Cervical ShorteningNCT03990324
Cervical Range of Motion and Stretching
A study testing Manual stretching in people with Cervical Shortening, run by University of Central Florida at 1 site in United States.
Trial summary
Cervical range of motion (ROM) is necessary to perform normal activities of daily living and deficits are associate with various pathologies. Currently, its unclear if specific myofascial stretches will improve cervical range of motion and decrease myofascial sensitivity. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Shortening
- What is being tested?
- Manual stretching
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2018to 25 Jan 2019
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ages of 18-60
- active cervical flexion, right lateral flexion OR left cervical lateral flexion <45˚
Who cannot join
- minors
- prisoners
- individuals with cognitive impairments
- recent neck surgeries
- pre-existing neck injuries
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Central Florida
Orlando, Florida, 32816
About this study
Official title: Immediate Changes in Cervical Range of Motion and Myofascial Sensitivity After Standardized Manual Stretches: a Randomized Controlled Trial
Cervical range of motion (ROM) is necessary to perform normal activities of daily living and deficits are associate with various pathologies. Currently, its unclear if specific myofascial stretches will improve cervical range of motion and decrease myofascial sensitivity. After a single session of the manual stretching procedure, participants immediately demonstrated increased cervical ROM and pressure pain thresholds.
Read the detailed description
Methods: Sixty participants with no history of neck pain or trauma were randomized into one of two groups: stretching group (n = 30), or control group (n = 30). The stretching group received a standardized manual stretching protocol. The control group did not received intervention. Pre and Post-test measurements were recorded for both groups. Within group differences and group by time interactions were evaluated for Cervical range of motion ROM and myofascial sensitivity. The immediate improvement in active ROM of the cervical spine may prompt clinicians to consider the sequencing of treatment. Stretching prior to active exercises may allow for active exercise through a larger ROM. Future research is needed to evaluate the immediate effects of stretching in the symptomatic population.
- Conditions
- Cervical Shortening
- Being tested
- Manual stretching
- Keywords
- range of motion, muscle sensitivity, muscle stretching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual stretchingProcedure or surgery
Manual stretching for the upper trapezius and levator scapulae muscle
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group did not received intervention and sat on a table for approximately 5 minutes |
| Stretching group | Experimental | The stretching group received a standardized manual stretching protocol Receives: Procedure: Manual stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion
CROM including flexion, extension, side bending left, side bending right, rotation left, and rotation right
Measured: 1 minute post-intervention
Secondary outcomes (1)
Pressure pain thresholds
The PPT was recorded using a Wagner FDX-25 hand-held digital pressure algometer (Wagner Instruments, Greenwich, CT). The investigator performed each assessment uniformly by applying force at the same rate of 5 Pa/second.
Measured: 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 posted18 Jun 2019
- Study start26 Jan 2018
- Primary completion18 Sep 2018
- Study completion25 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical ShorteningStudies 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
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Collaborators
- University of Indianapolis, Nova Southeastern University, Long Island University
- Responsible party
- Sponsor
- Investigators
- William J Hanney, PhD, Principal investigator, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990324
- Sponsor's protocol ID
- BIO-17-13405
- Status last verified
- Jun 2019
- First submitted
- 14 Jun 2019
- Last updated
- 21 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Changes in Cervical Range of Motion and Myofascial Sensitivity After Standardized Manual Stretches: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03990324
- Acronym / sponsor ID
- BIO-17-13405
- Conditions
- Cervical Shortening
- Keywords
- range of motion, muscle sensitivity, muscle stretching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Collaborators
- University of Indianapolis, Nova Southeastern University, Long Island University
- Study start
- 26 Jan 2018 (actual)
- Primary completion
- 18 Sep 2018 (actual)
- Study completion
- 25 Jan 2019 (actual)
- First posted
- 18 Jun 2019 (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.
Cervical range of motion (ROM) is necessary to perform normal activities of daily living and deficits are associate with various pathologies. Currently, its unclear if specific myofascial stretches will improve cervical range of motion and decrease myofascial sensitivity. After a single session of the manual stretching procedure, participants immediately demonstrated increased cervical ROM and pressure pain thresholds.
Detailed description
Methods: Sixty participants with no history of neck pain or trauma were randomized into one of two groups: stretching group (n = 30), or control group (n = 30). The stretching group received a standardized manual stretching protocol. The control group did not received intervention. Pre and Post-test measurements were recorded for both groups. Within group differences and group by time interactions were evaluated for Cervical range of motion ROM and myofascial sensitivity. The immediate improvement in active ROM of the cervical spine may prompt clinicians to consider the sequencing of treatment. Stretching prior to active exercises may allow for active exercise through a larger ROM. Future research is needed to evaluate the immediate effects of stretching in the symptomatic population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group did not received intervention and sat on a table for approximately 5 minutes |
| Stretching group | Experimental | Procedure: Manual stretchingThe stretching group received a standardized manual stretching protocol |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ages of 18-60
- active cervical flexion, right lateral flexion OR left cervical lateral flexion <45˚
Key exclusion criteria (5 listed)
- minors
- prisoners
- individuals with cognitive impairments
- recent neck surgeries
- pre-existing neck injuries
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 |
|---|---|---|
| Manual stretchingManual stretching for the upper trapezius and levator scapulae muscle | Procedure or surgery | Stretching group |
Primary outcome
Range of Motion
Time frame: 1 minute post-intervention
CROM including flexion, extension, side bending left, side bending right, rotation left, and rotation right
1 secondary outcome
Pressure pain thresholds
Time frame: 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 21 Jun 2019.
- 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.
William J Hanney, PhD principal investigator
University of Central Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual stretching in people with Cervical Shortening, run by University of Central Florida 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 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 21 Jun 2019. 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?
Range of Motion (time frame: 1 minute post-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 21 Jun 2019.