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Cervical Sensorimotor Control Training in Chronic Neck Pain

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ClinicalTrials.gov Identifier: NCT03933267
Recruitment Status : Completed
First Posted : May 1, 2019
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Riphah International University

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.

Condition or disease Intervention/treatment Phase
Nonspecific Chronic Neck Pain Other: Cervical sensorimotor control training exercises Other: Conventional Exercises Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Both experimental and control groups will be treated simultaneously with one treatment option common to both groups
Masking: Single (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.
Primary Purpose: Treatment
Official Title: Effects of Cervical Sensorimotor Control Training in Nonspecific Chronic Neck Pain
Actual Study Start Date : April 25, 2019
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: Cervical sensorimotor control training exercises

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 Name: Prioprioception Exercises

Active Comparator: Group II Control
this group of participant will receive Conventional physical therapy protocol.
Other: Conventional Exercises
conventional physical therapy protocol consisting of Generalized stretching and cervical strengthening exercises along with joint mobility exercises will be given to patients.




Primary Outcome Measures :
  1. Cervical Joint position error [ Time Frame: Baseline ]
    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

  2. Cervical Joint position error [ Time Frame: post 6th week ]
    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

  3. Clinical test of sensory interaction and balance (CTSIB) [ Time Frame: Baseline ]
    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

  4. Clinical test of sensory interaction and balance (CTSIB) [ Time Frame: post 6th week ]
    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 :
  1. Numeric pain rating scale (NPRS) [ Time Frame: Baseline ]
    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.

  2. Numeric pain rating scale (NPRS) [ Time Frame: post 6th week ]
    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.

  3. Neck Disability Index (NDI): [ Time Frame: Baseline ]
    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.

  4. Neck pain and disability index (NDI): [ Time Frame: post 6th week ]
    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.

  5. CROM (inclinometer) [ Time Frame: Baseline ]
    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.

  6. CROM (inclinometer) [ Time Frame: post 6th week ]
    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.

  7. Patient-Specific Functional Scale (PSFS) [ Time Frame: baseline ]
    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

  8. Patient-Specific Functional Scale (PSFS) [ Time Frame: post 6th week ]
    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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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03933267


Locations
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Pakistan
Pakistan Railway hospital
Rawalpindi, Punjab, Pakistan, 40100
Sponsors and Collaborators
Riphah International University
Investigators
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Principal Investigator: Huma Riaz, PHD* Riphah International University

Publications:
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Responsible Party: Riphah International University
ClinicalTrials.gov Identifier: NCT03933267     History of Changes
Other Study ID Numbers: RiphahIU Aruba Iram
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Riphah International University:
Cervical Pain
Kinesthesis

Additional relevant MeSH terms:
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Neck Pain
Pain
Neurologic Manifestations
Signs and Symptoms