Back to resultsImmediate Effects Cervicothoracic Manipulation Versus Passive Upper Trapezius Stretch
Primary Purpose
Neck Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Upper Trapezius Stretch
Cervicothoracic manipulation
No intervention
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain
Eligibility Criteria
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
Sites / Locations
- University of Nevada Las Vegas - Department of Physical Therapy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Other
Arm Label
Cervicothoracic manipulation
Upper trapezius stretch
Control group
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Cervical Range of Motion
Cervical Range of Motion in each cardinal plane (sagittal, coronal and transverse) will be measured in angular degrees using a CROM device
Secondary Outcome Measures
Pain Pressure Threshold
Pain Pressure Threshold measured using a standard handheld algometer with 1 cm round tip
Full Information
NCT ID
NCT02552290
First Posted
September 14, 2015
Last Updated
September 16, 2015
Sponsor
University of Nevada, Las Vegas
1. Study Identification
Unique Protocol Identification Number
NCT02552290
Brief Title
Immediate Effects Cervicothoracic Manipulation Versus Passive Upper Trapezius Stretch
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nevada, Las Vegas
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The proposed project seeks to evaluate the influence of cervicothoracic (CT) manipulation and passive stretching to the upper trapezius on pressure pain thresholds and range of motion (ROM) in individuals without recent complain of neck pain.
Detailed Description
Not needed
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cervicothoracic manipulation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Upper trapezius stretch
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Upper Trapezius Stretch
Intervention Description
Sustained stretch of upper trapezius muscle
Intervention Type
Other
Intervention Name(s)
Cervicothoracic manipulation
Intervention Description
Manipulation to the cervicothoracic spine
Intervention Type
Other
Intervention Name(s)
No intervention
Intervention Description
Wait
Primary Outcome Measure Information:
Title
Cervical Range of Motion
Description
Cervical Range of Motion in each cardinal plane (sagittal, coronal and transverse) will be measured in angular degrees using a CROM device
Time Frame
Immediately after the intervention
Secondary Outcome Measure Information:
Title
Pain Pressure Threshold
Description
Pain Pressure Threshold measured using a standard handheld algometer with 1 cm round tip
Time Frame
Two minutes and 5 Minutes after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilio J Puentedura, PT, DPT, PhD
Organizational Affiliation
UNLV
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nevada Las Vegas - Department of Physical Therapy
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89154
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Immediate Effects Cervicothoracic Manipulation Versus Passive Upper Trapezius Stretch
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