HeadacheNCT02422862
Clinical Effects of Upper Cervical Translatoric Mobilization in Patients With Headache
A study testing UC-TSM in people with Headache, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
Frequently, headache is associated with disorders of the cervical spine, specially on the upper cervical spine. Therefore, restoration of the upper cervical mobility is considered fundamental for the treatment of headache. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Headache
- What is being tested?
- UC-TSM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2014to Jan 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Present a history of headache.
Who cannot join
- Receive cervical treatment in the previous month.
- Present red flags for headache.
- Present any contraindications to manual therapy.
- Current involvement in compensations.
Trial locations and contacts
1 site in 1 country.
About this study
Frequently, headache is associated with disorders of the cervical spine, specially on the upper cervical spine. Therefore, restoration of the upper cervical mobility is considered fundamental for the treatment of headache.
Manual therapy interventions seek to restore upper cervical mobility through a wide range of therapeutic procedures, including mobilization or manipulation techniques. Previous systematic reviews reported preliminary evidence for the application of upper cervical manual therapy techniques for the management of headache.
Read more
The objective of this study is to study the effects of upper cervical translatoric spinal mobilization (UC-TSM) on headache intensity, cervical mobility and pressure pain threshold in subjects with headache. For this purpose, the investigators will conduct a randomized controlled trial. Volunteers with headache will participate in the study and will be randomly divided into control or treatment group. Treatment group will receive UC-TSM and the control group will receive no treatment.
Headache intensity, cervical mobility, temporomandibular mobility and pressure pain thresholds (PPT) will be measured before and immediately after each treatment session (3 treatment sessions in one week period) and after one month follow-up. At this moment, global perceived effect will be assessed.
- Conditions
- Headache
- Being tested
- UC-TSM
- Keywords
- Physiotherapy, Manual Therapy
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UC-TSMOther
Upper cervical translatoric spinal mobilization: a 30 minutes treatment consisting of 30" series of translatoric mobilizations of the upper cervical spine with 10" rest between sets. For that purpose, the patient is positioned in supine, with the cervical spine in neutral position. The therapist place a hand dorsally at the level of the vertebral arch of C1 with the metacarpophalangeal and radial border of the index finger. The other hand is placed posteriorly under the occiput, with the shoulder positioned anteriorly on the patient's forehead. The mobilization force is directed dorsally from the shoulder until the therapist feel a marked resistance and then apply slightly more pressure in order to perform a stretching mobilization.
| Study group | Role | What they receive |
|---|---|---|
| UC-TSM | Experimental | Upper cervical translatoric spinal mobilization (UC-TSM). UC-TSM is a physical therapy technique used to improve range of movement, consisting on a manual stretching of the cervical spine of the patient during 30 minutes. Receives: Other: UC-TSM |
| Control | No intervention | The control group receive no treatment intervention during 30 minutes (a similar time as the UC-TSM group). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache intensity as measured by Visual Analog Scale
Measured: From Baseline to one month follow-up
Secondary outcomes (5)
Cervical mobility as measured by cervical range of motion device (CROM)
Measured: 1 minute Pre-Intervention, 1 minute Post-Intervention, One month follow-up
Pressure pain threshold as measured by digital algometer (Somedic Farsta)
Measured: 1 minute Pre-Intervention, 1 minute Post-Intervention, One month follow-up
Temporomandibular joint mobility as measured by digital calipher (mouth opening)
Measured: 1 minute Pre-Intervention, 1 minute Post-Intervention, One month follow-up
Global Perceived Effect as measured by Global Perceived Effect Scale (-5 to +5 Likert Scale)
Measured: One month follow-up
Immediate headache intensity changes as measured by Visual Analog Scale
Measured: 1 minute Pre-Intervention, 1 minute Post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startJan 2014
- Primary completionAug 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HeadacheStudies 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
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel Malo Urriés, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422862
- Sponsor's protocol ID
- MMU.01.001
- Status last verified
- Feb 2016
- First submitted
- 13 Apr 2015
- Last updated
- 26 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Malo-Urries M, Tricas-Moreno JM, Estebanez-de-Miguel E, Hidalgo-Garcia C, Carrasco-Uribarren A, Cabanillas-Barea S. Immediate Effects of Upper Cervical Translatoric Mobilization on Cervical Mobility and Pressure Pain Threshold in Patients With Cervicogenic Headache: A Randomized Controlled Trial. J Manipulative Physiol Ther. 2017 Nov-Dec;40(9):649-658. doi: 10.1016/j.jmpt.2017.07.007.
PubMed 29229055
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of Upper Cervical Translatoric Mobilization in Patients With Headache
- ClinicalTrials.gov ID
- NCT02422862
- Acronym / sponsor ID
- MMU.01.001
- Conditions
- Headache
- Keywords
- Physiotherapy, Manual Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 21 Apr 2015 (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.
Frequently, headache is associated with disorders of the cervical spine, specially on the upper cervical spine. Therefore, restoration of the upper cervical mobility is considered fundamental for the treatment of headache.
Manual therapy interventions seek to restore upper cervical mobility through a wide range of therapeutic procedures, including mobilization or manipulation techniques. Previous systematic reviews reported preliminary evidence for the application of upper cervical manual therapy techniques for the management of headache.
The objective of this study is to study the effects of upper cervical translatoric spinal mobilization (UC-TSM) on headache intensity, cervical mobility and pressure pain threshold in subjects with headache. For this purpose, the investigators will conduct a randomized controlled trial. Volunteers with headache will participate in the study and will be randomly divided into control or treatment group. Treatment group will receive UC-TSM and the control group will receive no treatment.
Headache intensity, cervical mobility, temporomandibular mobility and pressure pain thresholds (PPT) will be measured before and immediately after each treatment session (3 treatment sessions in one week period) and after one month follow-up. At this moment, global perceived effect will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UC-TSM | Experimental | Other: UC-TSMUpper cervical translatoric spinal mobilization (UC-TSM). UC-TSM is a physical therapy technique used to improve range of movement, consisting on a manual stretching of the cervical spine of the patient during 30 minutes. |
| Control | No intervention | –The control group receive no treatment intervention during 30 minutes (a similar time as the UC-TSM group). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Present a history of headache.
Key exclusion criteria (4 listed)
- Receive cervical treatment in the previous month.
- Present red flags for headache.
- Present any contraindications to manual therapy.
- Current involvement in compensations.
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 |
|---|---|---|
| UC-TSMUpper cervical translatoric spinal mobilization: a 30 minutes treatment consisting of 30" series of translatoric mobilizations of the upper cervical spine with 10" rest between sets. For that purpose, the patient is positioned in supine, with the cervical spine in neutral position. The therapist place a hand dorsally at the level of the vertebral arch of C1 with the metacarpophalangeal and radial border of the index finger. The other hand is placed posteriorly under the occiput, with the shoulder positioned anteriorly on the patient's forehead. The mobilization force is directed dorsally from the shoulder until the therapist feel a marked resistance and then apply slightly more pressure in order to perform a stretching mobilization. | Other | UC-TSM |
Primary outcome
Headache intensity as measured by Visual Analog Scale
Time frame: From Baseline to one month follow-up
5 secondary outcomes
Cervical mobility as measured by cervical range of motion device (CROM)
Time frame: 1 minute Pre-Intervention, 1 minute Post-Intervention, One month follow-up
Pressure pain threshold as measured by digital algometer (Somedic Farsta)
Time frame: 1 minute Pre-Intervention, 1 minute Post-Intervention, One month follow-up
Temporomandibular joint mobility as measured by digital calipher (mouth opening)
Time frame: 1 minute Pre-Intervention, 1 minute Post-Intervention, One month follow-up
Global Perceived Effect as measured by Global Perceived Effect Scale (-5 to +5 Likert Scale)
Time frame: One month follow-up
Immediate headache intensity changes as measured by Visual Analog Scale
Time frame: 1 minute Pre-Intervention, 1 minute Post-Intervention
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 26 Feb 2016.
- Derived from this study: PubMed 29229055Malo-Urries M, Tricas-Moreno JM, Estebanez-de-Miguel E, Hidalgo-Garcia C, Carrasco-Uribarren A, Cabanillas-Barea S. Immediate Effects of Upper Cervical Translatoric Mobilization on Cervical Mobility and Pressure Pain Threshold in Patients With Cervicogenic Headache: A Randomized Controlled Trial. J Manipulative Physiol Ther. 2017 Nov-Dec;40(9):649-658. doi: 10.1016/j.jmpt.2017.07.007.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UC-TSM in people with Headache, run by Universidad de Zaragoza 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 1 inclusion and 4 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 26 Feb 2016. 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?
Headache intensity as measured by Visual Analog Scale (time frame: From Baseline to one month follow-up). 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 NCT02422862, which also lists 1 linked publication.
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 26 Feb 2016.