Upper Cervical Spine Rotational HypomobilityPhase 3NCT02404766
Effects of C0-C1 Mobilization in the Neutral Position in Subjects With Upper Cervical Rotational Hypomobility
A Phase 3 study testing C0-C1 dorsal glide manual mobilization and C7-T1 ventral cranial glide manual mobilization in people with Upper Cervical Spine Rotational Hypomobility, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
C1-C2 is the most mobile segment of the spine and its dysfunction is frequently associated to cervical pain and headache. However, serious neurovascular adverse effects have been documented through direct treatment of C1-C2 segment. Read more about this study
- Who is it for?
- Ages 18 to 66 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Cervical Spine Rotational Hypomobility
- What is being tested?
- C0-C1 dorsal glide manual mobilization and C7-T1 ventral cranial glide manual mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2012to Mar 2015
- Phase
- Phase 3
- 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 66 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- FRT with less than 32º or asymmetry of 10º between right and left, whenever one of the sides does not exceed physiological C1-C2 ROM (45º)
- Indication of grade III mobilization in C0-C1 and C7-T1 segments
- Aged 18-66
- Signed informed consent
Who cannot join
- Contraindication to manual therapy and red flags according to Rushton et al. (2012)
- Pain presence at the beginning or during the study
- Cervical treatment during the last three months
- Inability to tolerate FRT
- Involvement in litigation or compensation
Trial locations and contacts
1 site in 1 country.
About this study
C1-C2 is the most mobile segment of the spine and its dysfunction is frequently associated to cervical pain and headache. However, serious neurovascular adverse effects have been documented through direct treatment of C1-C2 segment. Although indirect treatment via adjacent segments and avoidance of end range of rotation and extension have been recommended for a safer and effective cervical treatment, there is no scientific evidence of the effectiveness of the indirect treatment approach in the cervical neutral position for C1-C2 hypomobility.
Due to that, the investigators designed a randomized controlled trial to compare the short-term effects in the Flexion Rotation Test (FRT) of a translatoric mobilization of C0-C1, a translatoric mobilization of C7-T1 and a control group in subjects with C1-C2 hypomobility.The primary hypothesis is that C0-C1 dorsal glide mobilization applied in the neutral cervical position can recover the C1-C2 rotational range of movement in subjects with upper cervical hypomobility.
- Being tested
- C0-C1 dorsal glide manual mobilization, C7-T1 ventral cranial glide manual mobilization
- Keywords
- manual therapy, cervical, range of movement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C0-C1 dorsal glide manual mobilizationOther
C7-T1 ventral cranial glide manual mobilizationOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | C0-C1 dorsal glide mobilization in the cervical neutral position. Receives: Other: C0-C1 dorsal glide manual mobilization |
| Intervention group 2 | Experimental | C7-T1 ventral cranial glide mobilization in the cervical neutral position Receives: Other: C7-T1 ventral cranial glide manual mobilization |
| Control group | No intervention | Not receiving any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline in Range of movement in Upper Cervical Spine
Flexion-rotation test measured by CROM device
Measured: 1 hour after intervention
Secondary outcomes (2)
Cervical range of movement in cardinal planes
Active cervical range of movement in sagittal, frontal and transversal planes measured by CROM device.
Measured: 1 hour after intervention
Upper cervical flexion and extension range of movement
Active upper cervical flexion and extension range of movement measured with CROM device
Measured: 1 hour after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startDec 2012
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Cervical Spine Rotational HypomobilityStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, César Hidalgo, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404766
- Sponsor's protocol ID
- CP23/2012
- Status last verified
- Mar 2015
- First submitted
- 26 Mar 2015
- Last updated
- 31 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of C0-C1 Mobilization in the Neutral Position in Subjects With Upper Cervical Rotational Hypomobility
- ClinicalTrials.gov ID
- NCT02404766
- Acronym / sponsor ID
- CP23/2012
- Keywords
- manual therapy, cervical, range of movement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 31 Mar 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.
C1-C2 is the most mobile segment of the spine and its dysfunction is frequently associated to cervical pain and headache. However, serious neurovascular adverse effects have been documented through direct treatment of C1-C2 segment. Although indirect treatment via adjacent segments and avoidance of end range of rotation and extension have been recommended for a safer and effective cervical treatment, there is no scientific evidence of the effectiveness of the indirect treatment approach in the cervical neutral position for C1-C2 hypomobility.
Due to that, the investigators designed a randomized controlled trial to compare the short-term effects in the Flexion Rotation Test (FRT) of a translatoric mobilization of C0-C1, a translatoric mobilization of C7-T1 and a control group in subjects with C1-C2 hypomobility.The primary hypothesis is that C0-C1 dorsal glide mobilization applied in the neutral cervical position can recover the C1-C2 rotational range of movement in subjects with upper cervical hypomobility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: C0-C1 dorsal glide manual mobilizationC0-C1 dorsal glide mobilization in the cervical neutral position. |
| Intervention group 2 | Experimental | Other: C7-T1 ventral cranial glide manual mobilizationC7-T1 ventral cranial glide mobilization in the cervical neutral position |
| Control group | No intervention | –Not receiving any intervention |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- FRT with less than 32º or asymmetry of 10º between right and left, whenever one of the sides does not exceed physiological C1-C2 ROM (45º)
- Indication of grade III mobilization in C0-C1 and C7-T1 segments
- Aged 18-66
- Signed informed consent
Key exclusion criteria (5 listed)
- Contraindication to manual therapy and red flags according to Rushton et al. (2012)
- Pain presence at the beginning or during the study
- Cervical treatment during the last three months
- Inability to tolerate FRT
- Involvement in litigation or compensation
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 |
|---|---|---|
| C0-C1 dorsal glide manual mobilization | Other | Intervention group |
| C7-T1 ventral cranial glide manual mobilization | Other | Intervention group 2 |
Primary outcome
Change in baseline in Range of movement in Upper Cervical Spine
Time frame: 1 hour after intervention
Flexion-rotation test measured by CROM device
2 secondary outcomes
Cervical range of movement in cardinal planes
Time frame: 1 hour after intervention
Upper cervical flexion and extension range of movement
Time frame: 1 hour after 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 31 Mar 2015.
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 Phase 3 study testing C0-C1 dorsal glide manual mobilization and C7-T1 ventral cranial glide manual mobilization in people with Upper Cervical Spine Rotational Hypomobility, 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 4 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 31 Mar 2015. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 in baseline in Range of movement in Upper Cervical Spine (time frame: 1 hour after intervention). 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 31 Mar 2015.