- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01917071
The Effect of Directional Specific Thoracic Spine Mobilization on Cervical Spine Pain
The Effect of Directional Specific Thoracic Spine Mobilization on Cervial Spine Pain.
Hypothesis: There is no difference in directional specific manipulation of the thoracic spine for patients with neck pain.
Patients seeking physical therapy for neck pain routinely have their thoracic spine manipulated. This study seeks to determine if directional limitations in the spine can be specifically determined and treated to decrease neck pain.
Study Overview
Detailed Description
Manipulation of the thoracic spine is the most commonly used manual therapy intervention by manual therapists. It is not known whether we can accurately assess and treat directional limitations in the thoracic spine to improve neck pain.
One way is to assess where the limitation is and treat it. Another method is to distract the joint. We want to know if matching the limitation to the manipulation method will give patients with neck pain better results.
The patient lays on their back. The therapist places a hand on the inferior vertebrae of the motion segment. The patient relaxes and the therapist pushes in an anterior to posterior direction either moving the vertebrae into flexion or entension.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15221
- Chatham University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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) history of whiplash within 6 weeks, cervical stenosis, CNS involvement, signs consistent with nerve root compression, previous surgery, pending legal action
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Matched Group
Receives thoracic spine manipulation in the direction of motion limitation.
|
a manual technique applied to the mid back to promote motion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neck Disability Index
Time Frame: 2 weeks
|
Objective, valid, reliable measure of function in patients with neck pain.
Completed as a survey.
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neck Pain
Time Frame: 2 weeks
|
Selection of 0 to 10 level of pain.
|
2 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Steve A Karas, DSc, PT, Chatham University
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
- Karasmatched
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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