at same.
An average of all activities scores will be use for analysis
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baseline
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Patient-Specific Functional Scale (PSFS)
Time Frame: post 6th week
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The patient-specific functional scale (PSFS) will be use to assess participants' functional status.
Participants will be ask to nominate 3 to 5 activities that they are unable to do or having difficulty doing because of their neck pain.
These activities will be rated on a 0-10 scale, where 0 is unable to perform the activity and 10 is able to perform the activity at same.
An average of all activities scores will be use for analysis
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post 6th week
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Javanshir K, Ortega-Santiago R, Mohseni-Bandpei MA, Miangolarra-Page JC, Fernandez-de-Las-Penas C. Exploration of somatosensory impairments in subjects with mechanical idiopathic neck pain: a preliminary study. J Manipulative Physiol Ther. 2010 Sep;33(7):493-9. doi: 10.1016/j.jmpt.2010.08.022.
- Saadat M, Salehi R, Negahban H, Shaterzadeh MJ, Mehravar M, Hessam M. Postural stability in patients with non-specific chronic neck pain: A comparative study with healthy people. Med J Islam Repub Iran. 2018 Apr 23;32:33. doi: 10.14196/mjiri.32.33. eCollection 2018.
- de Vries J, Ischebeck BK, Voogt LP, van der Geest JN, Janssen M, Frens MA, Kleinrensink GJ. Joint position sense error in people with neck pain: A systematic review. Man Ther. 2015 Dec;20(6):736-44. doi: 10.1016/j.math.2015.04.015. Epub 2015 May 2.
- Beinert K, Taube W. The effect of balance training on cervical sensorimotor function and neck pain. J Mot Behav. 2013;45(3):271-8. doi: 10.1080/00222895.2013.785928.
- Swait G, Rushton AB, Miall RC, Newell D. Evaluation of cervical proprioceptive function: optimizing protocols and comparison between tests in normal subjects. Spine (Phila Pa 1976). 2007 Nov 15;32(24):E692-701. doi: 10.1097/BRS.0b013e31815a5a1b.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RiphahIU Aruba Iram
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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