NCT03933267

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

August 9, 2019

Status Verified

August 1, 2019

Enrollment Period

2 months

First QC Date

April 27, 2019

Last Update Submit

August 8, 2019

Conditions

Keywords

Cervical PainKinesthesis

Outcome Measures

Primary Outcomes (4)

  • 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

    Baseline

  • 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

    post 6th week

  • 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

    Baseline

  • 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

    post 6th week

Secondary Outcomes (8)

  • Numeric pain rating scale (NPRS)

    Baseline

  • Numeric pain rating scale (NPRS)

    post 6th week

  • Neck Disability Index (NDI):

    Baseline

  • Neck pain and disability index (NDI):

    post 6th week

  • CROM (inclinometer)

    Baseline

  • +3 more secondary outcomes

Study Arms (2)

Group I

EXPERIMENTAL

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

Group II Control

ACTIVE COMPARATOR

this group of participant will receive Conventional physical therapy protocol.

Other: Conventional Exercises

Interventions

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.

Also known as: Prioprioception Exercises
Group I

conventional physical therapy protocol consisting of Generalized stretching and cervical strengthening exercises along with joint mobility exercises will be given to patients.

Group II Control

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • Previous history of neck and head trauma or surgery
  • Inflammatory joint disease
  • Systemic conditions
  • Cognitive impairment
  • Taking four or more medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan Railway hospital

Rawalpindi, Punjab Province, 40100, Pakistan

Location

Related Publications (5)

  • 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.

    PMID: 20937427BACKGROUND
  • 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.

    PMID: 30159284BACKGROUND
  • 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.

    PMID: 25983238BACKGROUND
  • 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.

    PMID: 23663191BACKGROUND
  • 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.

    PMID: 18007229BACKGROUND

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Huma Riaz, PHD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Both experimental and control groups will be treated simultaneously with one treatment option common to both groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2019

First Posted

May 1, 2019

Study Start

April 25, 2019

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

August 9, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations