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

July 27, 2015 updated by: Steve Karas, Chatham University

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

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15221
        • Chatham University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Steve A Karas, DSc, PT, Chatham University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

August 2, 2013

First Submitted That Met QC Criteria

August 5, 2013

First Posted (Estimate)

August 6, 2013

Study Record Updates

Last Update Posted (Estimate)

July 28, 2015

Last Update Submitted That Met QC Criteria

July 27, 2015

Last Verified

August 1, 2013

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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