The Effects of Thoracic Spine Mobilizations in Individuals With Neck Pain. (THSPMOBS)
Primary Purpose
Neck Pain
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobilization Type
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain
Eligibility Criteria
Inclusion Criteria:
- Patients with Neck Pain
- Ages 18 - 60
Exclusion Criteria:
- Red flags: leg weakness, night pain, history of cancer, upper motor neuron signs, infection, tumors, osteoporosis, fracture (Boissonnault, 2011) (Cleland, 2004), cervical stenosis, CNS involvement, signs consistent with nerve root compression, previous surgery, pending legal action
The inclusion and exclusion above represent a conservative approach based on combining criteria of recent studies in published review articles. (Cross, 2011; Walser, 2009
Sites / Locations
- Chatham UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mobilization
Arm Description
Group One: Mobilization Group: this group will receive grade 1,2,3,or 4 mobilization in prone based on the PT's clinical judgement. The treatment parameters will be recorded. Group Two: Grade 3-4 mobilization group: this group will receive a grade 3-4 mobilization, for 30 seconds form the first through sixth thoracic vertebrae.
Outcomes
Primary Outcome Measures
Neck Pain
0-10 scale
Neck Disability Index
Assessment of function of neck using a valid and reliable written tool.
Global Rating of Change
A written scale assessing overall improvement
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02356380
Brief Title
The Effects of Thoracic Spine Mobilizations in Individuals With Neck Pain.
Acronym
THSPMOBS
Official Title
The Effects of Thoracic Spine Mobilizations in Individuals With Neck Pain.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chatham University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine the affects of Physical Therapists clinical reasoning using thoracic spine mobilization for neck pain compared to a standard protocol.
Detailed Description
The purpose of this research is to compare the effects of two commonly used, safe, thoracic spine treatments: grade 1-4 as performed by Cleland et. al. and grade 1-4 mobilization to the thoracic spine as selected by the Physical Therapist for cervical spine pain. The immediate effects of thoracic spine mobilization have been shown to facilitate greater range of motion increases in the cervical spine and greater pain decreases within a treatment session and on follow-up visits. There is no research utilizing pain threshold perception as an objective outcome of these treatments. Only one study compared the two treatment techniques and concluded that future research should be completed which includes manual therapy for the thoracic spine. (Cleland 2007) If the PT identifies an appropriate patient they will ask if they are interested in being a research subject. The Physical Theapist recruiting subjects all have completed their Doctor of Physical Therapy Degree and have advanced training in manual Physical Therapy. The techniques employed are considered standard practice and are defined as entry level skills by the Comission of Accredicdation of Physical Therapy Programs. These techniques are typically taught in DPT degree programs.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mobilization
Arm Type
Experimental
Arm Description
Group One: Mobilization Group: this group will receive grade 1,2,3,or 4 mobilization in prone based on the PT's clinical judgement. The treatment parameters will be recorded.
Group Two: Grade 3-4 mobilization group: this group will receive a grade 3-4 mobilization, for 30 seconds form the first through sixth thoracic vertebrae.
Intervention Type
Other
Intervention Name(s)
Mobilization Type
Intervention Description
Group One: Mobilization Group: this group will receive grade 1,2,3,or 4 mobilization in prone based on the PT's clinical judgement. The treatment parameters will be recorded.
Group Two: Grade 3-4 mobilization group: this group will receive a grade 3-4 mobilization, for 30 seconds form the first through sixth thoracic vertebrae.
Primary Outcome Measure Information:
Title
Neck Pain
Description
0-10 scale
Time Frame
2 weeks
Title
Neck Disability Index
Description
Assessment of function of neck using a valid and reliable written tool.
Time Frame
2 weeks
Title
Global Rating of Change
Description
A written scale assessing overall improvement
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with Neck Pain
Ages 18 - 60
Exclusion Criteria:
Red flags: leg weakness, night pain, history of cancer, upper motor neuron signs, infection, tumors, osteoporosis, fracture (Boissonnault, 2011) (Cleland, 2004), cervical stenosis, CNS involvement, signs consistent with nerve root compression, previous surgery, pending legal action
The inclusion and exclusion above represent a conservative approach based on combining criteria of recent studies in published review articles. (Cross, 2011; Walser, 2009
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steve Karas, DSc
Phone
412 365 2798
Email
skaras@chatham.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Brett Windsor, PhD (c)
Phone
910-893-1723
Email
brettwindsor@gmail.com
Facility Information:
Facility Name
Chatham University
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15221
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steve A Karas, DSc
Phone
412-365-2798
Email
skaras@chatham.edu
First Name & Middle Initial & Last Name & Degree
Steve A Karas, DSc
12. IPD Sharing Statement
Learn more about this trial
The Effects of Thoracic Spine Mobilizations in Individuals With Neck Pain.
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