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The Effect of Directional Specific Thoracic Spine Mobilization on Cervical Spine Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
thoracic spine manipulation
Sponsored by
Chatham University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Chatham University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Matched Group

Arm Description

Receives thoracic spine manipulation in the direction of motion limitation.

Outcomes

Primary Outcome Measures

Neck Disability Index
Objective, valid, reliable measure of function in patients with neck pain. Completed as a survey.

Secondary Outcome Measures

Neck Pain
Selection of 0 to 10 level of pain.

Full Information

First Posted
August 2, 2013
Last Updated
July 27, 2015
Sponsor
Chatham University
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1. Study Identification

Unique Protocol Identification Number
NCT01917071
Brief Title
The Effect of Directional Specific Thoracic Spine Mobilization on Cervical Spine Pain
Official Title
The Effect of Directional Specific Thoracic Spine Mobilization on Cervial Spine Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chatham University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

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
Matched Group
Arm Type
Experimental
Arm Description
Receives thoracic spine manipulation in the direction of motion limitation.
Intervention Type
Other
Intervention Name(s)
thoracic spine manipulation
Intervention Description
a manual technique applied to the mid back to promote motion
Primary Outcome Measure Information:
Title
Neck Disability Index
Description
Objective, valid, reliable measure of function in patients with neck pain. Completed as a survey.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Neck Pain
Description
Selection of 0 to 10 level of pain.
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) history of whiplash within 6 weeks, cervical stenosis, CNS involvement, signs consistent with nerve root compression, previous surgery, pending legal action
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve A Karas, DSc, PT
Organizational Affiliation
Chatham University
Official's Role
Study Director
Facility Information:
Facility Name
Chatham University
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15221
Country
United States

12. IPD Sharing Statement

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The Effect of Directional Specific Thoracic Spine Mobilization on Cervical Spine Pain

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