Cervical Sensorimotor Control Training in Chronic Neck Pain
Primary Purpose
Nonspecific Chronic Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Cervical sensorimotor control training exercises
Conventional Exercises
Sponsored by
About this trial
This is an interventional treatment trial for Nonspecific Chronic Neck Pain focused on measuring Cervical Pain, Kinesthesis
Eligibility Criteria
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
Sites / Locations
- Pakistan Railway hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group I
Group II Control
Arm Description
This group of participant will receive Cervical sensorimotor control training exercises. In addition to it conventional physical therapy protocol will be given.
this group of participant will receive Conventional physical therapy protocol.
Outcomes
Primary Outcome Measures
Cervical Joint position error
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
Cervical Joint position error
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
Clinical test of sensory interaction and balance (CTSIB)
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
Clinical test of sensory interaction and balance (CTSIB)
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
Secondary Outcome Measures
Numeric pain rating scale (NPRS)
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.
Numeric pain rating scale (NPRS)
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.
Neck Disability Index (NDI):
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.
Neck pain and disability index (NDI):
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.
CROM (inclinometer)
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.
CROM (inclinometer)
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.
Patient-Specific Functional Scale (PSFS)
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
Patient-Specific Functional Scale (PSFS)
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
Full Information
NCT ID
NCT03933267
First Posted
April 27, 2019
Last Updated
August 8, 2019
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT03933267
Brief Title
Cervical Sensorimotor Control Training in Chronic Neck Pain
Official Title
Effects of Cervical Sensorimotor Control Training in Nonspecific Chronic Neck Pain
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 25, 2019 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Impaired cervical joint position sense is associated with neck pain. This study will determine the effects of sensorimotor control training exercises on cervical joint position, pain, ROM and function in nonspecific chronic neck pain. There will be two groups ; experimental and control. Half of study group will receive cervical sensorimotor control training exercises and half of study group will receive conventional physiotherapy protocol.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonspecific Chronic Neck Pain
Keywords
Cervical Pain, Kinesthesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Both experimental and control groups will be treated simultaneously with one treatment option common to both groups
Masking
Participant
Masking Description
This study will be single blinded randomized control trail, participants will be unaware of treatment groups, they will be randomly allocated through sealed envelope method.
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I
Arm Type
Experimental
Arm Description
This group of participant will receive Cervical sensorimotor control training exercises. In addition to it conventional physical therapy protocol will be given.
Arm Title
Group II Control
Arm Type
Active Comparator
Arm Description
this group of participant will receive Conventional physical therapy protocol.
Intervention Type
Other
Intervention Name(s)
Cervical sensorimotor control training exercises
Other Intervention Name(s)
Prioprioception Exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Exercises
Intervention Description
conventional physical therapy protocol consisting of Generalized stretching and cervical strengthening exercises along with joint mobility exercises will be given to patients.
Primary Outcome Measure Information:
Title
Cervical Joint position error
Description
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
Time Frame
Baseline
Title
Cervical Joint position error
Description
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
Time Frame
post 6th week
Title
Clinical test of sensory interaction and balance (CTSIB)
Description
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
Time Frame
Baseline
Title
Clinical test of sensory interaction and balance (CTSIB)
Description
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
Time Frame
post 6th week
Secondary Outcome Measure Information:
Title
Numeric pain rating scale (NPRS)
Description
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.
Time Frame
Baseline
Title
Numeric pain rating scale (NPRS)
Description
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.
Time Frame
post 6th week
Title
Neck Disability Index (NDI):
Description
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.
Time Frame
Baseline
Title
Neck pain and disability index (NDI):
Description
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.
Time Frame
post 6th week
Title
CROM (inclinometer)
Description
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.
Time Frame
Baseline
Title
CROM (inclinometer)
Description
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.
Time Frame
post 6th week
Title
Patient-Specific Functional Scale (PSFS)
Description
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
Time Frame
baseline
Title
Patient-Specific Functional Scale (PSFS)
Description
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
Time Frame
post 6th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huma Riaz, PHD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pakistan Railway hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
40100
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20937427
Citation
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.
Results Reference
background
PubMed Identifier
30159284
Citation
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.
Results Reference
background
PubMed Identifier
25983238
Citation
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.
Results Reference
background
PubMed Identifier
23663191
Citation
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.
Results Reference
background
PubMed Identifier
18007229
Citation
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.
Results Reference
background
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Cervical Sensorimotor Control Training in Chronic Neck Pain
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