DizzinessNCT02772042
Traction Manipulation of Upper Cervical Spine on Cervicogenic Dizziness
A study testing Intervention Group in people with Dizziness and Neck Pain, run by Andoni Carrasco at 1 site in Spain.
Trial summary
Manual therapy reduces symptoms in patients with cervicogenic dizziness. The mobilization and manipulation of upper cervical spine are the most popular treatment in this patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- What is being tested?
- Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2015to May 2017
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dizziness associated with neck stiffness and/or neck pain.
- Hypomobility of upper cervical spine.
- Sing the informed consent form.
Who cannot join
- Contraindications for Traction manipulation.
- Pending litigation or legal claim.
- Poor language and communication skills making difficult to understand the informed consent.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Unidad de Investgación en Fisioterapia. Universidad de Zaragoza
Zaragoza, 50009
About this study
Official title: Effectiveness of Traction Manipulation of Upper Cervical Spine on Cervicogenic Dizziness
Manual therapy reduces symptoms in patients with cervicogenic dizziness. The mobilization and manipulation of upper cervical spine are the most popular treatment in this patients. The International Federation of Orthopaedic Manipulative Physical Therapists suggest different recommendations for the safety application of manual therapy techniques in the upper cervical spine, traction manipulation techniques complies with this conditions. However, there isn´t investigation about the effect of traction manipulation in patients with cervicogenic dizziness. The aim of this study is to investigate the effects of traction manipulation in dizziness intensity, range of motion of cervical spine and quality of life on patients with cervicogenic dizziness.
- Being tested
- Intervention Group, Control Group
- Keywords
- Manual Therapy, Physiotherapy, Manipulation
- Medical subject headings
- Dizziness, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupOther
Control GroupOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Investigators will performed traction manipulation of those articulations of upper cervical spine with indication for this treatment. Before manipulation soft tissue techniques will be applied in order to prepare the joint. After manipulation the patient rest in supine position. The intervention will have a duration of 10 minutes. Receives: Other: Intervention Group |
| Control Group | Other | The patient of the control group maintain the supine position for 10 minutes. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of baseline in Dizziness Intensity (100mm VAS) at 1 week and 1 month
Measured: Baseline- 1 week- 1 month
Secondary outcomes (3)
Change of baseline in range of motion of cervical spine change (Tool: Cervical range of motion)
Measured: Baseline- 1 week- 1 month
Change of baseline in upper cervical spine range of motion (Tool: Cervical range of motion)
Measured: Baseline- 1 week- 1 month
Change of baseline in dizziness Handicap Inventory (questionnaire)
Measured: Baseline- 1 week- 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startOct 2015
- Primary completionNov 2015
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DizzinessStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andoni Carrasco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andoni Carrasco, Universidad de Zaragoza
- Investigators
- Andoni Carrasco, Pt, Principal investigator, Unidad de Investigación en Fisioterapia. Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772042
- Sponsor's protocol ID
- PI15/0230
- Status last verified
- May 2018
- First submitted
- 5 May 2016
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Traction Manipulation of Upper Cervical Spine on Cervicogenic Dizziness
- ClinicalTrials.gov ID
- NCT02772042
- Acronym / sponsor ID
- PI15/0230
- Keywords
- Manual Therapy, Physiotherapy, Manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Andoni CarrascoUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 13 May 2016 (estimated)
- 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.
Manual therapy reduces symptoms in patients with cervicogenic dizziness. The mobilization and manipulation of upper cervical spine are the most popular treatment in this patients. The International Federation of Orthopaedic Manipulative Physical Therapists suggest different recommendations for the safety application of manual therapy techniques in the upper cervical spine, traction manipulation techniques complies with this conditions. However, there isn´t investigation about the effect of traction manipulation in patients with cervicogenic dizziness. The aim of this study is to investigate the effects of traction manipulation in dizziness intensity, range of motion of cervical spine and quality of life on patients with cervicogenic dizziness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Intervention GroupInvestigators will performed traction manipulation of those articulations of upper cervical spine with indication for this treatment. Before manipulation soft tissue techniques will be applied in order to prepare the joint. After manipulation the patient rest in supine position. The intervention will have a duration of 10 minutes. |
| Control Group | Other | Other: Control GroupThe patient of the control group maintain the supine position for 10 minutes. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Dizziness associated with neck stiffness and/or neck pain.
- Hypomobility of upper cervical spine.
- Sing the informed consent form.
Key exclusion criteria (3 listed)
- Contraindications for Traction manipulation.
- Pending litigation or legal claim.
- Poor language and communication skills making difficult to understand the informed consent.
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 |
|---|---|---|
| Intervention Group | Other | Intervention Group |
| Control Group | Other | Control Group |
Primary outcome
Change of baseline in Dizziness Intensity (100mm VAS) at 1 week and 1 month
Time frame: Baseline- 1 week- 1 month
3 secondary outcomes
Change of baseline in range of motion of cervical spine change (Tool: Cervical range of motion)
Time frame: Baseline- 1 week- 1 month
Change of baseline in upper cervical spine range of motion (Tool: Cervical range of motion)
Time frame: Baseline- 1 week- 1 month
Change of baseline in dizziness Handicap Inventory (questionnaire)
Time frame: Baseline- 1 week- 1 month
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 7 May 2018.
- 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.
Andoni Carrasco, Pt principal investigator
Unidad de Investigación en Fisioterapia. Universidad de Zaragoza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Dizziness and Neck Pain, run by Andoni Carrasco at 1 site in Spain.
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 3 inclusion and 3 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 7 May 2018. 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 Spain. 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?
Change of baseline in Dizziness Intensity (100mm VAS) at 1 week and 1 month (time frame: Baseline- 1 week- 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2018.