Neck Pain MusculoskeletalNCT07704853
Assessing Tissue Response to High-Velocity Thrust Manipulations on Capsule Length and Stiffness at the C5-C6 Facet Joint Capsule
A study testing Long axis trust manipulation C5-C6 in people with Neck Pain Musculoskeletal, run by Florida Gulf Coast University at 1 site in United States.
Trial summary
This study is a quasi-experimental study collected quantitative data , with a pre-test-post-test design. Pre-intervention, baseline measurements of C5-C6 right facet joint length and width with the head of the treatment plinth downward at 45 and 90 degrees, (relative to the rest of the table) and stiffness at 90… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain Musculoskeletal
- What is being tested?
- Long axis trust manipulation C5-C6
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2025to 1 Aug 2026
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals between 18-35 without neck pain
- Able to to read and understand English
Who cannot join
- autoimmune disease
- down syndrome
- fusion, fracture
- spinal cord compression
- vascular pathology
- cancer,
Show all 9Show fewer
- any other conditions that induce severe instability
- inflammation
- weakened bone.
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida Gulf Coast University Marieb Hall 101
Fort Myers, Florida, 33965
About this study
Official title: Assessing Tissue Response to High-Velocity Thrust Manipulations: Measuring Lasting Changes in C5-C6 Facet Joint Capsule Length With Musculoskeletal Ultrasound and Stiffness With Elastography
This study is a quasi-experimental study collected quantitative data , with a pre-test-post-test design. Pre-intervention, baseline measurements of C5-C6 right facet joint length and width with the head of the treatment plinth downward at 45 and 90 degrees, (relative to the rest of the table) and stiffness at 90 degrees, were taken prior to applying the long-axis thrust manipulation. Post-intervention measures were taken immediately after a long axis thrust manipulation of C5-C6 and again at 24-hours after the manipulation. The baseline pre-intervention measures were then compared to the post-intervention measurements. The investigator performing the manipulation was blinded to the quantitative measurements of the ultrasound images. The ultrasound operator was blinded to the outcome of the manipulation.
Read the detailed description
The study takes place in Marieb Hall rooms 101 and 103 of Florida Gulf Coast University. After meeting the inclusion and exclusion criteria subjects sign the informed consent form described thoroughly on the following page. The participants undergo three recording sessions on two consecutive days. The first recording session consist of obtaining participant consent and general information, such as height and weight. The participants then has their baseline measures cervical flexion ROM, capsular length and width at both 45 and 90 degrees, and stiffness at 90 degrees, taken. The second and third session consist only of repeating these baseline measures post-manipulation and 24-hours post-manipulation respectively. Each participant will be provided a profile on the ultrasound unit, corresponding to their subject number, with each point in time having an individual exam within the profile. At these sessions, recordings are done in the prone position to measure length of the C5-C6 joint capsule and joint capsule tissue extensibility. Locating the articular pillar was a three-fold process. At the intervention table, the C7 spinous process is identified in upright sitting with palpation, due to its relevance in clinical examination and evaluation, serving as the first landmark. From this position, one of the measuring practitioners moves their finger cranially to the C6 spinous process. The participant's head is moved passively into extension, causing the spinous process to move away from the practitioner's finger, providing further confidence in location accurary. This landmark isthen marked for repeatability. The participant then has their cervical flexion range of motion measured with a fluid-filled inclinometer. A fluid-filled inclinometer utilizes gravity to quantify gross motion. This method is easily repeated and validated for clinical measurements. Each participant is given the instructions, "sit up straight and tuck your chin to your chest." At the ultrasound table, a goniometer is secured with the stationary arm in line with the table, the axis through the pivot point for the head of the table, and the moving line in line with the head of the table.
The participant is then instructed to lie prone on the table, with the head of the table positioned at 45 degrees. Anytime the head position of the table is altered, two researchers confirmed the angle of the goniometer. The 45 degree angle was selected to neutralize the natural lordosis of the lower cervical spine. The table insert is removed for the participant's face to lie within the opening. A piece of tape is placed at the base of the table opening . The participants are given the instructions, "tuck your chin and put the front of your chin on the piece of tape." From this point, the ultrasound probe is placed in a right paramedian sagittal/long-axis view. The probe was angled 15 degrees from lateral-to-medial in the posterior-to-anterior direction.
Beginning at the occipital bone, the probe is moved inferiorly. The articular pillar is known to have a jagged, sawtooth like appearance when observed from this angle. The trough at the bottom of the sawtooth indicates the inferior articular process of the cranial vertebra, while the following peak will be depicting the superior articular process of the following caudal vertebra.
This allowed the practitioners to count the peaks observed and identify the spinal levels visualized on the screen. The mark placed on the C6 spinous process is compared to probe location once the C6 level has been visualized on the screen. After the level is confirmed to be correct, the probe remained stationary on the participant. Once the correct level is visualized, the first screen capture video was taken and saved to the participant exam. The head of the table is then angled fully down towards the floor, measured at 90 degrees with the secured goniometer. By having the head of the table as far down as it allows, the process for achieving full cervical flexion remained standardized. This is also confirmed via palpation of the interspinous space of T1 and by both practitioners audibly confirming the observation of the thoracic spine flexion, indicating full cervical flexion is achieved. While the capsule could theoretically be put under more tension by utilizing multiplanar movements, utilizing only flexion offers a standardized, repeatable method that is less susceptible to confounding variables. As the probe remains stationary with the C5-C6 joint in view, the second screen capture video is taken. While remaining in the fully flexed position, the ultrasound operator start the elastography on the ultrasound unit. Once displayed on screen, a third screen capture video is taken.
The participant then returns to the initial table to receive the intervention. The practitioner performing the HVLA long axis C6-C6 manipulation on the right stands at the head of the plinth, on the right side of the patient positioned in supine. The practitioner's right hand is placed under C6, while the left hand is placed under the chin as the arm cradles the head. Using the left hand and arm, the practitioner passively rotated the head away and side-bent the head toward the targeted side. Once end-range motion is achieved, the practitioner provides a high-velocity low-amplitude long-axis thrust in a superior direction, parallel to the angle of the targeted segment.
Following the manipulation, the participant has their cervical range of motion re-measured, and the ultrasound imaging process is repeated in a new exam. Once the immediate post-intervention measures are taken, the subjects are instructed to come back for a third imaging session at the exact same time the following day. At the 24-hour follow-up, the participants cervical flexion range of motion is repeated, as well as the three ultrasound procedures.
- Conditions
- Neck Pain Musculoskeletal
- Being tested
- Long axis trust manipulation C5-C6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long axis trust manipulation C5-C6Other
Long axis trust manipulation C5-C6
| Study group | Role | What they receive |
|---|---|---|
| Sample | Experimental | C5-C6 long axis joint manipulation Receives: Other: Long axis trust manipulation C5-C6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
facet capsule length and width
MSK US measure facet length and with in mm
Measured: before intervention, immediately after, and at 24 hour follow up
Secondary outcomes (2)
Cervical motion
Max neck flexion motion in sitting measured in degrees
Measured: before intervention, immediately after, and at 24 hour follow up
elastography
tissue pliability assessment with MSK US
Measured: Before intervention, immediately after, and 24 hours after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start4 Feb 2025
- Primary completion1 Jun 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck Pain MusculoskeletalStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida Gulf Coast University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704853
- Sponsor's protocol ID
- 2025-10
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only unidentifiable data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Tissue Response to High-Velocity Thrust Manipulations: Measuring Lasting Changes in C5-C6 Facet Joint Capsule Length With Musculoskeletal Ultrasound and Stiffness With Elastography
- ClinicalTrials.gov ID
- NCT07704853
- Acronym / sponsor ID
- 2025-10
- Conditions
- Neck Pain Musculoskeletal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Florida Gulf Coast UniversityUniversity, hospital or other
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 15 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 is a quasi-experimental study collected quantitative data , with a pre-test-post-test design. Pre-intervention, baseline measurements of C5-C6 right facet joint length and width with the head of the treatment plinth downward at 45 and 90 degrees, (relative to the rest of the table) and stiffness at 90 degrees, were taken prior to applying the long-axis thrust manipulation. Post-intervention measures were taken immediately after a long axis thrust manipulation of C5-C6 and again at 24-hours after the manipulation. The baseline pre-intervention measures were then compared to the post-intervention measurements. The investigator performing the manipulation was blinded to the quantitative measurements of the ultrasound images. The ultrasound operator was blinded to the outcome of the manipulation.
Detailed description
The study takes place in Marieb Hall rooms 101 and 103 of Florida Gulf Coast University. After meeting the inclusion and exclusion criteria subjects sign the informed consent form described thoroughly on the following page. The participants undergo three recording sessions on two consecutive days. The first recording session consist of obtaining participant consent and general information, such as height and weight. The participants then has their baseline measures cervical flexion ROM, capsular length and width at both 45 and 90 degrees, and stiffness at 90 degrees, taken. The second and third session consist only of repeating these baseline measures post-manipulation and 24-hours post-manipulation respectively. Each participant will be provided a profile on the ultrasound unit, corresponding to their subject number, with each point in time having an individual exam within the profile. At these sessions, recordings are done in the prone position to measure length of the C5-C6 joint capsule and joint capsule tissue extensibility. Locating the articular pillar was a three-fold process. At the intervention table, the C7 spinous process is identified in upright sitting with palpation, due to its relevance in clinical examination and evaluation, serving as the first landmark. From this position, one of the measuring practitioners moves their finger cranially to the C6 spinous process. The participant's head is moved passively into extension, causing the spinous process to move away from the practitioner's finger, providing further confidence in location accurary. This landmark isthen marked for repeatability. The participant then has their cervical flexion range of motion measured with a fluid-filled inclinometer. A fluid-filled inclinometer utilizes gravity to quantify gross motion. This method is easily repeated and validated for clinical measurements. Each participant is given the instructions, "sit up straight and tuck your chin to your chest." At the ultrasound table, a goniometer is secured with the stationary arm in line with the table, the axis through the pivot point for the head of the table, and the moving line in line with the head of the table.
The participant is then instructed to lie prone on the table, with the head of the table positioned at 45 degrees. Anytime the head position of the table is altered, two researchers confirmed the angle of the goniometer. The 45 degree angle was selected to neutralize the natural lordosis of the lower cervical spine. The table insert is removed for the participant's face to lie within the opening. A piece of tape is placed at the base of the table opening . The participants are given the instructions, "tuck your chin and put the front of your chin on the piece of tape." From this point, the ultrasound probe is placed in a right paramedian sagittal/long-axis view. The probe was angled 15 degrees from lateral-to-medial in the posterior-to-anterior direction.
Beginning at the occipital bone, the probe is moved inferiorly. The articular pillar is known to have a jagged, sawtooth like appearance when observed from this angle. The trough at the bottom of the sawtooth indicates the inferior articular process of the cranial vertebra, while the following peak will be depicting the superior articular process of the following caudal vertebra.
This allowed the practitioners to count the peaks observed and identify the spinal levels visualized on the screen. The mark placed on the C6 spinous process is compared to probe location once the C6 level has been visualized on the screen. After the level is confirmed to be correct, the probe remained stationary on the participant. Once the correct level is visualized, the first screen capture video was taken and saved to the participant exam. The head of the table is then angled fully down towards the floor, measured at 90 degrees with the secured goniometer. By having the head of the table as far down as it allows, the process for achieving full cervical flexion remained standardized. This is also confirmed via palpation of the interspinous space of T1 and by both practitioners audibly confirming the observation of the thoracic spine flexion, indicating full cervical flexion is achieved. While the capsule could theoretically be put under more tension by utilizing multiplanar movements, utilizing only flexion offers a standardized, repeatable method that is less susceptible to confounding variables. As the probe remains stationary with the C5-C6 joint in view, the second screen capture video is taken. While remaining in the fully flexed position, the ultrasound operator start the elastography on the ultrasound unit. Once displayed on screen, a third screen capture video is taken.
The participant then returns to the initial table to receive the intervention. The practitioner performing the HVLA long axis C6-C6 manipulation on the right stands at the head of the plinth, on the right side of the patient positioned in supine. The practitioner's right hand is placed under C6, while the left hand is placed under the chin as the arm cradles the head. Using the left hand and arm, the practitioner passively rotated the head away and side-bent the head toward the targeted side. Once end-range motion is achieved, the practitioner provides a high-velocity low-amplitude long-axis thrust in a superior direction, parallel to the angle of the targeted segment.
Following the manipulation, the participant has their cervical range of motion re-measured, and the ultrasound imaging process is repeated in a new exam. Once the immediate post-intervention measures are taken, the subjects are instructed to come back for a third imaging session at the exact same time the following day. At the 24-hour follow-up, the participants cervical flexion range of motion is repeated, as well as the three ultrasound procedures.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sample | Experimental | Other: Long axis trust manipulation C5-C6C5-C6 long axis joint manipulation |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy individuals between 18-35 without neck pain
- Able to to read and understand English
Key exclusion criteria (9 listed)
- autoimmune disease
- down syndrome
- fusion, fracture
- spinal cord compression
- vascular pathology
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 |
|---|---|---|
| Long axis trust manipulation C5-C6Long axis trust manipulation C5-C6 | Other | Sample |
Primary outcome
facet capsule length and width
Time frame: before intervention, immediately after, and at 24 hour follow up
MSK US measure facet length and with in mm
2 secondary outcomes
Cervical motion
Time frame: before intervention, immediately after, and at 24 hour follow up
elastography
Time frame: Before intervention, immediately after, and 24 hours after
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 25 Aug 2026.
- Individual participant dataSharing planned: No. only unidentifiable data will be shared.
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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 Long axis trust manipulation C5-C6 in people with Neck Pain Musculoskeletal, 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 2 inclusion and 9 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 25 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. 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?
facet capsule length and width (time frame: before intervention, immediately after, and at 24 hour follow up). 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 25 Aug 2026.