- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02552290
Immediate Effects Cervicothoracic Manipulation Versus Passive Upper Trapezius Stretch
Effects of Cervicothoracic Manipulation and Passive Stretching to the Upper Trapezius Muscle on Pressure Pain Thresholds and Cervical Range of Motion on Healthy Individuals
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Nevada
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Las Vegas, Nevada, United States, 89154
- University of Nevada Las Vegas - Department of Physical Therapy
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1. No current history or past history of neck pain; able to lie on back or stomach without difficulty
Exclusion Criteria:
- 'Red flag' items indicated in your Neck Medical Screening Questionnaire such as history of a tumor, bone fracture, metabolic diseases, Rheumatoid Arthritis, osteoporosis, severe atherosclerosis, prolonged history of steroid use, etc.
- History of neck whiplash injury
- Diagnosis from your physician of cervical spinal stenosis (narrowing of spinal canal) or presence of symptoms (pain, pins and needles, numbness) down both arms
- Presence of central nervous system involvement such as exaggerated reflexes, changes in sensation in the hands, muscle wasting in the hands, impaired sensation of the face, altered taste, and presence of abnormal reflexes
- Evidence of neurological signs consistent with nerve root entrapment (pinched nerve in the neck)
- Prior surgery to your neck or upper back
- A medical condition which may influence assessment of pain or pressure pain thresholds (i.e. taking analgesics, sedatives, history of substance abuse, or cognitive deficiency)
- Diagnosis from your physician of fibromyalgia syndrome
- Currently pregnant, or could be pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cervicothoracic manipulation
Description of a Right C7/T1 manipulation.
The subject will lie prone.
The therapist will stand on the L side of the subject facing in a cephalic direction (towards the patient's head).
The therapist's right hand makes contact with the thumb on the right side of the spinous process of the first thoracic vertebra.
The therapist left hand supports the head making contact on the temporal bone.
The hand/neck is gently laterally flexed to the right, until slight tension is palpated in the tissues.
A high-velocity low-amplitude thrust will be applied towards the subjects left side.
If cavitation does not occur (an audible pop) the subject will be repositioned and the manipulation attempted a second time.
A maximum of 2 attempts will be performed for each side of the neck.
|
Manipulation to the cervicothoracic spine
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Active Comparator: Upper trapezius stretch
The subjects will be in a supine position. A researcher will passively place the subject's head into flexion, side-bending away and rotation towards the side to be stretched until the muscle barrier is met. The researcher will depress the subject's shoulder with 100 Newtons of force measured with a Micro FET pressure dynamometer (Hoggan Health Industries, Salt Lake City, UT).) Once this pressure amount is achieved the stretch will be held for 30 seconds. This will be repeated two times on each side. The subject will be asked to provide continuous feedback about the stretch felt and the degree of discomfort (if any) felt during the 30 second stretches. |
Sustained stretch of upper trapezius muscle
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Other: Control group
Subjects assigned to the control group will receive no intervention.
They will stay behind the curtained research area for approximately 3 minutes in a seated position.
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Wait
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cervical Range of Motion
Time Frame: Immediately after the intervention
|
Cervical Range of Motion in each cardinal plane (sagittal, coronal and transverse) will be measured in angular degrees using a CROM device
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Immediately after the intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Pressure Threshold
Time Frame: Two minutes and 5 Minutes after the intervention
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Pain Pressure Threshold measured using a standard handheld algometer with 1 cm round tip
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Two minutes and 5 Minutes after the intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emilio J Puentedura, PT, DPT, PhD, UNLV
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1303-4412
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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