- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03990324
Cervical Range of Motion and Stretching
June 19, 2019 updated by: University of Central Florida
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Orlando, Florida, United States, 32816
- University of Central Florida
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ages of 18-60
- active cervical flexion, right lateral flexion OR left cervical lateral flexion <45˚
Exclusion Criteria:
- minors
- prisoners
- individuals with cognitive impairments
- recent neck surgeries
- pre-existing neck injuries
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
NO_INTERVENTION: Control group
The control group did not received intervention and sat on a table for approximately 5 minutes
|
|
|
EXPERIMENTAL: Stretching group
The stretching group received a standardized manual stretching protocol
|
Manual stretching for the upper trapezius and levator scapulae muscle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 minute post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pressure pain thresholds
Time Frame: 1 minute post-intervention
|
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.
|
1 minute post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 26, 2018
Primary Completion (ACTUAL)
September 18, 2018
Study Completion (ACTUAL)
January 25, 2019
Study Registration Dates
First Submitted
June 14, 2019
First Submitted That Met QC Criteria
June 17, 2019
First Posted (ACTUAL)
June 18, 2019
Study Record Updates
Last Update Posted (ACTUAL)
June 21, 2019
Last Update Submitted That Met QC Criteria
June 19, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- BIO-17-13405
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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