Head and NeckNCT07725198
Immediate Neuromuscular Responses of the Obliquus Capitis Inferior Following Upper Cervical Manual Therapy
A study testing Thrust long-axis manipulation of C1-C2 in people with Head and Neck and Headache, run by Florida Gulf Coast University at 1 site in United States.
Trial summary
This study used a prospective, randomized, repeated-measures experimental design to investigate the immediate effects of two upper cervical manual therapy interventions on craniovertebral angle (CVA), clinician-perceived atlas position, and musculoskeletal ultrasound-derived obliquus capitis inferior (OCI) muscle… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Head and Neck, Headache
- What is being tested?
- Thrust long-axis manipulation of C1-C2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- read and understand English
- no previous history of cervical spine surgery or traumatic cervical injury
- no contraindications to cervical manual therapy
Who cannot join
- any absolute contraindications to cervical manipulation
- any other medical condition considered unsafe for manual therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Florida Gulf Coast University Marieb Hall 101
Fort Myers, Florida, 33965
Rob Sillevis, PhD, 239-7454312, rsillevis@fgcu.edu
About this study
This study used a prospective, randomized, repeated-measures experimental design to investigate the immediate effects of two upper cervical manual therapy interventions on craniovertebral angle (CVA), clinician-perceived atlas position, and musculoskeletal ultrasound-derived obliquus capitis inferior (OCI) muscle morphology
- Conditions
- Head and Neck, Headache
- Being tested
- Thrust long-axis manipulation of C1-C2
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrust long-axis manipulation of C1-C2Other
One thrust manipulation is provided in the thrust group. a 5 second long axis hold traction of C1-C2 was repeated 3 times in the mobilization group
| Study group | Role | What they receive |
|---|---|---|
| Long axis thrust manipulation group | Experimental | A single long axis thrust manipulation C1-C3 Receives: Other: Thrust long-axis manipulation of C1-C2 |
| Long axis thrust mobilization group | Sham comparator | 3 x 5 second Long axis traction hold of C1-C3 Receives: Other: Thrust long-axis manipulation of C1-C2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MSK Ultrasound
MSK Ultrasound measure of the Obliquues Capitis inferior muscle lenght and width
Measured: before intervention, immediately after, and 24 hours after intervention
Secondary outcomes (2)
Atlas position
Atlas position relative to the head measured wth palpation of C1 transverse process
Measured: before intervention, immediately after, and 24 hours after intervention
Craniovertebral angle
Measure of the Craniovertebral angle using photography
Measured: before intervention, immediately after, and 24 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 May 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and NeckStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida Gulf Coast University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Rob Sillevis,, Florida Gulf Coast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725198
- Sponsor's protocol ID
- 2025-11
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information will be shared by request only
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Neuromuscular Responses of the Obliquus Capitis Inferior Following Upper Cervical Manual Therapy
- ClinicalTrials.gov ID
- NCT07725198
- Acronym / sponsor ID
- 2025-11
- Conditions
- Head and Neck, Headache
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Florida Gulf Coast UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 24 Jul 2026 (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.
This study used a prospective, randomized, repeated-measures experimental design to investigate the immediate effects of two upper cervical manual therapy interventions on craniovertebral angle (CVA), clinician-perceived atlas position, and musculoskeletal ultrasound-derived obliquus capitis inferior (OCI) muscle morphology
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long axis thrust manipulation group | Experimental | Other: Thrust long-axis manipulation of C1-C2A single long axis thrust manipulation C1-C3 |
| Long axis thrust mobilization group | Sham comparator | Other: Thrust long-axis manipulation of C1-C23 x 5 second Long axis traction hold of C1-C3 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- read and understand English
- no previous history of cervical spine surgery or traumatic cervical injury
- no contraindications to cervical manual therapy
Key exclusion criteria (2 listed)
- any absolute contraindications to cervical manipulation
- any other medical condition considered unsafe for manual therapy.
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 |
|---|---|---|
| Thrust long-axis manipulation of C1-C2One thrust manipulation is provided in the thrust group. a 5 second long axis hold traction of C1-C2 was repeated 3 times in the mobilization group | Other | Long axis thrust manipulation group, Long axis thrust mobilization group |
Primary outcome
MSK Ultrasound
Time frame: before intervention, immediately after, and 24 hours after intervention
MSK Ultrasound measure of the Obliquues Capitis inferior muscle lenght and width
2 secondary outcomes
Atlas position
Time frame: before intervention, immediately after, and 24 hours after intervention
Craniovertebral angle
Time frame: before intervention, immediately after, and 24 hours after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: Yes. Information will be shared by request only
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thrust long-axis manipulation of C1-C2 in people with Head and Neck and Headache, run by Florida Gulf Coast University at 1 site in United States.
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 2 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: looking for participants now, as of the sponsor's last update on 28 Aug 2026. 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 United States. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rob Sillevis, PhD (239-7454312, rsillevis@fgcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MSK Ultrasound (time frame: before intervention, immediately after, and 24 hours 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 28 Aug 2026.