NCT05125250

Brief Summary

The feelings of imbalance, unsteadiness, and disorientation with cervicogenic dizziness is not clear. It has been suggested that a disruption of the normal afferent signals from the upper cervical proprioceptors to the vestibular nucleus results in an inaccurate depiction of head and neck orientation in space due to highly developed proprioceptive system that allows the neuromuscular control of cervical spine and effective use of vital organs in the head through unique connections to the vestibular and visual systems. Motor Control Therapeutic Exercises and vestibular exercises have been used to increase motor control and reduce pain and disability in patients with neck pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

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

First Submitted

Initial submission to the registry

November 8, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

November 15, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 18, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

December 12, 2022

Status Verified

December 1, 2022

Enrollment Period

8 months

First QC Date

November 8, 2021

Last Update Submit

December 9, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Dizziness Handicap Inventory Scale

    The purpose of this scale is to identify difficulties that you may be experiencing because of your dizziness. It has three subscales namely physical, emotional and functional. The total maximum score is 100 and minimum is 0.

    Change from Baseline ,dizziness to 4Weeks, 8 weeks

  • Neck Disability Index (NDI)

    This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life. Is 10 item scale each item assesses different neck pain complaints. The total maximum score is 50 and minimum is 0

    Change from Baseline , to 4Weeks, 8 weeks

  • Berg Balance Scale

    Berg Balance Scale is a 14 items scale, to assess static and dynamic balance. Scoring of this scale is done on a 5 point scale where 0 is inability to perform a task and 4 shows the independent task performance. The maximum score of this scale is 56 showing excellent performance

    Change from Baseline , balance and fall prevention to 4Weeks, 8 weeks

Study Arms (2)

Motor Control Group

EXPERIMENTAL

This group will receive treatment which comprises of therapeutic exercises, During the first 4 weeks, motor control and ROM exercises will be prescribed in order to improve muscular endurance of deep flexors muscles and to improve the ROM of cervical spine in flexion, extension, rotation and side bending and lateral rotation in. These exercises will be performed at a rate of 3 sets and an intensity of 15 repetitions per day

Other: Motor Control Group

Vestibular Group

ACTIVE COMPARATOR

This Group will receive vestibular exercises which comprises of postural awareness training; Standing on a balance board, Foveal vision exercises.

Other: Vestibular Group

Interventions

will received treatment which comprises of therapeutic exercises, During the first 4 weeks, motor control and ROM exercises will be prescribed in order to improve muscular endurance of deep flexors muscles and to improve the ROM of cervical spine in flexion, extension, rotation and side bending and lateral rotation in. These exercises will be performed at a rate of 3 sets and an intensity of 15 repetitions per day .

Motor Control Group

will receive vestibular exercises which comprises of postural awareness training, balance board exercises, Foveal vision exercises .

Vestibular Group

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 30-65 years
  • Gender both
  • Pain and dizziness lasting for at least 3 months;
  • Pain intensity corresponding to at least 3 points on a 10-point numeric pain rating scale;
  • Restricted cervical range of movement (flexion, extension, rotation and side-bending);
  • Presence of neck pain associated with disability according to the NDI greater than or equal to 5 points;
  • Presence of subjective dizziness associated with pain, movement, stiffness or specific postures of the cervical region

You may not qualify if:

  • Any other systemic or neurodegenerative pathology, presence of trauma or recent surgery to the head, face, neck or chest;
  • specific diagnosis of central or peripheral dizziness;
  • History of previous physical-therapy intervention for the cervical region;
  • Any cognitive impairment that hindered viewing of audiovisual material;
  • Difficulty understanding or communicating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan General Railway Hospital

Rawalpindi, 46000, Pakistan

Location

Related Publications (3)

  • Lystad RP, Bell G, Bonnevie-Svendsen M, Carter CV. Manual therapy with and without vestibular rehabilitation for cervicogenic dizziness: a systematic review. Chiropr Man Therap. 2011 Sep 18;19(1):21. doi: 10.1186/2045-709X-19-21.

    PMID: 21923933BACKGROUND
  • 4. Schenk RP, Coons LB, Bennett SE, Huijbregts PA. Cervicogenic dizziness: a case report illustrating orthopaedic manual and vestibular physical therapy comanagement. Journal of Manual & Manipulative Therapy. 2006 Jul 1;14(3):56E-68E.

    BACKGROUND
  • Schenk R, Coons LB, Bennett SE, Huijbregts PA: Cervicogenic dizziness: A case report illustrating manual and vestibular physical therapy comanagement. The Journal of Manual & Manipulative Therapy. 2006, 14 (3): E56-E68.

    BACKGROUND

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Misbah Ghous

    Riphah college of Rehabilitation and Allied Health sciences Islamabad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2021

First Posted

November 18, 2021

Study Start

November 15, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

December 12, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations