Cervical PainNCT05125250
Effects of Vestibular Exercises and Motor Control in Cervicogenic Dizziness
A study testing Vestibular Group in people with Cervical Pain, run by Riphah International University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Cervical Pain
- What is being tested?
- Vestibular Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Nov 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Vestibular Exercises and Motor Control on Cervical Spine Range of Motion and Balance in Cervicogenic Dizziness
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.
Read the detailed description
Cervicogenic dizziness is defined as a sensation of instability or disequilibrium that occurs with the pain and stiffness in cervical spine and is aggravated by neck movements or positions. Dizziness is a common indication in people with cervical spine dysfunction. cervicogenic dizziness as "a nonspecific sensation of altered orientation in space and disequilibrium originating from abnormal afferent activity from the neck" which is thought to be caused by disorders in the upper cervical spine and commonly it is associated with cervical stiffness neck pain or headache.
Motor control can also be defined as the capacity of how the central nervous system produces of useful movements that are coordinated and integrated with the rest of the body and the environment. Thus, motor control therapeutic exercises (MCTE) are used to improve the conditions of patients. Motor Control Therapeutic Exercises have been used to increase motor control and reduce pain and disability in patients with neck pain. MCTE comprised of cranio-cervical flexor exercise, cranio-cervical extensor exercise, co-contraction of flexors and extensors, a synergy exercise for retraining the strength of the deep neck flexors.
Schenk et al. have published case studies in which they describe the diagnosis, treatment, and outcomes of a patient with cervicogenic dizziness co-managed by a vestibular and an orthopedic manual physical therapist. They argue that manual therapy combined with vestibular rehabilitation may be superior in the treatment of cervicogenic dizziness. Literature states that vestibular exercises have been used to increase motor control and reduce pain and disability in patients with neck pain.
- Conditions
- Cervical Pain
- Being tested
- Motor Control Group, Vestibular Group
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor Control GroupOther
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 .
Vestibular GroupOther
will receive vestibular exercises which comprises of postural awareness training, balance board exercises, Foveal vision exercises .
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Vestibular Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: Change from Baseline , balance and fall prevention to 4Weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start15 Nov 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cervical PainStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Misbah Ghous, Principal investigator, Riphah college of Rehabilitation and Allied Health sciences Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125250
- Sponsor's protocol ID
- REC/00963 Amber
- Status last verified
- Dec 2022
- First submitted
- 8 Nov 2021
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 219239334. 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.
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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vestibular Exercises and Motor Control on Cervical Spine Range of Motion and Balance in Cervicogenic Dizziness
- ClinicalTrials.gov ID
- NCT05125250
- Acronym / sponsor ID
- REC/00963 Amber
- Conditions
- Cervical Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 18 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cervicogenic dizziness is defined as a sensation of instability or disequilibrium that occurs with the pain and stiffness in cervical spine and is aggravated by neck movements or positions. Dizziness is a common indication in people with cervical spine dysfunction. cervicogenic dizziness as "a nonspecific sensation of altered orientation in space and disequilibrium originating from abnormal afferent activity from the neck" which is thought to be caused by disorders in the upper cervical spine and commonly it is associated with cervical stiffness neck pain or headache.
Motor control can also be defined as the capacity of how the central nervous system produces of useful movements that are coordinated and integrated with the rest of the body and the environment. Thus, motor control therapeutic exercises (MCTE) are used to improve the conditions of patients. Motor Control Therapeutic Exercises have been used to increase motor control and reduce pain and disability in patients with neck pain. MCTE comprised of cranio-cervical flexor exercise, cranio-cervical extensor exercise, co-contraction of flexors and extensors, a synergy exercise for retraining the strength of the deep neck flexors.
Schenk et al. have published case studies in which they describe the diagnosis, treatment, and outcomes of a patient with cervicogenic dizziness co-managed by a vestibular and an orthopedic manual physical therapist. They argue that manual therapy combined with vestibular rehabilitation may be superior in the treatment of cervicogenic dizziness. Literature states that vestibular exercises have been used to increase motor control and reduce pain and disability in patients with neck pain.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motor Control Group | Experimental | Other: Motor Control GroupThis 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 |
| Vestibular Group | Active comparator | Other: Vestibular GroupThis Group will receive vestibular exercises which comprises of postural awareness training; Standing on a balance board, Foveal vision exercises. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • Age: 30-65 years
Key exclusion criteria (5 listed)
- • Any other systemic or neurodegenerative pathology, presence of trauma or recent surgery to the head, face, neck or chest;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor Control Groupwill 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 . | Other | Motor Control Group |
| Vestibular Groupwill receive vestibular exercises which comprises of postural awareness training, balance board exercises, Foveal vision exercises . | Other | Vestibular Group |
Primary outcome
Dizziness Handicap Inventory Scale
Time frame: Change from Baseline ,dizziness to 4Weeks, 8 weeks
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.
Neck Disability Index (NDI)
Time frame: Change from Baseline , to 4Weeks, 8 weeks
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
Berg Balance Scale
Time frame: Change from Baseline , balance and fall prevention to 4Weeks, 8 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Background: PubMed 21923933Lystad 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.
- Background4. 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.
- BackgroundSchenk 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Misbah Ghous principal investigator
Riphah college of Rehabilitation and Allied Health sciences Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular Group in people with Cervical Pain, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dizziness Handicap Inventory Scale (time frame: Change from Baseline ,dizziness to 4Weeks, 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05125250, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2022.